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.
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