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Last update 25 May 2025

Mesalamine

Last update 25 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

3-carboxy-4-hydroxyaniline, 5-aminosalicylic acid, m-Aminosalicylic acid

+ [43]

Target

PP2A

Action

inhibitors

Mechanism

PP2A inhibitors(Protein phosphatase 2A inhibitors)

Therapeutic Areas

Immune System DiseasesDigestive System DisordersHemic and Lymphatic Diseases

Active Indication

Ulcerative colitis, active moderateUlcerative proctitisCrohn Disease+ [5]

Inactive Indication

Colitis, CollagenousColitis, LymphocyticColorectal Cancer+ [7]

Originator Organization

Sanofi

Active Organization

AbbVie, Inc.Takeda Pharmaceuticals U.S.A., Inc.

Zeria Pharmaceutical Co., Ltd.

+ [10]

Inactive Organization

Shire Plc

Ferring Pharmaceuticals A/SWarner Chilcott Ltd.

+ [9]

License Organization

Ferring Holding SA

Aptalis Pharma LLC

Zhejiang Medical Technology Development Co., Ltd.

+ [8]

Drug Highest PhaseApproved

First Approval Date

Switzerland (01 Jan 1984),

Colitis, Ulcerative

RegulationOrphan Drug (United States), Orphan Drug (Japan)

Structure/Sequence

Molecular FormulaC7H7NO3

InChIKeyKBOPZPXVLCULAV-UHFFFAOYSA-N

CAS Registry89-57-6

340

Clinical Trials associated with Mesalamine

NCT06878495

/ Not yet recruitingNot ApplicableIIT

Optimizing IBD Management: a Comparative Study on the Efficacy and Safety of 5-ASA De-escalation in Patients with Ulcerative Colitis and Crohn's Disease on Stable Biologic or Immunomodulator Therapy

This study aims to evaluate the long-term outcomes of discontinuing 5-ASA in UC and CD patients receiving stable biologic or immunomodulator therapy using a prospective cohort based in the Busan-Ulsan-Gyeongnam region. It seeks to determine whether discontinuing 5-ASA is a safe treatment strategy in modern IBD management.

Start Date01 Apr 2025

Sponsor / Collaborator

Pusan National University Hospital

CTR20250742

/ Active, not recruitingNot Applicable

美沙拉秦肠溶片生物等效性试验

[Translation] Bioequivalence study of mesalazine enteric-coated tablets

主要研究目的评价中国健康成年受试者空腹及餐后条件下单次单剂量口服美沙拉秦肠溶片受试制剂（规格：0.25g，申办者：葵花药业集团佳木斯鹿灵制药有限公司）和参比制剂（商品名：Salofalk®，规格：0.25g，持证商：DR.FALK PHARAMA GmbH）后的药代动力学特点和生物等效性。次要研究目的研究美沙拉秦肠溶片受试制剂（规格：0.25g）和参比制剂（商品名：Salofalk，规格：0.25g）在中国健康成年受试者中的安全性。

[Translation]

Main study objectives To evaluate the pharmacokinetic characteristics and bioequivalence of the test formulation of mesalazine enteric-coated tablets (specification: 0.25g, applicant: Jiamusi Luling Pharmaceutical Co., Ltd., Sunflower Pharmaceutical Group) and the reference formulation (trade name: Salofalk®, specification: 0.25g, licensee: DR.FALK PHARAMA GmbH) after a single oral dose under fasting and postprandial conditions in healthy Chinese adult subjects. Secondary study objectives To study the safety of the test formulation of mesalazine enteric-coated tablets (specification: 0.25g) and the reference formulation (trade name: Salofalk, specification: 0.25g) in healthy Chinese adult subjects.

Start Date01 Apr 2025

Sponsor / Collaborator

Sunflower Pharmaceutical Group Jiamusi Luling Pharmaceutical Co., Ltd.

ChiCTR2500098522

/ SuspendedNot ApplicableIIT

Clinical study of mesalazine with probiotics to improve senile UC

Start Date25 Mar 2025

Sponsor / Collaborator

Sir Run Run Shaw Hospital

100 Clinical Results associated with Mesalamine

100 Translational Medicine associated with Mesalamine

100 Patents (Medical) associated with Mesalamine

9,424

Literatures (Medical) associated with Mesalamine

31 Dec 2025·ANNALS OF MEDICINE

Sodium butyrate alleviates DSS-induced inflammatory bowel disease by inhibiting ferroptosis and modulating ERK/STAT3 signaling and intestinal flora

Article

Author: Liu, Lulin ; Sun, Suxia ; He, Huaxing ; Chen, Nachuan ; Liu, Yingyin

BACKGROUND:

Inflammatory bowel disease (IBD), encompassing Crohn's disease (CD) and ulcerative colitis (UC), can seriously impact patients' quality of life. Sodium butyrate (NaB), a product of dietary fiber fermentation, has been shown to alleviate IBD symptoms. Some studies have shown that it is related to ferroptosis. However, the precise mechanism linking NaB, IBD, and ferroptosis is not clear.

