CDSCO panel rejects IQVIA proposed study of Proxalutamide in COVID patients
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New Delhi: Rejecting IQVIA's proposed study, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has denied the firm's request to conduct a Proxalutamide (GT0918) study in Covid-19 subjects.
This came after the firm presented the proposed study before the study protocol no. GT0918-US-3002 Version 1.0 dated 11-JUN-2021 before the committee.
Proxalutamide is an antagonist at the androgen receptor which leads to inhibition of androgen-induced receptor activation and results in the formation of inactive complexes that are not able to translocate to the nucleus. It also induces androgen receptor downregulation, furthering adrogen-induced receptor activation.
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