Pfizer Gets CDSCO Panel Nod To study Marstacimab

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-04-04 12:30 GMT | Update On 2025-04-04 12:30 GMT

Pfizer

New Delhi: The pharmaceutical major Pfizer has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the Phase 1b clinical study of Marstacimab as per the amendment presented by the firm.

This came after the firm presented Phase 1b clinical study protocol no. B7841014 amendment 1, dated 02 December 2024.

Marstacimab (PF-06741086) is a monoclonal antibody medication used as routine prophylaxis to prevent or reduce bleeding episodes in adults and adolescents with hemophilia A or B without inhibitors. It works by targeting the tissue factor pathway inhibitor (TFPI), a protein that naturally limits blood clot formation.

Marstacimab is a human monoclonal IgG1 antibody directed against the K2 to neutralize TFPI. Even in the absence of FVIII or FIX, marstacimab-induced inhibition of TFPI leads to increased generation of FXa and, ultimately, thrombin production and clot formation.

At the recent SEC meeting for Hematology held on 6th March 2025, the expert panel reviewed the Phase 1b clinical study protocol no. B7841014 Amendment 1 dated 02 December2024.

After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm

Also Read:Eris Lifesciences gets CDSCO Panel nod To Initiate Phase III CT of Esaxerenone Tablets

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Dr. Divya Colin

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.

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Pfizer Gets CDSCO Panel Nod To study Marstacimab

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