OBJECTIVE:

This study aimed to demonstrate that NaB suppresses ferroptosis, thereby alleviating inflammatory bowel disease (IBD) through modulation of the extracellular regulated protein kinases/signal transducer and activator of transcription 3 (ERK/STAT3) signaling pathway and intestinal flora.

METHODS:

An IBD model was established using 2.5% (w/v) dextran sulfate sodium (DSS). Mice were orally administered low-dose NaB, high-dose NaB , or 5-aminosalicylic acid (5-ASA). Ferroptosis-related molecules were measured using specific kits, and western blotting (WB) and real-time polymerase chain reaction (RT-qPCR) were used to determine the levels of the target molecules.

RESULTS:

NaB alleviated symptoms in IBD mice, including reduced weight loss, prolonged colon length, reduced disease activity index (DAI), and reduced spleen index and mRNA expression of inflammatory factors. Additionally, NaB reduced the content of Fe²⁺ and myeloperoxidase (MPO) and increased the content of GSH and the activity of superoxide dismutase (SOD), which reflected NaB-inhibited ferroptosis. Moreover, western blotting showed that NaB enhanced STAT3 and ERK phosphorylation. In addition, NaB regulates the composition and functions of flora related to IBD.

CONCLUSION:

NaB alleviates IBD by inhibiting ferroptosis and modulating ERK/STAT3 signaling and the intestinal flora.

01 Dec 2025·IMMUNOLOGIC RESEARCH

A patient with CVID-enteropathy successfully treated with ustekinumab

Article

Author: Grammatikos, Alexandros ; Marley, Fenella ; Lockett, Melanie ; Gompels, Mark

CVID (common variable immunodeficiency) is associated with a variety of gastrointestinal disorders including those mimicking Crohn's disease and ulcerative colitis. At present there is no clear trial data for the treatment of CVID enteropathy. There are no specific recommendations for treatment; however, it is commonly treated in a similar manner to inflammatory bowel disease, with corticosteroids, 5-aminosalicylates (5-ASA), azathioprine and anti-TNF therapy all being used. We describe the case of a 54-year-old with CVID-enteropathy presenting with diarrhoea and evidence of granulomatous inflammation on colonic biopsies. He was successfully treated with ustekinumab following failure/intolerance of prednisolone, 5-ASA and azathioprine. Features of CVID-enteropathy improved both clinically and histologically, with no evidence of serious treatment-related side effects.

01 Dec 2025·IMMUNOLOGIC RESEARCH

Protective role of ABCC drug subfamily resistance transporters (ABCC1-7) in intestinal inflammation

Article

Author: Miguel-Cruz, Erika ; Yamamoto-Furusho, Jesus K ; Barreto-Zuñiga, Rafel ; Furuzawa-Carballeda, Janette ; Fonseca-Camarillo, Gabriela ; Martínez-Benítez, Braulio

The ABCC subfamily contains thirteen members. Nine of these transporters are called multidrug resistance proteins (MRPs). The MRPs have been associated with developing ulcerative colitis (UC). This study aimed to evaluate the ABCC expression in UC patients and its role in a dextran sulfate sodium (DSS)-induced colitis mice model under 5-aminosalicylates or methylprednisolone treatment and compared with control without inflammation. DSS-induced colitis mice were treated with 5-aminosalicylates (50 mg/kg 24 h) or methylprednisolone (2 mg/kg 24 h). Human rectal biopsies were obtained from UC patients. The abcc-relative mRNA levels and protein expression were determined by RT-PCR and immunohistochemistry. abcc4, abcc5, and abcc6 mRNA levels were significantly increased in DSS-induced colitis compared to the other groups. The 5-aminosalicylate treatment dramatically increased the abcc2 and abcc3 mRNA levels vs. control. Methylprednisolone treatment increased abcc1 vs. DSS-induced colitis and colitis treated with 5-aminosalicylate. Immunohistochemical analysis revealed down-regulation of ABCC1/ABCC2/ABCC5/ABCC7 in mice colitis vs. control. Treatment with 5-aminosalicylate restored ABCC5 levels, while methylprednisolone restored ABCC2/ABCC5/ABCC7 in colitis mice at similar control levels. Relative mRNA levels of mrp1-5 were increased in active UC patients vs. control. ABCC2/ABCC4/ABCC7 were conspicuously expressed in the mucosa of 5-aminosalicylate and/or methylprednisolone-treated UC patients, while ABCC2/ABCC4/ABCC5/ABCC7 in submucosa, ABCC1/ABCC5/ABCC7 in muscular, and ABCC1/ABCC4/ABCC5/ABCC7 in serosa were expressed vs. controls. This is the first report about the differential up-regulation of the ABCC subfamily gene and protein expression in DSS-induced colitis under aminosalicylates or methylprednisolone treatment.

