The Subject Expert Committee (SEC) under the Central Drug Standard Control Organisation (CDSCO) has directed Sun Pharmaceutical Industries to conduct a Phase III clinical study on esaxerenone for resistant hypertension. This decision was made in response to Sun Pharma's proposal to manufacture and market esaxerenone tablets (2.5 mg and 5 mg). The proposal included a request for permission to conduct a Phase III clinical trial and comparative bioavailability studies.
Esaxerenone is a nonsteroidal mineralocorticoid receptor antagonist (MRA) used in the treatment of hypertension and diabetic nephropathies. It is designed as a selective, potent, and long-lasting MRA, developed using dihydropyridine calcium channel blockers like felodipine and nimodipine, known for their mineralocorticoid receptor blocking properties.
The SEC specified that esaxerenone tablets (2.5 mg and 5 mg) are not indicated for essential hypertension, aligning with current guidelines. The committee highlighted that another applicant had already received a recommendation to conduct a Phase III clinical trial for the same drug, specifically for resistant hypertension.
Furthermore, the committee has requested that Sun Pharma submit the bioequivalence (BE) study conducted for export purposes, along with the bioequivalence study protocol, for further review. The expert panel has instructed Sun Pharma to revise its Phase III protocol to focus on resistant hypertension and resubmit it for review.
