Umifenovir receives DCGI approval for Phase III clinical trial

Council of Scientific and Industrial Research constituent lab CSIR-Central Drug Research Institute (CDRI) Lucknow has received approval for carrying out Phase III randomised, double-blind, placebo-controlled trial of efficacy, safety and tolerability of antiviral drug Umifenovir.

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Key-Points

The Phase III Clinical Trials will be carried out at King George’s Medical University (KGMU), Dr Ram Manohar Lohia Institute of Medical Sciences (RMLIMS) and ERA’s Lucknow Medical College & Hospital, Lucknow.

This drug has a good safety profile and acts by preventing entry of the virus into human cells and also by priming the immune system.

Umifenovir is mainly used for treatment of influenza and is available in China and Russia, and has recently come into prominence due to its potential use for Covid19 patients.

To evaluate its efficacy in Indian patients, CSIR-CDRI has taken up the clinical trial.

CSIR-CDRI has developed the process technology for Umifenovir and licensed the process technology for manufacturing and marketing the drug to Medizest Pharmaceuticals, Goa, which has already received test license from DCGI.

The clinical trial application was processed on high priority as per the DCGI’s initiative against COVID-19.

The next steps of the trial are being fast-tracked to enable the availability of the drug to Indian patients as soon as possible.