News (Medical) associated with Mesalamine

15 Apr 2025

·www.prnewswire.com

Takeda's ENTYVIO Continues Growth Trajectory in Ulcerative Colitis and Crohn's Disease | DelveInsight

With the introduction of a subcutaneous formulation, ENTYVIO has expanded patient convenience and global accessibility. Continued growth is supported by rising IBD prevalence and ongoing geographic expansion. LAS VEGAS, April 15, 2025 /PRNewswire/ -- DelveInsight's " ENTYVIO Market Size, Forecast, and Market Insight Report" highlights the details around ENTYVIO, a gut-selective biologic developed by Takeda Pharmaceutical. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of ENTYVIO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Takeda Pharmaceutical's ENTYVIO (vedolizumab) Overview Vedolizumab is a biologic medication approved for both intravenous (IV) and subcutaneous (SC) use, with regulatory approvals varying by region. The SC formulation is authorized for use in the United States, European Union, and over 50 other countries, while the IV formulation has received approval in more than 70 countries, including the US and the EU. Collectively, vedolizumab IV and SC have accumulated over one million patient-years of global exposure. Vedolizumab is a humanized monoclonal antibody that selectively targets the alpha4beta7 integrin, blocking its interaction with mucosal addressin cell adhesion molecule 1 (MAdCAM-1) — a protein primarily found on blood vessels and lymph nodes in the gastrointestinal tract. This integrin is present on certain white blood cells involved in the inflammatory processes of ulcerative colitis and Crohn's disease. By disrupting the binding between alpha4beta7 integrin and MAdCAM-1, vedolizumab may reduce the migration of these immune cells into the gut, thereby decreasing inflammation. ENTYVIO Dosage For adults with ulcerative colitis, the advised dosage of ENTYVIO is 300 mg given through intravenous infusion at weeks 0, 2, and 6, followed by maintenance infusions every 8 weeks. Treatment should be discontinued if no clinical improvement is observed by week 14. Learn more about ENTYVIO projected market size for Crohn's disease and ulcerative colitis @ ENTYVIO Market Potential Crohn's disease is a progressive type of inflammatory bowel disease (IBD) that results in chronic inflammation throughout the gastrointestinal tract, most commonly affecting the terminal ileum and colon. This inflammation can lead to complications such as strictures, fistulas, and ulcers. In 2024, there were 1.1 million diagnosed prevalent cases of Crohn's disease in the United States. Current treatment approaches primarily include biologics such as adalimumab (HUMIRA and its biosimilars), ustekinumab (STELARA), infliximab (REMICADE and biosimilars), along with systemic corticosteroids, immunosuppressants, 5-aminosalicylic acid (5-ASA), and other therapies. Among these, adalimumab held the largest market share in the 7MM in 2024, generating around USD 4 billion in revenue for Crohn's disease treatment. In 2024, the market size of Crohn's disease was highest in the US among the 7MM, accounting for approximately USD 8 billion, which is further expected to increase at a CAGR of 4.5%. The Crohn's disease market is projected to expand due to the introduction of novel therapies with improved efficacy and more convenient routes of administration, broader use of biologics in pediatric populations, growing commercial opportunities in biologic-treated patients, advancements in biomarker development for early diagnosis, and the overall rising prevalence of the disease. Discover more about the Crohn's disease market in detail @ Crohn's Disease Market Report Ulcerative colitis is one of the primary types of chronic inflammatory bowel disease (IBD) affecting the gastrointestinal tract. It is an idiopathic and long-standing inflammation of the colonic mucosa, typically presenting with symptoms like diarrhea, abdominal discomfort, and rectal bleeding. In 2023, there were an estimated 3.1 million diagnosed prevalent cases of ulcerative colitis across the 7MM, with numbers expected to rise over the forecast period. According to current US treatment guidelines, mild-to-moderate cases are initially managed with aminosalicylates or by using corticosteroids for induction followed by maintenance therapy with aminosalicylates. For patients with moderate-to-severe disease, maintenance treatment may involve immunosuppressants like azathioprine or 6-mercaptopurine after corticosteroid induction. Alternatively, biologics—particularly anti-TNF agents such as infliximab or adalimumab—can be used alone or alongside immunosuppressants to achieve and sustain remission and mucosal healing. The treatment landscape across the 7MM is categorized into commonly used drug classes, including conventional therapies, anti-TNF agents, anti-adhesion molecule therapies, JAK inhibitors, and others, reflecting some variations in prescribing practices. Looking ahead, the anticipated introduction of novel therapies, increased focus on early detection, enhanced use in secondary care, improved implementation strategies, and growing disease awareness are likely to contribute to more effective management of ulcerative colitis. As a result, the ulcerative colitis market will grow from USD 8.4 billion in 2023 at a significant CAGR by 