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Ngenla (Somatrogon-Ghla)
Ngenla works by binding to the growth hormone receptor, mimicking the action of natural growth hormone to stimulate growth and development.
Ngenla (Somatrogon-Ghla) is a growth hormone therapy developed by Pfizer Ireland Pharmaceuticals. It targets the growth hormone receptor to treat growth hormone deficiency. Ngenla is a small molecule modality with a half-life of 37.7 hours. It was FDA-approved in 2023 for the treatment of growth hormone deficiency. Ngenla is a patented product with its commercial status currently owned by Pfizer Ireland Pharmaceuticals.
At a glance
| Generic name | Somatrogon-Ghla |
|---|---|
| Sponsor | Pfizer Ireland Pharmaceuticals |
| Target | Growth hormone receptor |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2023 |
Mechanism of action
Somatrogon-ghla binds to the GH receptor and initiates signal transduction cascade culminating in changes in growth and metabolism. Somatrogon-ghla binding leads to activation of the STAT5b signaling pathway and increases the serum concentration of Insulin-like Growth Factor (IGF-1). GH and IGF-1 stimulate metabolic changes, linear growth, and enhance growth velocity in pediatric patients with GHD.
Approved indications
- Growth hormone deficiency
Common side effects
- Injection site reactions
- Nasopharyngitis
- Headache
- Pyrexia
- Anemia
- Cough
- Vomiting
- Abdominal pain
- Rash
- Oropharyngeal pain
- Arthralgia
- Otitis media
Key clinical trials
- Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or With Idiopathic Short Stature. (PHASE3)
- Evaluation of (Cardio)Metabolic and Auxological Outcomes of GHD Patients Under rhGH or LAGH With Stratification According to IGF-1 Levels (NA)
- Korean Post-marketing Surveillance Ngenla® Pre-filled Pen Injection for the Treatment of Pediatric Patients With Growth Disturbance Due to Insufficient Secretion of Growth Hormone
- A Study to Learn About Somatrogon in Patients With Pediatric Growth Hormone Deficiency (p GHD) in India.
- Ngenla Subcutaneous Injection Special Investigation
- Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children (PHASE3)
- Patient Perception of Treatment Burden in Weekly Versus Daily Growth Hormone Injections in Children With GHD (PHASE3)
- Safety and Efficacy Study of MOD-4023 to Treat Children With Growth Hormone Deficiency (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |