Glenmark gets CDSCO Panel nod to study Glycopyrronium, Fluticasone Furoate, Vilanterol Powder for Inhalation
Glenmark Pharma USA launches Epinephrine Injection
New Delhi: In line with the revised Phase IV clinical trial protocol of Glycopyrronium 50 mcg plus Fluticasone Furoate 100 mcg plus Vilanterol 25 mcg Powder for Inhalation, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to Glenmark for conducting the Phase IV clinical trial of the proposed FDC.
In addition, the committee recommended that the firm submit the Phase IV clinical trial report to CDSCO for further review by the committee.
This came after the firm presented the proposal along with the revised Phase IV clinical trial (CT) protocol before the committee.
Glycopyrronium bromide belongs to a group of medicines called “anticholinergics”. These medicines help to prevent the formation of secretions that can cause problems in the respiratory tract. Glycopyrrolate, or glycopyrronium bromide, inhibits parasympathetic nerve impulses by selectively blocking the binding of acetylcholine to muscarinic receptors.
Fluticasone is used to treat seasonal and year-round allergy symptoms such as stuffy/runny nose, itching, and sneezing. It may also reduce other symptoms of seasonal allergies such as red, itchy, and watery eyes.
The mechanism of action of corticosteroids, like fluticasone, works to inhibit inflammatory cells, such as mast cells, neutrophils, lymphocytes, and macrophages. Fluticasone helps to inhibit the secretion of histamines, cytokines, and leukotrienes, which are commonly released with asthma and allergic responses.
Vilanterol is a long-acting beta2-adrenergic agonist used in combination with other bronchodilators for the management of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
At the recent SEC meeting for Pulmonary held on 11th March 2025, the expert panel reviewed the proposal along with the revised Phase IV CT protocol.
After detailed deliberation, the committee recommended granting permission to conduct the Phase IV clinical trial.
Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial report to CDSCO for further review by the committee.
Also Read: Zydus Healthcare Gets CDSCO Panel Nod To study Vilanterol plus Umeclidinium powder for inhalation
