Lupron

(Leuprolide)

ApprovedSmall molecule

Leuprolide is used to treat advanced prostate cancer and endometriosis by lowering hormone levels in the body. It's also used to treat central precocious puberty in children.[2] Lupron is currently approved and in use across 24 indications[4].[1]

Lupron is one of 533 small molecule programs targeting Insulin resistance. It is currently in Approved.

Indications

Total Trials

Active Trials

532

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Insulin ResistanceActive, not recruiting

HemangiomaActive, not recruiting

Cardiovascular DiseaseActive, not recruiting

Prostate AdenocarcinomaApproved

Prostate NeoplasmActive, not recruiting

HypogonadismActive, not recruiting

Prostate CarcinomaApproved

HyperandrogenismActive, not recruiting

Central Precocious PubertyApproved

AdenocarcinomaActive, not recruiting

Insulin ResistancePhase 2

Active, not recruiting

HemangiomaPreclinical

Active, not recruiting

Cardiovascular DiseasePhase 3

Active, not recruiting

Prostate AdenocarcinomaApproved

Approved

Prostate NeoplasmApproved

Active, not recruiting

HypogonadismPreclinical

Active, not recruiting

Prostate CarcinomaApproved

Approved

HyperandrogenismPhase 2

Active, not recruiting

Central Precocious PubertyApproved

Approved

AdenocarcinomaPhase 1

Active, not recruiting

Showing 10 of 24 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Lupron

AbbVie

Approved

3 2

Halaven

Eisai

Preclinical

38 3

Tykerb

GSK

Preclinical

80 4

Tecentriq

Roche

Preclinical

36 5

Prolia

Amgen

Preclinical

14 6

Megace

Bristol-Myers Squibb

Preclinical

4 7

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 8

Acupan

YYonsei University

Preclinical

1 9

Chantix

PPrism Pharmaceuticals

Preclinical

1 10

Aquasol E

NNational Eye Institute (NEI)

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Cardiac

NCT05320406

Phase 3Active, not recruiting

Prostate Adenocarcinoma

NCT05050084

Q2 2027

Phase 1/2Active, not recruiting

Prostate Cancer

NCT04194554

Q4 2027

Phase 2Recruiting

Prostate Cancer

NCT06330805

Q1 2028

Phase 2Recruiting

Quality of Life

NCT05765500

Phase 2Recruiting

Anatomic Stage I Breast Cancer AJCC V8

NCT07158021

Clinical

Trials by Indication[1]

Prostate Cancer20 trials

Trial of Radiotherapy With Leuprolide and Enzalutamide in High Risk Prostate Cancer

Terminated·UUniversity of California, San Francisco·Phase 2·NCT02508636·11 enrolled

Prediction of the PRONOUNCE Prostate Cancer Trial in Healthcare Claims Data

Completed·—··NCT04897958·14,417 enrolled

A Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Participants With a Rising Prostate Specific Antigen (PSA)

Terminated· Sanofi logo

Sanofi·Phase 3·NCT00514917·413 enrolled

Show 17 more trials

Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer

Completed· Pfizer logo

Pfizer·Phase 2·NCT01547299·52 enrolled

A Multi-Center Trial of Androgen Suppression With Abiraterone Acetate, Leuprolide, PARP Inhibition and Stereotactic Body Radiotherapy in Prostate Cancer

Active, not recruiting·UUniversity of Michigan Rogel Cancer Center·Phase 1/2·NCT04194554·102 enrolled

Bipolar Androgen-based Therapy for Prostate Cancer (BAT)

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT01750398·33 enrolled

External Beam Radiation Therapy (EBRT) With or Without Hormonal Therapy in Prostate Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 3·NCT00388804·39 enrolled

Hormonal Ablation, Imatinib Mesylate and Docetaxel for Patients With Prostate Cancer

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00500110·39 enrolled

Ipilimumab + Androgen Depravation Therapy in Prostate Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT01377389·30 enrolled

Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy

Completed·—·Phase 2·NCT02903368·118 enrolled

Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT

Not yet recruiting·BBaptist Health South Florida·Phase 2·NCT07455903·50 enrolled

Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer

Recruiting·OOhio State University Comprehensive Cancer Center·Phase 2·NCT06330805·70 enrolled

A Study of ELIGARD® in Hormone-dependent Prostate Cancer Patients

Completed· Astellas logo

Astellas·Phase 4·NCT03035032·107 enrolled

A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone Acetate in Male Participants With Prostate Cancer

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT00924469·58 enrolled

AASUR in High Risk Prostate Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT02772588·64 enrolled

A Study of Degarelix in Patients With Prostate Cancer

Completed· Ferring logo

Ferring·Phase 3·NCT00928434·409 enrolled

Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial

Recruiting·MMayo Clinic·Phase 2·NCT06378866·532 enrolled

Sunitinib Malate, Hormone Ablation and Radiation Therapy in Patients With Prostate Cancer

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT00631527·19 enrolled

The Efficacy and Safety of Degarelix One Month Dosing Regimens in Prostate Cancer

Completed· Ferring logo

Ferring·Phase 3·NCT00295750·620 enrolled

Study to Document Treatment Patterns and to Evaluate Leuprolide and Alternative Therapeutic Approaches to the Treatments of Advanced Prostate Cancer

Completed·AAbbott··NCT01081873·2,717 enrolled

Metastatic Prostate Cancer3 trials

S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer

Completed·SSWOG Cancer Research Network·Phase 2·NCT00028769·41 enrolled

Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer

Completed·VVA Office of Research and Development·Phase 2·NCT03298087·28 enrolled

Study of Abraxane Plus Hormonal Therapy as Initial Treatment of Unresectable or Metastatic Prostate Cancer

Terminated·TThe Methodist Hospital Research Institute·Phase 2·NCT00521781·14 enrolled

Breast Cancer3 trials

Extended Endocrine Therapy for Premenopausal Women With Breast Cancer

Completed·—·Phase 2·NCT00903162·17 enrolled

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments

Completed· Novartis logo

Novartis·Phase 2·NCT03056755·383 enrolled

Study of GnRH-A [Leuprorelin(Lorelin Depot] Plus Leterozole +/- Everolimus for Premenopausal Women With Metastatic Breast Cancer

Completed·—·Phase 2·NCT02344550·137 enrolled

Prostate Adenocarcinoma3 trials

Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)

Active, not recruiting·NNRG Oncology·Phase 3·NCT05050084·2,050 enrolled

Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk With Radiation (PREDICT-RT*)

Active, not recruiting·NNRG Oncology·Phase 3·NCT04513717·2,753 enrolled

Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy With or Without Adjuvant Docetaxel

Completed·NNRG Oncology·Preclinical·NCT03070886·612 enrolled

Testosterone2 trials

Testosterone Regulation of the Natriuretic Peptide System

Withdrawn·MMassachusetts General Hospital·N/A·NCT02269072

Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone

Completed·UUniversity of Washington·Phase 2·NCT00161421·18 enrolled

31 more indications

Precocious Puberty2 trials

Purification of Testis-Stimulating Factor in Precocious Puberty

Completed·NNational Center for Research Resources (NCRR)··NCT00004344·4 enrolled

Analysis of Genetic and Environmental Parameters Influencing Growth Rate of Precocious Puberty Children

Unknown status·UUniversity of Pisa·Phase 4·NCT00438217·100 enrolled

Hot flashes1 trial

Impact of Hot Flashes on Sleep and Mood Disturbance

Completed·MMassachusetts General Hospital·Phase 4·NCT01116401·29 enrolled

Motor Neuron Disease1 trial

Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease

Completed·NNational Center for Research Resources (NCRR)·Phase 2·NCT00004771·40 enrolled

Hemangioma1 trial

Randomized Study of Hormonal Regulation of Infantile Hemangioma

Completed·FFDA Office of Orphan Products Development·N/A·NCT00004436·30 enrolled

Cardiovascular Disease1 trial

A Trial Comparing Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Advanced Prostate Cancer and Cardiovascular Disease

