CDSCO Panel Clears Cipla's Glycopyrronium-Formoterol Inhaler for Phase IV Trial

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-07-23T17:00:00+05:30 | Updated On 23 July 2025 5:00 PM IST

New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted Cipla Limited approval to conduct a Phase IV clinical trial of its fixed-dose combination (FDC) inhalation therapy: Glycopyrronium (as Glycopyrrolate IP) 12.5 mcg + Formoterol Fumarate Dihydrate IP 6 mcg Inhaler.

This decision was taken during the SEC Pulmonary meeting held on 9th July 2025, after Cipla submitted the trial protocol in line with the conditions specified in the earlier permission granted under Form CT-23 dated 05.03.2025.

The committee, after detailed deliberation, recommended the grant of permission to conduct the Phase IV study and directed the firm to submit the Phase IV clinical trial report to CDSCO for further review.

Formoterol is a long-acting bronchodilator that relaxes airway muscles to improve airflow, while Glycopyrrolate is an anticholinergic that reduces secretions and further aids in easing respiration. The combination is intended for maintenance treatment in patients with chronic obstructive pulmonary disease (COPD).

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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