RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Special Review Project (China), Priority Review (China)

Structure/Sequence

Molecular FormulaC25H24N6O2

InChIKeyXYFPWWZEPKGCCK-GOSISDBHSA-N

CAS Registry936563-96-1

400

Clinical Trials associated with Ibrutinib

NCT06649812

/ Not yet recruitingPhase 2IIT

A Phase 2 Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed or Refractory CD10-Negative Diffuse-Large B-Cell Lymphoma (DLBCL) and High-Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements (HGBCL-DH-BCL2)

This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid® (ViPOR) works in treating patients with CD10 negative diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement (relapsed) and/or that has not responded to previous treatment (refractory). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Obinutuzumab, a monoclonal antibody, binds to a protein called CD20, which is found on B cells and some types of leukemia and lymphoma cells. Obinutuzumab may block CD20 and help the immune system kill cancer cells. Revlimid, a type of anti-angiogenesis agent and a type of immunomodulating agent, may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that cancers need to grow. ViPOR may be an effective treatment option for patients with relapsed and/or refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements.

Start Date07 Jul 2025

Sponsor / Collaborator

National Cancer Institute

NCT06958705

/ RecruitingPhase 2IIT

Study of the Efficacy and Safety of Venetoclax as Consolidation to Achieve Fix-Duration Treatment in CLL Patients Treated With BTK Inhibitor Monotherapy

This is an open-label, multicenter, phase 2, non-randomized study aiming to study the efficacy and safety of fixed-duration venetoclax consolidation in CLL patients who are on BTK inhibitor monotherapy. Patients who are on BTK inhibitor monotherapy for ≥ 6 months and still responsive are included. The study includes patients who are treatment-naive before taking BTK inhibitors. Patients will be treated with the BTK inhibitor plus full-dose venetoclax for 12 cycles after a standard 5-week dose ramp-up. Peripheral blood and bone marrow MRD status will be evaluated during and after the treatment. After the completion of combination therapy, patients will stop both BTK inhibitor and venetoclax and be followed.

Start Date01 Jun 2025

Sponsor / Collaborator

Third Affiliated Hospital of Nanjing Medical University

[+1]

NCT06357676

/ Not yet recruitingPhase 1/2IIT

A Phase Ib/II Study Evaluating the Clinical Activity of Glofitamab Plus Ibrutinib (GLIB) With Obinutuzumab Pretreatment in Previously Untreated Mantle Cell Lymphoma in Patients ≥ 65 or Ages 18-64 With High-Risk Features

This phase IB/II trial tests the safety, side effects and effectiveness of glofitamab plus ibrutinib with obinutuzumab for the treatment of patients with mantle cell lymphoma (MCL). Glofitamab is in a class of medications called bispecific monoclonal antibodies. It works by killing cancer cells. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). In the body, glofitamab binds to a receptor called CD3 on T-cells (a type of immune cells) and a receptor called CD20 on B-cells, a receptor that is often over-expressed on the surface of cancerous B-cells. When glofitamab binds to CD3 and CD20 receptors, it causes an immune response against the CD20-expressing cancerous B-cells. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Glofitamab plus ibrutinib with obinutuzumab may be safe tolerable and/or effective in treating patients with MCL.

Start Date09 May 2025

Sponsor / Collaborator

OHSU Knight Cancer Institute

[+2]

100 Clinical Results associated with Ibrutinib

100 Translational Medicine associated with Ibrutinib

100 Patents (Medical) associated with Ibrutinib

5,426

Literatures (Medical) associated with Ibrutinib

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Evaluation of Bruton’s Tyrosine Kinase (BTK) inhibition with alternative doses of ibrutinib in subjects with Chronic Lymphocytic Leukemia (CLL)

Article

Author: Smith, Emma ; Valenzuela, Belén ; Desphande, Sanjay ; Haddish-Berhane, Nahor ; Perez Ruixo, Juan José ; Srinivasan, Srimathi ; Treijtel, Nicoline ; Ouerdani, Aziz

Abstract:

Purpose:

To evaluate alternative ibrutinib dosing regimens that maintain Bruton’s tyrosine kinase (BTK) receptor occupancy over the entire dosing interval for CLL patients using a model-based approach.

