Bajaj Healthcare Secures CDSCO Nod for Phase III Trials of Epilepsy Drug Cenobamate

Bajaj Healthcare Ltd. announced today that it received formal approval from CDSCO’s Subject Expert Committee (SEC) to proceed with Phase III clinical trials for Cenobamate Tablets (12.5mg–200mg), an anti-seizure medication targeting drug-resistant focal-onset epilepsy in adults. The trials will assess efficacy, safety, and tolerability across diverse patient groups, with emphasis on recruiting government sites and establishing an independent data monitoring board. The company plans to manufacture the API in-house and aims for commercial launch post-trial success. Managing Director Anil Jain highlighted the milestone as critical to addressing India’s growing demand for advanced epilepsy treatments.

 

Sources: NSE Filing, CDSCO Meeting Documents