Quick answers
- What is Chenodiol used for?
- The FDA-approved label (Ctexli, Mirum Pharmaceuticals Inc., December 16, 2025) says: “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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Chenodiol have a boxed warning?
- The label we quote has no boxed warning, but 1 of 2 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Chenodiol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Chenodiol been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Chenodiol?
- 2 companies list prescription products of Chenodiol in the FDA NDC Directory, including Mirum Pharmaceuticals Inc. and Travere Therapeutics.
What Chenodiol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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.
— FDA label: Ctexli, Mirum Pharmaceuticals Inc., effective December 16, 2025. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
1 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Ctexli, Chenodal |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Mirum Pharmaceuticals Inc.1 product
- Travere Therapeutics1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA219488 CTEXLI | Mirum | February 21, 2025 | — |
Generic approvals (1)
- ANDA091019Lgm Pharma · October 22, 2009
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 618469, 877417, 2710422 |
|---|---|
| SPL set ID of the quoted label | 015384e7-4ac5-4782-a309-e40cd1421c5b |
| FDA labels (SPL) | 2 |
| FDA applications | NDA219488, 1 ANDA |
| Active ingredients (FDA) | CHENODIOL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ctexli, Mirum Pharmaceuticals Inc., effective December 16, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →