Skytrofa (previously Lonapegsomatropin Ascendis Pharma)



This medicine is authorised for use in the European Union.


Lonapegsomatropin Ascendis Pharma is a medicine that is used to improve growth in children and adolescents who do not produce enough growth hormone (growth hormone deficiency or GHD). The medicine is intended for children and adolescents from 3 up to 18 years of age.

GHD is rare, and Lonapegsomatropin Ascendis Pharma was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 17 October 2019. Further information on the orphan designation can be found here:

Lonapegsomatropin Ascendis Pharma contains the active substance lonapegsomatropin.

This EPAR was last updated on 31/01/2023

Authorisation details

Product details
Skytrofa (previously Lonapegsomatropin Ascendis Pharma)
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Growth and Development
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.


This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Ascendis Pharma Endocrinology Division A/S
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Tuborg Boulevard 12
2900 Hellerup

Product information

20/12/2022 Skytrofa (previously Lonapegsomatropin Ascendis Pharma) - EMEA/H/C/005367 - PSUSA/00010969/202202

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.


Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Pituitary and hypothalamic hormones and analogues

Therapeutic indication

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])

Assessment history

Related content

How useful was this page?

Add your rating
1 rating