Zydus Gets CDSCO Panel Nod for Phase III Trial of Dextromethorphan, Phenylephrine Cough Syrup FDC
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has granted permission to Zydus Healthcare Limited to conduct a Phase III clinical trial for its fixed-dose combination syrup containing Dextromethorphan Hydrobromide IP 10 mg and Phenylephrine Hydrochloride IP 5 mg per 5 ml.
The decision follows the Committee’s earlier recommendation dated July 9, 2025, after which Zydus Healthcare presented their proposal along with revised Phase III clinical trial protocol before the committee.
Dextromethorphan is an NMDA receptor antagonist used to treat cases of dry cough.It is a low-affinity uncompetitive NMDA antagonist and sigma-1 receptor agonist. It is also an antagonist of α3/β4 nicotinic receptors. However, the mechanism by which dextromethorphan's receptor agonism and antagonism translate to a clinical effect is not well understood.
Phenylephrine is an alpha-1 adrenergic agonist used in the management of hypotension, generally in the surgical setting associated with the use of anesthetics.
At the recent SEC meeting for pulmonary drugs, the expert panel reviewed Zydus Healthcare's proposal along with the revised Phase III clinical trial protocol.
After detailed deliberation, the committee recommended for the grant of permission to conduct the Phase III clinical trial. Accordingly, the expert panel suggested that the firm should submit the Phase III CT report to CDSCO for further review by the committee.
