Zydus announced its aims to launch the first new drug in US by early 2026

Zydus will enter a competitive field, with an FDA decision on CymaBay's PBC drug due in August

Zydus Lifesciences, headquartered in Ahmedabad, India, is gearing up to introduce its maiden new drug into the United States market by early 2026, targeting the lucrative sector for treating a form of liver disease, as per Managing Director Sharvil Patel's statement to Reuters. Having obtained a fast-track designation from the U.S. FDA in 2020 for its Saroglitazar drug, designed to combat primary biliary cholangitis (PBC), a chronic inflammatory liver ailment, the company is poised to enter the competitive landscape. Saroglitazar, which also holds orphan drug designations from both the FDA and European regulatory bodies, is currently undergoing mid-to-late-stage trials for PBC and is concurrently being assessed for its efficacy in treating Metabolic Dysfunction-Associated Steatohepatitis (MASH), a variant of fatty liver disease.

Zydus aims to bolster its portfolio in the rare disease segment, reminiscent of its previous acquisition of a drug targeting Menkes disease, a condition affecting copper metabolism in the body. Furthermore, Zydus is poised to venture into the realm of generic pharmaceuticals, with plans underway to launch a generic version of Novo Nordisk's renowned diabetes and weight-loss medication, Semaglutide, post the expiration of its patent in India. Zydus joins its Indian counterparts, including Sun Pharma, Cipla, Dr. Reddy's, and Lupin, in developing their respective versions of semaglutide, commercially known as Ozempic for diabetes and Wegovy for weight loss.