GnRH agonist
Leuprolide
Answer
Leuprolide is authorised or registered in the US, the UK, Canada, Switzerland, Brazil, Serbia, Singapore and Turkey: 8 of the 10 registers read. Highest trial phase: Phase 3 (2 phase 3 trials, 0 with posted results). It has 520 registered trials, 131 of them running. Brand names on the FDA label register: Vabrinty, Lupron Depot, Leuprolide Acetate and Leuprolide Acetate Depot.
RegulatorTrial register10 regulators' registers, read 2026-08-31 to 2026-10-03 · ClinicalTrials.gov and EU CTIS, read 2026-10-03
Not medical, legal or regulatory advice.
520 trials by status
Trial registerClinicalTrials.gov and EU CTIS · read 2026-10-03 · 102 trials have posted results
Trials first submitted per year
Trial registerClinicalTrials.gov first-submitted date, last 10 years · read 2026-10-03. 2026 is not complete. 309 trials carry no first-submitted date (EU CTIS publishes none, or the year is outside this range).
Status by jurisdiction
World map| Where | Status | Register | Read |
|---|---|---|---|
| United States | FDA-approved | FDA, openfda | 2026-10-03 |
| European Union | Not on the register | EMA, ema | 2026-08-31 |
| United Kingdom | Authorised | MHRA, uk-mhra | 2026-10-03 |
| Canada | Authorised | Health Canada, ca-dpd | 2026-10-03 |
| Australia | Status unknown | TGA, au-artg | not read |
| Switzerland | Authorised | Swissmedic, ch-swissmedic | 2026-09-03 |
| Brazil | Registado | ANVISA, br-anvisa | 2026-10-03 |
| Serbia | Authorised | ALIMS, rs-alims | 2026-09-03 |
| Singapore | Registered | HSA, sg-hsa | 2026-09-03 |
| Turkey | Ruhsatli | TITCK, tr-titck | 2026-09-03 |
An EU decision applies in the 30 territories the EU register covers: its member states, and Iceland, Liechtenstein and Norway. A dashed tile has no register read for this peptide.
Side effects
Trial registerCHANGE ALERTS
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One email when the status of Leuprolide changes on the register. You confirm your address first.
REGISTERED TRIALS
Newest 10 of 520 trials
| NCT05827081 | Phase IIIb Study of Ribociclib + ET in Early Breast Cancer currently recruiting participants · register updated 2026-10-02 |
|---|---|
| NCT04906395 | Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer running, but no longer enrolling · register updated 2026-09-29 |
| NCT03649724 | The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's completed · register updated 2026-09-21 |
| NCT07650240 | Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial currently recruiting participants · register updated 2026-09-18 |
| NCT03070886 | Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Remov running, but no longer enrolling · register updated 2026-09-14 |
| NCT02960022 | A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study running, but no longer enrolling · register updated 2026-09-11 |
| 2023-508607-20-00 | A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in no status recorded · register updated 2026-09-09 |
| NCT07801898 | Neoadjuvant Endocrine Therapy Combined With Chemotherapy in ER-positive, HER2-negative Stage I-III Breast Cancer not yet recruiting participants · register updated 2026-09-03 |
| NCT04557059 | A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer running, but no longer enrolling · register updated 2026-08-28 |
| NCT07793162 | A Phase Ia Trial Comparing the Pharmacokinetics/Pharmacodynamics, Safety, and Preliminary Efficacy of HHK001 and Enantone in Patie not yet recruiting participants · register updated 2026-08-28 |
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New trials, approvals and enforcement actions. One email a week.