SAIZEN
Saizen (somatropin) is a recombinant human growth hormone indicated for the treatment of growth failure and short stature in pediatric patients and growth hormone deficiency in adults. In children, the therapy is used to treat growth failure caused by inadequate endogenous growth hormone secretion, Noonan syndrome, Turner syndrome, and Prader-Willi syndrome. It is also indicated for pediatric patients born small for gestational age who fail to achieve catch-up growth and those with idiopathic short stature.
How SAIZEN Works
Somatropin binds to dimeric growth hormone receptors on the cell membranes of target tissues, initiating intracellular signal transduction. This process induces the production of growth-dependent proteins, such as IGF-1, which stimulates the differentiation and proliferation of chondrocytes in the growth plates of long bones. These interactions facilitate linear growth through increased cellular protein synthesis and various metabolic effects, including lipolysis and hepatic glucose output.
Details
- Status
- Prescription
- First Approved
- 1996-10-08
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SAIZEN Approval History
What SAIZEN Treats
6 indicationsSAIZEN is approved for 6 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Growth Hormone Deficiency
- Short Stature
- Noonan Syndrome
- Turner Syndrome
- Small for Gestational Age
- Prader-Willi Syndrome
Drugs Similar to SAIZEN
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
SAIZEN FDA Label Details
ProIndications & Usage
FDA Label (PDF)NORDITROPIN 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 Noonan syndrome, short stature associated with Turner syndrome, short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years, Idiopathic Short Stature (ISS), and growth failure due to Prader-Willi Syndrome • Adult : Replacement of endogenous GH in adults with growth hormone deficiency 1.1 Pediatric Patients NORDITROPIN is indicated for the ...
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.