Skytrofa, Skytrofa (previously lonapegsomatropin ascendis pharma)(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 | 9 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| skytrofa | Biologic Licensing Application | 2021-09-03 |
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
5 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Endocrine system diseases | D004700 | EFO_0001379 | E34.9 | — | — | 2 | — | — | 2 |
| Laron syndrome | D046150 | Orphanet_633 | E34.321 | — | — | 2 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Turner syndrome | D014424 | Orphanet_881 | Q96 | — | 2 | — | — | — | 2 |
Indications Phases 1
No data
Indications Without Phase
No data
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 | 1934255-39-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4298185 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB16220 |
| UNII ID | OP35X9610Y (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 34 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
0 adverse events reported
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