Is Seladelpar approved by the US FDA?

Drugs@FDA lists 1 application product line for Seladelpar, including LIVDELZI (Prescription).

Is Seladelpar authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Seladelpar: Lyvdelzi (previously Seladelpar Gilead).

Are there safety signals or safety updates for Seladelpar?

US FDA: 1 entry (latest 2026-01-30).

Active substance

Seladelpar

US FDA 1
EMA 1
Health Canada 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
LIVDELZI	EQ 10MG BASE	capsule · oral	GILEAD SCIENCES INC	Prescription	14 Aug 2024

EMA European Union — centrally authorised medicines

Lyvdelzi (previously Seladelpar Gilead) Gilead Sciences Ireland Unlimited Company · Authorised · ATC A05AX07

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
LYVDELZI	02561492	10 MG	CAPSULE · ORAL	GILEAD SCIENCES CANADA INC

Safety signals and safety-related labeling changes

US FDA 30 Jan 2026 LIVDELZI — safety-related labeling change
Labeling sections changed: Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for seladelpar →

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), 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.