TheraRadar
Data updated: May 26, 2026

LEUPROLIDE ACETATE

Oncology Approved 1998-08-04

LEUPROLIDE ACETATE is indicated for the treatment of Prostate Cancer.

Source: FDA Label • Sun Pharma
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
10
Indications
--
Phase 3 Trials
27
Years on Market

Details

Status
Prescription
First Approved
1998-08-04
Routes
SUBCUTANEOUS
Dosage Forms
SOLUTION

Companies

Sun Pharma UBI Sanofi SOMERSET THERAPS LLC EUGIA PHARMA AMNEAL PH HEALTH MEITHEAL ZYDUS PHARMS Novartis
Active Ingredient: LEUPROLIDE ACETATE

LEUPROLIDE ACETATE Approval History

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
60 FDA actions from 1998 to 2026
May 2026 SUPPL
Label · Labeling
Apr 2026 SUPPL
Label · Labeling
Nov 2025 ORIGINAL
Update

What LEUPROLIDE ACETATE Treats

1 indications

LEUPROLIDE ACETATE is approved for 1 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Prostate Cancer
Source: FDA Label

LEUPROLIDE ACETATE Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

CONJUGATED ESTROGENS
NOVAST LABS
2025 6 indic.
BILDYOS
SHANGHAI HENLIUS
2025 4 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in LEUPROLIDE ACETATE's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LEUPROLIDE ACETATE treats. First-in-class if their pivotal trials read out positive.

Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca
ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials

Drugs Similar to LEUPROLIDE ACETATE

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AKEEGA
ABIRATERONE ACETATE
1 shared
Johnson & Johnson
Shared indications:
Prostate Cancer
AMICAR
AMINOCAPROIC ACID
1 shared
EPIC PHARMA LLC
Shared indications:
Prostate Cancer
AMINOCAPROIC ACID
AMINOCAPROIC ACID
1 shared
AJENAT PHARMS
Shared indications:
Prostate Cancer
View all 20 similar drugs Pro
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Clinical Trial Registry

51 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
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
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
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
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
NCT00943956 CDR0000639358 CLCC-RHOMUS, CRAD001 C2486 Ph 1 completed Everolimus, Bicalutamide, and Leuprolide Acetate in Treating Patients Undergoing Radiation Therapy For High-Risk Locally Advanced Prostate Cancer
NCT00949962 EORTC-22043-30041 EU-20950, 2006-002772-17 Ph 3 terminated Post-operative or Early Salvage XRT and ADT for High Risk PCa
NCT01161563 results posted TRE1001 Ph 4 completed Randomized Crossover Trial to Assess the Tolerability of Gonadotropin Releasing Hormone (GnRH) Analogue Administration
NCT00805935 results posted 2008-05 Ph 4 completed Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)

Showing 50 of 51 trials

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

LEUPROLIDE ACETATE FDA Label Details

Indications & Usage

FDA Label (PDF)

LEUPROLIDE ACETATE is indicated for the treatment of Prostate Cancer.

Looking for the branded version?

LUPRON DEPOT

Full clinical data, patents, trials, and competitive landscape for leuprolide acetate.

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Data Sources

FDA Approval: ANDA078885 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.