Bajaj Healthcare gets CDSCO nod for phase III trials of suvorexant tablets for insomnia

Bajaj Healthcare Ltd on Saturday (October 4) said it has received approval from the Subject Expert Committee (SEC) (Neurology & Psychiatry) of the Central Drugs Standard Control Organisation (CDSCO) to conduct Phase III clinical trials of Suvorexant Tablets in India. The trials will be conducted for tablet strengths of 5 mg, 10 mg, 15 mg, and 20 mg.

The company is the first in India to secure this regulatory clearance for Suvorexant, marking a significant milestone in its drug development journey.

Suvorexant is a prescription drug used for treating insomnia in adults. It acts on the central nervous system to regulate the sleep-wake cycle, helping patients achieve better sleep onset and maintenance.

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The upcoming Phase III clinical trials will assess the efficacy, safety, and tolerability of Suvorexant across a broad patient base. This will be the final stage before regulatory submission. Upon successful completion, Bajaj Healthcare plans to seek marketing authorisation in select markets and move toward commercial launch.

Anil Jain, Managing Director, Bajaj Healthcare, said, "We are encouraged by the SEC’s recommendation and remain committed to advancing Suvorexant through the final stages of clinical development.

With our robust R&D infrastructure and GMP-compliant manufacturing capabilities, we are confident in our ability to deliver high-quality, impactful CNS solutions to patients worldwide."

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Shares of Bajaj Healthcare Ltd ended at ₹482.60, up by ₹2.95, or 0.62%, on the BSE.