2034. However, the high costs of new treatments and the financial burden of disease complications may pose challenges to widespread adoption. For a comprehensive view of the ulcerative colitis market, check out the Ulcerative Colitis Market Assessment Emerging Competitors of ENTYVIO Despite the presence of biosimilars, innovation in Crohn's disease and ulcerative colitis treatment remains strong, with several emerging therapies exploring new inflammatory pathways to improve efficacy and long-term outcomes. RHB-104, a combination macrolide antibiotic, is in Phase III trials targeting potential mycobacterial involvement. VELSIPITY, an S1P receptor modulator, works by limiting lymphocyte migration and reducing inflammation. TREMFYA, which inhibits IL-23, is under evaluation for its immune-modulating effects, while ABBV-154, a TNF inhibitor conjugated with a steroid, aims to enhance TNF suppression. Additional pipeline therapies include Merck's TL1A inhibitor Tulisokibart (PRA023/MK-7240) in Phase III and Pfizer's JAK3 inhibitor LITFULO in Phase II. Teva and Sanofi are also developing Duvakitug, a monoclonal antibody targeting TNFSF15. These investigational drugs represent significant progress for patients unresponsive to current treatments. A range of other promising candidates are in development, each targeting unique pathways. Landos Biopharma's Omilancor (BT-11) is in Phase II and acts via LANCL2, while AVB-114 from Avobis Bio/Alimentiv is also in Phase II. Abivax S.A.'s Obefazimod (ABX464) is being studied for its ability to upregulate miR-124. Roche's RVT-3101 (RG6631), an anti-TL1A antibody, is in Phase II trials, and Mesoblast's RYONCIL (Remestemcel-L), a mesenchymal stem cell therapy, is progressing in Phase III, offering regenerative potential. Other noteworthy agents in Phase II include Zasocitinib (TAK-279) from Takeda, a TYK2 inhibitor; AZD7798 from AstraZeneca, targeting CCR9; Sanofi's Balinatunfib (SAR441566), which blocks TNFR1 signaling; AGMB-129 from Agomab Therapeutics, targeting ALK5/TGFβR1; MBF-118 by Medibiofarma, a PPARγ partial agonist; and MORF-057 by Eli Lilly and Morphic Therapeutic, an α4β7 integrin inhibitor. Together, these developments illustrate a robust and diversified IBD pipeline. To know more about the number of competing drugs in development, visit @ ENTYVIO Market Positioning Compared to Other Drugs Key Milestones of ENTYVIO In April 2024, Takeda announced that the FDA has approved the subcutaneous (SC) formulation of ENTYVIO (vedolizumab) for maintenance treatment in adults with moderately to severely active Crohn's disease who have previously received induction therapy with the intravenous (IV) form of ENTYVIO. In September 2023, Takeda announced that the FDA has approved the SC formulation of ENTYVIO to be used as maintenance therapy in adults with moderately to severely active ulcerative colitis following induction treatment with the IV version of ENTYVIO. In September 2023, Takeda announced that the FDA has accepted for review its Biologics License Application (BLA) for the investigational subcutaneous formulation of ENTYVIO as a maintenance treatment for adults with moderately to severely active Crohn's disease, following induction therapy with the intravenous version of ENTYVIO. In April 2023, Takeda announced that the FDA has accepted for review its resubmitted Biologics License Application (BLA) for the investigational subcutaneous formulation of ENTYVIO as a maintenance treatment for adults with moderately to severely active ulcerative colitis following induction therapy with the intravenous version of ENTYVIO. In March 2023, Takeda announced that Japan's Ministry of Health, Labour, and Welfare has approved ENTYVIO Pens and prefilled syringes (108 mg for subcutaneous injection) for use as maintenance therapy in patients with moderate to severe ulcerative colitis. In May 2020, Takeda announced that the European Commission has approved the subcutaneous formulation of ENTYVIO, a gut-targeted biologic, for maintenance treatment in adults with moderately to severely active ulcerative colitis or Crohn's disease. In May 2019, Takeda announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved for an expanded indication of ENTYVIO, allowing its use in treating adult patients with moderately to severely active Crohn's disease. In May 2019, Takeda announced that the FDA has accepted for review the BLA for a SC formulation of vedolizumab, intended for maintenance treatment in adults with moderately to severely active ulcerative colitis. In November 2018, Takeda announced the launch of ENTYVIO in Japan for the treatment of patients with moderately to severely active ulcerative colitis. In June 2014, Takeda announced that ENTYVIO is now commercially available in the United States for treating adults with moderately to severely active ulcerative colitis or Crohn's disease. In May 2014, Takeda announced that the European Commission (EC) has granted Marketing authorization for ENTYVIO. It is the first and only biologic approved at the same time for treating adults with moderately to severely active ulcerative colitis and Crohn's disease who have not responded adequately to, lost response to, or were intolerant of conventional therapies or TNF-alpha inhibitors. In May 2014, Takeda announced that the FDA had granted simultaneous approval