Zydus Cadila, a research-driven, global healthcare provider, has received USFDA approval for its plan to initiate a Phase 2 clinical trial of Saroglitazar in patients with Non-Alcoholic Steatohepatitis (NASH) of the liver. This randomized, double-blind Phase 2 trial will evaluate Saroglitazar 1 mg, 2mg and 4 mg Vs. Placebo.
NASH is the area of significant unmet medical need in the USA with an estimated 6.5 million adults in the United States and five major European countries having advanced NASH. NASH is a liver disease in which fat accumulates in the liver. Obesity, insulin resistance, diabetes and lipid disorders lead to NAFLD which progresses to a lethal NASH situation.
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. It is the only Indian pharma company to launch its own patented NCE - Lipaglyn, the world’s first drug to be approved for the treatment of diabetic dyslipidemia.
