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Rhizen receives USFDA IND approval for oral anti-viral drug for treatment of COVID

Capital Market

Phase 1 clinical trial to begin early December 2020

Alembic Pharmaceuticals announced that its associate company, Rhizen Pharmaceuticals SA has received approval of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) to study its oral DHODH inhibitor for SARS-CoV-2 infection

Rhizen announced that initial study shall evaluate single ascending doses of RP7214 in healthy volunteers and that dosing is expected to commence in early December 2020. Rhizen also announced positive feedback from the FDA during its pre-IND discussion on its plans to follow-up this study with a multiple-ascending dose study in Covid-19 patients.

Alembic Pharmaceuticals through its wholly owned subsidiary holds 50% ownership in Rhizen.

 

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First Published: Dec 02 2020 | 11:14 AM IST

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