Methods:

Ibrutinib inhibits B-cell proliferation via irreversible binding of BTK. As IC50 is not an appropriate parameter to describe the potency of the inhibition in the presence of a covalent binding inhibitor. A BTK covalent binding model was developed using kinact/KI as key parameter to account for covalent binding. The ibrutinib-BTK covalent binding model was used to describe the effect of daily doses of 140, 280, 420 and 560 mg on the proportion of subjects with more than 90% BTK inhibition at steady state trough concentrations. Predictive performance of the model was assessed using the available ibrutinib BTK inhibition data following QD dosing. Model-based predictions were used to identify the minimum ibrutinib QD dose that provides more than 90% inhibition in more than 90% of the subjects.

Results:

The covalent binding model was able to describe the data and predicted that ibrutinib QD dose reduced from 420 mg to 280 mg or 140 mg may inhibit de novo synthetized BTK efficiently in a CLL population.

Conclusion:

Using a model-based approach showed that reducing the ibrutinib dosing regimen to 280 mg QD or even 140 mg in case of adverse events could maintain BTK inhibition over the entire dosing interval.

01 Dec 2025·Blood Research

Relative efficacy of systemic treatments for patients with relapsed/refractory chronic lymphocytic leukemia: a network meta-analysis according to 17p deletion/TP53 mutations

Article

Author: Lim, Joo Han ; Kim, Jinchul ; Lee, Moon Hee ; Cho, Jinhyun

Abstract:

Purpose:

This network meta-analysis aimed to evaluate the relative efficacy of systemic treatments in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL), focusing on key genetic mutations, specifically the 17p deletion and TP53 mutations.

Methods:

We conducted a systematic literature review to identify all publicly available randomized controlled trials (RCTs) using PubMed, EMBASE, the Cochrane database, and meeting abstracts published through December 2023. A Bayesian network meta-analysis was performed to estimate the hazard ratios (HRs) for progression-free survival (PFS) with 95% confidence intervals (CIs) and to determine the ranking of the included regimens.

Results:

Twelve trials involving 4,437 patients and 13 treatment options were included in the meta-analysis. Venetoclax plus rituximab and zanubrutinib emerged as the most effective treatments for the overall R/R CLL population, showing the lowest PFS HR (HR 0.62, 95% CI 0.32–1.20 and HR 0.65, 95% CI 0.49–0.86, respectively) versus ibrutinib, and were ranked as the best agent (surface under the cumulative ranking curve [SUCRA] value of both 90%, respectively) among the included drugs. In the 17p deletion/TP53 mutation subgroup, zanubrutinib demonstrated the most favorable efficacy (HR 0.52, 95% CI 0.31–0.88 versus ibrutinib) with the highest SUCRA value (97%). In patients without these mutations, venetoclax plus rituximab was the most effective (HR 0.49, 95% CI 0.26–0.94 versus ibrutinib) with a SUCRA value of 94%.

Conclusion:

Our findings highlight the superior efficacy of venetoclax plus rituximab and zanubrutinib for treating R/R CLL and confirm that the role of each regimen may vary depending on the clinically significant mutations.

01 Dec 2025·JOURNAL OF CLINICAL IMMUNOLOGY

Disseminated Aspergillosis in X-linked Agammaglobulinemia: Beyond the norm

Letter

Author: Rawat, Amit ; Vignesh, Pandiarajan ; Jindal, Ankur Kumar ; Thangaraj, Abarna ; Goel, Sumit ; Sil, Archan

X-linked agammaglobulinemia (XLA) due to a mutation in Bruton's tyrosine kinase (BTK), leads to the arrested development of B cells at the pro-B cell stage. This results in absent B cells and severe hypogammaglobulinemia. XLA patients usually present with recurrent sinopulmonary infection. Bacterial infections are the commonest [2], fungal infections like Pneumocystis jirovecii, Aspergillus and Candida species are rarely reported and they are associated with mortality in XLA [3]. We report a 3.5-year-old boy with disseminated aspergillosis, an uncommon presentation of XLA. Despite treatment with antifungals, including voriconazole and amphotericin B, the patient succumbed to the illness. Genetic analysis revealed a pathogenic variant in the BTK gene (R28H), confirming XLA diagnosis. This case highlights the potential for severe fungal infections in XLA patients and suggests broader immune system dysregulation beyond B-cell defects.

