Is Chenodeoxycholic acid authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Chenodeoxycholic acid: Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau).

Is Chenodeoxycholic acid authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 1 product containing Chenodeoxycholic acid, including CHENODEOXYCHOLIC ACID LEADIANT 250 MG HARD CAPSULES.

Active substance

Chenodeoxycholic acid

EMA 1
UK MHRA 1

Open in the medicines table

EMA European Union — centrally authorised medicines

Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau) Leadiant Biosciences Ireland Limited · Authorised · authorised 10 Apr 2017 · ATC A05AA01

Therapeutic indication (EMA)

Chenodeoxycholic acid is indicated for the treatment of inborn errors of primary bile acid synthesis due to sterol 27 hydroxylase deficiency (presenting as cerebrotendinous xanthomatosis (CTX)) in infants, children and adolescents aged 1 month to 18 years and adults.

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
CHENODEOXYCHOLIC ACID LEADIANT 250 MG HARD CAPSULES	PLGB 44975/0001	LEADIANT BIOSCIENCES LIMITED	POM

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.