Terminated· Ferring logo

Ferring·Phase 3·NCT02663908·545 enrolled

Melanoma1 trial

Melanoma Vaccine With Peptides and Leuprolide

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00254397·98 enrolled

Quality of Life1 trial

RecoverPC: Relugolix vs GnRH Agonist in Quality of Life

Recruiting·—·Phase 2·NCT05765500·110 enrolled

Fat Metabolism1 trial

Influence of Male Hormones on Regional Fat Metabolism

Completed·MMayo Clinic·Phase 1·NCT01160328·39 enrolled

Pregnancy1 trial

GnRH-a and Pregnancy Rate in In Vitro Fertilization (IVF) Cycles.

Completed·UUniversity of Ioannina·N/A·NCT01269125·180 enrolled

Luteal Phase Support1 trial

GnRH Agonist and Progesterone Versus Progesterone Only for Luteal Phase Support in Antagonist Cycles

Unknown status·QQueensland Fertility Group·Phase 3·NCT02262416·200 enrolled

Treatment1 trial

A Treatment Study for Premenstrual Syndrome (PMS)

Completed·NNational Institute of Mental Health (NIMH)·Phase 1·NCT00001259·60 enrolled

Bone Marrow Transplantation1 trial

Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT01338987·76 enrolled

Overweight1 trial

Effect of Short Term Ovarian Suppression on Androgen Overproduction in Overweight Girls With Androgen Excess

Withdrawn·UUniversity of Virginia·Phase 1·NCT01422096

Adenocarcinoma1 trial

Stereotactic Boost and Long-Term Androgen Deprivation for Adenocarcinoma of the Prostate

Completed·UUniversity of California, Davis·Phase 1·NCT02064036·17 enrolled

Hyperandrogenism1 trial

Phase II Randomized Study of Leuprolide Vs Oral Contraceptive Therapy Vs Leuprolide and Oral Contraceptive Therapy for Ovarian Hyperandrogenism

Completed·NNational Center for Research Resources (NCRR)·Phase 2·NCT00004763·45 enrolled

Hematopoietic Cell Transplant1 trial

Preservation of Ovarian Function After Hematopoietic Cell Transplant

Terminated·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT01343368·19 enrolled

GnRH Antagonist1 trial

Efficacy of Recombinant FSH/GnRH Antagonist Protocol With and Without LH Adjunct for Egg Bank Donation

Completed·MMichigan Reproductive Medicine·Phase 4·NCT02069808·38 enrolled

Androgen Deprivation Therapy1 trial

Micro RNAs to Predict Response to Androgen Deprivation Therapy

Completed·MMedical College of Wisconsin··NCT02366494·42 enrolled

Complete Response1 trial

Anti-Androgens and Cabazitaxel in Defining Complete Response in Prostatectomy (ACDC Trial)

Completed·UUniversity Health Network, Toronto·Phase 2·NCT02543255·76 enrolled

Insulin resistance1 trial

Insulin Resistance and Testosterone in Women

Completed·UUniversity of Pennsylvania·Phase 2·NCT00123110·35 enrolled

Central precocious puberty1 trial

Analysis of Body Mass Index in Central Precocious Puberty Patients Treated With Leuprolide Acetate

Unknown status·KKyungpook National University Hospital·Phase 4·NCT02974270·100 enrolled

Adult1 trial

Leuprolide in Treating Adults With Hypogonadotropism

Completed·UUniversity of Chicago·N/A·NCT00004438·45 enrolled

Endometrial1 trial

A Novel Approach to Endometrial Preparation in Recipients of Donor Eggs

Unknown status·—·N/A·NCT01424618·20 enrolled

Adjuvant1 trial

Adjuvant Ovarian Suppression Plus Aromatase Inhibitor or Tamoxifen in Young Women

Unknown status·FFirst Affiliated Hospital, Sun Yat-Sen University·Phase 3·NCT02914158·680 enrolled

