Five Indian pharmaceutical companies have partnered to conduct a clinical trial of Merck (MSD)’s experimental antiviral candidate molnupiravir to treat mild Covid-19 in an outpatient setting.

The partners are Cipla, Dr Reddy’s Laboratories, Sun Pharmaceutical Industries and Torrent Pharmaceuticals.

These companies separately signed non-exclusive voluntary licensing agreements with Merck between March and April this year to manufacture and supply the drug to India and more than 100 low and middle-income countries.

Molnupiravir is an oral drug designed to block the replication of various RNA viruses, including the SARS-CoV-2 virus.

Under the latest agreement, the partners will together sponsor, oversee and track the trial of the drug candidate in India.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Dr Reddy’s will perform the trial using its product, according to a directive issued by the Central Drugs Standard Control Organization’s Subject Expert Committee.

The remaining four companies must establish the equivalence of their product to Dr Reddy’s product.

Set to be carried out between this month and September 2021, the trial will follow the protocol approved by the Drugs Controller General of India. It will enrol 1,200 patients with mild Covid-19 across India.

If the study yields positive data, each of the five companies will individually seek regulatory approvals to produce and distribute molnupiravir for Covid-19 in the country.

Merck and its partner Ridgeback Biotherapeutics are currently assessing the drug in a global Phase III trial to treat non-hospitalised Covid-19 patients.

Earlier this year, Merck and Ridgeback reported preliminary data from a Phase IIa Covid-19 trial of molnupiravir in the US.

Data showed a decrease in time to negativity of infectious virus isolation in nasopharyngeal swabs from patients with symptomatic Covid-19.

In another development, Cipla has obtained regulatory approval to distribute Moderna’s Covid-19 vaccine in India, reported Reuters citing a senior government official.

While a definitive deal for commercial supply is yet to be signed, Cipla is aiding Moderna in the regulatory approval and the import of vaccines to be donated to the country.