Is Setmelanotide 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 Setmelanotide, including IMCIVREE (10 mg/ml, Solution for injection, SAR 12967.85).

Is Setmelanotide approved by the US FDA?

Drugs@FDA lists 1 application product line for Setmelanotide, including IMCIVREE (Prescription).

Is Setmelanotide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Setmelanotide: Imcivree.

Are there safety signals or safety updates for Setmelanotide?

US FDA: 1 entry (latest 2026-03-19).

Active substance

Setmelanotide

SFDA 1
US FDA 1
EMA 1
Health Canada 1
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
IMCIVREE	10 mg/ml	Solution for injection · Subcutaneous use	1 Vial	SAR 12967.85	NCE · Prescription	Rhythm Pharmaceuticals Netherlands	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
IMCIVREE	EQ 10MG BASE/ML (EQ 10MG BASE/ML)	solution · subcutaneous	RHYTHM	Prescription	25 Nov 2020

EMA European Union — centrally authorised medicines

Imcivree Rhythm Pharmaceuticals Netherlands B.V. · Authorised · authorised 16 Jul 2021 · ATC A08AA

Therapeutic indication (EMA)

Imcivree is indicated for the treatment of obesity and the control of hunger in adults and children 4 years of age and above with acquired hypothalamic obesity (aHO) due to hypothalamic injury or impairment. Imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed Bardet Biedl syndrome (BBS) in adults and children 2 years of age and above. Imcivree is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed loss-of-function biallelic pro-opiomelanocortin (POMC), including PCSK1, deficiency or biallelic leptin receptor (LEPR) deficiency in adults and children 2 years of age and above.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
IMCIVREE	02537745	10 MG / ML	SOLUTION · SUBCUTANEOUS	RHYTHM PHARMACEUTICALS, INC.

Safety signals and safety-related labeling changes

US FDA 19 Mar 2026 IMCIVREE — 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 setmelanotide →

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.