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 3d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SUPPRELIN is a histrelin acetate subcutaneous implant delivering approximately 65 mcg daily, indicated for central precocious puberty (CPP) in children. It works through GnRH receptor desensitization, initially stimulating then suppressing LH and FSH to reduce gonadal steroid production. The implant provides continuous hormone suppression over an extended dosing interval.
LOE Approaching
Product approaching loss of exclusivity with 30% competitive pressure; commercial teams should expect portfolio transition planning and potential downsizing.
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.