City-based Zydus Group today informed that it has initiated Phase-3 trials of the molecule for patients suffering from lipodystrophy. The trials are aimed at evaluating the safety and efficacy of Lipaglyn 4 mg versus standard-of-care with placebo in the treatment of lipodystrophy, a company statement said.
The move is seen as the newer therapeutic usage of its breakthrough drug LipaglynTM (Saroglitazar). The drug is already approved in India for treating diabetic dyslipidemia and hypertriglyceridemia.
Lipodystrophy is a problem with the way the body produces, uses, and stores fat. Inherited lipodystrophies are caused by mutations in a gene. Patients with lipodystrophy suffer from metabolic disorders, including lipid disorder and insulin resistance, that leads to diabetes. These disorders can also increase the risk for other problems such as heart or liver disease.
Pankaj Patel, CMD, Zydus Group, commented: “Following the launch of LipaglynTM in India, we continue to pursue additional clinical development in indications having significant unmet needs such as lipodystrophy. The results from the previously conducted Phase-II studies in patients with lipodystrophy have been encouraging and we are hopeful of extending the development of LipaglynTM for the treatment of lipodystrophy.”
Launched in September 2013, LipaglynTM (Saroglitazar) is a prescription drug and is a breakthrough therapy in the treatment of diabetic dyslipidemia and India’s first NCE to reach the market.