NDAINTRAMUSCULARPOWDER
Approved
Apr 1993
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
9
Data completeness
5/8 — Partial
LUPRON DEPOT-PED KIT (leuprolide acetate) by AbbVie is acetate, a gnrh agonist, acts as a potent inhibitor of gonadotropin secretion (lh and follicle stimulating hormone (fsh)) when given continuously in therapeutic doses. First approved in 1993.
Drug data last refreshed 2h ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LUPRON DEPOT-PED KIT is a GnRH agonist (leuprolide acetate) administered as an intramuscular injection in powder form for pediatric patients. It works by potently inhibiting gonadotropin secretion (LH and FSH) when given continuously in therapeutic doses. The product targets pediatric central precocious puberty and related endocrine conditions.
Peak4.4 years to LOE
Product is in peak commercial phase with established market presence; brand and field teams likely maintain steady sales operations with focus on market maintenance and pediatric specialist outreach.
Mechanism of Action
acetate, a GnRH agonist, acts as a potent inhibitor of gonadotropin secretion (LH and follicle stimulating hormone (FSH)) when given continuously in therapeutic doses.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty
Started Mar 2023
79 enrolled
Central Precocious Puberty
Leuprolide Acetate 3.75 mg Depot Injection for Patients With Advanced Prostate Cancer
Started Jul 2021
155 enrolled
Advanced Prostate Adenocarcinoma
Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer
Started Jul 2021
250 enrolled
Breast Cancer
A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)
Started Oct 2018
45 enrolled
Central Precocious Puberty (CPP)
Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty
Started Aug 2015
64 enrolled
Precocious Puberty, Central
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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.