704

News (Medical) associated with Ibrutinib

20 Jun 2025

·www.fiercepharma.com

Europe's CHMP gives thumbs up to ExCellThera's blood cancer cell therapy Zemcelpro

Europe’s Committee for Medicinal Products for Human Use has recommended marketing authorization for ExCellThera’s novel cell therapy Zemcelpro in certain blood cancer patients. In a first for the bloc, Europe’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for a new type of stem cell transplant therapy for certain blood cancer patients. The marketing endorsement was awarded to ExCellThera’s Zemcelpro and covers a recommended approval in adults with blood cancers that require an allogeneic hematopoietic stem cell transplantation (HSCT) following myeloablative conditioning for whom no other type of suitable donor cells is available.Zemcelpro contains stem cells from a donor’s umbilical cord blood, some of which have been grown and multiplied, the European Medicines Agency (EMA) said in a press release on the decision. By boosting the number of cells, Zemcelpro makes the stem cells from a small cord blood unit more effective, the European regulator explained. For several blood cancers—including leukemias, which are detected in the blood; lymphomas, which are found in the lymph nodes; and myelodysplastic syndrome and myelomas, which are diagnosed in the bone marrow—the only current curative treatment option is allogeneic HSCT. This type of transplant involves using donated stem cells to replace the patient’s bone marrow cells to form new marrow that produces healthy blood cells. The CHMP based its Zemcelpro recommendation on pooled analysis of two single-arm trials that included 25 patients. The studies found that 84% of patients who received Zemcelpro achieved neutrophil engraftment, when donor stem cells establish themselves in the recipient’s bone marrow and produce the white blood cells known as neutrophils within a median span of 20 days.Some 10,000 new blood cancer cases requiring bone marrow transplant crop up in Europe each year, ExCellThera estimates. Many of these patients do not have access to suitable donor cells largely because of the unavailability of matched donors, the company explained. ExCellThera said it expects to gain marketing authorization from the EMA in roughly two months' time. After winning an endorsement from the CHMP, prospective medicines must go before the European Commission for a final approval verdict.ExCellThera also plans to file for approval of Zemcelpro in the U.S., U.K. and other countries. Madrigal’s Rezdiffra among others gaining CHMP nodsThe committee has also given a thumbs up to Madrigal’s Rezdiffra for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), a disease where fat cells accumulate in the liver causing chronic inflammation. If the drug gains marketing authorization, it would become the first treatment in the EU for the condition. Fifteen months ago, Rezdiffra became the first drug approved for MASH in the U.S. Also making the grade this month was Teva blockbuster Austedo for patients with moderate-to-severe tardive dyskinesia. The FDA approved the treatment in the indication eight years ago. Tardive dyskinesia is an irreversible movement disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face, trunk and extremities and can be caused by medications used to treat mental health or gastrointestinal conditions.Meanwhile, Pfizer spinout SpringWorks Therapeutics has picked up a CHMP nod for Ogsiveo in adults with progressing desmoid tumors, which are marked by noncancerous soft tissue growths in the limbs and abdomen that often cause severe pain and disfigurement. The FDA approved Ogsiveo in the same indication in 2023.Also gaining a positive recommendation from the CHMP was Partner Therapeutics’ Imreplys for the treatment of patients exposed to myelosuppressive doses of radiation with hematopoietic sub-syndrome of acute radiation syndrome. The medicine is known as Leukine in the U.S. where it was approved in 2018. CHMP signs off on label expansions for 6 drugsAside from new approval recommendations, the CHMP has also endorsed labeled expansions for a half-dozen established medicines. The committee gave a thumbs up to Ipsen’s Cabometyx as a second-line treatment for patients with unresectable or metastatic, well differentiated extra-pancreatic (epNET) and pancreatic (pNET) neuroendocrine tumors. The FDA signed off Cabometyx in the indication three months ago. The treatment, which has been on the market since 2016, brought home sales of $1.8 billion last year.Also winning CHMP recommendations were Johnson & Johnson blockbusters Darzalex, for smoldering multiple myeloma, and Imbruvica, for patients with previously treated mantle cell lymphoma who would be eligible for autologous stem cell transplant. AbbVie partners with J&J on Imbruvica.The committee further signed off on expansions for GSK’s lupus treatment Benlysta, Bayer’s prostate cancer drug Nubeqa and Sanofi’s multiple myeloma medicine Sarclisa. CHMP opens re-examination of Lilly’s KisunlaElsewhere, fifteen months after giving a thumbs down to Eli Lilly’s Alzheimer’s disease treatment Kisunla in March of last year, the CHMP will give the medication a second look. The regulator said that it re-opened its examination of Kisunla on June 2. The FDA signed off on Kisunla in July of last year, opening up competition with Eisai and Biogen’s Alzheimer's rival Leqembi.

