AstraZeneca Gets CDSCO Panel Nod To study Tezepelumab

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-04-13T17:30:36+05:30 | Updated On 13 April 2025 5:30 PM IST

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New Delhi: Pharmaceutical major AstraZeneca Pharma India has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the Phase III clinical trial of Tezepelumab.

This came after AstraZeneca Pharma India presented phase III clinical study protocol no. D5241C00006 CSP version 1.0 dated 02 Dec 2024 and Local CSP Addendum IND-1 version 1.0 dated 03 Jan 2025.

Tezepelumab is a human monoclonal antibody used to treat severe asthma, specifically targeting thymic stromal lymphopoietin (TSLP) to reduce airway inflammation and asthma exacerbations.

Tezepelumab was developed as a biologic with a unique mechanism of action that involves inhibiting the action of thymic stromal lymphopoietin (TSLP). This epithelial cytokine activates a wide range of immune cells involved in airway inflammation in asthma

At the recent SEC meeting for Pulmonary held on 11th March 2025, the expert panel reviewed phase III clinical study protocol no. D5241C00006 CSP version 1.0 dated 02 Dec 2024 and Local CSP Addendum IND-1 version 1.0 dated 03 Jan 2025.

After detailed deliberation, the committee recommended granting permission to conduct the trial as presented by the firm.

Also Read: Zydus Healthcare Gets CDSCO Panel Nod To study Vilanterol plus Umeclidinium powder for inhalation

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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-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