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
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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.
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