Drug ApprovalCell TherapyClinical Result

17 Jun 2025

·www.einpresswire.com

The End Brain Cancer Initiative Partners with Curis to Pre-qualify for PCNSL TakeAim Lymphoma Clinical Trial

The End Brain Cancer Initiative Partners with Curis to Promote Awareness and Pre-qualify for PCNSL TakeAim Lymphoma Clinical Trial REDMOND, WA, UNITED STATES, June 16, 2025 / EINPresswire.com / -- FOR IMMEDIATE RELEASE Contact: Dellann Elliott Mydland, 425-785-8489, Dellann@EndBrainCancer.org The End Brain Cancer Initiative Partners with Curis to Promote Awareness and Pre-qualify for PCNSL TakeAim Lymphoma Clinical Trial The End Brain Cancer Initiative (EBCI) has partnered with Curis to promote awareness and pre-qualify patients for the company’s TakeAim Lymphoma Clinical Trial (CA-4948-101) clinical trial, an open-label, dose escalation and expansion trial of Emavusertib in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL) (NCT03328078). “We are proud to partner with the End Brain Cancer Initiative to help raise awareness for primary CNS lymphoma (PCNSL), a rare and challenging form of cancer non-Hodgkin lymphoma. Together, we aim to highlight the unmet medical needs of this patient community, provide relevant resources to patients and their care providers, along with increasing awareness of clinical trials,” shared the Chief Medical Officer of Curis Inc, Ahmed Hamdy, MD. “Curis is committed to developing emavusertib for the treatment of PCNSL and broader non-Hodgkin lymphoma indications.” Patients who would like to learn more about this clinical trial and see if they qualify can visit https://endbraincancer.org/curis-therapeutics/ or contact the End Brain Cancer Initiative’s Clinical Research Coordinator and Patient Navigator, Shreya Prakash, at Shreya@EndBrainCancer.org or 425-436-8688. About Curis Curis, located in Lexington, Massachusetts, is a biotechnology company focused on the development of Emavusertib, an orally available, small molecule IRAK4 inhibitor. Emavusertib is currently being evaluated in the TakeAim Lymphoma Phase 1/2 study (CA-4948-101) in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) in combination with the BTK inhibitor ibrutinib, as a monotherapy in the TakeAim Leukemia Phase 1/2 study (CA-4948-102) in patients with relapsed/refractory acute myeloid leukemia (AML) and relapsed/refractory high risk myelodysplastic syndrome (hrMDS), and as a frontline combination therapy with venetoclax and azacitidine in patents with AML (CA-4948-104). Emavusertib has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of PCNSL, AML and MDS and from the European Commission for the treatment of PCNSL. Curis, through its 2015 collaboration with Aurigene, has the exclusive license to Emavusertib (CA-4948). Curis licensed its rights to Erivedge ® to Genentech, a member of the Roche Group, under which they are commercializing Erivedge ® for the treatment of advanced basal cell carcinoma. For more information, visit Curis's website at https://www.curis.com/ . About the End Brain Cancer Initiative To support/donate to the End Brain Cancer Initiative’s increased access and health delivery for patients, mission, services and programs, please visit EndBrainCancer.org The End Brain Cancer Initiative (EBCI) is a 501(c)3 non-profit patient advocacy organization focused on disease education, awareness, outreach, increasing patient access and improving Standard of Care. The End Brain Cancer Initiative, formerly known as the Chris Elliott Fund (CEF), is dedicated to ensuring that all patients diagnosed with brain cancer, a brain tumor, or metastatic disease to the brain have equal access to advanced diagnostics, treatments, specialists, and clinical trial participation. We believe that IMMEDIATE ACCESS to these options provides this patient community with the best HOPE for survival and sustained quality of life. We partner with industry, patients, researchers, advocacy groups, medical teams, hospital networks and others to educate patients and their caregivers so they can have empowered conversations with their medical teams. Learn more about the End Brain Cancer Initiative or how to sponsor this annual campaign at EndBrainCancer.org. Dellann Elliott Mydland, End Brain Cancer Initiative, 425-785-8489, Dellann@EndBrainCancer.org ### Dellann Elliott Mydland End Brain Cancer Initiative +1 425-785-8489 email us here Visit us on social media: LinkedIn Instagram Facebook YouTube X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 1Orphan DrugLicense out/inDrug Approval

