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Eris Lifesciences gets CDSCO Panel nod To Initiate Phase III CT of Esaxerenone Tablets

New Delhi: Based on the bioequivalence (BE) study of the new drug Esaxerenone Tablets 1.25, 2.5 and 5 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended Eris Lifesciences for the grant of permission to initiate Phase III clinical trial for the new drug Esaxerenone tablets.
This came after Eris Lifesciences presented the BE study report before the committee.
Esaxerenone belongs to the class of non-steroidal mineralocorticoid receptor antagonists (MRAs), also known as antimineralocorticoid drugs. Esaxerenone, a nonsteroidal mineralocorticoid receptor blocker (MRB), is primarily used to treat hypertension and is also being explored for its potential in treating diabetic nephropathy and other kidney-related conditions.
Esaxerenone exerts its therapeutic effects by selectively binding to and inhibiting the mineralocorticoid receptor (MR). The MR is a nuclear receptor that, when activated by aldosterone, triggers a cascade of events leading to sodium and water retention, potassium excretion, and increased blood pressure.
At the recent SEC meeting for Cardiovascular held on 5th March 2025, the expert panel reviewed the BE study report.
After detailed deliberation, the committee noted the results of the BE study and recommended granting permission to initiate a Phase III clinical trial for New Drug Esaxerenone tablets.
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-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