What will the FDA's decision be on Saroglitazar by Zydus Therapeutics in 2026?

If the FDA's decision on Saroglitazar by Zydus Therapeutics in 2026 is a full approval or an accelerated approval, the market resolves to Yes. This market will resolve to No if the FDA's decision is a denial (CRL issued), a withdrawal by the sponsor, or a conditional approval — or if no decision is issued. Saroglitazar (sold under the brand name Lipaglyn in India) is an oral small-molecule drug developed by Zydus Therapeutics that is designed to simultaneously activate two molecular switches in the body — called PPAR-alpha and PPAR-gamma — which together regulate how the body handles fats and sugars. Think of it like a dual-dial thermostat for metabolism: turning up both dials at once aims to reduce harmful lipid buildup and improve insulin sensitivity more effectively than nudging just one dial. In the EPICS-III trial , it is being evaluated as a treatment for primary biliary cholangitis, a liver disease distinct from its original metabolic indications.