Glenmark Pharma gets DCGI's approval to conduct pivotal study of Crofelemer

28 Dec 2011 Evaluate

Glenmark Pharmaceuticals has obtained the DCGI (India) approval to conduct the pivotal study of Crofelemer in Acute Watery Diarrhoea patients. Post approval from the DCGI, dosing in patients has also commenced. This is a randomized, double blinded, placebo controlled, parallel Group, three arm, multicenter and multinational pivotal study that is being carried out to assess the Efficacy and Safety of two dosage regimens of Crofelemer Tablets in the Treatment of Moderate to Severe Acute Watery Diarrhoea in Adult Patients including cholera. This Phase III study will be done at leading centres in India and Bangladesh.

Glenmark Pharmaceuticals has an exclusive license from Napo Pharmaceuticals, Inc. to distribute and commercialize Crofelemer in 140 emerging countries (rest of world territories) including India for indications related to HIV, use in acute adult and pediatric diarrhoea.

Crofelemer is a novel, first-in-class anti-diarrhoeal agent that has a physiological and different mechanism of action from traditional anti-diarrhoeal agents. Besides its potential efficacious role in multiple diarrhoeal indications, Crofelemer controls diarrhoea with no drug-drug interactions, minimal systemic adsorption and, unlike current antidiarrhoeals, no serious side effects.

Glenmark Pharma Share Price

1465.30 -27.05 (-1.81%)
21-Nov-2024 16:59 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1777.65
Dr. Reddys Lab 1194.55
Cipla 1465.65
Lupin 2043.30
Zydus Lifesciences 944.25
View more..
© 2024 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.