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Last update 13 Sep 2025

Infliximab

Last update 13 Sep 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Avakine, CenTNF, Infliximab (Genetical Recombination)

+ [8]

Target

TNF-α

Action

inhibitors

Mechanism

TNF-α inhibitors(Tumor necrosis factor α inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesCardiovascular Diseases+ [7]

Active Indication

Mucocutaneous Lymph Node SyndromeBehcet's uveitisErythrodermic psoriasis+ [17]

Inactive Indication

Axial SpondyloarthritisBerylliosisCachexia+ [19]

Originator Organization

Janssen Global Services LLC

Active Organization

Janssen Biotech, Inc.Janssen Biologics BV

Mitsubishi Tanabe Pharma Corp.

+ [2]

Inactive Organization

Merck Sharp & Dohme Corp.

Xian-Janssen Pharmaceutical Ltd.Schering-Plough Corp.

+ [2]

License Organization

Diversigen, Inc.

Janssen Pharmaceuticals, Inc.

Nichi-Iko Pharmaceutical Co., Ltd.

+ [4]

Drug Highest PhaseApproved

First Approval Date

United States (24 Aug 1998),

Crohn Disease

RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan)

Structure/Sequence

Sequence Code 69035L

Source: *****

Sequence Code 69038H

Source: *****

485

Clinical Trials associated with Infliximab

NCT07120152

/ Not yet recruitingNot ApplicableIIT

A Pharmacokinetic-pharmacodynamic Modeling and Simulation Study of Subcutaneous Infliximab in Patients With Inflammatory Bowel Disease

A subcutaneous formulation of infliximab CT-P13 (Remsima, Celltrion) has been approved for clinical use in inflammatory bowel disease (IBD) and rheumatoid arthritis (RA) after demonstration of pharmacokinetic (PK) non-inferiority compared to intravenous CT-P13. The added value of the subcutaneous formulation of CT-P13 has been recognized by IBD physician expert, patients and nurses. However, further investigation is needed to select the right patients and timing for switching to the new subcutaneous formulation. Before investing resources into the design and execution of a prospective clinical trial to address these remaining clinical questions and concerns, an in silica simulation study using a population pharmacokinetic-pharmacodynamic (popPK-PD) model of CT-P13 would be highly informative. While popPK models of subcutaneous infliximab CT-P13 have been developed for both IBD and RA, a popPK-PD model is still awaited. The development of a popPK-PD model would allow us to bridge infliximab exposure and response, and address clinically relevant questions by focussing on therapeutic outcomes.

Start Date01 Sep 2025

Sponsor / Collaborator

Samsung Medical Center

[+3]

NCT07138898

/ Not yet recruitingPhase 2IIT

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

The purpose of this study is to assess the incidence of rheumatologic flares, changes in pain scores (VAS), changes in functional outcomes (PROMIS), wound complications, surgical site infections, and return trips to the operating room for rheumatology patients following shoulder replacements, comparing those who stop their immunosuppressants preoperatively for the same amount of time as suggested in the literature for hip and knee arthroplasty versus those who hold the medications for a shorter period of time preoperatively.

Start Date01 Sep 2025

Sponsor / Collaborator

NYU Langone Health

NCT07149441

/ Active, not recruitingNot ApplicableIIT

Efficacy and Mechanism of Fecal Microbiota Transplantation in the Treatment of Inflammatory Bowel Disease: an Open-label Randomized Controlled Study

This study enrolled 94 patients with UC or CD. Two groups received either 8-week intestinal bacterial transplant capsule therapy or biological therapy, respectively. The control group received biological therapy alone, while the experimental group received biological therapy combined with FMT. Both groups were followed up for 52 weeks after discharge. The efficacy of FMT capsule therapy on the subjects' UC or CD symptom-related scores and its effect on remodeling the intestinal flora were observed, and its safety was verified.

Start Date01 Aug 2025

Sponsor / Collaborator

Shanghai No. 10 People's Hospital

100 Clinical Results associated with Infliximab

100 Translational Medicine associated with Infliximab

100 Patents (Medical) associated with Infliximab

15,858

Literatures (Medical) associated with Infliximab

01 Jan 2026·TALANTA

Biosimilarity and advanced structural characterization of monoclonal antibodies charge variants using capillary zone electrophoresis and mass spectrometry

Article

Author: Joomun, Rania ; Gahoual, Rabah ; Alez-Martin, Lola ; François, Yannis-Nicolas ; Mignet, Nathalie ; Houzé, Pascal

Monoclonal antibodies (mAbs) structural complexity arises from their macromolecular nature and their propensity to undergo post-translational modifications (PTM), potentially leading to the formation of charge variants. Capillary zone electrophoresis (CZE) showed to be particularly relevant for their analysis, however the selectivity provided by CZE separation is not completely elucidated. In this work, CZE-UV analysis was used to characterize charge variants for biosimilars products corresponding to infliximab. Results demonstrated the possibility to identify faint variations between the different products showing its applicability to contribute to mAbs biosimilarity assessment. Enzymatic treatment allowed to attribute the origin of infliximab charge variants. CZE-UV analysis of pembrolizumab showed that none of the five charge variants separated were originating from C-terminal lysine residues and/or N-glycans. To enable further identification, an analytical strategy was developed to achieve CZE-UV fraction collection and enrichment of mAb charge variants followed by systematic offline characterization in CE coupled to tandem mass spectrometry (MS/MS). CE-MS/MS experiments allowed the identification of different types of PTMs such as N-terminal pyroglutamic acid formation and asparagine deamidation for charge variant fractions correlated with decreased mobility. In addition, for the first time succinimide intermediate formation could be successfully characterized using CE-MS/MS data, which could be correlated to increased mobility. Thus, the CZE-UV separation resulted from the synergistic effect of several simultaneous PTMs affecting the apparent mobilities of the charge variants. As a consequence, experiments illustrated the relevance and potential of intact mAbs analysis using CZE-UV to provide an overview of the structural diversity of therapeutic mAbs.

31 Dec 2025·ANNALS OF MEDICINE

Psoas muscle CT radiomics-based machine learning models to predict response to infliximab in patients with Crohn’s disease

Article

Author: Li, Shiyu ; Ying, Huiya ; Chen, Yuhao ; Yu, Fujun ; Chen, Zhuoyan ; Mei, Tianhao ; Hong, Yiwen ; Cai, Weimin ; Zeng, Yuan ; He, Yuanhang ; Zhang, Yuxuan

BACKGROUND:

Crohn's disease (CD) is a chronic inflammatory bowel disease, with infliximab (IFX) commonly used for treatment. However, no clinically applicable model currently exists to predict the response of patients with CD to IFX therapy. Given the strong association between sarcopenia and IFX treatment outcomes, this study developed computerized tomography radiomics-based machine learning (ML) models, utilizing psoas muscle volume as a proxy for skeletal muscle mass, to predict the response of patients with CD to IFX therapy.

