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
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 | 2024-04-09 |
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
40 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 | — | — | — | — | 1 | 4 | 6 | 11 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | 1 | — | 1 |
| Left ventricular hypertrophy | D017379 | EFO_0003896 | — | — | — | — | 1 | — | 1 |
| Hypertrophy | D006984 | EFO_0002460 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
No data
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 |
| Biological availability | D001682 | — | — | 1 | — | — | — | — | 1 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | — | 1 |
| Colorectal neoplasms | D015179 | — | — | 1 | — | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | — | 1 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | — | — | — | — | 1 |
| Sarcoma | D012509 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fatty liver | D005234 | EFO_0003934 | — | — | — | — | — | 1 | 1 |
| Metabolism | D008660 | GO_0008152 | — | — | — | — | — | 1 | 1 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | — | — | — | — | 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 | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201515 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00082 |
| UNII ID | N824AOU5XV (ChemIDplus, GSRS) |
Target
Agency Approved
GHR
GHR
Alternate
No data
Variants
No data
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Somavert – Pfizer
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 1,168 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,694 adverse events reported
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