Is Maralixibat registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Maralixibat, including Livmarli (9.5 mg/ml, Oral solution, SAR 125703.25).

Is Maralixibat approved by the US FDA?

Drugs@FDA lists 2 application product lines for Maralixibat, including LIVMARLI (Prescription); LIVMARLI (Prescription).

Is Maralixibat authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Maralixibat: Livmarli.

Are there safety signals or safety updates for Maralixibat?

US FDA: 1 entry (latest 2024-07-24).

Active substance

Maralixibat

SFDA 1
US FDA 2
EMA 2
Health Canada 6
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Livmarli	9.5 mg/ml	Oral solution · Oral use	1 Bottle	SAR 125703.25	NCE · Prescription	Mirum Pharmaceuticals	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
LIVMARLI	EQ 9.5MG BASE/ML; EQ 19MG BASE/ML	solution · oral	MIRUM	Prescription	29 Sep 2021
LIVMARLI	EQ 10MG BASE; EQ 15MG BASE; EQ 20MG BASE; EQ 30MG BASE	tablet · oral	MIRUM	Prescription	10 Apr 2025

EMA European Union — centrally authorised medicines

Livmarli Mirum Pharmaceuticals International B.V. · Authorised · authorised 9 Dec 2022 · ATC A05AX04

Therapeutic indication (EMA)

Livmarli is indicated for the treatment of: Cholestatic pruritus in patients with Alagille syndrome (ALGS) 2 months of age and older, Progressive familial intrahepatic cholestasis (PFIC) in patients 3 months of age and older. Livmarli tablets is indicated in adults and adolescents 12 years and older for the treatment of: Cholestatic pruritus in patients with Alagille syndrome (ALGS), Progressive familial intrahepatic cholestasis (PFIC).

Livmarli FGK Representative Service GmbH · Application withdrawn · ATC A05AX

Therapeutic indication (EMA)

Treatment of progressive familial intrahepatic cholestasis type 2 (PFIC2)

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
LIVMARLI	02539888	9.5 MG / ML	SOLUTION · ORAL	MIRUM PHARMACEUTICALS, INC.
LIVMARLI	02565234	10 MG	TABLET · ORAL	MIRUM PHARMACEUTICALS, INC.
LIVMARLI	02565242	15 MG	TABLET · ORAL	MIRUM PHARMACEUTICALS, INC.
LIVMARLI	02565250	20 MG	TABLET · ORAL	MIRUM PHARMACEUTICALS, INC.
LIVMARLI	02565269	30 MG	TABLET · ORAL	MIRUM PHARMACEUTICALS, INC.
LIVMARLI	02565277	19 MG / ML	SOLUTION · ORAL	MIRUM PHARMACEUTICALS, INC.

Safety signals and safety-related labeling changes

US FDA 24 Jul 2024 LIVMARLI — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for maralixibat →

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.