Conduct phase III clinical study on resistant hypertension: CDSCO Panel tells Sun Pharmaceutical Industries on Esaxerenone
Sun Pharma
New Delhi: Responding to the proposal presented by the drug major Sun Pharmaceutical Industries to manufacture and market the drug Esaxerenone tablets 2.5 mg and 5 mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to conduct a phase III clinical study on resistant hypertension.
This came after Sun Pharmaceutical Industries presented the proposal to manufacturer and market Esaxerenone tablets along with a request for grant of permission to conduct a phase III clinical trial and deliberations of comparative bioavailability before the committee.
Esaxerenone is a nonsteroidal mineralocorticoid receptor antagonist (MRA) used to treat hypertension and diabetic nephropathies.
Esaxerenone is a selective, potent, and long-lasting nonsteroidal mineralocorticoid receptor antagonist developed on the basis of dihydropyridine calcium channel blockers such as felodipine and nimodipine, which have mineralocorticoid receptor blocking properties.
The committee deliberated in detail that esaxerenone tablets (2.5 mg and 5 mg) are not indicated for essential hypertension as per the guidelines.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.