Business Update4 Oct 2025, 01:11 pm
Bajaj Healthcare Secures SEC-CDSCO Nod for Phase III Clinical Trials of Suvorexant Tablets
AI Summary
Bajaj Healthcare Limited has received a positive recommendation from the Subject Expert Committee (SEC) (Neurology & Psychiatry) of the Central Drugs Standard Control Organisation (CDSCO) to initiate Phase III clinical trials for Suvorexant Tablets, available in strengths of 5mg, 10mg, 15mg, and 20mg. This marks a pioneering step for the company, being the first in India to receive this regulatory nod for Suvorexant. The upcoming trials will evaluate the efficacy, safety, and tolerability of Suvorexant in a diverse patient population. Upon successful completion, Bajaj Healthcare intends to pursue marketing authorization in select markets.
Key Highlights
- Bajaj Healthcare received a positive recommendation from the SEC (Neurology & Psychiatry) of CDSCO for Phase III clinical trials of Suvorexant Tablets.
- Suvorexant is a prescription medication used to treat insomnia in adults.
- Bajaj Healthcare is the first company in India to receive regulatory nod for Suvorexant.
- The Phase III trials will evaluate the efficacy, safety, and tolerability of Suvorexant.
- Upon successful completion, Bajaj Healthcare intends to pursue marketing authorization in select markets.