Drugs / Lonapegsomatropin
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Skytrofa (previously Lonapegsomatropin Ascendis Pharma) | — | 2022-01-11 | europa.eu ↗ |
Trials 5 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT06433557 | Jul 2024 → Nov 2025 overdue | achondroplasia | Ascendis Pharma Growth Disorders A/S | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05690386 | Feb 2023 → Oct 2024 overdue | Turner syndrome | Ascendis Pharma Endocrinology Division A/S | Active not recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07221851 | Dec 2025 → Feb 2028 expected | SHOX-related short stature, Turner syndrome, fetal growth restriction, isolated short stature | Ascendis Pharma A/S | Recruiting | No outcome recorded |
| Phase 3 | NCT05171855 | Dec 2021 → Dec 2024 | pituitary deficiency | Ascendis Pharma Endocrinology Division A/S | Completed | No outcome recorded |
| Phase 3 | NCT04615273 | Dec 2020 → Nov 2023 | pituitary deficiency | Ascendis Pharma Endocrinology Division A/S | Completed | No outcome recorded |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Lonapegsomatropin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07221851 ↗ |
| Known as | SKYTROFA | “Lonapegsomatropin [SKYTROFA®]” NCT07221851 ↗ |
| Modality | Protein / enzyme biologic | “a long-acting growth hormone product” NCT05690386 ↗ |
| Route | Subcutaneous | “Lonapegsomatropin administered once-weekly by subcutaneous injection.” NCT04615273 ↗ |