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