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Ngenla (somatrogon)
Ngenla works by binding to the growth hormone receptor, mimicking the action of natural growth hormone.
At a glance
| Generic name | somatrogon |
|---|---|
| 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 failure due to inadequate secretion of endogenous growth hormone
Common side effects
- Injection site reactions
- Nasopharyngitis
- Headache
- Pyrexia
- Anemia
- Cough
- Vomiting
- Hypothyroidism
- Abdominal pain
- Rash
- Oropharyngeal pain
- Arthralgia
Drug interactions
- Glucocorticoid Replacement (e.g., cortisone acetate, prednisone)
- Supraphysiologic Glucocorticoid Treatment
- Cytochrome P450-Metabolized Drugs
- Oral Estrogen
- Insulin and/or Other Antihyperglycemic Agents
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ngenla CI brief — competitive landscape report
- Ngenla updates RSS · CI watch RSS
- Pfizer Ireland Pharmaceuticals portfolio CI