Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau)
What Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau) is used for
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.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
- Approved under exceptional circumstances: full data cannot be collected, usually because the disease is very rare.
Key facts
- Brand
- Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau)
- Active substance
- chenodeoxycholic acid
- Disease area
- Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors
- Medicine group
- Bile and liver therapy
- ATC code
- A05AA01
- Marketing authorisation holder
- Leadiant Biosciences Ireland Limited
- Authorised in the EU since
- 2017
Official information
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau) used for?
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.
What is the active substance in Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau)?
Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau) contains chenodeoxycholic acid.
Who makes Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau)?
The EU marketing authorisation holder is Leadiant Biosciences Ireland Limited.
Is Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau) an orphan medicine?
Yes. Chenodeoxycholic acid Leadiant (previously Chenodeoxycholic acid sigma-tau) is designated an orphan medicine in the EU, for a rare disease (Xanthomatosis, Cerebrotendinous; Metabolism, Inborn Errors).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, EU