METHODS:

In this retrospective study, patients with CD from two institutions were recruited between January 2010 and January 2023, following stringent inclusion and exclusion criteria. Regions of interest were delineated using 3D Slicer software, and radiomics features were extracted with the Pyradiomics package in Python. Z score standardization and independent sample t test were applied to identify optimal predictive features, which were then utilized in seven ML algorithms for training and validation. Model performance was assessed through receiver-operating characteristic curves, precision-recall curves, and calibration curve analyses, evaluating accuracy and clinical applicability. Binary logistic regression was employed to identify predictors of IFX treatment response.

RESULTS:

A total of 134 patients were included, divided into a training cohort (n = 84) and a validation cohort (n = 50). Twenty differential radiomics features were selected for integration into the ML models. All models demonstrated strong predictive performance in the validation cohort, with a mean area under the curve of 0.849. The eXtreme Gradient Boosting algorithm outperformed others, achieving an area under the curve of 0.910.

CONCLUSION:

Psoas computerized tomography radiomics-based ML models effectively predict the response of patients with CD to IFX therapy, with the eXtreme Gradient Boosting model exhibiting superior performance.

31 Dec 2025·ANNALS OF MEDICINE

Tumour necrosis factor inhibitors in Ulcerative colitis: real-world data on Therapeutic drug monitoring and evaluation of current treatment targets (STRIDE II)

Article

Author: Lundekvam, Jonas Andre ; Småstuen, Milada Cvancarova ; Medhus, Asle Wilhelm ; Warren, David J. ; Høivik, Marte Lie ; Bolstad, Nils ; Anisdahl, Karoline

BACKGROUND:

The benefit of therapeutic drug monitoring (TDM) and implementation of recommendations from the Selection of Therapeutic Targets in Inflammatory Bowel Disease (IBD, STRIDE) are discussed in the IBD community. We report real-world data in ulcerative colitis patients receiving first-line tumour necrosis factor inhibitor (TNFi) treatment followed by TDM, and assess how implementation of the STRIDE II recommendations might affect clinical practice.

METHODS:

Adult, biologically naïve UC patients starting TNFi between 2014 and 2021 at Oslo University Hospital were included in a medical chart review study, and data were collected at three and twelve months after the start of treatment. Target serum drug levels were defined as ≥7.5 mg/L for adalimumab and ≥5 mg/L for infliximab.

RESULTS:

Of 141 included patients, 36% were in clinical and biochemical (combined) remission after twelve months. Among 102 treatment persistent patients, 54% were in combined remission after twelve months. Target drug level at three months was associated with clinical remission at twelve months (OR = 2.97, 95% CI [1.24-7.12]) and biochemical remission at twelve months (OR = 2.64, 95% CI [1.03-6.77]). In total, 56% of recorded dosage adjustments were related only to serum drug levels.

CONCLUSIONS:

Combined remission rates at twelve months for treatment persistent patients suggest that 46% should have been considered for a change of treatment according to the STRIDE II recommendations. A majority of dosage adjustments were made proactively. Target drug level at three months was associated with remission at twelve months and supports the use of proactive TDM.

175

News (Medical) associated with Infliximab

25 Aug 2025

·www.prnewswire.com

Crohn's Disease Market Projected to Grow at 4.3% CAGR (2020-2034), Driven by Improved Diagnosis, Pediatric Label Expansion, and New Second-line Therapies | DelveInsight

