Torrent''s molecule awaiting phase 1 trial approval

Torrent Pharmaceuticals Limited, the Rs 318-crore Ahmedabad-based pharmaceutical company, has lined up its first new chemical entity, or NCE, with the Drug Controller General of India for phase 1 clinical trial approvals. The company commenced its drug discovery programme in 1997 and has so far invested around Rs 80 crore in it, including in a state-of-the-art research facility in Ahmedabad.

Registered as TRC 266 with the Indian Patent Office and in other Paris Convention countries, the molecule has cleared pre-clinical evaluations and would enter phase 1 trials following drug controller’s approval. TRC 266 is a coronary vasodilator with long-term efficacy and is not known to cause low blood pressure as in the case of other vasodilators.

Torrent is preparing for the submission of another NCE in the cardiovascular segment to the drug controller for phase 1 studies. A company spokesperson, while confirming the development, added that three other patent applications have been recently filed in India pertaining to the cardiovascular segment. Though the company’s drug discovery programme is centred on cardiovasculars, it is also venturing into another high-value segment of anti-diabetics.

Other Indian companies that are conducting phase 1 trials in India for their discoveries are Ranbaxy and Dr Reddy’s Laboratories. Ranbaxy has initiated phase 1 studies for Pravosin for the treatment of benign prostatic hyperplasia, and Dr Reddy’s will shortly conduct a similar study for its anti-cancer compound DRF 1042.