Suven Life Sciences Achieves 100% Patient Enrolment for MDD Phase-2b Trial Months Ahead of Schedule

Suven Life Sciences Limited, a biopharmaceutical company specialising in Central Nervous System (CNS) disorders, has achieved a significant milestone by completing 100% patient enrolment in its Phase-2b clinical trial of Ropanicant for Major Depressive Disorder (MDD), more than two months ahead of schedule. The randomised, double-blind, placebo-controlled study is being conducted across 35 sites in the USA, aiming to enrol approximately 195 patients for a six-week treatment duration. Ropanicant, a nicotinic α4β2 receptor antagonist, is being evaluated for its efficacy and safety in improving MDD symptoms, with the primary measure being the Montgomery-Asberg Depression Rating Scale (MADRS). The rapid recruitment pace highlights strong engagement from both investigators and participating patients.

The successful completion of enrolment sets the stage for the next milestones in the trial's timeline. The Last Patient Out (LPO) is anticipated by the end of February 2026, marking the conclusion of the patient treatment period. Following this, Suven Life Sciences expects the topline efficacy and safety results to be readout by May 2026. Safety data from the study are being continuously monitored, and to date, no significant safety concerns have been observed. This progress brings the company closer to potentially introducing a new therapeutic option for patients suffering from MDD.

About the Company

Suven Life Sciences Limited (Suven) is a biopharmaceutical company dedicated to the discovery and clinical development of novel medicines for Central Nervous System (CNS) disorders and other unmet medical needs, including Alzheimer’s disease (AD), Parkinson’s disease (PD), Major Depressive Disorder (MDD), and sleep disorders. The company maintains a robust pipeline featuring five advanced clinical-stage assets. Key candidates include Masupirdine (SUVN-502), currently in a Global Phase-3 study for agitation in Alzheimer's dementia; Samelisant (SUVN-G3031), being advanced for excessive daytime sleepiness in narcolepsy; and Ropanicant (SUVN-911), undergoing a Phase-2b study for MDD. Beyond its clinical assets, Suven holds full intellectual property rights for its drugs in major markets and continues to invest in seven additional research programs across multiple indications.

This small-cap company has a market cap of Rs 3,806 crore with zero debt. The stock is up over 70 per cent from its 52-week low of Rs 102.70 per share with multibagger returns of 170 per cent in 3 years.

Disclaimer: The article is for informational purposes only and not investment advice.