Cardiac1 trial

RElugolix VErsus LeUprolide Cardiac Trial

Active, not recruiting·EEmory University·Phase 2·NCT05320406·94 enrolled

Abiraterone Acetate1 trial

REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial

Recruiting·EEmory University·Phase 3·NCT06650579·72 enrolled

Postmenopausal Women1 trial

Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC

Completed· Novartis logo

Novartis·Phase 3·NCT02941926·3,246 enrolled

Endometriosis1 trial

Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery

Completed·UUniversitas Diponegoro·Phase 3·NCT06145438·80 enrolled

Early Breast Cancer1 trial

A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)

Recruiting· Novartis logo

Novartis·Phase 3·NCT05827081·1,400 enrolled

Anatomic Stage I Breast Cancer AJCC v81 trial

Phase 2 Interventional Trial of Ovarian Function Suppression for Breast Cancer (OFS)

Recruiting·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT07158021·75 enrolled

Unspecified1 trial

Leuprolide in Determining the Cause of Gonadotropin Deficiency

Completed·UUniversity of Chicago·N/A·NCT00004426·90 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 9, 1985

LUPRON

NDA NDA019010

Jan 26, 1989

LUPRON DEPOT

NDA NDA019732

Oct 22, 1990

LUPRON DEPOT

NDA NDA020011

Apr 16, 1993

LUPRON DEPOT-PED KIT

NDA NDA020263

Dec 22, 1995

LUPRON DEPOT

NDA NDA020517

Mar 7, 1997

LUPRON DEPOT

NDA NDA020708

Mar 3, 2000

VIADUR

NDA NDA021088

Jan 23, 2002

ELIGARD KIT

NDA NDA021343

Jul 24, 2002

ELIGARD KIT

NDA NDA021379

Feb 13, 2003

ELIGARD KIT

NDA NDA021488

Dec 14, 2004

ELIGARD KIT

NDA NDA021731

Aug 28, 2018

LEUPROLIDE ACETATE FOR DEPOT SUSPENSION

NDA NDA205054

May 1, 2020

FENSOLVI KIT

NDA NDA213150

May 25, 2021

CAMCEVI KIT

NDA NDA211488

Aug 25, 2025

CAMCEVI ETM

NDA NDA219745

Sources

References

[1]
ClinicalTrials.gov — 63 trial records for Leuprolide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Lupron drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Leuprolide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Leuprolide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA219745). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Lupron. U.S. Food & Drug Administration.
[7]
SEC EDGAR — AbbVie company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Gonadotropin-Releasing Hormone Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AbbVie

Patent Landscape[6]

Patent Cliff

Jan 16, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10646572Jan 16, 2027

9572857Jan 16, 2027

9744207Jan 16, 2027

9617303Mar 22, 2028

8921326Feb 5, 2031

5 more patents

12133878Dec 18, 2037

11717555Jan 1, 2039

11771841Dec 22, 2041

11931559Dec 22, 2041

12397120Dec 22, 2041

Lupron

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Prostate Cancer20 trials

Metastatic Prostate Cancer3 trials

Breast Cancer3 trials

Prostate Adenocarcinoma3 trials

Testosterone2 trials

Precocious Puberty2 trials

Hot flashes1 trial

Motor Neuron Disease1 trial

Hemangioma1 trial

Cardiovascular Disease1 trial

Melanoma1 trial

Quality of Life1 trial

Fat Metabolism1 trial

Pregnancy1 trial

Luteal Phase Support1 trial

Treatment1 trial

Bone Marrow Transplantation1 trial

Overweight1 trial

Adenocarcinoma1 trial

Hyperandrogenism1 trial

Hematopoietic Cell Transplant1 trial

GnRH Antagonist1 trial

Androgen Deprivation Therapy1 trial

Complete Response1 trial

Insulin resistance1 trial

Central precocious puberty1 trial

Adult1 trial

Endometrial1 trial

Adjuvant1 trial

Cardiac1 trial

Abiraterone Acetate1 trial

Postmenopausal Women1 trial

Endometriosis1 trial

Early Breast Cancer1 trial

Anatomic Stage I Breast Cancer AJCC v81 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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