Data updated: May 26, 2026
LUPRON (leuprolide acetate)
Trial Activity: Stable 2 active trials
Oncology
Approved 1985-04-09
Development Insights
Icahn School of Medicine at Mount Sinai conducting 2 trials (50%)
10 indications explored (Broad Platform)
→ prostate cancer (2 trials)
→ high-risk prostate cancer (1 trials)
→ leukemia (1 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
41
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1985-04-09
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
LUPRON Approval History
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
35 FDA actions from 1985 to 2026
May 2002 SUPPL Priority
Mfg
Dec 2000 SUPPL Priority
Mfg
Nov 1999 SUPPL Priority
Mfg
Sep 1998 SUPPL Priority
Mfg
Jan 1998 SUPPL Priority
Mfg
Jul 1997 SUPPL Priority
Mfg
May 1996 SUPPL Priority
Mfg
Apr 1996 SUPPL Priority
Mfg
May 1994 SUPPL Priority
Mfg
Jun 1993 SUPPL Priority
Mfg
Jul 1992 SUPPL Priority
Mfg
Oct 1991 SUPPL Priority
Mfg
May 1988 SUPPL Priority
Mfg
Jan 1988 SUPPL Priority
Mfg
Mar 1987 SUPPL
Label
Jan 1987 SUPPL Priority
Mfg
Jul 1986 SUPPL Priority
Mfg
Apr 1985 ORIGINAL Priority
New Drug
What LUPRON Treats
1 FDA approvalsOriginally approved for its first indication in 1985 .
- Other (1)
Other
(1 approval)- • Approved indication (Apr 1985) Priority
📋
Clinical Trial Registry
55 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06169124 | NCI-2023-06524 NCI-2023-06524, NRG-GY033 | Ph 2 | active not recruiting | Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors |
| NCT05669664 | NCI-2022-10701 NCI-2022-10701, 10553 | Ph 2 | active not recruiting | Testing the Anti-cancer Drug Darolutamide in Patients With Testosterone-Driven Salivary Gland Cancers |
| NCT03070886 | NRG-GU002 NCI-2016-00963, NRG-GU002 | Ph 2, Ph 3 | completed | Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery |
| NCT04484818 | EA8183 NCI-2020-02383, EA8183 | Ph 3 | active not recruiting | Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study |
| NCT04423211 | EA8191 NCI-2020-02686, EA8191 | Ph 3 | recruiting | Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging |
| NCT06305598 | I-3298823 NCI-2024-01390, I-3298823 | Ph 1 | recruiting | Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer |
| NCT02960022 | 9785-CL-0123 2016-001694-32, 2023-510298-33-00 | Ph 2 | recruiting | A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study |
| NCT03361735 results posted | 17085 NCI-2017-02192 | Ph 2 | active not recruiting | Radium Ra 223 Dichloride, Hormone Therapy and Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Prostate Cancer |
| NCT07027124 | STUDY-23-01400 | Ph 2 | recruiting | Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer |
| NCT01786265 | 2012-0993 NCI-2018-01856, 2012-0993 | Ph 2 | active not recruiting | Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer |
| NCT01674140 e3 results posted | S1207 S1207, U10CA032102 | Ph 3 | active not recruiting | S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer |
| NCT04455750 CASPAR | A031902 NCI-2020-02360, U10CA180821 | Ph 3 | active not recruiting | A Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy |
| NCT03902951 | 18-001037 NCI-2019-00337 | Ph 2 | active not recruiting | Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer |
| NCT04734730 | 20476 NCI-2020-10199, 20476 | Ph 2 | recruiting | Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer |
| NCT01746849 | 12-077 | Ph 2 | active not recruiting | Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation |
| NCT03007732 results posted | 16703 NCI-2017-01340 | Ph 2 | completed | Pembrolizumab +/- SD-101 in Hormone-Naïve Oligometastatic Prostate Cancer With RT and iADT |
| NCT02023463 | 13P.461 2013-027, JT 2970 | Ph 1 | active not recruiting | Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk Prostate Cancer |
| NCT05896293 | FD007843 | Ph 2 | recruiting | Kisspeptin Administration Subcutaneously to Patients With IHH |
| NCT06348264 | SDC-1 | Ph 2 | recruiting | Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma |
| NCT03678025 | S1802 NCI-2018-01738, S1802 | Ph 3 | recruiting | Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer |
| NCT05605964 | MVT-601-056 | Ph 3 | completed | Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate |
| NCT02278185 results posted | 14-0909.cc NCI-2014-02219 | Ph 2 | completed | Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer |
| NCT03951831 | AAAS1863 | Ph 2 | active not recruiting | REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer |
