Leuprorelin

Phase 3Small molecule

Takeda

Leuprorelin is one of 239 small molecule programs targeting Breast Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

238

Competitors

Pipeline

Status by Indication[3][1]

Indication

Breast CancerActive, not recruiting

Metastatic Breast CancerActive, not recruiting

Salivary Gland CancerActive, not recruiting

Metastatic Prostate CancerActive, not recruiting

AtrophyActive, not recruiting

Cesarean SectionActive, not recruiting

ProstatectomyActive, not recruiting

Central Precocious PubertyCompleted

Prostate CancerActive, not recruiting

Breast CancerPhase 2

Active, not recruiting

Metastatic Breast CancerPhase 3

Active, not recruiting

Salivary Gland CancerPreclinical

Active, not recruiting

Metastatic Prostate CancerPreclinical

Active, not recruiting

AtrophyPreclinical

Active, not recruiting

Cesarean SectionPreclinical

Active, not recruiting

ProstatectomyPhase 3

Active, not recruiting

Central Precocious PubertyPhase 3

Completed

Prostate CancerPhase 3

Active, not recruiting

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Leuprorelin

Takeda

Phase 3

8 2

Voltaren

Novartis

Preclinical

1 3

Zolymbus

AbbVie

Preclinical

1 4

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 5

Duragesic-100

CCephalon

Preclinical

2 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

2 7

Spravato

WWim Janssens

Preclinical

2 8

Tricor

JJagotec

Preclinical

1 9

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 10

Acupan

YYonsei University

Preclinical

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

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Breast Cancer

NCT07159451

Q3 2027

Phase 3Active, not recruiting

Prostatectomy

NCT01442246

Q4 2027

Phase 2Recruiting

Liver Disease

NCT05478083

Phase 3Active, not recruiting

Endometriosis

NCT07015268

Phase 3Active, not recruiting

Prostate Cancer

NCT04302454

Q4 2028

Phase 2Active, not recruiting

Breast Cancer

NCT03900637

Clinical

Trials by Indication[1]

Prostate Cancer9 trials

A Phase 2 Study to Evaluate the Safety and Efficacy of TAK-385, Together With a Leuprorelin Observational Cohort, in Participants With Prostate Cancer

Completed· Takeda logo

Takeda·Phase 2·NCT02083185·136 enrolled

COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer

Active, not recruiting·—·Phase 4·NCT06627530·144 enrolled

Study in Men With Prostate Cancer to Assess the Safety, Pharmacokinetics and Testosterone-Lowering Efficacy of TAK-448

Terminated· Takeda logo

Takeda·Phase 1/2·NCT01132404·9 enrolled

Show 6 more trials

Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"

Completed· Takeda logo

Takeda··NCT03209492·333 enrolled

Leuprorelin Associated With Radiotherapy Versus Leuprorelin Alone in T3 - T4 or pT3 (on Biopsy) N0, M0 Prostate Cancer

Completed· Takeda logo

Takeda·Phase 3·NCT01122121·273 enrolled

Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"

Completed· Takeda logo

Takeda··NCT02167893·11,288 enrolled

Androgen Deprivation Therapy on Bone Mineral Density Change in Prostate Cancer Patients

Unknown status·WWonju Severance Christian Hospital·Phase 4·NCT04248621·164 enrolled

A Study of the Effect of Enantone LP 11.25 mg (Leuprorelin) on the Histological Progression of Indolent Prostate Cancer

Completed· Takeda logo

Takeda·Phase 3·NCT02085252·116 enrolled

Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy

Active, not recruiting·UUniversity Medical Center Groningen·Phase 3·NCT04302454·280 enrolled

Breast Cancer8 trials

Bevacizumab Plus Paclitaxel Optimization Study With Interventional Aintenance Endocrine Therapy in Breast Cancer

Completed·JJapan Breast Cancer Research Group·Phase 2·NCT01989780·160 enrolled

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

Recruiting·GGustave Roussy, Cancer Campus, Grand Paris·Phase 2·NCT07159451·140 enrolled

Study to Compare Neoadjuvant Combination of Trastuzumab and Pertuzumab With Concurrent Taxane Chemotherapy or Endocrine Therapy and Quality of Life Assessment Under Adjuvant Therapy in Operable HER2+/HR+ Breast Cancer Patients

