PremiumNEW DELHI: MSN Laboratories Pvt Ltd on Tuesday announced that it is starting phase 3 clinical trial of molnupiravir capsules for treatment of mild-to-moderate covid-19 in India.
The company said it had received a clearance from the Drugs Controller General of India V.G. Somani last week to conduct the clinical trial on mild to moderate covid-19 patients.
It will soon start clinical trials on more than 2,400 patients suffering from mild to moderate covid-19 at more than 40 sites across India. MSN said the trials will begin dosing volunteer patients soon.
MSN’s phase 3 trial is the third firm to start such a study for the drug in India, after Natco Pharma and Hetero Labs, whose trials are underway.
Molnupiravir is an experimental antiviral drug that is currently being studied for covid-19 treatment globally. The drug was initially developed by US-based Ridgeback Biotherapeutics, who later partnered with Merck & Co for further development.
Merck has signed voluntary licensing agreements with Cipla Ltd, Dr Reddy’s Laboratories, Emcure Pharmaceuticals Ltd, Hetero Labs Ltd and Sun Pharmaceutical Industries Ltd, allowing the drug to be manufactured and marketed in India.
The Ufirm, which is also known as Merck Sharp & Dohme (MSD) outside US, is conducting a phase 3 trial for the treatment of non-hospitalized patients with confirmed covid-19 in the US.
MSN Laboratories, which is not related to MSD, as well as Natco Pharma are not part of the voluntary licensing agreement but are still going ahead with their trials in India.
The company said its research and development team has developed both the active pharmaceutical ingredient and formulation for the drug, and is expecting to launch soon after successful conclusion of clinical study followed by regulatory approval.
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