The Crohn's disease pipeline includes several drugs in mid- and late-stage development, poised for approval in the near future in both adults and pediatrics. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including RHB-104, Tulisokibart, LITFULO (ritlecitinib), AGMB-129, Duvakitug, and others. The expected launch of these therapies shall further create a positive impact on the Crohn's disease market. LAS VEGAS, Aug. 25, 2025 /PRNewswire/ -- DelveInsight's Crohn's Disease Market Insights report includes a comprehensive understanding of current treatment practices, Crohn's disease emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Crohn's Disease Market Report According to DelveInsight's analysis, the market size for Crohn's disease was found to be USD 10.8 billion in the 7MM, with roughly 8-10% of it being the pediatric market in 2024. The United States accounted for the highest market size of Crohn's disease, approximately 78% of the total market size in 7MM in 2024, in comparison to the other major markets, i.e., EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Adalimumab (HUMIRA and its generics) accounted for the highest market share of ~ USD 4 billion in 2024 for the treatment of Crohn's disease in the 7MM. Based on DelveInsight's assessment in 2024, the 7MM had 2.1 million diagnosed prevalent cases of Crohn's disease, out of which almost 200,000 cases are pediatric. In 2024, it was estimated that almost 60% of the cases were within the moderate-to-severe category as compared to mild severity in the US. Leading Crohn's disease companies developing emerging therapies, such as RedHill Biopharma, Merck, Teva Pharmaceutical, Pfizer, Agomab Therapeutics, Sanofi, Medibiofarma, Eli Lilly, NImmune, Avobis Bio, Abivax, Roche, Telavant, Mesoblast, Takeda, AstraZeneca, and others, are developing novel Crohn's disease drugs that can be available in the Crohn's disease market in the coming years. The promising Crohn's disease therapies in the pipeline include RHB-104, Tulisokibart (MK-7240, PRA023), Duvakitug (TEV-574), LITFULO (Ritlecitinib/PF-06651600), AGMB-129, Balinatunfib (SAR441566), MBF-118, MORF-057, Omilancor (BT-11), AVB-114, Obefazimod (ABX464), Afimkibart (RVT-3101 or RG6631), RYONCIL (Remestemcel-L), Zasocitinib (TAK-279), AZD7798, and others. Discover what is the best medicine for Crohn's disease @ Crohn's Disease Medication List Crohn's Disease Market Dynamics Crohn's disease can be managed through nutritional support, medication, and surgery in more severe cases. Treatment typically begins with glucocorticosteroids such as budesonide, although 5-Aminosalicylates (5-ASA) are considered when steroids are not suitable. For moderate disease, immunomodulators like azathioprine, methotrexate, and 6-mercaptopurine are commonly used. However, long-term steroid use is generally avoided due to potential side effects. Over time, biologic and small-molecule therapies for Crohn's disease have seen considerable advancements, varying in approval timelines, mechanisms of action, dosing schedules, and clinical effectiveness. REMICADE, the first TNF inhibitor approved in 1998, later gained approval for pediatric use in 2006. HUMIRA, introduced in 2007, provided an alternative for patients not responding to traditional treatments or REMICADE. In 2008, CIMZIA became the first PEGylated TNF inhibitor, offering extended half-life and reduced immune response. These therapies differ in administration routes; REMICADE is given via IV infusion every eight weeks, whereas HUMIRA and CIMZIA are administered subcutaneously, allowing for at-home treatment. In addition to TNF inhibitors, newer biologics and small molecules have broadened therapeutic options with unique mechanisms. ENTYVIO, approved in 2014, is a gut-specific α4β7 integrin blocker, initially given intravenously with maintenance every eight weeks; a subcutaneous version was introduced in 2024. STELARA, launched in 2016, targets IL-12 and IL-23 by blocking the p40 subunit, with an IV induction followed by SC dosing every eight weeks. SKYRIZI, approved in 2022, inhibits IL-23 and follows an IV induction schedule at Weeks 0, 4, and 8, then shifts to subcutaneous maintenance. It demonstrated 61% clinical remission at Week 52 in trials. RINVOQ, a JAK1 inhibitor approved in 2023, represents a small-molecule alternative targeting the JAK/STAT pathway and is taken orally, 45 mg daily for induction, followed by 15 mg or 30 mg maintenance. OMVOH, a selective IL-23 p19 subunit blocker, received approval in 2025, with IV induction and subcutaneous maintenance every four weeks. While currently small molecules and biologics are ruling the Crohn's disease treatment space, in 2018, a cell therapy was also introduced in the market. ALOFISEL (darvadstrocel), an allogeneic stem cell therapy, was approved in the EU (2018) and Japan (2021) for complex perianal fistulas in Crohn's disease patients. However, despite initial promise, Takeda discontinued its marketing authorization in the EU (December 2024), withdrawing the product as the clinical benefit of ALOFISEL was no longer sufficient to justify its continued use in the EU. Additionally, the company has removed the planned pediatric trial for refractory complex perianal fistulas from its pipeline, limiting future expansion into younger patient populations. The discontinuation of ALOFISEL highlights the ongoing challenges in developing and commercializing advanced regenerative therapies for Crohn's disease, particularly in niche indications. Regarding the challenges for biologics, the rise of biosimilars has lowered treatment costs and increased accessibility to biologic therapies. The first REMICADE biosimilar was introduced in 2016; as of now several biosimilars of REMICADE are approved, including INFLECTRA, RENFLEXIS, AVSOLA, and others. In 2023, biosimilars for HUMIRA, including AMJEVITA and CYLTEZO, entered the market, further enhancing affordability. TYRUKO, the first biosimilar for TYSABRI, was approved in Germany in 2024, indicating continued growth in the biosimilars landscape. With STELARA experiencing a 4% sales decline, now amplified by the entry of biosimilars in the US, Johnson & Johnson has now TREMFYA. TREMFYA's FDA approval in March 2025—offering both IV and SC induction and a dual-acting mechanism is expected to solidify Johnson & Johnson's IBD leadership. Despite these advances, challenges such as physician resistance, patient hesitation, and