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Drug ReportsSomatrogon
Ngenla(somatrogon)
Ngenla (somatrogon) is a protein pharmaceutical. Somatrogon was first approved as Ngenla on 2022-02-14. It is used to treat growth disorders in the USA. It has been approved in Europe to treat growth and development.
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EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
physiological phenomenaD010829
Trade Name
FDA
EMA
Ngenla
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)
Somatrogon
Tradename
Proper name
Company
Number
Date
Products
Ngenlasomatrogon-ghlaPfizerN-761184 RX2023-06-27
2 products
Labels
FDA
EMA
No data
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
— H01AC08: Somatrogon
HCPCS
No data
Clinical
Clinical Trials
13 clinical trials
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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_633E34.321134—210
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/patients———1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSomatrogon
INNsomatrogon
Description
Somatrogon, sold under the brand name Ngenla, is a medication for the treatment of growth hormone deficiency. Somatrogon is a glycosylated protein constructed from human growth hormone and a small part of human chorionic gonadotropin which is appended to both the N-terminal and C-terminal.
Classification
Protein
Drug classgrowth hormone derivatives
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL4297830
ChEBI ID—
PubChem CID—
DrugBankDB14960
UNII ID6D848RA61B (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 53 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3 adverse events reported
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