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
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 |
---|---|---|---|---|---|
Somavert | pegvisomant | Pharmacia & Upjohn Company LLC | N-21106 RX | 2003-03-25 | 5 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
somavert | Biologic Licensing Application | 2020-04-16 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
acromegaly | — | D000172 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
pegvisomant, Somavert, Pharmacia & Upjohn Company LLC | |||
2110-03-25 | Orphan excl. |
Patent Expiration
No data
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 |
---|---|---|---|---|---|---|---|---|---|
Acromegaly | D000172 | — | — | 3 | 9 | 6 | 18 | ||
Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | 1 | — | 1 |
Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | 1 | — | 1 |
Left ventricular hypertrophy | D017379 | EFO_0003896 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Pituitary diseases | D010900 | E23.7 | — | — | 1 | — | — | 1 | |
Polyostotic fibrous dysplasia | D005359 | Orphanet_562 | Q78.1 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Insulin resistance | D007333 | EFO_0002614 | — | 1 | — | — | 1 | 2 | |
Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Laron syndrome | D046150 | Orphanet_633 | E34.321 | — | — | — | — | 2 | 2 |
Fatty liver | D005234 | — | — | — | — | 1 | 1 | ||
Metabolism | D008660 | GO_0008152 | — | — | — | — | 1 | 1 | |
Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | — | — | — | 1 | 1 |
Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | — | — | 1 | 1 |
Fibrosis | D005355 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | PEGVISOMANT |
INN | pegvisomant |
Description | Somatotropin precursor (Growth hormone) (GH) |
Classification | Protein |
Drug class | PEGylated compounds, covalent attachment of macrogol (polyethylene glycol) polymer |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
PDB | — |
CAS-ID | 218620-50-9 |
RxCUI | 278739 |
ChEMBL ID | CHEMBL1201515 |
ChEBI ID | — |
PubChem CID | — |
DrugBank | DB00082 |
UNII ID | N824AOU5XV (ChemIDplus, GSRS) |
Target
Agency Approved
GHR
GHR
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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