payer-related issues persist. In the pediatric segment, treatment-related challenges are even more pronounced due to limited approved options. HUMIRA and REMICADE remain the primary TNF inhibitors, but early disease onset, aggressive progression, and long-term immunosuppression risks create significant unmet needs. Recently, in April 2025, the European Commission approved STELARA for the treatment of moderately to severely active Crohn's disease in paediatric patients. While biologics have improved management, immunogenicity and secondary loss of response remain key concerns. To address these gaps, pharmaceutical companies are advancing novel mechanisms of action, including integrin blockers, IL-12/IL-23 inhibitors, and JAK inhibitors, aiming for improved efficacy, safety, and durability in pediatric patients. The anticipated approvals of ENTYVIO in the near future, followed by RINVOQ and OMVOH for pediatric Crohn's disease patients, will diversify the therapeutic landscape, offering more personalized treatment options based on disease severity and individual patient response. The Crohn's disease market dynamics are expected to change in the coming years. Biologics continue to dominate Crohn's disease treatment, with TNF inhibitors (HUMIRA, REMICADE), IL-12/23 inhibitors (STELARA), and IL-23 inhibitors (SKYRIZI) offering strong efficacy and long-term disease control. In contrast, the development of new treatments such as JAK inhibitors, immunomodulators, and first-in-class therapies like Tulisokibart (TL1A inhibitor) and AGMB-129 (ALK5/TGFβR1 inhibitor) reflects a promising shift toward more targeted options with improved clinical profiles, subcutaneous formulations, and greater convenience, driving higher penetration in the moderate-to-severe patient population and paving the way for Crohn's disease market innovation. Overall, the Crohn's disease market is undergoing a transformative shift. With continued investment in next-generation biologics, oral small molecules, and novel combinations, the Crohn's disease treatment landscape is set to evolve significantly, reshaping the standard of care for both adult and pediatric patients. To know more about FDA-approved drugs for Crohn's disease, visit @ Crohn's Disease Treatment Crohn's Disease Pipeline Therapies and Key Companies The promising late- and mid-stage emerging pipeline assets for Crohn's disease include RHB-104 (RedHill Biopharma), Tulisokibart (Merck), LITFULO (Pfizer), AGMB-129 (Agomab Therapeutics), Duvakitug (Teva Pharmaceuticals and Sanofi), and others. RHB-104, developed by RedHill Biopharma, is an investigational oral capsule with strong intracellular, antimycobacterial, and anti-inflammatory properties. It has the potential to be a groundbreaking therapy. RedHill has completed two Phase III clinical trials (NCT03009396 and NCT01951326). The MAP US study, a randomized, double-blind, placebo-controlled Phase III trial in Crohn's disease, achieved both its primary and key secondary endpoints. Further clinical trials are needed to support a New Drug Application (NDA), with a new study expected to launch in mid-2025. No recent updates are available, and the drug is not visible in the company's pipeline. RedHill Biopharma is also developing RHB-204, a next-generation formulation of RHB-104 with an optimized formulation for the treatment of Crohn's disease. RHB-204 is patent-protected until at least 2041, and has an expected pediatric orphan designation (subject to FDA approval to transfer from RHB-104). Tulisokibart is a humanized monoclonal antibody targeting the novel protein TL1A, which is linked to intestinal inflammation and fibrosis. The antibody is believed to bind both soluble and membrane-bound forms of TL1A, potentially blocking inflammatory pathways and reducing fibrosis in inflammatory bowel disease (IBD). This could be significant in modifying disease progression. Following Merck's acquisition of Prometheus Biosciences in June 2023, Tulisokibart is now part of Merck's portfolio. The drug is protected by US patents extending into the 2040s and is currently in two Phase III trials for Crohn's disease. AGMB-129 is an orally administered, gastrointestinal-restricted small molecule that inhibits ALK5 (TGFβR1), a key mediator in fibrotic processes. It is specifically developed for treating Fibrostenosing Crohn's Disease (FSCD). TGFβ is a central regulator of fibrosis, and early clinical data support its potential as a therapeutic target. In October 2024, the company raised USD 89 million in a Series D round, with participation from new investors including Sanofi and Invus, along with support from existing backers. In May 2025, Agomab Therapeutics presented interim data from the Phase IIa STENOVA trial at Digestive Disease Week 2025. The primary endpoint of favorable safety and tolerability of AGMB-129 was met at both doses. The study also met its two predefined secondary endpoints of pharmacokinetics (PK) and target engagement in the first 44 patients. The other therapies in the pipeline for Crohn's disease treatment include Omilancor (BT-11): NImmune AVB-114: Avobis Bio/Alimentiv Obefazimod (ABX464): Abivax RVT-3101 (RG6631): Roche RYONCIL (Remestemcel-L): Mesoblast Zasocitinib (TAK-279): Takeda AZD7798: AstraZeneca Balinatunfib (SAR441566): Sanofi MBF-118: Medibiofarma MORF-057: Eli Lilly/Morphic Therapeutic And others As potential therapies are being investigated for the treatment of Crohn's disease, it is safe to predict that the treatment space will significantly impact the Crohn's disease market during the forecast period. Moreover, the anticipated launch of emerging therapies are poised to transform the Crohn's disease market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the Crohn's disease market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. However, several factors may impede the growth of the Crohn's disease market. Despite the emergence of novel treatments, a significant portion of Crohn's disease patients remains refractory to multiple therapies, underscoring the need for breakthrough innovations beyond current biologic and small-molecule options; however, biological therapies remain expensive and face accessibility challenges, JAK inhibitors like RINVOQ are limited by serious safety concerns, and brand erosion following the patent expiry of market leaders such as REMICADE, HUMIRA, ENTYVIO, and STELARA is expected to lead to sales decline. Moreover, Crohn's