Umifenovir gets DCGI approval for Phase III clinical trial

Developed and licensed the process technology for Umifenovir

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Umifenovir
Umifenovir is mainly used for the treatment of influenza and is available in China and Russia, and has recently come into prominence due to its potential use for Covid-19 patients. Photo by National Cancer Institute on Unsplash

CSIR constituent lab CSIR-Central Drug Research Institute (CDRI) Lucknow has received permission for carrying out Phase III randomized, Double-blind, Placebo-controlled trial of efficacy, safety, and tolerability of antiviral drug Umifenovir. The Phase III clinical trials will be carried out at King George’s Medical University (KGMU), Ram Manohar Lohia Institute of Medical Sciences (RMLIMS), and ERA’s Lucknow Medical College & Hospital, Lucknow.

This drug claims to have a good safety profile and acts by preventing the entry of viruses into human cells and by priming the immune system. Umifenovir is mainly used for the treatment of influenza and is available in China and Russia, and has recently come into prominence due to its potential use for Covid-19 patients. To evaluate its efficacy in Indian patients, CSIR-CDRI has taken up the clinical trial. Further, it has developed the process technology for Umifenovir in record time and licensed the economic process technology for manufacturing and marketing the drug to Medizest Pharmaceuticals Goa, who have already received test license from DCGI.

Tapas Kundu, director CSIR-CDRI, said that all the raw materials for the drug are indigenously available. If the clinical trial is successful, Umifenovir can be a safe, efficacious, affordable drug against Covid-19 and can be part of the National Program against Covid-19. Kundu also added that this drug has the potential for prophylactic use.

Shekhar Mande, DG-CSIR, highlighted that this clinical trial is an integral part of the CSIR strategy of repurposing drugs for Covid-19 and complimented the team of scientists of CSIR-CDRI.

According to the press note, the clinical trial application was processed on high priority as per the DCGIs initiative against Covid-19. The next steps of the trial are fast-tracked to enable availability of the drug to Indian patients as soon as possible.

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