BLAINJECTIONINJECTABLEPriority Review
Approved
Aug 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
SEROSTIM (somatropin) by Emergent BioSolutions is cells. First approved in 1996.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SEROSTIM (somatropin) is a recombinant human growth hormone (GH) administered by injection that treats growth hormone deficiency (GHD) and related conditions by binding to GH receptors on target cells, triggering intracellular signaling that induces production of IGF-1 and other anabolic proteins. The drug stimulates skeletal growth, protein synthesis, and metabolic effects in pediatric and adult patients. Somatropin has been approved for nearly three decades and remains the standard-of-care GH replacement therapy.
$0.107BPart D
LOE ApproachingProduct approaching loss of exclusivity with $107M annual Part D spend, suggesting moderate brand team size focused on transition planning and managed care retention.
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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Clinical Study of Long-Term Administration of Inpegsomatropin Injection in Participants With Idiopathic Short Stature Who Have Completed Phase Ⅲ Clinical Trials
Started Sep 2026
300 enrolled
Idiopathic Short Stature
The Efficacy and Safety of Inpegsomatropin Injection in Children With Turner Syndrome (TS) and Short Stature
Started Jul 2026
84 enrolled
Turner Syndrome
Safety, Pharmacokinetic (PK) Profile and Efficacy of Inpegsomatropin Injection in Adults With Growth Hormone Deficiency
Started Jun 2026
36 enrolled
Adult Growth Hormone Deficiency
A Study to Learn How Different Injector Pens Affect the Study Medicine Called Genotropin (Somatropin) Delivery and Taken up Into the Blood in Healthy Adults
Started Apr 2026
27 enrolled
Healthy
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
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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.