BLASUBCUTANEOUSINJECTABLEPriority Review
Approved
Aug 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
Priority Review
INCRELEX (mecasermin) by Ipsen is insulin-like growth factor-1 (igf-1) is a key hormonal mediator on statural growth. First approved in 2005.
Drug data last refreshed 14h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INCRELEX (mecasermin) is a recombinant human insulin-like growth factor-1 (IGF-1) administered subcutaneously to treat growth failure in pediatric patients with severe IGF-1 deficiency. It activates the Type 1 IGF-1 receptor to stimulate statural growth by promoting glucose, fatty acid, and amino acid uptake in growing tissues. This is a hormone replacement therapy addressing a rare genetic growth disorder.
LOE Approaching
Product is in late-stage lifecycle with modest competitive pressure (30%), suggesting a smaller, specialized commercial organization preparing for patent expiration.
Mechanism of Action
Insulin-like growth factor-1 (IGF-1) is a key hormonal mediator on statural growth. Under normal circumstances, growth hormone (GH) binds to its receptor in the liver, and other tissues, and stimulates the synthesis/secretion of IGF-1. In target tissues, the Type 1 IGF-1 receptor, which is…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Increlex Treatment of Children With Chronic Liver Disease and Short Stature
Started Jun 2011
0Growth FailureChronic Liver Disease
Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).
Started Dec 2008
500 enrolled
IGF1 Deficiency
IGFD Registry: A Patient Registry for Monitoring Long-term Safety and Efficacy of Increlex
Started Jun 2006
1,378 enrolled
Primary Insulin-like Growth Factor-1 Deficiency
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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.