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Ulcerative Colitis Clinical Trials And Studies 2025: EMA, PDMA, FDA Approvals, Mechanism Of Action, ROA, NDA, IND, And Companies
DelveInsight's, "Ulcerative Colitis Pipeline Insight 2025" report provides comprehensive insights about 70+ companies and 75+ pipeline drugs in Ulcerative Colitis Pipeline Landscape. It covers the Ulcerative Colitis pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Ulcerative Colitis therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
Explore the comprehensive insights by DelveInsight and stay ahead in understanding the Ulcerative Colitis Treatment Landscape. Click here to read more @ Ulcerative Colitis Pipeline Outlook
Key Takeaways from the Ulcerative Colitis Pipeline Report
Discover groundbreaking developments in Ulcerative Colitis therapies! Gain in-depth knowledge of key Ulcerative Colitis clinical trials, emerging drugs, and market opportunities @ Ulcerative Colitis Clinical Trials Assessment
Ulcerative Colitis Emerging Drugs Profile
Obefazimod is an oral small-molecule drug candidate in clinical development for the treatment of moderately to severely active ulcerative colitis (UC) and has demonstrated anti-inflammatory activity in preclinical studies and in both Phase IIa and Phase IIb clinical trials. Currently, the drug is in Phase III stage of its clinical trial for the treatment of ulcerative colitis.
ABBV-668 is under development for the treatment of crohn's disease, unspecified immunological disorders and ulcerative colitis. The drug candidate acts by targeting receptor interacting serine/threonine protein kinase 1 (RIPK1). It is administered through oral route. Currently, the drug is in Phase II stage of its clinical trial for the treatment of ulcerative colitis.
Anti-TL1A (TEV-'574) is a potentially best-in-class human IgG1 monoclonal antibody that targets tumor necrosis factor (TNF)-like ligand 1A (TL1A), also known as TNF superfamily member 15. TL1A signaling is believed to amplify inflammation and drives fibrosis associated with asthma and inflammatory bowel disease (IBD); thus, targeting TL1A with TEV-'574 may mitigate the over-active immune response in these conditions. Anti-TL1A (TEV-'574) is currently in Phase 2b clinical trials for the treatment of ulcerative colitis (UD) and Crohn's disease (CD), two types of inflammatory bowel disease. The safety and efficacy of anti-TL1A (TEV-'574) have not been reviewed by any regulatory authority. Currently, the drug is in Phase II stage of its clinical trial for the treatment of ulcerative colitis.
SOR102 combines anti-TNF and anti-IL-23 vorabodies into a single dual-acting molecule a trypsin cleavable linker releases the monomers to independently engage their targets throughout intestinal tissue. SOR102 provides combination therapy locally within inflamed tissue with minimal risk of systemic immunosuppression. Overall benefits of dual targeting approach increased efficacy through blockade of different inflammatory mechanisms of IBD. Currently, the drug is in Phase I stage of its clinical trial for the treatment of ulcerative colitis.
The Ulcerative Colitis Pipeline Report Provides Insights into
Stay informed about the Ulcerative Colitis pipeline trends! Uncover critical updates on therapeutic innovations and their potential impact on patients and the healthcare industry @ Ulcerative Colitis Unmet Needs
Ulcerative Colitis Companies
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, and others.
Ulcerative Colitis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.
Ulcerative Colitis Products have been categorized under various Molecule types such as
Transform your understanding of the Ulcerative Colitis Pipeline! See the latest progress in drug development and clinical research @ Ulcerative Colitis Market Drivers and Barriers, and Future Perspectives
Scope of the Ulcerative Colitis Pipeline Report
"Stay Ahead in Gastroenterology Research–Access the Full Ulcerative Colitis Pipeline Analysis Today! @ Ulcerative Colitis Drugs and Companies
Table of Content
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J&J, Merck And Lilly To Collaborate On Clinical Trials Database
Hannah Blake
pharmaphorum
J&,J's Janssen, has announced its plans to collaborate with Merck and Lilly to establish a global cross-pharmaceutical database, designed to improve efficiencies of industry-sponsored clinical trials.
The initiative, called Investigator Databank, will serve as a one-stop repository where key information about clinical trial sites, such as infrastructure and Good Clinical Practice (GCP) training records, is housed. The aim is to allow pharma to reduce time-consuming, and sometimes redundant, administrative tasks involved in identifying appropriate clinical trial sites. The databank will not include any patient data.
"The current clinical trial environment is inefficient, costly and unsustainable. The Investigator Databank can help expedite the process to achieve our most important goal – to deliver high-quality, effective novel medicines to the patients who are waiting for them. We are enthusiastic about working with other industry leaders to collectively apply our expertise, capabilities and shared passion for advancing science and improving lives."
