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Seladelpar Lysine Dihydrate

Lyvdelzi (previously Seladelpar Gilead) · ATC code A05AX07

Also known as: Seladelpar

Key facts
Active substance
Seladelpar Lysine Dihydrate
ATC code
A05AX07
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Lyvdelzi 10 mg hard capsules
Marketing authorisation holder
Gilead Sciences Ireland Unlimited Company
Information as of
2026-10-28

Key facts

Seladelpar (as seladelpar lysine dihydrate) is a peroxisome proliferator-activated receptor delta (PPARδ) agonist. It is used to treat primary biliary cholangitis (PBC) in adults.

What it is used for

  • Primary biliary cholangitis (PBC) in adults, in combination with ursodeoxycholic acid (UDCA) when response to UDCA alone is inadequate, or as monotherapy in those unable to tolerate UDCA (Lyvdelzi).

Dosing

  • Lyvdelzi 10 mg hard capsules: 10 mg once daily, with or without food.
  • Missed dose: take the next dose at the scheduled time; no double dose.
  • No dose adjustment in the elderly or in mild, moderate and severe renal impairment; dialysis patients not studied.
  • Mild hepatic impairment (Child-Pugh A): no adjustment; consider stopping if moderate impairment develops; not recommended in severe hepatic impairment.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients.

Important warnings

  • Dose-dependent transaminase increases at higher doses: check liver tests at baseline and routinely thereafter; consider interruption if they worsen and permanent discontinuation if they worsen again.
  • Avoid in complete biliary obstruction; interrupt if obstruction is suspected.
  • Co-administration of probenecid is not recommended.
  • Contains less than 1 mmol sodium (23 mg) per capsule.

Side effects

  • Most frequent: abdominal pain (11.1%), headache (7.2%), nausea (6.5%) and abdominal distension (3.9%); these were non-serious and did not lead to discontinuation.

Interactions

  • Probenecid increased seladelpar AUC 2-fold; concomitant use is not recommended.
  • Dual or multiple inhibitors of transporters such as BCRP, OATP1B1, OATP1B3 and OAT3 (e.g. ciclosporin) may increase exposure; monitor for adverse effects. See the full text for more.

Pregnancy and breastfeeding

  • Limited data; as a precaution, avoid use during pregnancy.
  • Breast-feeding: weigh breast-feeding against therapy.

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.

Full official text →

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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)

Source: European Medicines Agency (EMA), product information

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

  1. European Medicines Agency. Lyvdelzi (previously Seladelpar Gilead) – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/lyvdelzi-epar-product-information_en.pdf

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.