ZOMACTON
Zomacton (somatropin) is a recombinant human growth hormone used to treat growth failure and short stature in both pediatric and adult populations. In children, it is indicated for growth hormone deficiency, Turner syndrome, idiopathic short stature, SHOX deficiency, and those born small for gestational age who fail to achieve catch-up growth. For adults, the medication serves as a replacement therapy for inadequate endogenous growth hormone secretion. The drug addresses various genetic and developmental conditions that prevent patients from reaching normal height ranges or maintaining metabolic balance.
How ZOMACTON Works
Somatropin functions by binding to dimeric growth hormone receptors located on the cell membranes of target tissues. This interaction triggers intracellular signaling that induces the production of growth-dependent proteins, including insulin-like growth factor 1 (IGF-1). These proteins stimulate skeletal growth by promoting the differentiation and proliferation of cells within the growth plates of long bones. Additionally, the drug facilitates linear growth and metabolic regulation by increasing cellular protein synthesis and stimulating hepatic glucose output.
Details
- Status
- Prescription
- First Approved
- 1995-05-25
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ZOMACTON Approval History
What ZOMACTON Treats
5 indicationsZOMACTON 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
- Turner Syndrome
- Idiopathic Short Stature
- Short Stature Homeobox-Containing Gene Deficiency
- Small for Gestational Age
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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.
ZOMACTON FDA Label Details
ProIndications & Usage
FDA Label (PDF)ZOMACTON is a recombinant human growth hormone indicated for: Pediatric: Treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated with Turner syndrome, idiopathic short stature (ISS), short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency, and short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years. Adult: Replacement of endogenous GH in adults with GH deficiency 1.1 Pediatric Patients ZOMACTON is indicated for the treatment of pediatr...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.