Leuprolide Acetate clinical trials
Leuprolide Acetate is named as an intervention in 10 current clinical trials in our Canada, China, South Korea, Israel, Mexico, UK, USA, France, Spain, Italy, Netherlands, Sweden, Denmark, Poland, Austria, Norway, Brazil, Taiwan, Australia, Germany, Belgium, Czechia, Turkey, Japan and Switzerland registers. 2 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is SWOG Cancer Research Network (2). The most-studied condition is Prostate Cancer.
Where Leuprolide Acetate is approved
All regulators →Of the three regulators tracked here, the first to approve Leuprolide Acetate was the US, on 9 Apr 1985. It is approved in 2 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Leuprolide Acetate patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Leuprolide Acetate, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 10 listed patents; the last listed expires 22 Dec 2041 (US 12397120).
- Latest patent on the drug substance itself: 22 Dec 2041 (US 11931559).
- Exclusivity NS: New strength, until 25 Aug 2028.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Leuprolide Acetate
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Leuprolide Acetate works
All drug targets →- Gonadotropin-releasing hormone receptor agonist AgonistTarget: GNRHR gonadotropin releasing hormone receptor✓ In ChEMBL and the Guide to Pharmacology
- Short staturePhase 3
- Breast cancerPhase 3
- EndometriosisPhase 3
- Precocious pubertyPhase 3
- Prostate adenocarcinomaPhase 3
- Prostate carcinomaPhase 3
- Uterine corpus leiomyomaPhase 3
- CancerPhase 2/3
- Insulin resistancePhase 2
- Ovarian HyperandrogenismPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1201199, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 1175, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Leuprolide Acetate
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Leuprolide Acetate
- ATC code
- L02AE02
- ChEMBL
- CHEMBL1201199
- DrugBank
- DB00007
- PubChem CID
- 657181
- CAS number
- 53714-56-0
- FDA UNII
- EFY6W0M8TG
- Wikidata
- Q907160
- Wikipedia
- Leuprorelin
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Leuprolide Acetate
10 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Conditions studied with Leuprolide Acetate
15 conditionsAll 15 conditions
| Condition (as registered) | Trials |
|---|---|
| Prostate Cancer | 3 |
| Stage IV Prostate Cancer AJCC v8 | 2 |
| Stage IVA Prostate Cancer AJCC v8 | 2 |
| Breast Cancer | 2 |
| Salivary Gland Neoplasm Duct | 1 |
| Castration Levels of Testosterone | 1 |
| Metastatic Prostatic Adenocarcinoma | 1 |
| Castration-resistant Prostate Cancer Patients with Oligometastases | 1 |
| Stage I Prostate Adenocarcinoma AJCC v7 | 1 |
| Stage II Prostate Adenocarcinoma AJCC v7 | 1 |
| Stage III Prostate Adenocarcinoma AJCC v7 | 1 |
| Castration-Resistant Prostate Carcinoma | 1 |
| Metastatic Prostate Adenocarcinoma | 1 |
| Hormone Sensitive Prostate Cancer | 1 |
| Cancer of the Prostate | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Leuprolide Acetate trials
How many clinical trials are testing Leuprolide Acetate?
10 current trials in our Canada, China, South Korea, Israel, Mexico, UK, USA, France, Spain, Italy, Netherlands, Sweden, Denmark, Poland, Austria, Norway, Brazil, Taiwan, Australia, Germany, Belgium, Czechia, Turkey, Japan and Switzerland registers name Leuprolide Acetate (also registered as A-43818) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Leuprolide Acetate trials recruiting patients?
Yes. 2 of the 10 trials are recruiting: 1 with sites in China, 1 with sites in Mexico and 1 with sites in Switzerland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Leuprolide Acetate clinical trials?
SWOG Cancer Research Network (2), Astellas Pharma Global Development, Inc (1), Peking University First Hospital (1) and Sir Mortimer B. Davis - Jewish General Hospital (1), among 9 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Leuprolide Acetate works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Leuprolide Acetate works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Leuprolide Acetate (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.