Sun Pharma Gets SEC Nod to Begin Phase III Trial of Cough Drug Gefapixant
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has recommended granting permission to initiate a Phase III clinical trial for the new drug Gefapixant Tablets 45 mg, based on the bioequivalence (BE) study submitted by Sun Pharma Laboratories.
This recommendation was made following a detailed review of the BE study report presented during the SEC Pulmonary meeting held on 28th May 2025.
Gefapixant is a first-in-class, non-narcotic, selective P2X3 receptor antagonist being developed for the treatment of refractory or unexplained chronic cough—a condition estimated to affect 5–10% of adults globally, defined as a cough lasting more than eight weeks.
The drug works by inhibiting ATP binding to P2X3 receptors, thereby reducing excessive activation of vagal C fibers by extracellular ATP, which dampens the cough reflex.
Following deliberation, the SEC concluded that the results of the BE study supported further clinical development and therefore recommended the initiation of the Phase III clinical trial. The committee has directed the company to submit the results of the Phase III trial to CDSCO for further evaluation.
