Clinical Trials
14
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
1
7.1%
Completed
8
57.1%
Not yet recruiting
1
7.1%
Terminated
4
28.6%
No approval data available
- vTv Therapeutics has amended its license agreement with Newsoara Biopharma to grant exclusive worldwide rights to develop and commercialize HPP737, a novel PDE4 inhibitor for inflammation-mediated diseases. - The expanded partnership includes a $20 million upfront payment, with potential milestone payments totaling up to $115 million plus tiered royalties on net sales. - HPP737 demonstrates improved tolerability compared to existing PDE4 inhibitors, showing little to no gastrointestinal distress in Phase 1 studies while maintaining potent anti-inflammatory activity. - The deal transforms a regional collaboration into a global partnership, allowing Newsoara to leverage its development capabilities across multiple markets including China, U.S., and Australia.
- vTv Therapeutics and M42's IROS have submitted a Phase 2 clinical study protocol to UAE health authorities to evaluate cadisegliatin as an oral adjunctive therapy to insulin in type 2 diabetes patients. - The 12-month, placebo-controlled trial will enroll approximately 300 patients across UAE, Jordan, and Tunisia, representing the longest cadisegliatin study to date. - Participants will be randomized to receive either 400 mg or 800 mg of cadisegliatin once daily or placebo, with the first patient visit expected in Q1 2026. - The study targets a critical unmet need in the Middle East, where type 2 diabetes prevalence among UAE nationals is among the highest globally.
- vTv Therapeutics secured $80 million in PIPE financing from healthcare institutional investors and the T1D Fund to advance development of cadisegliatin, a potential first-in-class oral adjunctive therapy for type 1 diabetes. - The funding will support the ongoing CATT1 Phase 3 trial evaluating cadisegliatin's ability to reduce hypoglycemic events and improve glycemic control in type 1 diabetes patients. - Cadisegliatin is a novel liver-selective glucokinase activator that has received FDA Breakthrough Therapy designation, with topline Phase 3 results expected in the second half of 2026. - The financing includes participation from existing investors Samsara BioCapital and the T1D Fund, as well as new investors Trails Edge Capital Partners and Invus.
- A comprehensive pipeline analysis reveals over five companies developing RAGE inhibitors across multiple clinical stages, with promising applications in chronic inflammatory diseases and neurodegenerative disorders. - vTv Therapeutics leads the field with azeliragon in Phase II trials targeting Alzheimer's disease and glioblastoma, demonstrating the therapeutic potential of blocking RAGE-ligand interactions. - RAGE inhibitors show clinical promise in diabetic nephropathy, atherosclerosis, and neurodegenerative conditions by halting inflammatory pathways through receptor blockade. - The emerging therapeutic class faces development challenges including target specificity and off-target effects, but ongoing research continues to optimize selectivity and safety profiles.
- DelveInsight's 2025 report reveals over 200 companies are actively developing more than 200 pipeline therapies for diabetes treatment, indicating a highly competitive and innovative landscape. - Several promising late-stage candidates are advancing through Phase III trials, including Cadisegliatin (vTv Therapeutics) for type 1 diabetes and Insulin efsitora alfa (Eli Lilly) as a once-weekly basal insulin. - Recent clinical trial announcements from major pharmaceutical companies demonstrate continued investment in diabetes research, with studies comparing novel formulations and combination therapies. - The pipeline encompasses diverse therapeutic approaches including liver-selective glucokinase activators, ultra-rapid-acting insulin analogs, and oral GLP-1 receptor agonists targeting different aspects of diabetes management.
- FDA has lifted the clinical hold on vTv Therapeutics' cadisegliatin program, allowing the CATT1 Phase 3 trial for type 1 diabetes to resume after addressing concerns about a chromatographic signal. - The company plans to amend the protocol to shorten the trial duration from 12 to 6 months, expediting topline data collection while maintaining the original primary endpoint of measuring hypoglycemia rates. - Cadisegliatin, a liver-selective glucokinase activator, has potential to become the first oral adjunctive therapy to insulin for type 1 diabetes, having been well-tolerated in over 500 subjects to date.
