Suven Life Sciences Announces First Patient Randomized in Phase-2b Trial

Suven Life Sciences announced that the first patient has been randomized in its Phase-2b clinical trial evaluating Ropanicant for the treatment of Major Depressive Disorder (MDD). The Phase-2b study is being conducted exclusively in the USA under US FDA IND, with topline data expected in the second half of 2026.

The Phase-2b double-blinded, placebo-controlled study builds on the positive results of the completed Phase-2a trial, which demonstrated favorable safety and significant improvement in depressive symptoms. The study will enroll approximately 195 patients across 35 sites in the USA for a treatment duration of six weeks and will evaluate the efficacy and safety of Ropanicant in patients with major depressive disorder, compared to placebo, in improving symptoms of depression as measured by the MADRS.

Mr. Venkat Jasti, Chairman and MD of Suven Life Sciences, stated that this milestone reflects the company's commitment to developing innovative treatments for patients suffering from MDD. Mr. Ramakrishna Nirogi, Ph. D., President & Chief Scientific Officer of Suven Life Sciences, added that Ropanicant's unique mechanism of action as an a4ẞ2 antagonist, combined with its rapid onset, no sexual side effects, and potential pro-cognitive benefits, positions it as a differentiated clinical candidate for the treatment of MDD.

Ropanicant (SUVN-911) is a novel, potent, and selective a4ẞ2 nAChR antagonist being developed for the treatment of MDD. It has shown robust efficacy in various animal models of depression and may overcome limitations of existing treatments by providing a rapid onset of action, avoiding sexual dysfunction, and enhancing cognitive functions.

Suven Life Sciences has a portfolio of advanced-stage clinical candidates and research programs designed for CNS disorders, including Alzheimer's disease (AD), Sleep disorders, Parkinson's disease (PD), Schizophrenia, Pain disorders, and Gastrointestinal disorders. The company has 5 clinical-stage assets across focus areas.