disease treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the Crohn's disease market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the Crohn's disease market growth. Discover more about Crohn's disease drugs in development @ Crohn's Disease Clinical Trials Recent Developments in the Crohn's Disease Market In July 2025, the Phase III trial evaluating VELSIPITY (Etrasimod) a product of Arena (a wholly owned subsidiary of Pfizer), for the treatment of adult participants with moderately to severely active Crohn's disease, was terminated due to lack of efficacy in sub-study 1. In June 2025, Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) seeking to expand approval of STELARA for the treatment of children two years and older with moderately to severely active Crohn's disease. In March 2025, the FDA approved TREMFYA (guselkumab), the first and only IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, for the treatment of adults with moderately to severely active Crohn's disease. In March 2025, Celltrion announced the U.S. launch of STEQEYMA (ustekinumab-stba), a biosimilar to STELARA (ustekinumab), following FDA approval in December 2024. STEQEYMA is approved for the same indications as STELARA, offering consistent treatment for patients and healthcare providers. In February 2025, Eli Lilly and Company announced the results from the VIVID-2 open-label extension study, which showed the majority of patients with moderate-to-severely active Crohn's disease receiving 2 years of continuous treatment with OMVOH achieved long-term clinical and endoscopic outcomes, including those (43.8%) with previous biologic failure at the Crohn's and Colitis Congress (CCC). In January 2025, the FDA approved OMVOH (mirikizumab) for Crohn's disease, further solidifying the IL-23 inhibitor class. With strong long-term efficacy, OMVOH is also being investigated for pediatric patients, potentially addressing a significant unmet need in this population. Crohn's Disease Overview Crohn's disease is a long-term inflammatory disorder of the gastrointestinal (GI) tract and is classified under inflammatory bowel disease (IBD). Although it can impact any part of the digestive tract, from the mouth to the anus, it most frequently affects the small intestine and colon. Its exact cause is still unknown, but it's thought to arise from a mix of genetic predisposition, environmental triggers, and immune system irregularities. Crohn's disease symptoms can differ in intensity and may include abdominal discomfort, persistent diarrhea, weight loss, fatigue, and nutrient deficiencies. While a cure has yet to be found, treatment aims to control inflammation, relieve symptoms, and prevent complications through the use of medications, biologic therapies, lifestyle adjustments, and sometimes surgical intervention. Continuous research and innovation in targeted treatments are expanding the options available, offering renewed hope for better management and improved quality of life for those affected. Diagnosing Crohn's disease can be complex due to symptom overlap with other GI disorders, such as ulcerative colitis and irritable bowel syndrome (IBS). Physicians use a comprehensive diagnostic approach that includes a clinical assessment, lab work, imaging, and endoscopic evaluations. Blood tests can reveal signs of inflammation, anemia, or nutritional imbalances, while stool tests help exclude infections. Imaging methods like CT scans, MRIs, and intestinal ultrasounds provide detailed insights into areas of inflammation, narrowing, or abnormal connections. Endoscopic procedures, such as colonoscopy and upper endoscopy, offer a direct look at the intestinal lining and allow for tissue biopsies to confirm the diagnosis. Because no single test can definitively confirm Crohn's, a combination of diagnostic tools is used to establish an accurate diagnosis and guide effective treatment planning. Crohn's Disease Epidemiology Segmentation The Crohn's disease epidemiology section provides insights into the historical and current Crohn's disease patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The Crohn's disease market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Diagnosed Crohn's Disease Prevalence Age-specific Diagnosed Crohn's Disease Prevalence Severity-specific Diagnosed Crohn's Disease Prevalence Scope of the Crohn's Disease Market Report Therapeutic Assessment: Crohn's Disease current marketed and emerging therapies Crohn's Disease Market Dynamics: Key Market Forecast Assumptions of Emerging Crohn's Disease Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Crohn's Disease Market Access and Reimbursement Download the report to understand which factors are driving Crohn's disease market trends @ Crohn's Disease Market Forecast Table of Contents Related Reports Inflammatory Bowel Disease Market Inflammatory Bowel Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key IBD companies including Takeda Pharmaceutical, Janssen Pharmaceuticals, Hoffmann-La Roche, Genentech, AbbVie, Boehringer Ingelheim, Gilead Sciences, Arena Pharmaceuticals, Eli Lilly, AstraZeneca, among others. Ulcerative Colitis Market Ulcerative Colitis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ulcerative colitis companies including Arena Pharmaceuticals, Pfizer, Abivax, Reistone Biopharma, InDex Pharmaceuticals, AbbVie, Boehringer Ingelheim, Janssen Pharmaceuticals, Landos Biopharma, NImmune, Merck, Mesoblast, among others. Crohn's Disease Pipeline Crohn's Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Crohn's disease companies, including TiumBio Co., Jiangsu Gensciences Inc., Pfizer, Novo Nordisk, Genzyme, AbbVie, Bayer, Spark Therapeutics, G & P Bioscience, Gritgen Therapeutics, Biocad, Belief Biomed, Chugai Pharmaceutical, Staidson Beijing BioPharmaceuticals, Jiangsu Gensciences, Poseida Therapeutics, Chia Tai Tianqing Pharmaceutical Group, Takeda, among others. Ulcerative Colitis Pipeline Ulcerative Colitis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key ulcerative colitis companies, including Oppilan Pharma, Genentech, Teva Branded Pharmaceutical, Boehringer Ingelheim, Sorriso Pharmaceuticals, Reistone Biopharma, Celgene, AnaptysBio, Rise Therapeutics, Merck, AltruBio, AbbVie, Immunic AG, Kissei Pharmaceutical Co, Lmito Therapeutics, Morphic Therapeutic, Oncostellae, Palatin Technologies, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultDrug ApprovalPhase 2Orphan Drug

