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CinCor Pharma on track to initiate Phase 3 program for baxdrostat in 1H23
The Fly

CinCor Pharma on track to initiate Phase 3 program for baxdrostat in 1H23

CinCor Pharma announced the completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration on the anticipated Phase 3 program for baxdrostat in hypertension. Baxdrostat is a once daily potentially first-in-class, highly selective aldosterone synthase inhibitor. On February 17, 2023, the Company received the official meeting minutes from the End-of-Phase 2 meeting with the FDA held on January 18, 2023 reflecting that the FDA has agreed with the Company on the dosing cohorts to be used in the planned Phase 3 program, the size of the required treated patient population for purposes of determining safety and the overall endpoints and patient population size to be treated in the anticipated Phase 3 clinical program. In addition, the FDA indicated that no further Phase 1 or Phase 2 clinical trials are needed prior to initiation of the pivotal Phase 3 program. The Company anticipates that the Phase 3 program is on track to initiate in the first half of 2023.

Published first on TheFly

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