Glenmark Gets CDSCO Panel Nod to study Indacaterol, Glycopyrrolate,Mometasone Furoate FDC drug
New Delhi: The drug major Glenmark has got a go-ahead from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) to conduct the Phase IV clinical trial of the fixed-dose combination (FDC) capsule containing Indacaterol (as acetate) equivalent to Indacaterol 150 mcg plus Glycopyrrolate IP equivalent to glycopyrronium 50 mcg plus Mometasone Furoate IP 160 mcg Dry Powder for inhalation.
This came after the drug major Glenmark presented the Phase IV clinical trial protocol of the FDC pulmonary drug each capsule containing Indacaterol (as acetate) plus Glycopyrrolate IP plus MometasoneFuroate IP 160 mcg Dry Powder for inhalation before the committee.
Indacaterol is an inhaled long-acting beta-2 adrenergic agonist used to relax bronchial smooth muscle and improve symptoms and airflow obstruction caused by Chronic Obstructive Pulmonary Disease (COPD) and moderate to severe asthma.
Glycopyrrolate, also known as glycopyrronium, is an anticholinergic drug. It is a synthetically created quaternary amine with pyridine and a cyclopentane moiety within the compound's structure. Glycopyrrolate has been widely used as a preoperative medication to inhibit salivary gland and respiratory secretions.
Glycopyrronium is a muscarinic antagonist with the highest affinity for M1 receptors, followed by M3, M2/M4, and M5. Muscarinic receptors M1 to M4 are found in the lung, although M3 is predominantly responsible for bronchoconstriction and airway secretions.
Mometasone furoate is a corticosteroid used to treat asthma, allergic rhinitis, nasal congestion, nasal polyps, dermatitis, and pruritus. In asthma, mometasone is believed to inhibit mast cells, eosinophils, basophils, and lymphocytes. There is also evidence of inhibition of histamine, leukotrienes, and cytokines,
At the recent SEC meeting for Pulmonary held 6th of June 2023, the expert panel reviewed the Phase IV clinical trial protocol presented by Glenmark of FDC containing Indacaterol (as acetate) plus Glycopyrrolate plus Mometasone Furoate IP 160 mcg Dry Powder for inhalation.
After detailed deliberation, the committee recommended for conduct of the Phase IV clinical trial. Accordingly, the expert panel stated that the firm should submit the Phase IV clinical trial report to CDSCO for further review by the committee.
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