Lonapegsomatropin
As of the edition of 20 October 2026, Lonapegsomatropin is a protein: marketed, first approved in 2021 (US); acts on GHR; US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Protein
- Brand name
- Skytrofa
- First approved
- 25 August 2021 (US)
- Approvals on record
- 15 in 2 regions
- Holder of the most recent approval
- Ascendis Pharma A/S
- Registered trials
- 5, 0 stopped early
- Disease areas
- Hormones; Bones, joints and muscles; Nervous system; Heart and blood vessels; Inherited and neonatal; Pregnancy and women's health
US protection
US protection ends in 2033.
US protection ends in 2033, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Ascendis Pharma A/S. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Lonapegsomatropin.
Target
| Gene | Protein | UniProt |
|---|---|---|
| GHR | Growth hormone receptor | P10912 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 2 | 1 | 0 | 1 | 0 |
| Phase 3 | 4 | 2 | 1 | 0 |
| All trials | 5 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Ascendis Pharma A/S | Originator and Lead sponsor of trials | 2020 to now |