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 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SEROSTIM (somatropin) is a recombinant human growth hormone that binds to GH receptors on target cells, triggering intracellular signaling and IGF-1 production to stimulate protein synthesis, lipolysis, and skeletal growth. It is indicated for growth hormone deficiency in pediatric and adult patients, as well as HIV-associated wasting syndrome. The drug works by promoting cellular protein synthesis and hepatic glucose output while facilitating linear growth in children through effects on bone growth plates.
$0.107BPart D
LOE ApproachingThe product is approaching loss of exclusivity with modest Part D utilization, suggesting a contracting team focused on maximizing remaining patent life.
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)
The Efficacy and Safety of Inpegsomatropin Injection in Children With Turner Syndrome (TS) and Short Stature
Started Jun 2026
84 enrolled
Turner Syndrome
Safety, Pharmacokinetic (PK) Profile and Efficacy of Inpegsomatropin Injection in Adults With Growth Hormone Deficiency
Started May 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
26 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
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
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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.