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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
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
physiological phenomenaD010829
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name
Status
Last Update
sogroyaBiologic Licensing Application2021-10-01
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
18 clinical trials
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Mock data
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Indications Phases 4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Laron syndromeD046150Orphanet_633E34.321615214
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients33
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)
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
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 82 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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