SUPPRELIN
LOE ApproachingNDAINJECTIONINJECTABLEPriority Review
Approved
Dec 1991
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
SUPPRELIN by Takeda is continuously. Approved for children with central precocious puberty (cpp), children with central precocious puberty (cpp) (). First approved in 1991.
Drug data last refreshed 22h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SUPPRELIN is a histrelin acetate subcutaneous implant that delivers approximately 65 mcg daily, indicated for central precocious puberty (CPP) in children. It works through initial GnRH agonism followed by pituitary desensitization, suppressing LH and FSH to halt premature sexual development. The mechanism involves reversible down-regulation of GnRH receptors and desensitization of gonadotropes.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), signaling potential team contraction or transition focus.
Mechanism of Action
continuously. It delivers approximately 65 mcg histrelin acetate per day. Both animal and human studies indicate that following an initial stimulatory phase, chronic, subcutaneous administration of histrelin acetate desensitizes responsiveness of the pituitary gonadotropin which, in turn causes a…
Indications (2)
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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.