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Drug ReportsLonapegsomatropin
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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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
physiological phenomenaD010829
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
Skytrofalonapegsomatropin-tcgdAscendis PharmaN-761177 RX2021-08-25
9 products
Labels
FDA
EMA
Brand Name
Status
Last Update
skytrofaBiologic Licensing Application2024-05-07
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
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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
Laron syndromeD046150Orphanet_633E34.321——3—25
Endocrine system diseasesD004700EFO_0001379E34.9——3——3
Pituitary dwarfismD004393EFO_1001109E23.0——3——3
Pituitary diseasesD010900—E23.7——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SyndromeD013577———1———1
Turner syndromeD014424Orphanet_881Q96—1———1
Gonadal dysgenesisD006059———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
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLonapegsomatropin
INNlonapegsomatropin
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 classtricyclic compounds; atropine derivatives; PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL4298185
ChEBI ID—
PubChem CID—
DrugBankDB16220
UNII IDOP35X9610Y (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 78 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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479 adverse events reported
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