NGENLA
NGENLA (somatrogon-ghla) is a human growth hormone analog indicated for the treatment of pediatric patients aged 3 years and older. It is used to address growth failure in children resulting from an inadequate secretion of endogenous growth hormone. The medication provides a therapeutic intervention for pediatric patients who do not produce sufficient natural growth hormone to maintain expected growth rates.
How NGENLA Works
Somatrogon-ghla functions by binding to the growth hormone receptor, which initiates a signal transduction cascade. This process leads to the activation of the STAT5b signaling pathway and increases serum concentrations of Insulin-like Growth Factor (IGF-1). These biological actions stimulate linear growth and enhance growth velocity while inducing metabolic changes. This mechanism addresses the underlying deficiency in pediatric patients to promote physical development.
Details
- Status
- Prescription
- First Approved
- 2023-06-27
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
NGENLA Approval History
What NGENLA Treats
1 indicationsNGENLA is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Growth Hormone Deficiency
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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.
NGENLA FDA Label Details
ProIndications & Usage
FDA Label (PDF)NGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone. NGENLA is a human growth hormone analog indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone .
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.