Shares of Bajaj Healthcare Ltd climbed 2.88% to Rs 498 in Monday’s early session after the company announced a major regulatory milestone. The firm 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 its insomnia drug Suvorexant Tablets in India.
The trials will cover tablet strengths of 5 mg, 10 mg, 15 mg, and 20 mg, marking Bajaj Healthcare’s first such approval in this drug category. The company is also the first in India to secure regulatory clearance for Suvorexant, reflecting strong progress in its central nervous system (CNS) research portfolio.
Suvorexant is used globally for the treatment of insomnia, acting on the central nervous system to regulate the sleep-wake cycle and improve sleep onset and maintenance. The upcoming Phase III trials will assess its efficacy, safety, and tolerability across a larger patient group — a critical step before seeking marketing authorisation.
Managing Director Anil Jain said the company is “encouraged by the SEC’s recommendation” and remains focused on bringing Suvorexant through the final development stages. He highlighted Bajaj Healthcare’s GMP-compliant manufacturing and robust R&D infrastructure, emphasizing the firm’s commitment to delivering innovative CNS solutions.
At the time of writing, Bajaj Healthcare shares were up Rs 13.95, trading at Rs 498 on the NSE, with an intraday high of Rs 506.45 and a market capitalization of Rs 15,670 crore.
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