29 Jul 2025

·investors.kiniksa.com

Kiniksa Pharmaceuticals Reports Second Quarter 2025 Financial Results and Recent Portfolio Execution

– ARCALYST® (rilonacept) Q2 2025 net product revenue of $156.8 million, representing 52% year-over-year growth –– ARCALYST 2025 expected net product revenue increased to $625 - $640 million –– KPL-387 Phase 2/3 clinical trial in recurrent pericarditis initiated; Phase 2 data expected in 2H 2026 –– Cash balance increased by $39.4 million in Q2 2025 to $307.8 million –– Conference call and webcast scheduled for 8:30 am ET today – LONDON, July 29, 2025 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications, today reported second quarter 2025 financial results and recent portfolio execution. “Our robust commercial performance in the second quarter was driven by expanding ARCALYST penetration across the recurrent pericarditis population, supported by growth among both new and repeat prescribers. For 2025, we’ve raised our ARCALYST net sales guidance to between $625 and $640 million from between $590 and $605 million. This represents 52% year-over-year growth at the midpoint, highlighting the ongoing strength of the ARCALYST commercialization more than four years after launch,” said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. “In addition, we are excited that the Phase 2 dose-focusing portion of the pivotal Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis is now recruiting. We expect data from this part of the study in the second half of 2026 and potential market entry in the 2028/2029 timeframe.” Portfolio ExecutionARCALYST (IL-1α and IL-1β cytokine trap) ARCALYST net product revenue was $156.8 million for the second quarter of 2025. Since launch, more than 3,475 prescribers have written ARCALYST prescriptions for recurrent pericarditis. As of the end of the second quarter of 2025, average total duration of ARCALYST therapy in recurrent pericarditis was approximately 30 months. As of the end of the second quarter of 2025, approximately 15% of the target 14,000 multiple-recurrence patients were actively on ARCALYST treatment. KPL-387 (monoclonal antibody IL-1 receptor antagonist) Kiniksa is recruiting patients in the dose-focusing portion of the Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis. The company expects data from this portion of the trial in the second half of 2026. Subsequently, Kiniksa plans to initiate the pivotal portion of the trial. KPL-1161 (Fc-modified monoclonal antibody IL-1 receptor antagonist) Kiniksa is conducting Investigational New Drug (IND)-enabling development activities with a target profile of quarterly subcutaneous (SC) dosing. Financial Results Total revenue for the second quarter of 2025 was $156.8 million, compared to $108.6 million for the second quarter of 2024. Kiniksa did not record any license and collaboration revenue for the second quarter of 2025, compared to $5.2 million for the second quarter of 2024. Total operating expenses for the second quarter of 2025 were $136.6 million, compared to $108.7 million for the second quarter of 2024. Total operating expenses for the second quarter of 2025 included $52.4 million in collaboration expenses, which were driven by ARCALYST collaboration profitability, compared to $30.0 million for the second quarter of 2024. Total operating expenses for the second quarter of 2025 included $8.9 million in non-cash, share-based compensation expense, compared to $7.4 million for the second quarter of 2024. Net income for the second quarter of 2025 was $17.8 million, compared to a net loss of $3.9 million for the second quarter of 2024. As of June 30, 2025, Kiniksa had $307.8 million of cash, cash equivalents, and short-term investments and no debt. Kiniksa did not record any license and collaboration revenue for the second quarter of 2025, compared to $5.2 million for the second quarter of 2024. Total operating expenses for the second quarter of 2025 included $52.4 million in collaboration expenses, which were driven by ARCALYST collaboration profitability, compared to $30.0 million for the second quarter of 2024. Total operating expenses for the second quarter of 2025 included $8.9 million in non-cash, share-based compensation expense, compared to $7.4 million for the second quarter of 2024. Financial Guidance Kiniksa expects 2025 ARCALYST net product revenue of between $625 million and $640 million, compared to prior guidance of between $590 million and $605 million. Kiniksa expects its current operating plan to remain cash flow positive on an annual basis. Conference Call Information Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, July 29, 2025, to discuss second quarter 2025 financial results and recent portfolio execution. Individuals interested in participating in the call via telephone may register here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. To access the webcast, please visit the Investors and Media section of Kiniksa’s website. A replay of the event will also be available on Kiniksa’s website within approximately 48 hours after the event. About KiniksaKiniksa is a biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating diseases by discovering, acquiring, developing, and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. Kiniksa’s portfolio of assets is based on strong biologic rationale or validated mechanisms and offers the potential for differentiation. For more information, please visit www.kiniksa.com. About ARCALYSTARCALYST is a weekly, subcutaneously injected recombinant dimeric fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling. ARCALYST was discovered by Regeneron Pharmaceuticals, Inc. (Regeneron) and is approved by the U.S. Food and Drug Administration (FDA) for recurrent pericarditis, cryopyrin-associated periodic syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome, and deficiency of IL-1 receptor antagonist (DIRA). The FDA granted Breakthrough Therapy designation to ARCALYST for the treatment of recurrent pericarditis in 2019 and Orphan Drug exclusivity to ARCALYST in 2021 for the treatment of recurrent pericarditis and reduction in risk of recurrence in adults and pediatric patients 12 years and older. The European Commission granted Orphan Drug Designation to ARCALYST for the treatment of idiopathic pericarditis in 2021. IMPORTANT SAFETY INFORMATION ABOUT ARCALYST ARCALYST may affect your immune system and can lower the ability of your immune system to fight infections. Serious infections, including life-threatening infections and death, have happened in patients taking ARCALYST. If you have any signs of an infection, call your doctor right away. Treatment with ARCALYST should be stopped if you get a serious infection. You should not begin treatment with ARCALYST if you have an infection or have infections that keep coming back (chronic infection). While taking ARCALYST, do not take other medicines that block interleukin-1, such as Kineret® (anakinra), or medicines that block tumor necrosis factor, such as Enbrel® (etanercept), Humira® (adalimumab), or Remicade® (infliximab), as this may increase your risk of getting a serious infection. Talk with your doctor about your vaccine history. Ask your doctor whether you should receive any vaccines before you begin treatment with ARCALYST. Medicines that affect the immune system may increase the risk of getting cancer. Stop taking ARCALYST and call your doctor or get emergency care right away if you have any symptoms of an allergic reaction. Your doctor will do blood tests to check for changes in your blood cholesterol and triglycerides. Common side effects include injection-site reactions (which may include pain, redness, swelling, itching, bruising, lumps, inflammation, skin rash, blisters, warmth, and bleeding at the injection site), upper respiratory tract infections, joint and muscle aches, rash, ear infection, sore throat, and runny nose. For more information about ARCALYST, talk to your doctor and see the Product Information. About KPL-387KPL-387 is an independently developed, investigational, fully human immunoglobulin G2 (IgG2) monoclonal antibody that binds human interleukin-1 receptor 1 (IL-1R1), inhibiting the signaling of the cytokines IL-1α and IL-1β. Kiniksa believes KPL-387 could expand the treatment options for recurrent pericarditis patients by enabling dosing with a single monthly SC injection in a liquid formulation. About KPL-1161KPL-1161 is an independently developed, investigational, Fc-modified IgG2 monoclonal antibody that binds IL-1R1, inhibiting the signaling of the cytokines IL-1α and IL-1β, with a target profile of quarterly SC dosing. Kiniksa is currently engaging in IND-enabling development activities for KPL-1161. Forward-Looking StatementsThis press release contains forward-looking statements. In some cases, you can identify forward looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding: our expectation that ARCALYST 2025 net product revenue will increase to between $625 million and $640 million; our expectation to have data from the Phase 2 dose-focusing portion of our clinical trial of KPL-387 in recurrent pericarditis in the second half of 2026, and our plan to initiate the pivotal portion of the trial thereafter; our expectation to have potential market entry of KPL-387 in 2028 or 2029; our expectation that our current operating plan will remain cash flow positive on an annual basis; our target profile of monthly dosing via a single subcutaneous injection in a liquid formulation for KPL-387; our target profile of quarterly dosing for KPL-1161; our beliefs about the mechanisms of our assets and potential impact of their approach; and our belief that our portfolio of assets offers the potential for differentiation. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including without limitation, the following: delays or difficulty in enrollment of patients in, and activation or continuation of sites for, our clinical trials; delays or difficulty in completing our clinical trials as originally designed; potential for changes between final data and any preliminary, interim, top-line or other data from clinical trials; our inability to replicate results from our earlier clinical trials or studies; impact of additional data from us or other companies, including the potential for our data to produce negative, inconclusive or commercially uncompetitive results; potential undesirable side effects caused by our products and product candidates; our inability to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities; potential for applicable regulatory authorities to not accept our filings, delay or deny approval of any of our product candidates or require additional data or trials to support approval; our reliance on third parties as the sole source of supply of the drug substance and drug product used in our products and product candidates; raw material, important ancillary product and drug substance and/or drug product shortages; our reliance on third parties to conduct research, clinical trials, and/or certain regulatory activities for our product candidates; complications in coordinating requirements, regulations and guidelines of regulatory authorities across jurisdictions for our clinical trials; business development activities and their impact on our financial performance and strategy; changes in our operating plan, business development strategy or funding requirements; existing or new competition; current and future healthcare reforms, including those affecting the delivery of or payment for healthcare products and services; and the impact of global economic policy, including any uncertainty in national and international markets. These and other important factors discussed in our filings with the U.S. Securities and Exchange Commission, including under the caption “Risk Factors” contained therein, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we disclaim any intention or obligation to update or revise any forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. ARCALYST® is a registered trademark of Regeneron Pharmaceuticals, Inc. Every Second Counts! ® Kiniksa Investor & Media ContactJonathan Kirshenbaum(781) 829-3949jkirshenbaum@kiniksa.com

