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NGENLA (Somatrogon) (ngenla-somatrogon)
NGENLA (Somatrogon) is an investigational long-acting recombinant human growth hormone developed by Pfizer for the treatment of growth hormone deficiency in children. It aims to reduce the frequency of injections compared to daily growth hormone treatments. The drug has not yet received FDA approval and is currently in clinical trials. Preliminary data suggest that it may offer comparable efficacy to existing treatments with a more convenient dosing schedule. However, the safety profile and long-term outcomes are still under evaluation.
At a glance
| Generic name | ngenla-somatrogon |
|---|---|
| Sponsor | Pfizer |
| Drug class | Recombinant human growth hormone |
| Target | Growth hormone receptor |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
Approved indications
- Idiopathic short stature in pediatric patients 2 years of age and older
- Short stature associated with Turner syndrome in pediatric patients 2 years of age and older
- Short stature associated with SHOX deficiency in pediatric patients 2 years of age and older
- Short stature associated with idiopathic growth hormone deficiency in pediatric patients 2 years of age and older
- Short stature associated with other causes of growth hormone deficiency in pediatric patients 2 years of age and older
Pipeline indications
Common side effects
Drug interactions
- Insulin
- Oral hypoglycemic agents
- Thiazide diuretics
- Beta-blockers
- Glucocorticoids
- Other growth hormone-releasing agents
Key clinical trials
- Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or With Idiopathic Short Stature. (PHASE3)
- 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
- Ngenla Subcutaneous Injection Special Investigation
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- NGENLA (Somatrogon) CI brief — competitive landscape report
- NGENLA (Somatrogon) updates RSS · CI watch RSS
- Pfizer portfolio CI