Lonapegsomatropin clinical trials
Also written ACP-011.
How each study uses lonapegsomatropin is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study
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Approvals
The first approval found in each region, with its record
- United States
- 25 Aug 2021 · SKYTROFA · BLA 761177 (FDA, Drugs@FDA)
- European Union
- 11 Jan 2022 · Skytrofa (previously Lonapegsomatropin Ascendis Pharma) · EMEA/H/C/005367 (EMA)
From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out
How studies write it
Studies that test it under each name
Studies by the year they started
5 studies that test it; most in 2019 (1)
| Year | Studies |
|---|---|
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2023 | 1 |
| 2025 | 1 |
By phase
A phase 1/2 study counts in both.
What it is tested for
Each study’s main condition, where its own words name it, so a study counts once.
Who runs them
Industry 5 · Other 0
Ascendis Pharma Endocrinology Division A/S (3) · Ascendis Pharma A/S (1) · Visen Pharmaceuticals (Shanghai) Co., Ltd. (1)
Studies
Open first, then newest update. How each study uses lonapegsomatropin is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.
Testing it · 5
- Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient DisordersRecruitingPhase 3Ascendis Pharma A/SNCT07221851Written as Lonapegsomatropin [SKYTROFA®]
- A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone DeficiencyCompletedPhase 3Ascendis Pharma Endocrinology Division A/SNCT04615273Written as Lonapegsomatropin
- A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone DeficiencyCompletedPhase 3Ascendis Pharma Endocrinology Division A/SNCT05171855Written as Lonapegsomatropin
- A Trial to Investigate Different Doses of Lonapegsomatropin Compared to Somatropin in Individuals With Turner SyndromeActive, not recruitingPhase 2Ascendis Pharma Endocrinology Division A/SNCT05690386Written as Lonapegsomatropin
- Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Chinese Pediatric Growth Hormone DeficiencyStatus unknownPhase 3Visen Pharmaceuticals (Shanghai) Co., Ltd.NCT04326374Written as TransCon hGH
Codes
What other systems call lonapegsomatropin · ClinicalTrials.gg INT001918
- MeSH (NLM) C000723007lonapegsomatropinConfirmed ClinicalTrials.gov, NLM
- UNII (FDA) OP35X9610YLONAPEGSOMATROPINConfirmed FDA, NLM, Wikidata
- RxNorm 2569562One source FDA
- Wikidata Q108291908lonapegsomatropinConfirmed FDA, NLM, Wikidata
- NCI Thesaurus C174805LonapegsomatropinOne source FDA
- DrugBank DB16220One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C000723007 | lonapegsomatropin | Confirmed ClinicalTrials.gov, NLM |
| UNII (FDA) | OP35X9610Y | LONAPEGSOMATROPIN | Confirmed FDA, NLM, Wikidata |
| RxNorm | 2569562 | — | One source FDA |
| Wikidata | Q108291908 | lonapegsomatropin | Confirmed FDA, NLM, Wikidata |
| NCI Thesaurus | C174805 | Lonapegsomatropin | One source FDA |
| DrugBank | DB16220 | — | One source Wikidata |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.