Lyvdelzi (previously Seladelpar Gilead)
What Lyvdelzi (previously Seladelpar Gilead) is used for
Lyvdelzi is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.
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).
- PRIME: a priority medicine that the EMA supported early because it may meet an unmet need.
- Conditional approval: approved on less complete data because the need is high; more data must follow.
Key facts
- Brand
- Lyvdelzi (previously Seladelpar Gilead)
- Active substance
- seladelpar lysine dihydrate
- Disease area
- Liver Cirrhosis, Biliary
- Medicine group
- Bile and liver therapy
- ATC code
- A05AX07
- Marketing authorisation holder
- Gilead Sciences Ireland Unlimited Company
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 Lyvdelzi (previously Seladelpar Gilead) used for?
Lyvdelzi is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.
What is the active substance in Lyvdelzi (previously Seladelpar Gilead)?
Lyvdelzi (previously Seladelpar Gilead) contains seladelpar lysine dihydrate.
Who makes Lyvdelzi (previously Seladelpar Gilead)?
The EU marketing authorisation holder is Gilead Sciences Ireland Unlimited Company.
Is Lyvdelzi (previously Seladelpar Gilead) an orphan medicine?
Yes. Lyvdelzi (previously Seladelpar Gilead) is designated an orphan medicine in the EU, for a rare disease (Liver Cirrhosis, Biliary).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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