By: IPP Bureau
Last updated : December 12, 2025 11:19 am
The Phase-2b study is a randomized, double-blind, placebo-controlled trial that will enroll approximately 195 patients across 35 sites in the USA
Suven Life Sciences Limited, a clinical-stage biopharmaceutical company focused on discovering and developing innovative treatments for Central Nervous System (CNS) disorders, announced that its Phase-2b clinical trial of Ropanicant, a nicotinic α4β2 receptor antagonist for treating Major Depressive Disorder (MDD) has successfully achieved its 100% patient enrolment milestone of anticipated randomization, more than two months ahead of schedule. This study is conducted exclusively in USA.
The Phase-2b study is a randomized, double-blind, placebo-controlled trial that will enroll approximately 195 patients across 35 sites in the USA for a treatment duration of six weeks. The study will evaluate the efficacy and safety of Ropanicant in patients with MDD, compared to placebo, in improving symptoms of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS).
In less than six months from study initiation, the trial successfully reached its full enrollment target of 195 patients for randomization. The pace of recruitment underscores the strong engagement from both investigators and participating patients.
Safety data from the study is being monitored continuously, with no significant concerns observed to date.
Suven anticipate topline efficacy and safety results in May 2026.
"I am deeply grateful to the patients, caregivers, investigators, and our clinical development team for their exceptional commitment in helping us achieve this milestone so rapidly. Together, we are advancing an important scientific effort to evaluate the potential of Ropanicant in patients with MDD. This collective progress moves us closer to delivering new therapeutic options that can meaningfully improve patient lives," said Venkat Jasti, Chairman and Managing Director of Suven Life Sciences.
"Today's milestone represents another exciting step forward as we advance the investigation of Ropanicant in patients with MDD. We reached 100% patient enrolment milestone approximately six months from study initiation, reflecting the high interest from patients and physicians in a potential treatment option with novel mechanism of action. If positive, ropanicant has a potential to transform the lives of people affected by MDD and those around them. Our focus remains on advancing the program efficiently, and we look forward to presenting outcome of this trial by May 2026" said Dr. Ramakrishna Nirogi, President and CSO of Suven Life Sciences.