New Delhi:Lupin Limited has received recommendations from the Subject Expert Committee, under the Central Drugs Standard Control Organization (CDSCO) to conduct a Phase IV clinical trial of its fixed-dose combination (FDC) inhaler containing Budesonide IP 200 mcg + Glycopyrronium Bromide eq. to Glycopyrronium 12.5 mcg + Formoterol Fumarate Dihydrate IP 6 mcg (Metered Dose Inhaler). The proposal was presented in light of the condition mentioned in permission in Form CT-23 dated 25.04.2025. After reviewing the company’s submission, the committee noted: “After detailed deliberation, the committee recommended for grant of permission to conduct the Phase IV clinical trial with condition that participant’s age should be modified to ≥40 years with COPD.” Further, the SEC directed that “the revised Phase IV Clinical Trial protocol should be submitted to CDSCO for review. Further, after approval from CDSCO the firm should submit Phase IV Clinical Trial report for further review by the Committee.” The recommendation paves the way for Lupin to continue advancing its respiratory pipeline, particularly targeting patients with chronic obstructive pulmonary disease (COPD).
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