NDASUBCUTANEOUSPOWDER1 Generic Approved
Approved
May 2020
Lifecycle
Peak
Competitive Pressure
15/100
Clinical Trials
9
Data completeness
4/8 — Partial
Drug data last refreshed 59m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FENSOLVI KIT is a subcutaneous powder formulation of leuprolide acetate, a GnRH agonist approved in 2020 for hormone-responsive cancers and endometriosis. The drug suppresses luteinizing hormone and follicle-stimulating hormone, reducing sex hormone production. It is administered as a subcutaneous injection via a reconstitution kit.
Peak15.3 years to LOE
Product is at peak lifecycle with moderate competitive pressure (15 competitors); commercial teams are focused on market penetration and defending share against established generics.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
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.