chenodeoxycholic acid
Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau) · ATC code A05AA01
Also known as: Chenodesoxycholsäure, Kenodeoksikolik asit
- Key facts
- Active substance
- chenodeoxycholic acid
- ATC code
- A05AA01
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Chenodeoxycholic acid Leadiant 250 mg hard capsules
- Marketing authorisation holder
- Leadiant Biosciences Ireland Limited
- Information as of
- 2026-10-28
Key facts
Chenodeoxycholic acid is a primary bile acid used to treat inborn errors of bile acid synthesis due to sterol 27-hydroxylase deficiency (cerebrotendinous xanthomatosis, CTX).
What it is used for
- Treatment of inborn errors of primary bile acid synthesis due to sterol 27-hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis) in infants, children and adolescents aged 1 month to 18 years and in adults.
Dosing
- Adults: starting dose 750 mg/day in three divided doses; can be increased in 250 mg increments to a maximum of 1,000 mg/day if serum cholestanol and/or urine bile alcohols remain elevated.
- Children (1 month–18 years): starting dose 5 mg/kg/day in three divided doses, up to a maximum of 15 mg/kg/day.
- The lowest effective dose that normalises cholestanol and/or urine bile alcohols is chosen; levels are monitored every 3 months until metabolic control, then at least annually, together with liver function.
- Capsules are swallowed whole with water, with or without food; for children who cannot swallow them, the content can be added to sodium bicarbonate solution 8.4%.
- Renal or hepatic impairment: no data; careful monitoring and individual titration. No adjustment in the elderly. A missed dose is not doubled.
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
Important warnings
- Cholestanol, urine bile alcohols and liver function should be checked at least annually; more often during fast growth, illness or pregnancy.
- Rising liver enzymes may indicate overdose.
- Co-administration with ciclosporin, sirolimus, phenobarbital or oral contraceptives is not recommended.
- Women of childbearing potential should use an effective method of contraception.
Side effects
- Adverse reactions are generally mild to moderate.
- Not known: constipation, transaminases increased, jaundice.
Interactions
- Colestipol and antacids containing aluminium hydroxide and/or smectite bind the drug; take them 2 hours before or after.
- Colestyramine: take chenodeoxycholic acid one hour before or 4-6 hours after.
- Ciclosporin and sirolimus can reduce chenodeoxycholic acid synthesis; co-administration not recommended.
Pregnancy and breastfeeding
- Not recommended during pregnancy and in women of childbearing potential not using contraception; CTX with high cholestanol has been associated with adverse pregnancy outcomes.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau)Leadiant Biosciences Ireland Limited · EMEA/H/C/004061
Source: European Medicines Agency (EMA), product information
Turkey
- CeteixINPHARMUS İLAÇ SAN. TİC. A.Ş. · 1 register entry
- KendeoHUMANİS SAĞLIK A.Ş. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 4 more European countries
- Iceland
- Chenodeoxycholic Acid
- Liechtenstein
- Chenodeoxycholic Acid
- Norway
- Chenodeoxycholic Acid
- Portugal
- Xebyl
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
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Sources
- European Medicines Agency. Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau) – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/chenodeoxycholic-acid-leadiant-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.