OMNITROPE
Omnitrope (somatropin) is a recombinant human growth hormone indicated for the treatment of growth failure in pediatric patients and growth hormone deficiency in adults. In children, it is used for conditions including growth hormone deficiency, Prader-Willi Syndrome, Turner Syndrome, and idiopathic short stature. It is also indicated for pediatric patients born small for gestational age who do not achieve catch-up growth by age two. For adults, the therapy serves as a replacement for endogenous growth hormone in cases of either childhood-onset or adult-onset deficiency.
How OMNITROPE Works
Somatropin functions by binding to dimeric growth hormone receptors located on the cell membranes of target tissues. This binding initiates intracellular signal transduction, leading to various pharmacodynamic effects. Some actions, such as skeletal growth and protein synthesis, are primarily mediated by insulin-like growth factor-1 (IGF-1) produced in the liver and local tissues. Other effects, such as lipolysis, result from the direct action of the hormone on target cells.
Details
- Status
- Prescription
- First Approved
- 2006-05-30
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
OMNITROPE Approval History
What OMNITROPE Treats
5 indicationsOMNITROPE is approved for 5 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Growth Hormone Deficiency
- Prader-Willi Syndrome
- Small for Gestational Age
- Turner Syndrome
- Idiopathic Short Stature
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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.
OMNITROPE FDA Label Details
ProIndications & Usage
FDA Label (PDF)OMNITROPE is a recombinant human growth hormone indicated for: • Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome, and Idiopathic Short Stature • Adult: Treatment of adults with either adult onset or childhood onset GHD 1.1 Pediatric Patients OMNITROPE is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (GH). OMNITROPE is indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi Synd...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.