Bajaj Healthcare gets phase III trial nod for insomnia drug Suvorexant

Bajaj Healthcare Limited announced on October 4, 2025, that it has received a positive recommendation from the Subject Expert Committee (SEC) (Neurology & Psychiatry) of the Central Drugs Standard Control Organisation (CDSCO). This permits the company to initiate Phase III clinical trials for Suvorexant Tablets, available in strengths of 5mg, 10mg, 15mg, and 20mg.

This marks Bajaj Healthcare as the first company in India to secure regulatory approval for Suvorexant, a prescription medication for adult insomnia. The Phase III trials will assess the efficacy, safety, and tolerability of Suvorexant, a crucial step before marketing authorization in selected markets.

Anil Jain, managing director of Bajaj Healthcare Limited, expressed confidence in the company's R&D and manufacturing capabilities, aiming to deliver high-quality CNS solutions. The development strengthens their neurology portfolio and aligns with their strategy to address unmet medical needs in chronic and lifestyle-related disorders.