Is Lonapegsomatropin approved by the US FDA?

Drugs@FDA lists 1 application product line for Lonapegsomatropin, including SKYTROFA (Prescription).

Is Lonapegsomatropin authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Lonapegsomatropin: Skytrofa (previously Lonapegsomatropin Ascendis Pharma).

Are there safety signals or safety updates for Lonapegsomatropin?

US FDA: 1 entry (latest 2025-07-25).

Active substance

Lonapegsomatropin

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
SKYTROFA	3MG; 3.6MG; 4.3MG; 5.2MG; 6.3MG; 7.6MG; 9.1MG; 11MG; 13.3MG	injectable · injection	ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S	Prescription	25 Aug 2021

EMA European Union — centrally authorised medicines

Skytrofa (previously Lonapegsomatropin Ascendis Pharma) Ascendis Pharma Endocrinology Division A/S · Authorised · authorised 11 Jan 2022 · ATC H01AC09

Therapeutic indication (EMA)

Growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency [GHD])

Safety signals and safety-related labeling changes

US FDA 25 Jul 2025 SKYTROFA — 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 lonapegsomatropin →

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.