Futibatinib and its Impurities

Futibatinib, sold under the brand name Lytgobi, is an oral, potent, selective, and irreversible small molecule inhibitor. It is for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene fusions or other rearrangements. Reference standards of Futibatinib API, and its pharmacopeial, non pharmacopeial impurities, and stable isotopes are listed below.