of ENTYVIO for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease. Discover how ENTYVIO is shaping the Crohn's disease and ulcerative colitis treatment landscape @ ENTYVIO Infusion ENTYVIO Market Dynamics ENTYVIO has established itself as a leading biologic therapy in the treatment of moderate to severe ulcerative colitis and Crohn's disease. As a gut-selective integrin antagonist, ENTYVIO offers a differentiated mechanism of action compared to anti-TNF therapies, which contributes to its positioning as a safer long-term option, particularly for patients at risk of systemic immunosuppression. Its favorable safety profile and efficacy in inducing and maintaining remission have led to its widespread adoption, particularly among patients who have failed previous therapies. The biologics market for inflammatory bowel disease is highly competitive, with key players including HUMIRA, REMICADE, STELARA, and newer entrants like SKYRIZI and RINVOQ. ENTYVIO has managed to capture significant market share by appealing to both gastroenterologists and patients seeking gut-targeted treatment. Its intravenous formulation, though initially a barrier, has been partially offset by the 2019 launch of the subcutaneous version in global markets, enhancing patient convenience and adherence. However, uptake in the US for the SC version has been slower due to regulatory timelines and physician inertia. Biosimilar competition is also a factor shaping ENTYVIO's future market dynamics. While biosimilars of anti-TNFs are gaining traction, ENTYVIO currently remains insulated due to patent protections, with biosimilar entry expected post-2026. This provides Takeda a limited window to maximize revenue, expand its patient base, and reinforce brand loyalty. Strategic moves such as expanding indications, enhancing real-world evidence, and increasing global access will be crucial to maintaining its competitive edge. Moreover, the shift in payer dynamics and healthcare cost containment efforts are increasingly influencing biologic prescribing behavior. Takeda must continue to demonstrate value through outcome-based contracts and cost-effectiveness data. As newer agents with novel mechanisms enter the market, maintaining differentiation and proving long-term value will be central to ENTYVIO's sustained success. Dive deeper to get more insight into ENTYVIO's strengths & weaknesses relative to competitors @ ENTYVIO Market Drug Report Table of Contents Related Reports Crohn's Disease Market Crohn's 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 Crohn's disease companies including Novo Nordisk, Eli Lilly and Company, MedImmune, Boehringer Ingelheim, Raziel Therapeutics, Altimmune, Saniona, YSOPIA Bioscience, Innovent Biologics, Glaceum, Shionogi, Aardvark Therapeutics, NuSirt Biopharma, Novartis, CSPC Baike (Shandong) Biopharmaceutical, Jiangsu HengRui Medicine, Carmot Therapeutics, Pfizer, Sciwind Biosciences, Empros Pharma, 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 Janssen, RedHill Biopharma, Amgen, Pfizer, Prometheus Biosciences, AgomAb Therapeutics, Hoffmann-La Roche, Gilead Sciences, Eli Lilly and Company, Celgene, AstraZeneca, Mesoblast, Alfasigma, Tiziana Life Sciences, Abivax, Arena Pharmaceuticals, Cytocom, HAV Vaccines Ltd, Enzo Biochem Inc., Stero Biotechs, Reistone Biopharma Company Limited, Qu Biologics, Pfizer, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceuticals, Soligenix, Immunic, Pfizer, Atlantic Healthcare, 4D Pharma, Landos Biopharma, Janssen, Roche, Eisai, Bristol-Myers Squibb, Iltoo Pharma, Suzhou Connect Biopharmaceuticals, Theravance Biopharma, TaiwanJ Pharmaceuticals, Celularity, Cerecor, GlaxoSmithKline, KangStem Biotech, Immunic, Alpha Cancer Technologies, Koutif Therapeutics, Tract Therapeutics, Trio medicines, ChemoCentryx, Algernon Pharmaceuticals, Neuclone, JHL Biotech, Innovative Pharmacological Research (IPHAR) Co Ltd, Innovation Pharmaceuticals, Exeliom Biosciences SAS, AbbVie, Finch Therapeutics, Akeso Biopharma, Draconis Pharma, MakScientific, Engitix, Origo Biopharma, Navidea Biopharmaceuticals, Orchard Therapeutics, Xbrane, Thetis Pharmaceuticals, Temisis Therapeutics, Synedgen, Synlogic, Morphic Therapeutic, Metacrine, Curacle, Commence Bio Inc, Cloud Pharmaceuticals, Chong Kun Dang Pharmaceutical Corp, Avobis Bio LLC, Avexegen Therapeutics, Assembly Biosciences, Aibios Co Ltd, Aclaris Therapeutics, Athos Therapeutics, Denali Therapeutics, Educell doo, among others. Ulcerative Colitis Market Ulcerative Colitis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key Ulcerative Colitis companies, including Eli Lilly and Company, Lipid Therapeutics, Hoffmann-La Roche, Arena Pharmaceuticals, InDex Pharmaceuticals, EA Pharma, Theravance Biopharma, Boehringer Ingelheim, Janssen Research & Development, Lycera, LG Chem, Iltoo Pharma, Immunic, Hutchison Medipharma, Tianjin Hemay Pharmaceutical, Celgene, 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 Eli Lilly and Company, Lipid Therapeutics, Hoffmann-La Roche, Arena Pharmaceuticals, InDex Pharmaceuticals, EA Pharma, Theravance Biopharma, Boehringer Ingelheim, Janssen Research & Development, Lycera, LG Chem, Iltoo Pharma, Immunic, Hutchison Medipharma, Tianjin Hemay Pharmaceutical, Celgene, 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 2Drug ApprovalPhase 3Immunotherapy

