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 2025-05-31T17:56:54+05:30 | Updated On 31 May 2025 5:56 PM IST

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.

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

FinerenoneCDSCObayerphase 3 trial

Dr. Divya Colin

Doctor of Pharmacy

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751