AstraZeneca Gets CDSCO Panel Nod To study Baxdrostat Tablets and Dapagliflozin Tablets
New Delhi: AstraZeneca has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the trial of Baxdrostat Tablets 1mg/2mg and Dapagliflozin Tablets 10 mg with the condition that the India-specific addendum with respect to rescue criteria and management of hypotension shall be submitted to CDSCO.
This came after AstraZeneca presented phase 3 clinical study protocol no. D6972C00002 CSP version 2.0 dated 12 Nov 2024.
Baxdrostat is a drug that reduces aldosterone levels in the body to treat high blood pressure and other conditions. It's an aldosterone synthase inhibitor (ASI) that's being studied as a treatment for hypertension, chronic kidney disease, and primary aldosteronism.
The mechanism of action of Baxdrostat is a selective inhibitor of aldosterone synthase, which reduces the production of aldosterone. Aldosterone is a hormone that can contribute to high blood pressure, inflammation, and organ fibrosis. Baxdrostat can lower blood pressure in patients who are resistant to other drugs.
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