BLAINJECTIONINJECTABLE9 Generics Approved
Approved
May 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BIO-TROPIN (somatropin) is a recombinant human growth hormone cytokine approved in 1995 for treatment of growth hormone deficiency, Turner syndrome, small for gestational age, and idiopathic short stature. It works by binding to growth hormone receptors on cells, triggering intracellular signaling that induces IGF-1 production and downstream effects including chondrocyte proliferation, protein synthesis, and skeletal growth stimulation. Somatropin increases linear growth velocity in pediatric patients by promoting growth plate development and cellular protein synthesis.
LOE Approaching
BIO-TROPIN is in late-stage lifecycle with approaching loss of exclusivity, signaling potential portfolio transition and focus on brand differentiation or lifecycle extension strategies.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
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.