Andreas Koester, MD, PhD, Head, Clinical Trial Innovation/External Alliances, Janssen Research &, Development.
As many as 10,000 clinical investigators have been putting in their data into the Investigator Databank in order to collect feedback on the process, which was limited to just the three big pharma companies while still in initial stages. Now, Janssen, Merck and Lilly are inviting other pharma companies to add their own information to the databank.
This Janssen-led project will serve as a foundation for the TransCelerate BioPharma Inc initiative, which was launched earlier this year. TransCelerate is a collaboration of ten pharma companies, which aims to identify and overcome common drug development challenges in order to improve the quality of clinical studies and to bring new medicines to patients faster.
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Related news:
Drugmakers collaborate to facilitate drug tests (Bloomberg Businessweek)
Drugmakers collaborate on database aimed at facilitating experimental drug testing process (Washington Post)
Reference links:
J&,J press release
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Merck Shares Results From Phase III Clinical Trial Of Winrevair In Pulmonary Arterial Hypertension
Winrevair (sotatercept-csrk), compared to placebo, reduced the risk of all-cause death, lung transplantation, and hospitalization.
Image Credit: © photon_photo - stock.Adobe.Com
Merck has announced positive results from the Phase III ZENITH clinical trial of Winrevair (sotatercept-csrk) for the treatment of patients with pulmonary arterial hypertension (PAH) functional class (FC) III or IV at high risk of mortality who were on maximum tolerated background PAH therapy. According to the results, Winrevair reduced the relative risk of major morbidity and mortality events.1
In the study, Winrevair reduced the risk of a composite of all-cause death, lung transplantation, and hospitalization. For patients treated with the therapy, only 17.4% experienced one or more major morbidity and mortality events compared to 54.7% in the placebo arm.
In a press release, Marc Humbert, MD, PhD, department of respiratory and intensive care medicine Hospital Bicêtre (AP-HP), University Paris-Saclay and Inserm Unit 999 said: "The ZENITH study represents the first PAH clinical trial with a primary endpoint comprised entirely of major outcome measures—all-cause death, lung transplantation and hospitalization for PAH. Winrevair had a significant and clinically meaningful impact on the composite of these outcomes, and together with the growing body of evidence from the clinical development program, these data support the practice-changing potential of Winrevair for a broad range of patients with PAH."
According to Merck, this trial was stopped early due to overwhelming efficacy demonstrated in the primary endpoint. As a result, the key secondary endpoint of overall survival did not reach its heightened mark that was required to establish statistical significance at the interim analysis.
"The impressive results from ZENITH demonstrated that patients on Winrevair had a 76 percent risk reduction in the composite of all-cause death, lung transplantation and hospitalization for PAH compared to placebo, with improvement observed early in treatment and increasing benefit throughout the study," Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said in the press release. "These results led to the ZENITH study being the first PAH clinical trial stopped early due to overwhelming efficacy, representing an important milestone in clinical research with promise for the PAH community."
Earlier in January, Merck announced it had ended another Phase III trial of Winrevair early. The HYPERION study, evaluating Winrevair in recently diagnosed adults with PAH FC II or III at intermediate or high risk of disease progression, was concluded after positive data emerged from ZENITH's interim analysis as well as a review of the totality of data from the Winrevair clinical program to date. Patients will now be able to receive Winrevair through the SOTERIA open-label extension study.2
In an earlier press release, Barr said: "Based on the strong, positive interim efficacy data from the ZENITH trial, as well as the totality of available WIinrevair data, we concluded that it would not be ethical to continue the HYPERION study. We are grateful to the dedicated community of patients who participated in these studies and are pleased to offer the option of receiving Winrevair through the Phase III SOTERIA open-label extension study."
Merck plans to share results from the HYPERION study later this year.
1. WINREVAIR™ (sotatercept-csrk) Reduced the Risk of a Composite of All-Cause Death, Lung Transplantation and Hospitalization for Pulmonary Arterial Hypertension (PAH) by 76% Compared to Placebo in the Phase 3 ZENITH Trial. News release. Merck. March 31, 2025. Accessed April 1, 2025. Https://www.Merck.Com/news/winrevair-sotatercept-csrk-reduced-the-risk-of-a-composite-of-all-cause-death-lung-transplantation-and-hospitalization-for-pulmonary-arterial-hypertension-pah-by-76-compared-to-placebo-i/
2. Merck Announces Decision to Stop Phase 3 HYPERION Trial Evaluating WINREVAIR™ (sotatercept-csrk) Early and Move to Final Analysis. News release. Merck. January 30, 2025. Accessed April 1, 2025. Https://www.Merck.Com/news/merck-announces-decision-to-stop-phase-3-hyperion-trial-evaluating-winrevair-sotatercept-csrk-early-and-move-to-final-analysis/
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