SOMAVERT
SOMAVERT (pegvisomant) is a growth hormone receptor antagonist indicated for the treatment of acromegaly. It is used for patients who have had an inadequate response to surgery or radiation therapy, or for whom these treatments are not appropriate. The therapeutic goal of SOMAVERT is to normalize serum insulin-like growth factor-1 (IGF-1) levels.
How SOMAVERT Works
Pegvisomant selectively binds to growth hormone (GH) receptors on cell surfaces, which blocks endogenous growth hormone from binding to those receptors. This action interferes with GH signal transduction and inhibits the biological activity of growth hormone. Consequently, the drug decreases serum concentrations of IGF-1 and other GH-responsive proteins, such as the acid-labile subunit of IGF-1 and insulin-like growth factor binding protein-3.
Details
- Status
- Prescription
- First Approved
- 2003-03-25
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
SOMAVERT Approval History
What SOMAVERT Treats
1 indicationsSOMAVERT is approved for 1 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Acromegaly
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SOMAVERT FDA Label Details
ProIndications & Usage
FDA Label (PDF)SOMAVERT is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-1 (IGF-1) levels. SOMAVERT is a growth hormone receptor antagonist indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-1 (IGF-1) levels.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.