Completed·PPalleos Healthcare GmbH·Phase 2·NCT03272477·257 enrolled

Show 5 more trials

PersonaLized neoAdjuvant Strategy ER Positive and HER2 Negative Breast Cancer TO Increase BCS Rate

Active, not recruiting·SSeoul National University Hospital·Phase 2·NCT03900637·122 enrolled

Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey: "QOL Survey in Premenopausal Breast Cancer Patients"

Completed· Takeda logo

Takeda··NCT02134977·2,816 enrolled

Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"

Completed· Takeda logo

Takeda··NCT03209518·312 enrolled

Leuprorelin Acetate SR 11.25 mg for Injection Specified Drug-use Survey "Long-term Use Survey on Premenopausal Breast Cancer Patients (96 Weeks)"

Completed· Takeda logo

Takeda··NCT02154139·651 enrolled

Neo-adjuvant Chemotherapy With Letrozole in Patients With Estrogen Receptor Positive/HER-2 Negative Breast Cancer

Unknown status·NNational Cancer Center, Korea·Phase 2·NCT03497702·114 enrolled

Endometriosis8 trials

Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis

Completed·TTaipei Veterans General Hospital, Taiwan··NCT03778359·5,000 enrolled

Role of Suppression of Endometriosis With Progestins Before IVF-ET

Completed·NNational Research Centre, Egypt·N/A·NCT04500743·134 enrolled

Efficacy and Safety of TAK-385 in the Treatment of Endometriosis

Completed· Takeda logo

Takeda·Phase 2·NCT01458301·487 enrolled

Show 5 more trials

A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis

Completed· Takeda logo

Takeda·Phase 2·NCT01452685·397 enrolled

Late Phase II Clinical Study of KLH-2109 in Patients With Endometriosis

Completed·KKissei Pharmaceutical Co., Ltd.·Phase 2·NCT02778919

A Clinical Study of KLH-2109 in Patients With Endometriosis

Active, not recruiting·KKissei Pharmaceutical Co., Ltd.·Phase 3·NCT07015268·288 enrolled

Clinical Study to Evaluate Efficacy and Safety of TAK-385 40 mg Compared With Leuprorelin in Patients With Endometriosis

Completed·AASKA Pharmaceutical Co., Ltd.·Phase 3·NCT03931915·335 enrolled

A Study to Assess the Effectiveness and Safety of Different Doses of ASP1707 Compared to Placebo for Endometriosis Associated Pelvic Pain

Completed· Astellas logo

Astellas·Phase 2·NCT01767090·912 enrolled

Central precocious puberty4 trials

A Study to Assess the Safety and Efficacy of Leuprorelin in Central Precocious Puberty in Chinese Participants

Completed· Takeda logo

Takeda·Phase 4·NCT02427958·307 enrolled

Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine

Completed·—·Phase 4·NCT03963752·126 enrolled

An Open Label, Multicenter, Single-arm and Prospective Study to Assess the Efficacy and Safety of Leuprorelin 3M in the Treatment of Central Precocious Puberty (CPP)

Completed· Takeda logo

Takeda·Approved·NCT05341115·79 enrolled

Show 1 more trial

A Single-Arm, Open-Label, Multicenter, Prospective Clinical Study to Evaluate the Effectiveness and Safety of Leuprorelin 1-Month (4-Week) Formulation Administered for 24 Months in Children With Central Precocious Puberty

Recruiting·LLG Chem·Approved·NCT07710430·43 enrolled

Treatment3 trials

Intermittent Hormonal Therapy With Leuprorelin and Flutamide in the Treatment of Stage D2 or TxNxM1b,c

Completed· Takeda logo

Takeda·Phase 2·NCT00817739·341 enrolled

Comparison of Two Pharmacological Treatments of Pedophilia

Terminated·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 3·NCT00601276·48 enrolled

A Phase IIIb Study of Intermittent Versus Continuous Hormone Deprivation Treatment With ELIGARD

Completed· Astellas logo

Astellas·Phase 3·NCT00378690·706 enrolled

15 more indications

Uterine Fibroid3 trials

A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids

Completed· Takeda logo

Takeda·Phase 3·NCT02655237·281 enrolled

A Pharmacodynamic Study of Leuprorelin Gelatin-Free Formulation in Female Subjects With Uterine Fibroids.

