Dr. Reddy's Laboratories gets nod to conduct phase 3 clinical trial for Sputnik V vaccine in India

16 Jan 2021 Evaluate

Dr. Reddy's Laboratories has received approval from the Drugs Control General of India (DCGI) to conduct phase 3 clinical trial for the Sputnik V vaccine in India. The phase 3 study of Sputnik V will be conducted on 1500 subjects as part of the randomized, doubleblind, parallel-group, placebo-controlled study in India. Earlier, the Data and Safety Monitoring Board (DSMB) reviewed the safety data from the phase 2 clinical trial of the vaccine and recommended the phase 3 recruitment. In its report, the DSMB concluded that no safety concerns were identified and the study met the primary endpoints of safety.

In September 2020, Dr. Reddy’s partnered with Russian Direct Investment Fund (RDIF) to conduct the clinical trials of the Sputnik V vaccine and for its distribution rights in India.

Dr. Reddy's Laboratories is a multinational pharmaceutical company based in Hyderabad, Telangana in India. It manufactures and markets a wide range of pharmaceuticals in India and overseas.

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