Umifenovir gets DCGI nod for Phase III clinical trial against COVID-19
CSIR-CDRI has developed the process technology for Umifenovir and licensed the process technology for manufacturing and marketing of the drug to Medizest Pharmaceuticals, Goa, which has already received test license from DCGI
CSIR constituent lab CSIR-Central Drug Research Institute (CDRI) Lucknow, has received permission for carrying out Phase III randomised, 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), Dr Ram Manohar Lohia Institute of Medical Sciences (RMLIMS) and ERA’s Lucknow Medical College & Hospital, Lucknow.
Reportedly, 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 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. The clinical trial is to evaluate its efficacy in Indian patients. 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.
Prof Tapas Kundu, Director, CSIR-CDRI said that all the raw materials for the drug are indigenously available and if the clinical trial is successful, Umifenovir can be a safe, efficacious, affordable drug against COVID-19 and can be part of National Programme against COVID-19. Prof Kundu also added that this drug has the potential for prophylactic use.
Dr 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, Nilanjana Majumdar, Ajay Kumar Srivastava, Chandra Bhushan Tripathi and Nayan Ghosh, who were coordinated by Dr Ravishankar Ramachandran, Nodal Scientist. The formulation and documentation team included PR Mishra, V Bhosale, RK Tripathi and S Sharma of CSIR-CDRI.
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.