NGENLA (somatrogon-ghla)
NGENLA is indicated for the treatment of Growth Hormone Deficiency.
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.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-06-27
- Patent Cliff
- 2030
- 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
NGENLA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07226089 MISSION | 0081-24-RMC | Ph 3 | recruiting | Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or With Idiopathic Short Stature. |
| NCT03831880 results posted | C0311002 2018-000918-38 | Ph 3 | completed | Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD |
| NCT03810664 | CP-4-011 | Ph 1 | completed | A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations |
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
Indications & Usage
FDA Label (PDF)NGENLA is indicated for the treatment of Growth Hormone Deficiency.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment