Lupin's Phase IV Report for Glycopyrronium, Vilanterol Inhalation Gets CDSCO Panel Nod
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has accepted the Phase IV clinical trial report submitted by Lupin Limited for its fixed-dose inhalation product containing Glycopyrronium Bromide 63 mcg (equivalent to 50 mcg of Glycopyrronium) and Vilanterol Trifenatate 40 mcg (equivalent to 25 mcg of Vilanterol), confirming that the post-marketing study requirements for the combination have been satisfactorily met.
The firm presented the Phase IV clinical trial report in line with the earlier SEC recommendation dated 05.03.2024 and the conditions specified under Form CT-23 dated 15.11.2023.
The formulation combines two well-established bronchodilators used in chronic airway disorders. Glycopyrronium Bromide, a long-acting muscarinic antagonist (LAMA), provides sustained bronchodilation by reducing airway smooth muscle contraction, while Vilanterol, a long-acting beta-agonist (LABA), enhances airflow through prolonged airway relaxation. The dual-therapy approach is commonly used in chronic obstructive pulmonary disease (COPD) and other long-term respiratory conditions requiring continuous maintenance bronchodilation.
According to the SEC minutes, after detailed deliberation, the committee “noted and agreed to the result of the clinical trial report” submitted by the company. No additional comments, requirements or modifications were recorded by the panel.
The submission marks the completion of the product’s post-marketing clinical trial obligations under the New Drugs and Clinical Trials (NDCT) Rules, 2019, which mandate Phase IV evaluation for fixed-dose combinations requiring post-approval surveillance.
Lupin Limited is a major Indian multinational pharmaceutical company with a broad portfolio spanning generic medicines, branded formulations and advanced drug-delivery systems. The company is also active in respiratory therapy and markets products such as Vilfuro-G, a triple-combination inhaler for COPD management in India.