27 Nov 2024

·pharma.economictimes.indiatimes.com

Zydus eyes M&A, licensing to build its US specialty business

New Delhi: Zydus Lifesciences may take the M&A or licensing route to acquire commercial assets for building a specialty portfolio and prepare ground for the possible launch of its liver therapy, saroglitazar, in the US. The Ahmedabad-based drugmaker is also looking at potential acquisitions to diversify into medical devices and expand diagnostics and nutrition businesses, managing director Sharvil Patel tells Viswanath Pilla and George Smith Alexander. Edited excerpts: US generics has been the most profitable segment for Zydus . Can you sustain this as some products may see competition? We will continue to invest in US market. If we take a two-three-year view of our business, it will continue to perform well and at a very good profitability. We have a robust pipeline with numerous exclusive launches planned, contributing to sustained revenue growth. Each year, we file over 30 abbreviated new drug applications (for generic products) and launch 25-30 products. This ensures a steady flow of new offerings, including high-value products like the generic versions of Revlimid, Asacol HD and mirabegron, along with upcoming launches like sitagliptin 505(b)(2) (FY26F launch), palbociclib tablet (FY27) and riociguat (FY28). What is your US plan, especially around orphan and rare diseases? We are committed to building a specialty play in the US, and economics makes it better if we have something commercially ready and build on it along with saroglitazar. Next year we have a readout on Saro. If we see positive traction, we would want to be in a way that we can have more than one product to go into the market with. So, potentially, licensing or M&A would be an opportunity for us to look at. That is something we will be aggressively pursuing. Analysts say Zydus is passive on acquisitions compared to some competitors who have grown by deals; is this going to change? Not in India, but overseas-yes. More so in the US. So, we will look at other (markets) but those will not be very large, but the US would be the larger ticket item for us. Which are the other geographies that interest you for M&A? Europe is something that we want to see whether we can really create (something). We are not big in Europe right now. We are evaluating to see if that is one geography that does make sense or not. Also, valuations are more reasonable sometimes in these markets. Beyond that, other markets, we are just tactical. Profits have grown more compared with revenue in the past seven years. What can we expect 5-6 years down the line? On financial side, whatever we'll do, we'll do profitably. It's not growth at any cost but profitable growth. (By) 2030 we said we want to be a discovery-led organisation, and make sure that we meet the unmet medical needs that exist. How is Zydus diversification plan into medical devices panning out? In medical devices, we are looking at cardiovascular, orthopaedic and nephrological (or nephrology), through organic and inorganic ways. We are partnering in some places, we are licensing in some places, with the agreement that once it scales up, we can manufacture in India. Do you have plans for going global with your biosimilars portfolio? In India, we have 12-13 biologics. We are seeing approvals in other markets, such as Russia, Mexico. We are seeing globalisation of our biologics from 2025. We are building a facility which is getting commissioned in Q1 of next year. We are bullish on biologics front.

AcquisitionLicense out/in

13 Sep 2024

·synapse.patsnap.com

Johnson & Johnson's Dual IL-23 Inhibitor Guselkumab Receives FDA Approval for Ulcerative Colitis