12 Jun 2025

·www.prnewswire.com

4 Emerging Graft versus Host Disease Therapies That Could Change the Treatment Landscape | DelveInsight

Key companies, such as CSL Behring, Equillium, Biocon, and medac, are advancing their assets through late-stage graft versus host disease clinical trials, driving innovation in the graft versus host disease market and creating significant growth opportunities. LAS VEGAS, June 12, 2025 /PRNewswire/ -- Graft versus host disease (GvHD) is an immune-driven disorder caused by a complex interplay between the donor's and recipient's adaptive immune systems. It typically manifests in two main forms: acute (aGvHD) and chronic (cGvHD). As per DelveInsight's analysis, approximately 60,000 allogeneic transplants and around 55,000 GvHD cases occurred in the 7MM in 2024. These numbers are projected to grow at a notable CAGR over the forecast period from 2025 to 2034. Corticosteroids like prednisone and methylprednisolone are the primary first-line treatments, often combined with other immunosuppressants. Mild GcHD is managed with topical steroids, while systemic cases require stronger immunosuppressive therapy. Several treatments for GvHD have received FDA approval in the US, including ORENCIA (abatacept), JAKAFI/JAKAVI (ruxolitinib), IMBRUVICA (ibrutinib), and REZUROCK (belumosudil), among others. In the upcoming GvHD treatment market landscape, there are a plethora of companies investigating agents in various stages of development. To know more about the graft versus host disease clinical trials market, visit @ Graft versus Host Disease Market DelveInsight estimates that the market size for GvHD is expected to grow from USD 1.4 billion in 2024 with a significant CAGR of 8.2% by 2034. This anticipated growth is driven by advancements in treatment options, greater healthcare access, and a rising prevalence of the condition, which together foster higher demand for innovative and effective therapies. The current pipeline for graft versus host disease includes a range of drugs with diverse mechanisms of action (MoA). CSL964 (Alpha 1 Antitrypsin), EQ001 (Itolizumab; Bmab600), MaaT013, and MC0518 are the most promising drugs that are in the late-stage of development for GvHD treatment. Ongoing research and current trials have the potential to change the GvHD market. Keen to know how the GvHD market will evolve by 2034? Find out @ Graft versus Host Disease (GvHD) Market Forecast Apart from this, several GvHD drugs currently in the early stages of development include RLS-0071 by ReAlta Life Sciences, Vimseltinib by Deciphera Pharmaceuticals, ASC-930 by ASC Therapeutics, RGI-2001 by REGiMMUNE, CYP-001 by Cynata Therapeutics, arsenic trioxide (As2O3) by BioSenic (Medsenic), TRX103 (Tregs) by Tr1X, TCD601 (Siplizumab) by ITB-MED, F-652 by Evive Biotech, RHPRG4 by Lubris BioPharma, XBI302 by Xbiome, RG6287 by Genentech, ALTB-168 by AltruBio, and SER-155 by Seres Therapeutics. Now, let's examine the late-stage pipeline therapies under investigation for GvHD treatment CSL Behring's ZEMAIRA CSL964 Alpha-1 Antitrypsin, an Alpha1-Proteinase Inhibitor (A1-PI) developed by CSL Behring, is being studied for the treatment of steroid-refractory acute graft-versus-host disease (aGvHD) and for the prevention of aGvHD in high-risk patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). It is currently in Phase III clinical trials for the treatment of steroid-refractory aGvHD and is also being evaluated in Phase II/III trials for its potential in preventing aGvHD. Equillium/Biocon's EQ001 EQ001 (Itolizumab; Bmab600) is a first-in-class immune-modulating antibody that targets CD6 to suppress the activation and migration of harmful T cells responsible for releasing pro-inflammatory cytokines in autoimmune and inflammatory conditions such as GvHD, moderate-to-severe uncontrolled asthma, and lupus nephritis. By acting on the CD6-ALCAM signaling pathway, Itolizumab selectively inhibits pathogenic effector T cells (Teffs) while preserving regulatory T cells (Tregs), which are essential for immune system balance. Currently, EQ001 is undergoing a Phase III clinical trial in combination with corticosteroids as a first-line therapy for GvHD.In March 2025, Equillium reported topline Phase III EQUATOR trial results for itolizumab in first-line aGVHD. While the study did not show a meaningful difference in CR or ORR at Day 29 versus placebo, itolizumab demonstrated statistically significant and clinically meaningful improvements in longer-term outcomes, including CR at Day 99, duration of response, and failure-free survival. In April 2025, the FDA declined to grant Breakthrough Therapy designation or support an Accelerated Approval pathway for itolizumab, citing limitations in the EQUATOR study data. Discover which therapies are expected to