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Compound · clinical trials

Leuprorelin clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 9 trials in our Canada, Israel, Netherlands, Mexico, China, France, Brazil and South Korea registers that name Leuprorelin as an intervention. Synced 27 Sep 2026
9Current trials
4Recruiting now
6Lead sponsors
8Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards
At a glance

Leuprorelin is named as an intervention in 9 current clinical trials in our Canada, Israel, Netherlands, Mexico, China, France, Brazil and South Korea registers. 4 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is NRG Oncology (3). The most-studied condition is Prostate Cancer.

Where Leuprorelin is approved

All regulators →

Leuprorelin was first approved in the EU on 24 May 2022.

USUnited States (FDA)
No FDA approval of a single-substance product in Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
24 May 2022
Camcevi
EMA product page
First centralised authorisation
CACanada (Health Canada)
No new-drug Notice of Compliance since 1994
First new-drug NOC

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.

Trials by status

  • Recruiting444%
  • Active, closed556%

Trials by phase

  • Phase 3333%
  • Phase 2222%
  • Phase 4222%
  • Not applicable111%
  • Phase 2/3111%
01

Clinical trials of Leuprorelin

9 trials
StudyPhaseStatusLead sponsorRegisters
A Study of Leuprorelin 1-Month (4-Week) Formulation in Children With Central Precocious Puberty
NCT07710430 · ClinicalTrials.gov ↗ · Central Precocious Puberty
Phase 4 Recruiting LG Chem South Korea
A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease
NCT05478083 · ClinicalTrials.gov ↗ · Polycystic Liver Disease, Autosomal Dominant Polycystic Kidney
Phase 2 Recruiting University Medical Center Groningen Netherlands
A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer
NCT07159451 · ClinicalTrials.gov ↗ · Breast Cancer
Phase 2 Recruiting Gustave Roussy, Cancer Campus, Grand Paris France
Comparison of the Therapeutic Effects of Vaginal Repair With Leuprorelin and Vaginal Repair in the Treatment of Cesarean Section Scar Defect
NCT05206682 · ClinicalTrials.gov ↗ · Cesarean Section; Dehiscence
Not applicable Recruiting Xinhua Hospital, Shanghai Jiao Tong University School of Medicine China
COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer
NCT06627530 · ClinicalTrials.gov ↗ · Prostate Cancer
Phase 4 Active, closed Brazilian Clinical Research Institute Brazil
Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy
NCT04302454 · ClinicalTrials.gov ↗ · Prostate Cancer
Phase 3 Active, closed University Medical Center Groningen Netherlands
Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial
NCT04513717 · ClinicalTrials.gov ↗ · Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
Phase 3 Active, closed NRG Oncology Canada, Mexico, Israel
Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial
NCT05050084 · ClinicalTrials.gov ↗ · Prostate Adenocarcinoma
Phase 3 Active, closed NRG Oncology Canada, Mexico, Israel
Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery
NCT03070886 · ClinicalTrials.gov ↗ · Stage I Prostate Adenocarcinoma AJCC v7, Stage II Prostate Adenocarcinoma AJCC v7, Stage III Prostate Adenocarcinoma AJCC v7
Phase 2/3 Active, closed NRG Oncology Canada, Israel

Registers 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.

02

Leuprorelin across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

15 single-substance products containing Leuprorelin on the HPRA medicines list.

All 15 Irish products →

Supply shortages

No entry for Leuprorelin in the EMA, FDA or German BfArM shortage lists we track.

03

Conditions studied with Leuprorelin

12 conditions
Prostate Cancer2Prostate Adenocarcinoma2Cesarean Section; Dehiscence1Breast Cancer1Polycystic Liver Disease1Autosomal Dominant Polycystic Kidney1Stage III Prostate Cancer AJCC v81Stage IVA Prostate Cancer AJCC v81Stage I Prostate Adenocarcinoma AJCC v71Stage II Prostate Adenocarcinoma AJCC v71Stage III Prostate Adenocarcinoma AJCC v71Central Precocious Puberty1
04

Sponsors

lead sponsor per trial
Lead sponsorTrials
NRG Oncology3
University Medical Center Groningen2
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1
Gustave Roussy, Cancer Campus, Grand Paris1
Brazilian Clinical Research Institute1
LG Chem1
05

By country register

RegisterTrialsRecruiting
Clinical trials in Canada30
Clinical trials in Israel30
Clinical trials in Netherlands21
Clinical trials in Mexico20
Clinical trials in China11
Clinical trials in France11
Clinical trials in Brazil10
Clinical trials in South Korea11

A trial with sites in more than one country appears in each of those registers.

06

Related compounds

07

Questions about Leuprorelin trials

How many clinical trials are testing Leuprorelin?

9 current trials in our Canada, Israel, Netherlands, Mexico, China, France, Brazil and South Korea registers name Leuprorelin as a drug or biological intervention, as of the registry sync on 27 September 2026. Completed and withdrawn studies are not counted.

Are Leuprorelin trials recruiting patients?

Yes. 4 of the 9 trials are recruiting: 1 with sites in Netherlands, 1 with sites in China, 1 with sites in France and 1 with sites in South Korea. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Leuprorelin clinical trials?

NRG Oncology (3), University Medical Center Groningen (2), Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (1) and Gustave Roussy, Cancer Campus, Grand Paris (1), among 6 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Is Leuprorelin licensed in Ireland?

Yes. The HPRA medicines list includes 15 single-substance products containing Leuprorelin, for example ELIGARD 22.5 mg powder and solvent for solution for injection (Recordati Industria Chimica e Farmaceutica SpA). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Leuprorelin shortage?

Not in the lists we track: Leuprorelin has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

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 Leuprorelin works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Leuprorelin works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Leuprorelin (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 27 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.