Sun Pharma Laboratories Gets CDSCO Panel Nod To study Esaxerenone Tablets
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-03-26 12:30 GMT | Update On 2025-03-26 12:30 GMT
New Delhi: Sun Pharma Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a Phase III clinical trial for the new drug Esaxerenone tablets 1.25, 2.5 and 5 mg.
However, this approval is subject to the condition that all the investigators should be cardiologists and the list of the investigators should be submitted to CDSCO accordingly.
This came after the firm presented a revised phase III clinical trial (CT) protocol (Protocol No. ICR/24/016, Version No. 1.0, dated 10th December 2024) before the committee.
Esaxerenone is a non-steroidal mineralocorticoid receptor blocker (MRB) for treating hypertension and is being developed for diabetic nephropathies and renal disease. Esaxerenone is a selective MRB, meaning it blocks the activation of the mineralocorticoid receptor (MR), which is involved in regulating blood pressure and electrolyte balance.
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 revised phase III CT protocol (Protocol No. ICR/24/016, Version No. 1.0, dated 10th December 2024) for the new drug Esaxerenone tablets 1.25, 2.5 and 5 mg.
After detailed deliberation, the committee noted that some of the investigators are MDs in medicine.
Accordingly, the committee recommended granting permission to conduct a Phase III clinical trial for New Drug Esaxerenone tablets as per the protocol presented, subject to the condition that all the investigators should be cardiologists and a list of the investigators should be submitted to CDSCO accordingly.
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