grab major GvHD market share @ Graft versus Host Disease Treatment Market MaaT Pharma's MaaT013 MaaT013 is a standardized, donor-derived microbiome ecosystem therapy characterized by high richness and diversity. It includes BUTYCORE, a consortium of bacterial species known for producing anti-inflammatory short-chain fatty acids. The therapy is designed to reestablish the balance between the patient's gut microbiome and immune system, aiming to enhance immune tolerance and responsiveness, thereby addressing steroid-resistant, gastrointestinal-dominant aGvHD. MaaT013 has been granted Orphan Drug Designation (ODD) by both the US FDA and the EMA. In December 2024, MaaT Pharma shared encouraging updated results from its Early Access Program at the ASH 2024 Annual Meeting. Subsequently, in January 2025, the company announced promising topline findings from the Phase III ARES trial, where MaaT013 achieved a 62% overall gastrointestinal response rate by Day 28, marking a significant advancement as a third-line treatment for GI-aGvHD. medac's MC0518 MC0518 is an investigational mesenchymal stromal cell (MSC) therapy developed by Medac GmbH, currently undergoing clinical trials for the treatment of steroid-refractory acute graft-versus-host disease (SR-aGvHD) following allogeneic hematopoietic stem cell transplantation. This therapy leverages the immunomodulatory properties of MSCs to mitigate the severe inflammatory responses characteristic of SR-aGvHD, a condition where the donor's immune cells attack the recipient's tissues despite steroid treatment. The IDUNN trial, a pivotal Phase III study, is evaluating the efficacy and safety of MC0518 compared to the best available therapy (BAT) in pediatric and adolescent patients. The primary endpoint is the overall response rate (ORR) at Day 28, with secondary objectives including overall survival (OS) up to 24 months and freedom from treatment failure (FFTF) within six months. Preclinical assessments have demonstrated that MC0518 is well-tolerated, with no evidence of tumorigenicity or significant adverse effects in animal models. Discover more about drugs for GvHD in development @ Graft versus Host Disease Clinical Trials The anticipated launch of these emerging therapies for GvHD are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the GvHD market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight's latest published market report, titled as Graft versus Host Disease Market Insight, Epidemiology, and Market Forecast – 2034 , will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the GvHD country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The GvHD market report offers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total allogenic transplant cases Total Graft Versus Host Disease Cases Type-specific Cases of Graft Versus Host Disease Acute Graft Versus Host Disease Cases by Grading Acute Graft Versus Host Disease Cases by Organ Involvement Chronic Graft Versus Host Disease Cases by Grading Chronic Graft Versus Host Disease Cases by Organ Involvement Total Treated Cases of Graft Versus Host Disease Mortality Adjusted Treated Cases of Graft Versus Host Disease The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM GvHD market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this GvHD market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the GvHD market. Also, stay abreast of the mitigating factors to improve your market position in the GvHD therapeutic space. Related Reports Graft versus Host Disease Epidemiology Forecast Graft versus Host Disease Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted GvHD epidemiology in the 7MM, i.e., the United States, EU4 (Germany, Spain, Italy, France) and the United Kingdom, and Japan. Graft versus Host Disease Pipeline Graft versus Host 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 GvHD companies, including Abbisko Therapeutics, Equillium, Theriva Biologics, Seres Therapeutics, CytoMed Therapeutics, Beijing Tide Pharmaceutical, CTI BioPharma, ViGenCell, Lipella Pharmaceuticals, Cellestia Biotech, Seres Therapeutics, Jiangsu HengRui Medicine Therapeutics, Genentech, AltruBio, Orca Bio, GSK, Amgen , among others. Acute Graft versus Host Disease Pipeline Acute Graft versus Host 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 acute GvHD companies, including MaaT Pharma, Medac, CSL Behring, Humanigen, Ironwood Pharmaceuticals, ReAlta Life Sciences, Roche, Incyte Corporation , among others. Ocular Graft versus Host Disease Pipeline Ocular Graft versus Host 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 ocular GvHD companies, including Cambium Medical Technologies, Glia LLC., Ocular Discovery, Selagine , 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 ResultImmunotherapyBreakthrough TherapyOrphan Drug

