Skytrofa, Skytrofa (previously lonapegsomatropin ascendis pharma)(lonapegsomatropin)
Lonapegsomatropin, Skytrofa (lonapegsomatropin) is a protein pharmaceutical. Lonapegsomatropin was first approved as Skytrofa on 2021-08-25. It has been approved in Europe to treat growth and development.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| physiological phenomena | D010829 |
Trade Name
FDA
EMA
Skytrofa
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Lonapegsomatropin
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Skytrofa | lonapegsomatropin-tcgd | Ascendis Pharma | N-761177 RX | 2021-08-25 | 9 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| skytrofa | Biologic Licensing Application | 2024-05-07 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
39 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Laron syndrome | D046150 | Orphanet_633 | E34.321 | 7 | 3 | 4 | 4 | 2 | 20 |
| Pituitary dwarfism | D004393 | EFO_1001109 | E23.0 | — | 3 | 4 | 5 | — | 12 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | — | 2 | 4 | 3 | — | 9 |
| Dwarfism | D004392 | — | E34.31 | — | 2 | — | 1 | 3 | 6 |
| Fetal growth retardation | D005317 | EFO_0000495 | — | — | — | — | 1 | — | 1 |
| Developmental disabilities | D002658 | EFO_0003852 | F89 | — | — | — | 1 | — | 1 |
| Fatty liver | D005234 | EFO_0003934 | — | — | — | — | 1 | — | 1 |
| Adenoma | D000236 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pituitary diseases | D010900 | — | E23.7 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | — | 2 | — | — | 1 | 3 |
| Turner syndrome | D014424 | Orphanet_881 | Q96 | — | 2 | — | — | 1 | 3 |
| Gonadal dysgenesis | D006059 | — | — | — | 2 | — | — | 1 | 3 |
| Achondroplasia | D000130 | — | Q77.4 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Primary ovarian insufficiency | D016649 | EFO_0004266 | E28.3 | — | — | — | — | 1 | 1 |
| Growth disorders | D006130 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | Lonapegsomatropin |
| INN | lonapegsomatropin |
| Description | Lonapegsomatropin, sold under the brand name Skytrofa, is a human growth hormone used for the treatment of growth hormone deficiency. Lonapegsomatropin is a prodrug of somatropin.
|
| Classification | Protein |
| Drug class | tricyclic compounds; atropine derivatives; PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4298185 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB16220 |
| UNII ID | OP35X9610Y (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 80 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
479 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use