The Drug Controller General of India (DCGI) has given approval to conduct early stage clinical studies of an investigative drug against diarrhoea in Indian patients.

Phase 2 trials of the anti-diarrhoeal product, Crofelemer will be conducted by the Mumbai-based Glenmark Pharmaceuticals.

Crofelemer has shown significant anti-diarrhoeal activities in multiple clinical trials with approximately 1500 patients, according to an official release.

The trial is expected to commence this year, and will involve sixty adult patients suffering from acute diarrhoea in a prospective, randomised, parallel group using a controlled double-blind placebo method. "The trial will be concluded within three months from the start of dosing," the release added.

"We are happy with the progress that crofelemer is showing. If approved, the drug has the potential to meet a large and unsatisfied need for safe and effective medication for the treatment of diarrhoea," Glenn Saldanha, managing director & CEO of Glenmark, stated.

Derived from a rain forest plant, crofelemer is originally developed by the US-based Napo Pharmaceuticals Inc. In July Last year, Napo reached a development and commercialization agreement with Glenmark.

Under the terms of the agreement, the company will be responsible for marketing crofelemer in over 140 countries, including India, for three indications, viz. AIDS diarrhoea, infectious diarrhoea and paediatric diarrhoea.

In return, the company will provide low-cost and large-scale manufacturing in FDA-approved manufacturing facilities and upon marketing will pay royalties ranging from high single digits to early teens on net sales to Napo. The company expects to launch the drug in 2008 in the first territory.

Glenmark has the rights to market the drug as a treatment for AIDS related diarrhoea, infectious diarrhoea and paediatric diarrhoea, and upon launch will pay up to 14 pct royalties on sales to Napo, the release added.

Crofelemer has completed phase II trial in the US, for traveller's diarrhoea, and the product has been granted 'fast-track' status as a treatment for diarrhoea in people with AIDS/HIV and irritable bowel syndrome.

California-based Napo listed in London at the end of July, raising 11.9 mln stg to fund further studies and launches.