Is Macimorelin approved by the US FDA?

Drugs@FDA lists 1 application product line for Macimorelin, including MACRILEN (Discontinued).

Is Macimorelin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Macimorelin: Ghryvelin (previously Macimorelin Aeterna Zentaris).

Are there safety signals or safety updates for Macimorelin?

US FDA: 1 entry (latest 2026-07-23).

Active substance

Macimorelin

US FDA 1
EMA 1
Safety 1

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
MACRILEN	EQ 60MG BASE/POUCH	for solution · oral	AETERNA ZENTARIS	Discontinued	20 Dec 2017

EMA European Union — centrally authorised medicines

Ghryvelin (previously Macimorelin Aeterna Zentaris) Atnahs Pharma Netherlands B.V. · Authorised · authorised 11 Jan 2019 · ATC V04CD06

Therapeutic indication (EMA)

This medicinal product is for diagnostic use only. GHRYVELIN is indicated for the diagnosis of growth hormone deficiency (GHD) in adults.

Safety signals and safety-related labeling changes

US FDA 23 Jul 2026 MACRILEN — safety-related labeling change
Labeling sections changed: Use in Specific Populations

All safety entries for macimorelin →

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.