NDAORALTABLETPriority Review
Approved
Feb 2025
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Mechanism of Action
(chenodeoxycholic acid) is a primary bile acid, synthesized from cholesterol in the liver. In CTX, the major bile acid synthesis pathways are disrupted due to partial or total deficiency in sterol 27-hydroxylase encoded by the CYP27A1 gene. CTEXLI may act to replace deficient levels of the…
Pharmacologic Class:
Bile Acid
Indications (1)
Loss of Exclusivity
LOE Date
Feb 21, 2028
24 months away
Exclusivity Expiry
Feb 21, 2028