Clinical Trials
17
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
2
11.8%
Completed
9
52.9%
No Longer Available
2
11.8%
Recruiting
4
23.5%
No approval data available
- Ropanicant 45 mg twice-daily met the primary endpoint with a clinically meaningful MADRS score improvement versus placebo at Week 6 (ML-estimated mean difference: -3.572, p=0.038). - Secondary endpoints including the Sheehan Disability Scale (p=0.039) also showed evidence of treatment benefit, with CGI-S and QLDS trending favorably. - Ropanicant was generally well tolerated, with most adverse events mild to moderate and no unexpected safety signals identified. - Suven plans to engage global regulatory authorities to discuss Phase 3 clinical development plans for Ropanicant in MDD.
- Suven Life Sciences achieved 100% patient enrollment in its Phase 2b trial of Ropanicant for major depressive disorder, completing recruitment of 195 patients more than two months ahead of schedule. - The randomized, double-blind, placebo-controlled trial is evaluating the nicotinic α4β2 receptor antagonist across 35 US sites over six weeks of treatment. - Safety monitoring has shown no significant concerns to date, with topline efficacy and safety results expected by May 2026. - The rapid enrollment pace reflects strong interest from patients and physicians in this novel mechanism of action for treating depression.
- Anthem Biosciences, a Contract Research, Development, and Manufacturing Organization (CRDMO), is launching a ₹3,395 crore IPO from July 14-16 with shares priced at ₹540-570 each. - The company reported strong financial performance with revenue growing 30% year-on-year to ₹1,844 crore in FY25 and profit after tax increasing 23% to ₹451 crore. - The IPO is entirely an offer for sale by existing shareholders, meaning no proceeds will go to the company for expansion or operations. - Anthem operates integrated pharmaceutical services from drug discovery to manufacturing, specializing in complex fermentation-based APIs including probiotics, enzymes, and biosimilars.
• Suven Life Sciences has dosed the first subjects in a Phase 1 clinical trial of SUVN-I6107 for cognitive disorders. • The Phase 1 trial is a randomized, double-blind, placebo-controlled study to assess safety, tolerability, pharmacokinetics, and pharmacodynamics. • SUVN-I6107 is a novel, potent, and selective muscarinic M1 positive allosteric modulator, showing efficacy in animal models. • The trial is being conducted in the US under FDA acceptance of an Investigational New Drug application.
• Suven Life Sciences announced positive results from its Phase 2a proof-of-concept study of Ropanicant (SUVN-911) in patients with moderate to severe Major Depressive Disorder (MDD). • Ropanicant, an α4β2 nicotinic acetylcholine receptor (nAChR) antagonist, demonstrated promising safety and efficacy outcomes in the open-label Phase 2a study. • Suven plans to advance Ropanicant into a double-blind, placebo-controlled Phase 2b clinical study in MDD patients, anticipated to start in early 2025. • The company will present these findings at the upcoming Neuroscience 2024 conference, highlighting its portfolio of new chemical entities.
