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  • AstraZeneca Gets CDSCO...

AstraZeneca Gets CDSCO Panel Nod To study Baxdrostat Tablets and Dapagliflozin Tablets

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-02-07T18:00:30+05:30  |  Updated On 7 Feb 2025 6:00 PM IST
Justify Sample Size Hike in FDC Trial of Zibotentan-Dapagliflozin, CDSCO Panel Tells AstraZeneca
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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

BaxdrostatdapagliflozinastrazenecacdscoAstra Zeneca
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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