Lupin Secures CDSCO Panel Clearance for Phase III COPD Inhaler Trial
New Delhi: Lupin Limited has received recommendations from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) to conduct a Phase III clinical trial of its triple fixed-dose combination (FDC) metered dose inhaler (MDI) containing Fluticasone Furoate 50 mcg + Umeclidinium Bromide eq. to Umeclidinium 31.25 mcg + Vilanterol Trifenatate eq. to Vilanterol 12.5 mcg.
According to the minutes of the SEC meeting held on August 22, 2025, “The firm presented the proposal along with Phase III Clinical Trial protocol before the committee. After detailed deliberation, the committee recommended for grant of permission to conduct the Phase III Clinical Trial with the following conditions:”
The conditions specified by the committee include:
“Participant’s age should be modified to ≥40 years with COPD.”
“More Government sites should be included and the sites should be geographically distributed.”
The committee further stated, “Accordingly, the revised Phase III Clinical Trial protocol should be submitted to CDSCO for review. Further, after approval from CDSCO the firm should submit Phase III Clinical Trial report for further review by the Committee.”
The recommendations mark a step forward in Lupin’s respiratory portfolio, particularly for Chronic Obstructive Pulmonary Disease (COPD), where triple inhaler combinations are increasingly considered standard of care for patients not adequately controlled on dual therapies.
Lupin Limited, headquartered in Mumbai, is among India’s pharmaceutical companies with a strong global footprint, known particularly for its respiratory, cardiovascular, and central nervous system drug portfolios. The company has been expanding its inhalation therapies, aiming to provide innovative treatments for asthma and Chronic Obstructive Pulmonary Disease (COPD), a disease that affects millions of patients in India and globally.
