GENOTROPIN
GENOTROPIN 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 to treat growth failure associated with growth hormone deficiency, Prader-Willi syndrome, Turner syndrome, idiopathic short stature, and being born small for gestational age without catch-up growth. For adults, the medication serves as a replacement therapy for endogenous growth hormone deficiency resulting from either childhood-onset or adult-onset causes. The drug provides a therapeutic means to address both physical growth limitations and metabolic deficiencies related to inadequate hormone secretion.
How GENOTROPIN Works
GENOTROPIN is a recombinant human growth hormone that is therapeutically equivalent to the hormone naturally produced by the pituitary gland. In pediatric patients, the medication stimulates linear growth and normalizes concentrations of Insulin-like Growth Factor-I (IGF-I). In adults with growth hormone deficiency, the drug works to reduce fat mass, increase lean body mass, and induce beneficial changes in lipid metabolism. By replacing deficient levels of endogenous hormone, it restores biological processes necessary for growth and metabolic regulation.
Details
- Status
- Prescription
- First Approved
- 1995-08-24
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
GENOTROPIN Approval History
What GENOTROPIN Treats
5 indicationsGENOTROPIN is approved for 5 conditions since its original approval in 1995. 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.
GENOTROPIN FDA Label Details
ProIndications & Usage
FDA Label (PDF)GENOTROPIN 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 GENOTROPIN is indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone. GENOTROPIN is indicated for the treatment of pediatric patients who have growth failure due to Pr...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.