On September 11, 2024, Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for the treatment of moderate to severe active ulcerative colitis (UC) in adult patients. The company claims that Tremfya is the first and only dual-acting inhibitor targeting interleukin 23 (IL-23) to be approved for this indication, solidifying Johnson & Johnson’s leadership position in the field of inflammatory bowel diseases. About GuselkumabGuselkumab is the first IL-23 inhibitor globally approved, selectively binding to the p19 subunit of IL-23 and blocking its interaction with the IL-23 receptor. This mechanism of action yields significant therapeutic effects across various autoimmune diseases. Guselkumab not only inhibits IL-23 but also interacts with the CD64 receptor on cells that produce IL-23. Tremfya has garnered approvals for treating plaque psoriasis, active psoriatic arthritis, and UC. Additionally, in June 2024, Johnson & Johnson submitted a supplemental Biologics License Application (sBLA) to the FDA for the treatment of moderate to severe active Crohn's disease (CD) in adults. Study Data Supporting ApprovalThe FDA's approval for UC was primarily based on data from the Phase 2b/3 QUASAR study. This study assessed the efficacy and safety of Tremfya in adult patients with moderate to severe active UC who had an inadequate response or intolerance to conventional therapies, other biologics, and/or JAK inhibitors. The results demonstrated that 50% of patients receiving Tremfya 200 mg subcutaneously (SC) every four weeks (q4w), and 45% of patients receiving Tremfya 100 mg SC every eight weeks (q8w), achieved the primary endpoint of clinical remission at Week 44, compared to 19% of those receiving placebo (p<0.001). Additionally, one year after maintenance therapy, 34% (200 mg) and 35% (100 mg) of patients achieved endoscopic remission, as opposed to 15% in the placebo group (p<0.001). During the induction treatment phase, the most common adverse reactions (>2%) for both Tremfya and placebo groups were respiratory infections. In the maintenance phase, the most frequent adverse reactions (>3%) among patients treated with Tremfya or placebo included injection site reactions, joint pain, and upper respiratory infections. About IL-23 p19 DrugsIL-23 p40 serves as a common subunit for both IL-12 and IL-23, with p40 antibodies providing a classical immunotherapy by blocking both IL-12 and IL-23 pathways. However, recent developments in IL-23 p19 antibodies, exemplified by guselkumab, have shown superior efficacy and safety profiles compared to p40 antibodies. The p19 subunit, besides forming the classical inflammatory cytokine IL-23 with p40, can also combine with EBI3 to form IL-39, which activates pathways involving IL-23R and gp130. Both IL-23 and IL-39 can trigger intracellular JAK-STAT signaling pathways, thereby stimulating the secretion of IL-17A/F. This sophisticated approach to targeting IL-23 not only reaffirms Johnson & Johnson’s innovative footprint in treating inflammatory and autoimmune diseases but also signals a promising horizon for patients battling these chronic conditions. In October 2023, Eli Lilly's Omvoh (mirikizumab) received FDA approval for the treatment of adults with moderately to severely active ulcerative colitis (UC). This marks the first IL-23p19 antagonist approved for this patient group. Additionally, AbbVie's risankizumab was the first IL-23 inhibitor to receive FDA approval for inflammatory bowel disease (IBD). It was approved for Crohn’s disease (CD) in June 2022 and for UC in June 2024. About Inflammatory Bowel Disease (IBD)IBD is a nonspecific, chronic, relapsing inflammatory condition of the intestines, commonly presenting with symptoms such as diarrhea, rectal bleeding, abdominal pain, fatigue, and weight loss. The precise cause and mechanism of IBD are not fully understood. However, the prevailing theory suggests that it involves an autoimmune dysfunction triggering an abnormal immune response, leading the immune system to attack normal cells in the digestive tract. IBD includes two main disorders: ulcerative colitis (UC) and Crohn's disease (CD). UC causes inflammation and ulcers on the surface lining of the colon and rectum, whereas CD can affect any part of the digestive tract, typically involving deeper layers of the gut lining. In rare cases, it can also affect the colon and upper gastrointestinal tract. In 2019, the global prevalence of IBD was approximately 4.9 million, with China accounting for 910,000 patients. From 1990 to 2019, the incidence of IBD in Chinese men increased from 1.72 cases per 100,000 to 3.35 cases per 100,000, while in women, the numbers rose from 1.20 to 2.45 per 100,000. The current global market for IBD therapies has expanded to $18 billion. Research indicates that the migration of white blood cells into intestinal tissue is key to the onset and persistence of IBD. This process depends on the specific binding between adhesion molecules on endothelial cells (such as VCAM-1, MAdCAM-1) and integrins on white blood cells, composed of α and β subunits. Targeting and inhibiting these specific interactions can effectively treat intestinal inflammation in IBD. Elevated levels of cytokines such as tumor necrosis factor-alpha (TNF-α), interleukin-12/23 (IL-12/23), and leukocyte adhesion molecules are commonly seen during active disease phases of IBD. Inhibiting these cytokines can effectively disrupt downstream inflammatory responses and leukocyte chemotaxis, which lead to mucosal damage. Other targets such as the Janus kinase (JAK)/STAT pathway and gut microbiota are increasingly being recognized for their roles in IBD. Since the etiology and pathogenesis of IBD remain unclarified, it cannot be cured. Current drug therapies focus on reducing inflammation, maintaining remission, lowering relapse rates, and reducing the need for surgery. Common treatments include anti-inflammatory drugs, immunosuppressants, antibiotics, small molecule oral drugs, and biologics. Compared to traditional drugs like 5-aminosalicylic acids, steroids, and immunosuppressants, biologics are becoming the mainstream treatment for IBD due to their clearer efficacy and better safety profiles. Johnson & Johnson's Position in IBDIn the IBD sphere, Johnson & Johnson has developed TNF-α inhibitors infliximab and golimumab, each generating over $2 billion in sales in 2023. In addition to guselkumab, the company is developing the first IL-12/23 antibody Stelara (ustekinumab) and the oral IL-23 inhibitor JNJ-2113 for IBD indications. Furthermore, the company is working on a combination therapy for recurrent patients using guselkumab and golimumab (JNJ-8408). According to incomplete statistics, Johnson & Johnson currently has nearly 20 drugs in development for the treatment of inflammatory bowel disease. How to obtain the latest research advancements in the field of biopharmaceuticals? In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!

100 Deals associated with Mesalamine

External Link

KEGG	Wiki	ATC	Drug Bank
D00377	Mesalamine	A07EC02	DB00244

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Ulcerative colitis, active moderate	Canada	Tillotts Pharma AG	30 Jun 2017
Ulcerative proctitis	United States	AbbVie, Inc.	05 Jan 2001
Crohn Disease	Japan	KYORIN Pharmaceutical Co., Ltd.	16 Apr 1996
Gastrointestinal Diseases	United States	Takeda Pharmaceuticals U.S.A., Inc.	10 May 1993
Proctitis	United States	Mylan Specialty LP	24 Dec 1987
Proctocolitis	United States	Mylan Specialty LP	24 Dec 1987
Colitis, Ulcerative	Switzerland	Sanofi	01 Jan 1984

