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.
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