BLAINJECTIONINJECTABLE9 Generics Approved
Approved
May 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
OMNITROPE (somatropin) by Novartis. Approved for recombinant human growth hormone [epc]. First approved in 2006.
Drug data last refreshed 18h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OMNITROPE (somatropin) is a recombinant human growth hormone approved by the FDA in 2006 for injection. It binds to growth hormone receptors on target cells, triggering intracellular signaling that induces production of IGF-1 and other GH-dependent proteins. The drug stimulates skeletal growth in pediatric patients with growth hormone deficiency (GHD) by promoting chondrocyte differentiation and proliferation at the growth plates, while also driving protein synthesis, hepatic glucose output, and lipolysis. It is a foundational therapy in the GHD treatment landscape for children requiring growth acceleration.
$0.0BPart D
Mechanism of Action
Pharmacologic Class:
Recombinant Human Growth Hormone
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Safety, Pharmacokinetic (PK) Profile and Efficacy of Inpegsomatropin Injection in Adults With Growth Hormone Deficiency
Started May 2026
36 enrolled
Adult Growth Hormone Deficiency
The Efficacy and Safety of Inpegsomatropin Injection in Children With Short Stature Born Small for Gestational Age
Started Jan 2026
141 enrolled
Small for Gestational Age
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Started Dec 2025
186 enrolled
Turner SyndromeShort Stature Homeobox Gene MutationIdiopathic Short Stature+1 more
The Efficacy and Safety of Inpegsomatropin Injection in Children With Idiopathic Short Stature
Started Apr 2025
300 enrolled
Idiopathic Short Stature
A Phase 2 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of Navepegritide in Combination With Lonapegsomatropin in Children With Achondroplasia
Started Jul 2024
22 enrolled
Achondroplasia
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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.