100 Deals associated with Ibrutinib

External Link

KEGG	Wiki	ATC	Drug Bank
D10223	Ibrutinib	L01XE27	DB09053

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Lymphoplasmacytic Lymphoma	Japan	Janssen Pharmaceutical KK	23 Dec 2022
Marginal Zone B-Cell Lymphoma	United States	Pharmacyclics LLC	18 Jan 2017
Chronic graft-versus-host disease	Mexico	Janssen-Cilag SA de CV	01 Mar 2015
Small Lymphocytic Lymphoma	Mexico	Janssen-Cilag SA de CV	01 Mar 2015
Mantle cell lymphoma recurrent	European Union	Janssen-Cilag International NV	21 Oct 2014
Mantle cell lymphoma recurrent	Iceland	Janssen-Cilag International NV	21 Oct 2014
Mantle cell lymphoma recurrent	Liechtenstein	Janssen-Cilag International NV	21 Oct 2014
Mantle cell lymphoma recurrent	Norway	Janssen-Cilag International NV	21 Oct 2014
Mantle cell lymphoma refractory	European Union	Janssen-Cilag International NV	21 Oct 2014
Mantle cell lymphoma refractory	Iceland	Janssen-Cilag International NV	21 Oct 2014
Mantle cell lymphoma refractory	Liechtenstein	Janssen-Cilag International NV	21 Oct 2014
Mantle cell lymphoma refractory	Norway	Janssen-Cilag International NV	21 Oct 2014
Waldenstrom Macroglobulinemia	South Korea	Janssen Korea Ltd.	08 Aug 2014
Chronic Lymphocytic Leukemia	United States	Pharmacyclics LLC	12 Feb 2014
Mantle-Cell Lymphoma	United States	Pharmacyclics LLC	13 Nov 2013

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Waldenstrom's macroglobulinaemia recurrent	Phase 3	United Kingdom	Janssen-Cilag Ltd.	03 Feb 2020
Hepatitis B, Chronic	Phase 3	Hong Kong	Janssen LP	01 Nov 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	United States	Janssen Research & Development LLC	01 Jul 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	United States	Pharmacyclics LLC	01 Jul 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	Belgium	Janssen Research & Development LLC	01 Jul 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	Belgium	Pharmacyclics LLC	01 Jul 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	Brazil	Pharmacyclics LLC	01 Jul 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	Brazil	Janssen Research & Development LLC	01 Jul 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	Bulgaria	Janssen Research & Development LLC	01 Jul 2016
Refractory Mature B-Cell Non-Hodgkin Lymphoma	Phase 3	Bulgaria	Pharmacyclics LLC	01 Jul 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