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ulcerative colitis, active severe	Phase 3	China	Zeria Pharmaceutical Co., Ltd.	01 Nov 2010
Colitis, Lymphocytic	Phase 3	Germany	Dr. Falk Pharma GmbH	01 May 2010
Irritable Bowel Syndrome	Phase 3	Italy	Sofar SpA	01 Dec 2007
Colitis, Collagenous	Phase 3	Germany	Dr. Falk Pharma GmbH	01 Mar 2007
Diverticulitis	Phase 3	Italy	Sofar SpA	01 Oct 2005
Mucositis	Phase 3	Italy	Sofar SpA	01 Sep 2004
Eosinophilic Esophagitis	Phase 2	Switzerland	Dr. Falk Pharma GmbH	09 Feb 2023
Colorectal Cancer	Phase 2	Italy	Sofar SpA	01 Oct 2012
Diarrhea	Phase 2	United States	Bausch Health Americas, Inc.	01 Jul 2010
Irritable bowel syndrome with diarrhea	Phase 2	United States	Bausch Health Americas, Inc.	01 Jul 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEWS Manual	Not Applicable	Colitis, Ulcerative	198	口服5-ASA or 直肠5-ASA or 联合治疗	mpcylptfwg(wxgewncfqx) = hydynkmwbq hurylqhbqb (oorpkxhakb ) View more	Positive	05 Mar 2025
NEWS Manual	Not Applicable	Colitis, Ulcerative	-	5-ASA 低剂量（<2 g/天）	pnphwdsjak(ksjsvrpqkg) = ltncwnpwit mzfvddtqnw (oeacjuyxxb )	Positive	26 Feb 2025
				5-ASA 低剂量联合治疗	pnphwdsjak(ksjsvrpqkg) = zvzgghtxtp mzfvddtqnw (oeacjuyxxb )
REALASA (NEWS) Manual	Not Applicable	Colitis, Ulcerative First line	-	5-ASA	dtivjwvtxx(acfxwspshn) = 约50%的患者在182天时对初始5-ASA治疗保持依从性，但这一比例在730天时降至30%。 lfygftqrrv (ukqcsgbtxs )	Positive	26 Feb 2025
UEGW2024	Not Applicable	Colitis, Ulcerative	-	Mesalazine (Asacol)	cyrbblsxzh(bbyvzqllrl) = dqnizyucvq qvedzplwjz (lpjlzglqwk ) View more	-	13 Oct 2024
				Ozanimod (Zeposia)	cyrbblsxzh(bbyvzqllrl) = bppusyldlh qvedzplwjz (lpjlzglqwk ) View more
NCT02093663 (Pubmed)	Phase 3	Colitis, Ulcerative Maintenance	107	Low-dose multimatrix mesalamine (900-2400 mg)	rwgjomstdd(oqoqyyzupz) = Overall, 246 treatment-emergent adverse events (TEAEs) were reported in 73 patients (69.5%); 23 TEAEs in 14 patients (13.3%) were considered related to the study drug. No treatment-related deaths were reported. aghisteqdd (ngpkctebms ) View more	Positive	01 Nov 2023
				High-dose multimatrix mesalamine (1800-4800 mg)
DDW2023	Not Applicable	Colitis, Ulcerative	-	pH-dependant Mesalazine (5-ASA) Formulation 1	pxfsnflqma(hiedpxpqww) = jctgojujkg cmxiuctmar (ymzsuvbbqz )	-	09 May 2023
				pH-dependant Mesalazine (5-ASA) Formulation 2	pxfsnflqma(hiedpxpqww) = fztudbjjzf cmxiuctmar (ymzsuvbbqz )
ASN2022	Not Applicable	Colitis, Ulcerative ESR \| MPO \| PR3 antibodies	-	Mesalamine	vwvhlnxksf(nygfmfdftm) = Mesalamine induced FSGS must be considered in the differential early on presentation of a patient with nephrotic syndrome to ensure adequate and appropriate treatment to preserve kidney function pdlpvzglvm (olgmfnydgf )	Negative	05 Nov 2022
SSTOPPING (UEGW2022)	Not Applicable	Colitis, Ulcerative Maintenance	177	5-aminosalicyclic acid (5-ASA)	stbvqdojoc(ctnxvhvxar) = ltjpfobkeo drjplizebg (adkntezmnt )	Positive	09 Oct 2022
				Placebo	stbvqdojoc(ctnxvhvxar) = zyubqfgbaj drjplizebg (adkntezmnt )
DDW2022	Not Applicable	Colitis, Ulcerative	-	5ASA (Control group)	nolgxeopti(etohctzilj) = gpqekgtwdh suaogvrwlf (mztmbkaasx ) View more	-	21 May 2022
NCT02261636 (IMPACT, Pubmed \| J Gastrointestin Liver Dis)	Not Applicable	Colitis, Ulcerative	151	Mesalazine ≥4 g/day	vewiqppyaz(yzawvuyftm) = aeujtjbktr ybfxgcxoam (uebywoajdc ) View more	Positive	19 Mar 2022
				Mesalazine 2-<4 g/day	vbhtzdchpd(eeuzbboihr) = xynbupaxpc ptarxmdgxc (zkdlmigybk )

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