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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
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
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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
Clinical Trials
19 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_633E34.321615—315
Pituitary dwarfismD004393EFO_1001109E23.0515—314
Endocrine system diseasesD004700EFO_0001379E34.9513—211
SyndromeD013577————2——2
Turner syndromeD014424Orphanet_881Q96——2——2
Gonadal dysgenesisD006059————2——2
Noonan syndromeD009634Orphanet_648Q87.19——2——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DwarfismD004392HP_0003510E34.31—1——12
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———3————3
Renal insufficiencyD051437HP_0000083N191————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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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
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 134 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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15 adverse events reported
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