Orphan DrugBreakthrough TherapyFinancial StatementPhase 2

21 Jul 2025

·www.prnewswire.com

RedHill Receives Positive FDA Feedback on Pathway to Approval of Groundbreaking RHB-204 for Crohn's Disease

The positive FDA feedback allows for: A novel Phase 2 RHB-204[1] study, planned to be the first ever clinical study in a specifically defined Mycobacterium avium subspecies paratuberculosis infected (MAP-positive) Crohn's disease (CD) patient population Groundbreaking approach testing MAP as a root cause of CD, supporting RHB-204 as a potential paradigm-shifting therapy treating both the suspected cause of Crohn's disease and its symptoms RedHill has initiated two new collaborations with leading academic centers utilizing cutting-edge rapid and accurate MAP detection diagnostics – the lack of which has previously been a major barrier to advancing the Company's novel anti-MAP Crohn's disease program Innovative design enables a smaller sample size allowing for lower study costs and faster time to completion Funding for this ground-breaking program expected to be non-dilutive; Grant application submitted and discussions ongoing for additional non-dilutive financing Patent protected through 2041, orally-administered RHB-204, a next-generation optimized formulation of RedHill's RHB-104 designed to further enhance tolerability, safety and patient adherence, is supported by positive RHB-104[2] Phase 3 safety and efficacy results, which delivered a statistically significant 64% improvement in efficacy[3] Expected transferal of pediatric orphan drug designation to RHB-204 as well as potential for breakthrough therapy designation, fast track designation, additional regulatory exclusivity and priority review voucher The multibillion-dollar Crohn's disease market is expected to expand significantly, with sales in the key markets growing from $13.6 billion in 2024 to over $19 billion in 2033[4], presenting significant commercial potential for new, paradigm changing, FDA-approved therapies RALEIGH, N.C. and TEL AVIV, Israel, July 21, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it received positive feedback from the U.S. Food and Drug Administration (FDA), following a scheduled Type C meeting, in which the FDA provided guidance on the pathway to approval for the Company's potentially groundbreaking RHB-204 Crohn's disease (CD) development program. The positive FDA feedback allows for the planned RHB-204 Phase 2 study to be the first ever clinical trial in Crohn's disease to test a specifically defined population of Mycobacterium avium subspecies paratuberculosis infected (MAP-positive) CD patients. Testing MAP as a root cause of Crohn's, this groundbreaking approach could potentially make RHB-204, if approved, a paradigm-shifting new therapy treating both the suspected cause of the disease and its symptoms. A major hurdle in previous clinical studies for new therapies directed at MAP has been the ability to rapidly and accurately detect MAP – one of the slowest growing bacteria on the planet. The Company is collaborating with two leading academic centers for the provision of cutting-edge MAP detection diagnostics, supporting the study's novel design and the potential future commercial application of RHB-204. The Phase 2 study is expected to have primary endpoints of mucosal remission (considered by FDA as a new gold standard in efficacy evaluation in Crohn's disease), correlated with MAP status and clinical remission, per FDA guidance. These endpoints are supported by the positive RHB-104 Phase 3 study safety and efficacy results. The endpoints and expected use of imaging and cutting-edge MAP detection methods to correlate mucosal healing with MAP infection eradication, enable a potentially smaller sample size allowing for substantially lower study costs and faster time to completion. Patent protected until 2041, RHB-204, is a novel next-generation optimized formulation of Phase 3-stage RHB-104, designed to support enhanced tolerability, safety and adherence, with a 40% pill burden reduction, and thus, potentially, better outcomes. The development of RHB-204 is supported by a strong foundation of clinical efficacy and safety data from the randomized, double-blind, placebo-controlled 331-patient Phase 3 study of RHB-104 in active CD, which successfully met its primary and secondary endpoints, showing RHB-104 plus standard of care (SoC) to be 64% more effective than SoC alone. The data from this study, published in the peer-reviewed journal, Antibiotics[5], also demonstrated the safety and efficacy of concomitant use of RHB-104 with anti-TNFs, immunomodulators and steroids, suggesting that RHB-204 could be a transformative safe and effective, stand-alone or combination, oral therapy. Up to 40% of CD patients fail to respond to anti-TNF treatment, and over time a similar number of responders lose response and have disease flare-ups[5]. Additionally, many existing treatment options are both expensive and intravenously administered, further increasing the cost burden. Moreover, several of these existing therapies have known safety issues, including Black Box Warnings. A safe and effective orally administered therapy would provide a welcome alternative approach. The CD market is expected to expand significantly over the 2024–2033 forecast period, with sales in the United States, Japan, and five major European markets, growing from $13.6 billion to $19.1 billion at a compound annual growth rate (CAGR) of 3.87%[4]. Funding for this ground-breaking program is expected to be non-dilutive. RedHill is actively pursuing partnering and collaborations for this program, including via an innovation development grant application already submitted and ongoing discussions with non-dilutive external funding sources. RHB-204 is expected to benefit from the transferal of pediatric orphan drug designation from RHB-104 and, where applicable, the Company intends to explore the potential for additional regulatory process designations, such as breakthrough therapy designation and fast track designations that may provide additional exclusivity or potential for priority review vouchers. About Crohn's Disease Crohn's disease (CD) is a form of Inflammatory Bowel Disease (IBD) causing inflammation of digestive tract tissue that can lead to abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition. CD can be highly debilitating and remains a serious burden for both patients and healthcare systems: destroying quality of life and even leading to life-threatening complications. There is no known cure for Crohn's disease. According to the Cleveland Clinic, experts estimate that more than three-quarters of a million Americans and approximately 6-8 million people globally have Crohn's disease Commonly used FDA-approved therapies in the treatment of CD include: Abbvie's Humira® (adalimumab), Janssen's Remicade® (infliximab) and Stelara® (Ustekinumab), BMS's Zeposia® (ozanimod) and Pfizer's Xeljanz® (tofacitinib). About RHB-204 RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, at specific doses designed to safely and effectively treat Mycobacterium avium subspecies paratuberculosis-positive (MAP-positive)-related Crohn's disease. Patent protected until at least 2041, and with an expected pediatric orphan designation (subject to FDA approval to transfer from RHB-104), RHB-204 is a next-generation formulation of RHB-104 with an optimized formulation for the treatment of CD. It contains the same three antimicrobial agents with potent intracellular, anti-mycobacterial and anti-inflammatory properties, and with an optimized dosing profile, RHB-204 provides the potential for enhanced tolerability, safety and compliance with a 40% pill burden reduction. RHB-204 is supported by a strong foundation of clinical data from the positive safety and efficacy results achieved in the Phase 3 study of RHB-104 in CD, with its potential further demonstrated using mucosal healing imaging, considered to be the gold standard for efficacy evaluation in CD. Originally developed for the treatment of pulmonary NTM disease caused by MAC, RHB-204 was granted FDA Fast Track and Orphan Drug Designation, in addition to QIDP Designation under the Generating Antibiotic Incentives Now Act (GAIN Act), extending U.S. post-approval U.S. market exclusivity to a potential total of 12 years. RHB-204 has additionally been granted EU Orphan Designation, providing eligibility for 10 years EU post-approval market exclusivity. RedHill has protection for RHB-204, and its use in treating pulmonary MAC disease, until 2041. About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal drug Talicia, for the treatment of Helicobacter pylori (H. pylori) infection in adults[6], with submission planned for marketing authorization in other territories. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple indications with U.S. Government and academic collaborations for development for radiation and chemical exposure indications such as Gastrointestinal-Acute Radiation Syndrome (GI-ARS), a Phase 2 study in prostate cancer in combination with Bayer's darolutamide and a Phase 2/3 program for hospitalized COVID-19 patients; (ii) RHB-204, an all-in-one, fixed-dose, orally administered, combination antibiotic therapy with a planned Phase 2 study for Crohn's disease and Phase 3-stage for pulmonary nontuberculous mycobacterial (NTM) disease; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (v) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America. More information about the Company is available at / X.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: market and other conditions; the Company's ability to regain and maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk of market and other conditions and that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 10, 2025. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. 1. RHB-204 is an investigational new drug, not available for commercial distribution in the United States. 2. RHB-104 is an investigational new drug, not available for commercial distribution in the United States. 3. Graham DY, et al. Randomized, Double-Blind, Placebo-Controlled Study of Anti-Mycobacterial Therapy (RHB-104) in Active Crohn's Disease. Antibiotics (Basel). 2024 Jul 25;13(8):694. doi: 10.3390/antibiotics13080694. PMID: 39199994; PMCID: PMC11350828. 4. DataMonitor - Disease Analysis: Crohn's Disease, September 2024. 5. Singh S, George J, Boland BS, Vande Casteele N, Sandborn WJ. Primary Non-Response to Tumor Necrosis Factor Antagonists is Associated with Inferior Response to Second-line Biologics in Patients with Inflammatory Bowel Diseases: A Systematic Review and Meta-analysis. J Crohns Colitis. 2018 May 25;12(6):635-643. doi: 10.1093/ecco-jcc/jjy004. PMID: 29370397; PMCID: PMC7189966. 6. Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . Category: R&D Company contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma +972-54-6543-112 [email protected] Logo: SOURCE RedHill Biopharma Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Fast TrackPhase 2Clinical ResultOrphan Drug

