NDAINJECTIONINJECTABLE
Approved
Mar 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
12
Data completeness
4/8 — Partial
LUPRON DEPOT (leuprolide acetate) by AbbVie is long-acting gnrh analog. First approved in 1997.
Drug data last refreshed 30m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LUPRON DEPOT (leuprolide acetate) is a long-acting GnRH agonist administered as a quarterly injection that suppresses pituitary gonadotropins and reduces gonadal steroid secretion. It is indicated for hormone-dependent cancers (prostate, breast) and hormone-responsive conditions such as endometriosis and uterine fibroids. The drug's reversible mechanism makes it suitable for both palliative and adjunctive therapeutic roles.
LOE Approaching
As LUPRON DEPOT approaches loss of exclusivity, brand teams are likely consolidating and shifting focus toward lifecycle management and defensive positioning against generic/biosimilar entrants.
Mechanism of Action
long-acting GnRH analog. A single injection of LUPRON DEPOT 11.25 mg results in an initial stimulation followed by a prolonged suppression of pituitary gonadotropins. Repeated dosing of LUPRON DEPOT 11.25 mg at quarterly intervals results in decreased secretion of gonadal steroids. Consequently,…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
A Study of Leuprolide Acetate Depot in Children With Central Precocious Puberty
Started Mar 2023
80 enrolled
Central Precocious Puberty
Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer
Started Jul 2021
250 enrolled
Breast Cancer
Leuprolide Acetate 3.75 mg Depot Injection for Patients With Advanced Prostate Cancer
Started Jul 2021
155 enrolled
Advanced Prostate Adenocarcinoma
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.