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Drug ReportsSomapacitan
Sogroya(somapacitan)
Sogroya (somapacitan) is a small molecule pharmaceutical. Somapacitan was first approved as Sogroya on 2021-03-31. It has been approved in Europe to treat growth.
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FDA Novel Drug Approvals 2020
Events Timeline
Commercial
Clinical
Drug
Target
Variants
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Safety
Events Timeline
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FDA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
physiological phenomenaD010829
Trade Name
FDA
EMA
Sogroya
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)
Somapacitan
Tradename
Proper name
Company
Number
Date
Products
Sogroyasomapacitan-becoNovo NordiskN-761156 RX2020-08-28
3 products
Labels
FDA
EMA
Brand Name
Status
Last Update
sogroyaBiologic Licensing Application2023-04-28
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
H: Systemic hormonal preparations, excl. sex hormones and insulins
H01: Pituitary and hypothalamic hormones and analogues
H01A: Anterior pituitary lobe hormones and analogues
H01AC: Somatropin and somatropin agonists
H01AC07: Somapacitan
HCPCS
No data
Clinical
No data
Drug
General
Drug common nameSomapacitan
INNsomapacitan
Description
Somapacitan, sold under the brand name Sogroya, is a growth hormone medication. Somapacitan is a human growth hormone analog. Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology.
Classification
Small molecule
Drug classgrowth hormone derivatives
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C=C(CCCCCCCCCCCCCCCc1nnn[nH]1)NS(=O)(=O)CCCC(=O)NCCOCCOCC(=O)N[C@@H](CCC(=O)N[C@@H](CCC(=O)NCCOCCOCC(=O)N[C@@H](CCCCNC(=O)CSC[C@H](N)C(=O)O)C(N)=O)C(=O)O)C(=O)O
Identifiers
PDB
CAS-ID1338578-34-9
RxCUI
ChEMBL IDCHEMBL3707290
ChEBI ID
PubChem CID129894493
DrugBankDB15093
UNII ID8FOJ430U94 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
No data
Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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