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Treats cerebrotendinous xanthomatosis (CTX). NDA 219488, held by Mirum. Chenodiol.
As of Nov 13, 2026, NDA 219488 (Ctexli), held by Mirum, was first approved by FDA on Feb 21, 2025, with 0 approved supplements and 0 published complete response letters.
First approved: Feb 21, 2025
Review: Priority
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
CTEXLI is indicated for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. CTEXLI is a bile acid indicated for treatment of cerebrotendinous xanthomatosis (CTX) in adults.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
