Zydus Healthcare gets CDSCO Panel nod to study Fluticasone Furoate, Glycopyrronium, Vilanterol FDC

Glycopyrronium is an anticholinergic agent used to treat hyperhidrosis, severe drooling, and COPD, used with other medications to treat ulcers, and used in anesthesia.

Vilanterol is a selective long-acting beta2-adrenergic agonist. Its pharmacological effect is attributable to stimulation of intracellular adenylyl cyclase which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cAMP). Increases in cyclic AMP are associated with the relaxation of bronchial smooth muscle and inhibition of the release of hypersensitivity mediators from mast cells in the lungs.

At the recent SEC meeting for pulmonary held on 5th October 2023, the expert panel reviewed the proposal along with the Phase III clinical trial protocol of the FDC pulmonary drug Fluticasone Furoate plus Glycopyrronium plus Vilanterol Trifenatate powder for inhalation in capsule presented by the drug major Zydus Healthcare.

After detailed deliberation, the committee recommended the grant of permission for conducting the proposed Phase III clinical trial.

In addition, the expert panel suggested that the firm should submit a Phase III clinical trial report to CDSCO for further review by the committee.

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