Suven Life Sciences Begins Phase-2B Trial for Ropanicant in MDD, Marks Key Milestone in CNS Drug Development

Image Source: Suven Life Sciences

Suven Life Sciences Ltd has announced the randomization of the first patient in its Phase-2B clinical trial for Ropanicant (SUVN-911), a novel α4β2 nAChR antagonist being developed for moderate to severe Major Depressive Disorder (MDD). The trial represents a critical step in validating the drug’s safety and efficacy following promising Phase-2A results.

Key Highlights:

The Phase-2B trial is a multicenter, randomized, open-label study across 10 sites in the US.
Approximately 36 patients will be enrolled, meeting DSM-5 criteria for MDD without psychotic features.
Patients are randomized into three dosing arms: 45 mg once daily, 30 mg twice daily, and 45 mg twice daily.
The primary objective is to assess safety and tolerability; secondary endpoints include changes in MADRS scores at Week 2.

Strategic Context:

Ropanicant has shown rapid onset of action, pro-cognitive effects, and no sexual dysfunction in earlier studies.
The compound’s intellectual property is secured across major global markets.
Suven aims to present topline data by October 2024, with potential progression to Phase-3 contingent on results.

Market Outlook:

The trial underscores Suven’s commitment to CNS innovation, with Ropanicant positioned to address unmet needs in depression treatment.
Investors remain cautiously optimistic, with the stock trading flat post-announcement amid broader market volatility.

Sources: Express Pharma, MarketScreener, Share Bazaar, The Hindu BusinessLine, Suven Life Sciences Corporate Filings (July 2025)