Bayer Gets CDSCO Panel Nod To Conduct Phase 3 Trial for Finerenone

Written By :  Dr. Divya Colin
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-05-31 12:26 GMT   |   Update On 2025-05-31 12:26 GMT

New Delhi: Bayer Pharmaceutical has received approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the trial of mineralocorticoid receptor antagonist Finerenone, or BAY 94-8862.

This came after the firm presented phase III clinical study protocol no.: 20186 amendment 4 version 5.0 dated 21-JUN-2024.

Finerenone, or BAY 94-8862, is a mineralocorticoid receptor antagonist indicated to reduce the risk of sustained decline in glomerular filtration rate, end stage kidney disease, cardiovascular death, heart attacks, and hospitalization due to heart failure in adults with chronic kidney disease associated with type II diabetes mellitus.

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At the recent SEC meeting Renal held on 20th May 2025, the expert panel reviewed the phase III clinical study protocol no.: 20186 amendment 4 version 5.0 dated 21-JUN-2024.

After detailed deliberation, the committee recommended for grant of permission to conduct the trial as presented by the firm.

Also Read: Dr Reddy's Gets SEC Nod for Higher Semaglutide Dose in Ongoing Phase III Study, Govt Sites Mandated



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