CDSCO Panel Approves AstraZeneca’s Protocol Amendment Proposal To Study antihypertensive drug Baxdrostat

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the pharmaceutical major AstraZeneca protocol amendment proposal to study Baxdrostat Tablets 1 mg/2 mg.

This came after the firm presented protocol amendment version 2.0 dated 26 April 2024 protocol no. D6970C00008. This is a study to investigate the efficacy and safety of baxdrostat in participants with uncontrolled hypertension on two or more medications, including participants with resistant hypertension.

Baxdrostat is a drug that’s being developed to treat conditions like hypertension, chronic kidney disease, and primary aldosteronism. It’s an oral, small-molecule inhibitor of aldosterone synthase, an enzyme that produces aldosterone in the adrenal gland. Baxdrostat is a selective inhibitor of aldosterone synthase, which reduces the production of aldosterone. Aldosterone levels that are too high can lead to inflammation, organ fibrosis, and systemic hypertension, which can contribute to cardiovascular events.

At the recent SEC meeting for Cardiovascular held on 11th December 2024, the expert panel reviewed the protocol amendment version 2.0 dated 26 April 2024 protocol no. D6970C00008.

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

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