| NCT00687739 POWER results posted | 06-0512 R01AG018198 | Ph 3 | completed | Prevention of Obesity in Women Via Estradiol Regulation |
| NCT02685397 PCS IX | PCS IX | Ph 2, Ph 3 | active not recruiting | Management of Castration-Resistant Prostate Cancer with Oligometastases |
| NCT01194271 results posted | 2009-0135 NCI-2010-01974 | Ph 2 | completed | Neoadjuvant Ipilimumab in Prostate Cancer |
| NCT03572387 results posted | GCO 16-0752 | Ph 2 | completed | A Pilot Study of 5-AZA and ATRA for Prostate Cancer With PSA-only Recurrence After Local Treatment |
| NCT00651326 DART | PR12 CAN-NCIC-PR12, CDR0000589247 | Ph 3 | terminated | Androgen Suppression and Radiation With/Out Docetaxel in High-Risk Localized Prostate Cancer |
| NCT00771017 | CDR0000616570 ECOG-E3806 | Ph 2 | withdrawn | Androgen Ablation Therapy With or Without Vaccine Therapy in Treating Patients With Prostate Cancer |
| NCT02058706 results posted | 2013-083 NCI-2014-00212, 2013-083 | Ph 2 | completed | LHRH Analogue Therapy With Enzalutamide or Bicalutamide in Treating Patients With Hormone Sensitive Prostate Cancer |
| NCT03043807 results posted | J16151 IRB00120414 | Ph 2 | completed | A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy |
| NCT02716974 oligo-mets results posted | J1618 IRB00070003 | Ph 2 | completed | A Study of Definitive Therapy to Treat Prostate Cancer |
| NCT04225221 results posted | 19-2343 R21MH121726 | Ph 2 | completed | Neurobiology of Bulimia Nervosa |
| NCT02770391 results posted | CASE5815 | Ph 2 | completed | Apalutamide and Leuprolide in Intermediate and High-risk Prostate Cancer |
| NCT04331717 BASH-PC | J1943 IRB00207275 | Ph 2 | withdrawn | Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer |
| NCT02268175 results posted | 14-283 | Ph 2 | completed | Enzalutamide/Leuprolide +/- Abiraterone/Pred in Prostate |
| NCT03085095 HERO results posted | MVT-601-3201 2017-000160-15 | Ph 3 | completed | A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer |
| NCT04585932 | 2019-1093 NCI-2020-02553, 2019-1093 | Ph 2 | withdrawn | Androgen Deprivation Therapy and Apalutamide With or Without Radiation Therapy for the Treatment of Biochemically Recurrent Prostate Cancer, RESTART Study |
| NCT02064582 results posted | STU 082013-032 | Ph 2 | completed | Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer |
| NCT02168062 results posted | 135513 NCI-2015-01058 | Ph 2 | terminated | Supportive Therapy in Androgen Deprivation Clinic in Improving Health Outcomes and Managing Side Effects in Patients With Prostate Cancer |
| NCT03093272 results posted | 16-485 | Ph 2 | terminated | A Study of Docetaxel + ARN-509 in Castration-Resistant Prostate Cancer |
| NCT00937768 results posted | MC0852 NCI-2009-01147, 08-001519 | Ph 2 | terminated | Leuprolide Acetate or Goserelin Acetate Compared With Observation in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy |
| NCT02969590 results posted | OHSU IRB 11532 | Ph 4 | completed | Regulation of Cervical Mucus Secretion |
| NCT03544073 GRAET | 2018-03-14 | Ph 3 | withdrawn | GnRH Agonist at Embryo Transfer: IVF Outcomes |
| NCT01163084 results posted | NCI-2010-01737 NCI-2010-01737, CDR0000670590 | Ph 1, Ph 2 | terminated | Leuprolide Acetate or Goserelin Acetate With or Without Vismodegib Followed by Surgery in Treating Patients With Locally Advanced Prostate Cancer |
| NCT01120236 results posted | NCI-2011-02003 NCI-2011-02003, SWOG-S0925 | Ph 2 | completed | Bicalutamide and Goserelin or Leuprolide Acetate With or Without Cixutumumab in Treating Patients With Newly Diagnosed Metastatic Prostate Cancer |
| NCT01023061 RAD1 results posted | 7048 NCI-2009-01346, 7048 - AbiRAD | Ph 2 | completed | Abiraterone Prednisone and Hormonal Therapy Before and During Radiation Therapy in Localized Prostate Cancer |
| NCT01431391 results posted | P10-2 | Ph 2 | completed | Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer |
| NCT02107391 | SP002 2011-004986-34 | Ph 2 | completed | Phase II Study of DCVAC/PCa Added to Hormone Therapy for Men With Metastatic Prostate Cancer |
| NCT02212197 results posted | HS-12-460 | Ph 2 | completed | Phase II Study of Subcutaneous Injection Depot of Leuprolide Acetate in Patient With Prostate Cancer |
Showing 50 of 55 trials
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LUPRON FDA Label Details
Track LUPRON with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment