BLAINJECTIONINJECTABLE
Approved
Jun 2023
Lifecycle
Growth
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
3/8 — Basic
NGENLA (somatrogon-ghla) by Pfizer is somatrogon-ghla binds to the gh receptor and initiates a signal transduction cascade culminating in changes in growth and metabolism. First approved in 2023.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NGENLA (somatrogon-ghla) is a recombinant human growth hormone (GH) analog approved by the FDA in June 2023 for treating growth hormone deficiency (GHD) in pediatric patients. It works by binding to GH receptors, activating STAT5b signaling, and increasing IGF-1 levels to stimulate linear growth and metabolic changes. The drug is administered via injection and represents a new formulation option in the growth hormone replacement market.
Growth
Early-stage launch product with moderate competitive pressure (30/100); expect growing team investment in market share capture over next 2-3 years.
Mechanism of Action
Somatrogon-ghla binds to the GH receptor and initiates a 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…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
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
Started Jun 2024
565 enrolled
Pediatric Growth Hormone Deficiency
A Study to Compare the Experiences of Taking Daily Growth Hormone Injections to Weekly Ngenla in Children With Low Levels of Growth Hormone
Started Jan 2024
0Pediatric Growth Hormone Deficiency
Ngenla Subcutaneous Injection Special Investigation
Started Feb 2023
1 enrolled
Growth Hormone Deficiency Without Epiphyseal Closure
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.