100 Deals associated with Infliximab

External Link

KEGG	Wiki	ATC	Drug Bank
D02598	Infliximab	L04AB02	DB00065

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Mucocutaneous Lymph Node Syndrome	Japan	Mitsubishi Tanabe Pharma Corp.	21 Dec 2015
Behcet's uveitis	Japan	Mitsubishi Tanabe Pharma Corp.	26 Jan 2007
Erythrodermic psoriasis	Japan	Mitsubishi Tanabe Pharma Corp.	17 Jan 2002
Psoriasis vulgaris	Japan	Mitsubishi Tanabe Pharma Corp.	17 Jan 2002
Pustular psoriasis	Japan	Mitsubishi Tanabe Pharma Corp.	17 Jan 2002
Ankylosing Spondylitis	European Union	Janssen Biologics BV	13 Aug 1999
Ankylosing Spondylitis	Iceland	Janssen Biologics BV	13 Aug 1999
Ankylosing Spondylitis	Liechtenstein	Janssen Biologics BV	13 Aug 1999
Ankylosing Spondylitis	Norway	Janssen Biologics BV	13 Aug 1999
Arthritis, Psoriatic	European Union	Janssen Biologics BV	13 Aug 1999
Arthritis, Psoriatic	Iceland	Janssen Biologics BV	13 Aug 1999
Arthritis, Psoriatic	Liechtenstein	Janssen Biologics BV	13 Aug 1999
Arthritis, Psoriatic	Norway	Janssen Biologics BV	13 Aug 1999
Colitis, Ulcerative	European Union	Janssen Biologics BV	13 Aug 1999
Colitis, Ulcerative	Iceland	Janssen Biologics BV	13 Aug 1999
Colitis, Ulcerative	Liechtenstein	Janssen Biologics BV	13 Aug 1999
Colitis, Ulcerative	Norway	Janssen Biologics BV	13 Aug 1999
Crohn's disease, active moderate	European Union	Janssen Biologics BV	13 Aug 1999
Crohn's disease, active moderate	Iceland	Janssen Biologics BV	13 Aug 1999
Crohn's disease, active moderate	Liechtenstein	Janssen Biologics BV	13 Aug 1999

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Behcet Syndrome	Phase 3	Japan	Mitsubishi Tanabe Pharma Corp.	01 Jan 2012
Axial Spondyloarthritis	Phase 3	-	Merck Sharp & Dohme Corp.	01 Sep 2009
Polymyalgia Rheumatica	Phase 3	Spain	Schering-Plough Corp.	01 Jun 2007
Myositis	Phase 3	-	Schering-Plough Corp.	05 Mar 2007
Pustulosis of Palms and Soles	Phase 3	Canada	Schering-Plough Corp.	01 Mar 2007
Hepatitis C, Chronic	Phase 3	-	Merck Sharp & Dohme Corp.	18 Jul 2005
Erythema Infectiosum	Phase 3	United States	Schering-Plough Corp.	01 Mar 2005
Erythema Infectiosum	Phase 3	Austria	Schering-Plough Corp.	01 Mar 2005
Erythema Infectiosum	Phase 3	Belgium	Schering-Plough Corp.	01 Mar 2005
Erythema Infectiosum	Phase 3	Canada	Schering-Plough Corp.	01 Mar 2005

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05168475 (BIOVAS, CTgov)	Phase 2	Purpura, Schoenlein-Henoch \| Primary Angiitis of the Central Nervous System \| Takayasu Arteritis ... View more	22	Tocilizumab+Rituximab (Infliximab)	ugkjiwkmqg = iwoodnmgnv jmdjfxpuok (mxiyrenulz, cursvfqgvj - zcmhpxvarg) View more	-	17 Jun 2025
				Infliximab+Tocilizumab (Rituximab)	ugkjiwkmqg = gtajuwbpuq jmdjfxpuok (mxiyrenulz, jhlmljovog - dygmgmkigv) View more
EULAR2025	Not Applicable	Rheumatic Diseases	34	Subcutaneous Infliximab (rheumatic disease in remission)	wdydxtwsqq(vlnvcxlqwh) = vwtomqkobp nkpfniatmn (okhawtpcqr, 0.37) View more	Positive	11 Jun 2025
NCT02711202 (CTgov)	Not Applicable	Neoplasms	20	Remicade+Tacrolimus+Sirolimus+MabCampath, (Sirolimus)	zzzbkbxcin = ewcfkvkhdp jcktkrazub (zbcozpabvc, gktphafitt - rrmubxfcey) View more	-	04 Jun 2025
				Remicade+Tacrolimus+MabCampath, (Tacrolimus)	zzzbkbxcin = tuasliykkm jcktkrazub (zbcozpabvc, anltjzxhzk - yhwsvizlrd) View more
ASCO2025	Not Applicable	Drug-Related Side Effects and Adverse Reactions	166	Steroid-sparing agents (SSAs)	excliksaew(bfrdgsohib) = aafpiuectk ktlakbrprr (vrhmbqenld ) View more	Positive	30 May 2025
AACR2025	Not Applicable	Colitis Second line	-	Infliximab	dgrygufmij(wrvtoxazhx) = mwqkxygagt dqqcrpcgzo (ehfyvoceou )	-	27 Apr 2025
				Vedolizumab	dgrygufmij(wrvtoxazhx) = jsajatlnbf dqqcrpcgzo (ehfyvoceou )
["ACTIVE"] (Pubmed \| Gut)	Not Applicable	Colitis, Ulcerative Maintenance	64	Infliximab + Azathioprine	hrzhoiwteo(alwccvpvad): risk ratio = 3.85 (95% CI, 1.15 - 12.88), P-Value = 0.03 View more	Positive	01 Feb 2025
				Azathioprine
1485 (SITC2024)	Not Applicable	Colitis First line	29	Infliximab	dendagkuxh(qgyiqadpee) = both groups had a similar rate of mild adverse events (AEs), most of which were deemed unrelated to SIT use wwiikitrek (jgisgdnbbf )	Positive	05 Nov 2024
				Vedolizumab
UEGW2024	Not Applicable	Inflammatory Bowel Diseases	-	Infliximab	ipmzebxqzs(dokryyhomx) = 8 (10.4%) had an allergic reaction, which was attributed to INF. Allergic reactions had a tendency of correlation with ADA existence, as 4/5 patients with allergic reaction and TLs <1 Î¼g/mL had positive ADAs, while 4/10 patients with positive ADAs reported allergic reaction, compared to 1/10 patients with negative anti- bodies (p=0.152) dwktfthegr (psjvdodzac )	-	13 Oct 2024
UEGW2024	Not Applicable	Inflammatory Bowel Diseases	-	infliximab (Patients with immunological hypersensitivity)	uowwhohfss(twefcyhreo) = vlvonefxxa jimfmryoyt (nmturzxxue ) View more	Negative	13 Oct 2024
				infliximab (Patients without immunological hypersensitivity)	uowwhohfss(twefcyhreo) = vqksdsepqu jimfmryoyt (nmturzxxue ) View more
NCT02770040 (PREDICT-UC, Pubmed \| Lancet Gastroenterol Hepatol)	Phase 4	Colitis, Ulcerative	138	10 mg/kg infliximab	qobdtoxnet(misofniaym) = doppsofcmj iudaqdkbfn (gvqppickyj ) View more	Positive	01 Sep 2024
				5 mg/kg infliximab	qobdtoxnet(misofniaym) = bcumsfbzai iudaqdkbfn (gvqppickyj ) View more

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