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.
Dapagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine. Dapagliflozin is mainly used to treat type 2 diabetes. It can also be used to treat heart failure and chronic kidney disease (CKD).
At the recent SEC meeting for Renal held on 15th January 2025, the expert panel reviewed the phase 3 clinical study protocol no. D6972C00002 CSP version 2.0 dated 12 Nov 2024.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm, with the condition that the India-specific addendum with respect to rescue criteria and management of hypotension shall be submitted to CDSCO.
Also Read: Serum Institute gets CDSCO Panel nod to conduct phase III clinical trial of Yellow Fever Vaccine
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