Completed· Takeda logo

Takeda·Phase 2·NCT00776074·80 enrolled

A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia

Completed·KKissei Pharmaceutical Co., Ltd.·Phase 3·NCT05440383·287 enrolled

Liver Disease1 trial

A GnRH Agonist IN Pre-menopausal Women STudy to Treat Severe Polycystic Liver Disease

Recruiting·UUniversity Medical Center Groningen·Phase 2·NCT05478083·36 enrolled

Cesarean Section1 trial

Comparison of the Therapeutic Effects of Vaginal Repair With Leuprorelin and Vaginal Repair in the Treatment of Cesarean Section Scar Defect

Recruiting·XXinhua Hospital, Shanghai Jiao Tong University School of Medicine·N/A·NCT05206682·94 enrolled

Prostate Adenocarcinoma1 trial

Treatment of Hot Flushes Caused by Leuprorelin 11.25 mg in Prostate Adenocarcinoma

Completed· Takeda logo

Takeda·Phase 3·NCT01011751·311 enrolled

Short stature1 trial

Somatropin + Leuprorelin vs Somatropin Alone in Pubertal Children With Idiopathic Short Stature

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00355030·91 enrolled

Atrophy1 trial

Specified Drug-Use Survey of Leuprorelin Acetate Injection Kit 11.25 mg "All-Case Investigation: Spinal and Bulbar Muscular Atrophy (SBMA)"

Recruiting· Takeda logo

Takeda··NCT03555578·1,890 enrolled

Metastatic Prostate Cancer1 trial

Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland

Completed· Pfizer logo

Pfizer··NCT05701007·1,083 enrolled

Female1 trial

To Compare the Safety and Pharmacokinetics of PT105 With PT105R in Healthy Postmenopausal Female Volunteers

Unknown status·PPeptron, Inc.·Phase 1·NCT04783636·40 enrolled

Radiotherapy1 trial

RADAR Trial - Randomised Androgen Deprivation and Radiotherapy

Completed·TTrans Tasman Radiation Oncology Group·Phase 3·NCT00193856·1,071 enrolled

Prostatectomy1 trial

Evaluation of Adjuvant Hormonal Treatment for 24 Months After Radical Prostatectomy in High Risk of Recurrence Patients.

Active, not recruiting·UUNICANCER·Phase 3·NCT01442246·700 enrolled

Premature Ovarian Failure1 trial

A Multicenter Open-label Clinical Study on the Prevention of Premature Ovarian Failure After HSCT

Unknown status·FFirst Affiliated Hospital Xi'an Jiaotong University·N/A·NCT05667428·200 enrolled

Leuprolide Acetate1 trial

Generation of Positive Biological Samples to Leuprolide Acetate for Doping Control

Completed·PParc de Salut Mar·Phase 1·NCT02920359·5 enrolled

Salivary Gland Cancer1 trial

Exploratory Study of Molecular Profile-Associated Evidence Guided Precision Therapy for Salivary Gland Cancer（MAPS）

Unknown status·SShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University··NCT05087706·182 enrolled

Myoma1 trial

PGL4001 Versus GnRH-agonist in Uterine Myomas

Completed·PPregLem SA·Phase 3·NCT00740831·301 enrolled

Unspecified1 trial

Detect V / CHEVENDO (Chemo vs. Endo)

Active, not recruiting·PProf. Wolfgang Janni·Phase 3·NCT02344472·271 enrolled

Sources

References

[1]
ClinicalTrials.gov — 49 trial records for Leuprorelin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Leuprorelin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Leuprorelin. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Takeda company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Takeda

Leuprorelin

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q3 2027

Q4 2027

Q4 2028

Trials by Indication[1]

Prostate Cancer9 trials

Breast Cancer8 trials

Endometriosis8 trials

Central precocious puberty4 trials

Treatment3 trials

Uterine Fibroid3 trials

Liver Disease1 trial

Cesarean Section1 trial

Prostate Adenocarcinoma1 trial

Short stature1 trial

Atrophy1 trial

Metastatic Prostate Cancer1 trial

Female1 trial

Radiotherapy1 trial

Prostatectomy1 trial

Premature Ovarian Failure1 trial

Leuprolide Acetate1 trial

Salivary Gland Cancer1 trial

Myoma1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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