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.
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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 | 14 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| skytrofa | Biologic Licensing Application | 2025-09-04 |
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
41 clinical trials
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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 | 1 | 3 | 5 | 5 | 2 | 16 |
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | — | 2 | 5 | 3 | — | 10 |
| Dwarfism | D004392 | — | E34.31 | — | 3 | 1 | 1 | 2 | 7 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Turner syndrome | D014424 | Orphanet_881 | Q96 | — | 2 | 1 | — | 1 | 4 |
| Failure to thrive | D005183 | — | — | — | — | 2 | — | 1 | 3 |
| Pituitary diseases | D010900 | — | E23.7 | — | — | 1 | — | — | 1 |
| Sex chromosome disorders | D025064 | — | — | — | — | 1 | — | — | 1 |
| Chromosome disorders | D025063 | EFO_0003831 | Q99.9 | — | — | 1 | — | — | 1 |
| Noonan syndrome | D009634 | Orphanet_648 | Q87.19 | — | — | 1 | — | — | 1 |
| Sex chromosome disorders of sex development | D058533 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | — | 1 | — | — | 1 | 2 |
| Gonadal dysgenesis | D006059 | — | — | — | 1 | — | — | 1 | 2 |
| 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
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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
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Variants
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Financial
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Trends
PubMed Central
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Additional graphs summarizing 94 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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489 adverse events reported
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