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Somavert(pegvisomant)
Somavert (pegvisomant) is a protein pharmaceutical. Pegvisomant was first approved as Somavert on 2002-11-12. It is used to treat acromegaly in the USA. It has been approved in Europe to treat acromegaly. The pharmaceutical is active against growth hormone receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
nervous system diseasesD009422
endocrine system diseasesD004700
Trade Name
FDA
EMA
Somavert
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)
Pegvisomant
Tradename
Proper name
Company
Number
Date
Products
SomavertpegvisomantPharmacia & Upjohn Company LLCN-21106 RX2003-03-25
5 products
Labels
FDA
EMA
Brand Name
Status
Last Update
somavertBiologic Licensing Application2020-04-16
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
acromegaly—D000172—
Agency Specific
FDA
EMA
Expiration
Code
pegvisomant, Somavert, Pharmacia & Upjohn Company LLC
2110-03-25Orphan excl.
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
— H01AX: Other anterior pituitary lobe hormones and analogues in atc
— H01AX01: Pegvisomant
HCPCS
No data
Clinical
Clinical Trials
33 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AcromegalyD000172——39618
ObesityD009765EFO_0001073E66.9———1—1
Heart failureD006333EFO_0003144I50———1—1
Left ventricular hypertrophyD017379EFO_0003896———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pituitary diseasesD010900E23.7——1——1
Polyostotic fibrous dysplasiaD005359Orphanet_562Q78.1——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Insulin resistanceD007333EFO_0002614—1——12
Metabolic syndromeD024821EFO_0000195E88.81—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—1———12
Biological availabilityD0016821————1
Prostatic neoplasmsD011471C611————1
Colorectal neoplasmsD0151791————1
Breast neoplasmsD001943EFO_0003869C501————1
Lung neoplasmsD008175C34.901————1
SarcomaD0125091————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Laron syndromeD046150Orphanet_633E34.321————22
Fatty liverD005234————11
MetabolismD008660GO_0008152————11
OsteoporosisD010024EFO_0003882M81.0————11
Glucose intoleranceD018149HP_0000833R73.03————11
FibrosisD005355————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePEGVISOMANT
INNpegvisomant
Description
Somatotropin precursor (Growth hormone) (GH)
Classification
Protein
Drug classPEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID218620-50-9
RxCUI278739
ChEMBL IDCHEMBL1201515
ChEBI ID—
PubChem CID—
DrugBankDB00082
UNII IDN824AOU5XV (ChemIDplus, GSRS)
Target
Agency Approved
GHR
GHR
Organism
Homo sapiens
Gene name
GHR
Gene synonyms
NCBI Gene ID
Protein name
growth hormone receptor
Protein synonyms
GH receptor, growth hormone binding protein, mutant growth hormone receptor, serum binding protein, Somatotropin receptor
Uniprot ID
Mouse ortholog
Ghr (14600)
growth hormone receptor (P16882)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Somavert - Pfizer
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 932 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,295 adverse events reported
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