BLASUBCUTANEOUSINJECTABLEPriority Review
Approved
Aug 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
SEROSTIM LQ (somatropin) by Emergent BioSolutions is cells. Approved for growth hormone deficiency, turner syndrome, small for gestational age and 4 more indications. First approved in 1996.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SEROSTIM LQ is a recombinant human growth hormone (somatropin) administered via subcutaneous injection that binds to growth hormone receptors on cells to trigger intracellular signaling and production of IGF-1 and related proteins. It treats seven indications spanning pediatric growth disorders (GHD, Turner syndrome, SGA, ISS, PWS, CKD) and HIV-related wasting by stimulating skeletal growth, protein synthesis, and metabolic effects. The drug works by directly stimulating chondrocyte differentiation and proliferation, increasing hepatic glucose output, and promoting lipolysis across multiple tissues.
LOE Approaching
Approaching loss of exclusivity signals declining revenue and potential team contraction; careers should prioritize LOE defense strategies or transition planning within the next 12-24 months.
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 (7)
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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.