BLAINJECTIONINJECTABLEPriority Review
Approved
Aug 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
SEROSTIM (somatropin) by Emergent BioSolutions is cells. Approved for growth hormone deficiency, small for gestational age, adult growth hormone deficiency and 2 more indications. First approved in 1996.
Drug data last refreshed 18h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SEROSTIM (somatropin) is a recombinant human growth hormone approved as an injectable therapeutic indicated for short stature associated with Turner syndrome and idiopathic short stature (ISS) with height standard deviation score ≤-2. The drug works by binding to growth hormone receptors on target cells, triggering intracellular signaling that induces production of IGF-1 and other growth-promoting proteins, thereby stimulating chondrocyte proliferation, hepatic glucose output, protein synthesis, and ultimately skeletal growth and linear height velocity in pediatric patients. SEROSTIM is a legacy biologic therapy developed by Emergent BioSolutions with approval dating to 1996, positioned as a foundational treatment in the growth hormone replacement and growth promotion market.
$0.1BPart D
Mechanism of Action
cells. This interaction results in intracellular signal transduction and subsequent induction of transcription and translation of GH-dependent proteins including IGF-1, IGF BP-3 and acid-labile subunit. Somatropin has direct tissue and metabolic effects or effects mediated indirectly by IGF-1,…
Indications (5)
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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.