MSD Receives CDSCO Panel Nod to Conduct Phase III Trial of Enlicitide Decanoate

New Delhi: Pharmaceutical major MSD Pharmaceuticals has received a positive recommendation from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) to conduct a Phase III clinical trial of Enlicitide Decanoate in India.

The recommendation came after the expert panel reviewed the company's proposed Phase III clinical study protocol.However, the recommendation is subject to a key condition that MSD Pharmaceuticals Private Limited must provide the Investigational Medicinal Product (IMP) free of cost to eligible trial participants as part of post-trial access until the drug receives market authorization in India.

At the recent SEC meeting, the company presented Phase III clinical study protocol No. MK-0616-038, Version 00 dated June 20, 2025, seeking permission to conduct the clinical trial of Enlicitide Decanoate.

Enlicitide Decanoate is an investigational lipid-lowering therapy being developed for the management of hypercholesterolemia and cardiovascular risk reduction. The drug belongs to a new class of oral PCSK9 inhibitors designed to reduce low-density lipoprotein cholesterol (LDL-C) by inhibiting the proprotein convertase subtilisin/kexin type 9 (PCSK9) pathway, thereby increasing the liver's ability to remove LDL cholesterol from the bloodstream.

After detailed deliberations, the expert panel recommended granting permission to conduct the Phase III clinical trial as proposed by the firm.

The SEC meeting minutes state:

"The committee recommended the grant of permission to conduct the trial as presented by the firm with the condition that the firm shall provide the Investigational Medicinal Product for Post-Trial Access (free of cost) till market authorization in India."