Therapy Areas: Cardiovascular
Dr. Reddy's, RDIF Approved to Conduct Clinical Trial for Sputnik V Vaccine in India
20 October 2020 - - Indian drugmaker Dr. Reddy's Laboratories Ltd. and Russian sovereign wealth fund Russian Direct Investment Fund have received approval from the Drug Control General of India to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India, the principals said.

This will be a multi-center and randomized controlled study, which will include safety and immunogenicity study.

Earlier in September 2020, Dr. Reddy's and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of the partnership, RDIF shall supply 100m doses of the vaccine to Dr. Reddy's upon regulatory approval in India.

On August 11, 2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world's first registered vaccine against COVID-19 based on the human adenoviral vectors platform.

Sputnik V is currently undergoing phase 3 clinical trial in Russia and the proposed number of subjects is 40,000. Additionally, phase 3 clinical trial of the vaccine has commenced in the UAE last week.

Dr. Reddy's Laboratories Ltd. (BSE: 500124) (NSE: DRREDDY) (NYSE: RDY) is an integrated pharmaceutical company.

Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy's operates in markets across the globe. The company's major markets include USA, India, Russia and CIS countries, and Europe.

Russian Direct Investment Fund is Russia's sovereign wealth fund established in 2011 to make equity co-investments, primarily in Russia, alongside reputable international financial and strategic investors. RDIF acts as a catalyst for direct investment in the Russian economy.
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