RESONATE-2; ELEVATE-TN; SEQUOIA (ASCO2025)	Phase 3	Chronic Lymphocytic Leukemia First line	537	Ibrutinib	gbxiwbfzlv(uigdgqojep) = uopikazwjd tylpdapglt (rqesnfczjf, 75.6 - 92.1) View more	Positive	30 May 2025
				Acalabrutinib	gbxiwbfzlv(uigdgqojep) = axnxmjfxjn tylpdapglt (rqesnfczjf, 67.5 - 81.1) View more
NCT03112174 (SYMPATICO, ASCO2025)	Phase 3	Mantle-Cell Lymphoma First line	78	Ibrutinib 560 mg + Venetoclax 400 mg	qftszkrbmw(efcidabqnm) = hdsucziddj fhnbljgojf (mqerdcswzl, 87 - 99) View more	Positive	30 May 2025
NCT02910583 (CAPTIVATE, ASCO2025)	Phase 2	Small Lymphocytic Lymphoma First line del(17p) \| unmutated IGHV \| mutated IGHV ... View more	202	Ibrutinib + Venetoclax	epixmoovje(dbuxrwvkue) = occurred in 24 pts across the entire study period, including 12 initial treatment and 4 retreatment TEAEs aeatrpugok (euykqjikrr )	Positive	30 May 2025
NCT04802590 (OASIS II, ASCO2025)	Phase 2	Mantle-Cell Lymphoma	102	Ibrutinib/CD20mAb	zmvqgxmbkc(oojvivhldl) = dumqpgxcsu hhjrygvixq (zlmbicegib, 42.4% - 65%) View more	Positive	30 May 2025
				Ibrutinib/CD20mAb/Venetoclax	zmvqgxmbkc(oojvivhldl) = buhhxlrnzf hhjrygvixq (zlmbicegib, 71.7% - 89.7%) View more
RESONATE-2, ELEVATE-TN, SEQUOIA (EHA2025)	Phase 3	Chronic Lymphocytic Leukemia First line	537	Ibrutinib	marrtriedk(ldxifxcqke) = iizbqgzluh eqzbjjexez (enxfggdelo, 75.6 - 92.1) View more	Positive	22 May 2025
				Acalabrutinib	marrtriedk(ldxifxcqke) = ydjiheohvk eqzbjjexez (enxfggdelo, 67.5 - 81.1) View more
SYMPATICO (EHA2025)	Phase 3	Mantle-Cell Lymphoma First line TP53 mutation	78	Ibrutinib 560 mg + Venetoclax 400 mg	uubmipdrdr(oabddephok) = tskxrzabzj qnqrmmboao (qyftkxqhci ) View more	Positive	22 May 2025
CAPTIVATE (EHA2025)	Phase 2	Chronic Lymphocytic Leukemia \| Small Lymphocytic Lymphoma First line unmutated IGHV \| mutated IGHV \| uMRD4	202	Ibrutinib + Venetoclax	absdsdvfpl(lancqbwsom) = 24 patients across the entire study period, including 12 initial treatment and 4 retreatment treatment-emergent adverse events pzqydyieka (ttwakatibv )	Positive	22 May 2025
PB3301 (EHA 12025 \| EHA 22025)	Not Applicable	Diffuse Large B-Cell Lymphoma c-myc \| Bcl-6 \| TP 53 ... View more	14	R-CHOP-lenalidomide-ibrutinib therapy	uhdgdpwwej(uyjtshluqu) = znzypsqixh ygzrqmxmxr (wmnraimauf ) View more	Positive	14 May 2025
				R-mini-CHOP-lenalidomide-ibrutinib therapy	rmfdqfdgim(jvwbpgjwco) = tysayvddee lmeeyyghbz (cgtlobyhxm )
GAIA/CLL13 (EHA2025)	Phase 3	Chronic Lymphocytic Leukemia unmutated IGHV \| mutated IGHV	926	Venetoclax-Obinutuzumab	fdvivkuqbx(wcmzhxlbjy) = oiskqhveib tqsdfoeqal (cqpdscoehr ) View more	Positive	14 May 2025
				Venetoclax-Ibrutinib-Obinutuzumab	fdvivkuqbx(wcmzhxlbjy) = dzdguehqbw tqsdfoeqal (cqpdscoehr ) View more
PB2691 (EHA2025)	Not Applicable	Chronic Lymphocytic Leukemia TP53-mutated	-	Ibrutinib	ppqqkahlji(msghdgqspk) = 67.20 μM vs. 144 μM IC50, p<0.01 qhwrqbrxdu (qhhutqnxbs )	-	14 May 2025
				Curcumin

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