Data updated: Jun 28, 2026
Benign Prostatic Hyperplasia Clinical Trial Landscape
Benign Prostatic Hyperplasia is being studied across 145 clinical trials registered since 2008, with 33 programs currently active. The competitive pipeline includes 9 active Phase 3 trials, 7 active Phase 2 trials, and 8 active Phase 1 trials.
Top industry sponsors include Resurge Therapeutics Inc., Addpharma Inc., AJU Pharm Co., Ltd..
Trial activity
33 active / 145 total since 2008
Active by phase 9 Ph3 / 47 7 Ph2 / 31 8 Ph1 / 25 9 Ph4 / 42
Sponsor activity
Who is running trials now — green active, blue completed, red failed/terminated.
Sorted by active Active Done Failed
Resurge Therapeutics Inc. 2 0 0
Addpharma Inc. 2 0 0
AJU Pharm Co., Ltd. 2 0 0
Chong Kun Dang Pharmaceutical 1 6 0
Shanghai Huilun Pharmaceutical Co., Ltd. 1 1 0
Eurofarma Laboratorios S.A. 1 0 0
Xintian Pharmaceutical 1 0 0
Eli Lilly 0 11 1
Astellas 0 6 0
Jeil Pharmaceutical Co., Ltd. 0 4 0
Health Ever Bio-Tech Co., Ltd. 0 4 0
Nymox Corporation 0 4 0
Sophiris Bio Corp 0 3 0
Light Sciences Oncology 0 3 0
How the field has grown
New-trial starts peaked in 2026 (13 registered); 2025 saw 9. The right-hand chart shows median Phase 3 enrollment by start year — the number in parentheses is that year's Phase 3 trial count (18 in total), so single-trial years (and years with no Phase 3 starts) are obvious. Both are by trial start date; the current year is partial.
New trials started by year
2016 3
2017 4
2018 1
2019 6
2020 4
2021 6
2022 3
2023 5
2024 10
2025 9
2026 13
TheraRadar.com
Median Phase 3 enrollment by start year
2016 (2) 435
2017 (0) 0
2018 (0) 0
2019 (1) 423
2020 (2) 110
2021 (4) 223
2022 (0) 0
2023 (1) 138
2024 (3) 150
2025 (3) 50
2026 (2) 533
TheraRadar.com
Full trial pipeline
Every active and completed trial across Phase 1–4, with enrollment analytics. Sortable, filterable, exportable with Pro.
NCT07209150 NOT YET RECRUITING
Randomized Controlled Trial of Different Antibiotic Duration Prior to Prostate Enucleation Surgery
Ohio State University n=250
NCT07146386 NOT YET RECRUITING
A Phase III Clinical Study of H077 Sustained-Release Tablets Compared With Silodosin Capsules in the Treatment of Benign Prostatic Hyperplasia
Shanghai Huilun Pharmaceutical Co., Ltd. n=728
NCT07017452 NOT YET RECRUITING
Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia
University of Manitoba n=48
NCT07017439 NOT YET RECRUITING
Investigating the Adjunctive Use of Mirabegron in the Early Post-Rezum Procedure Period
University of Manitoba n=50
NCT06546735 NOT YET RECRUITING
Efficacy and Safety of Two Fixed-dose Combinations in Men with Lower Urinary Tract Symptoms Associated with Benign Prostatic Hyperplasia. (BENIPRO)
Eurofarma Laboratorios S.A. n=816
NCT06558539 NOT YET RECRUITING
Tibial Nerve Stimulation for Post-BPH Overactive Bladder
Qing Yuan n=90
NCT06491108 RECRUITING
Medications for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia
Tanta University n=150
NCT05620784 RECRUITING
Intra-operative Loop Diuretics to Improve Same-day Discharge Rates After HoLEP
Northwestern University n=138
NCT04807010 NOT YET RECRUITING
PROARTE -PROstate ARTery to Reduce the Symptoms of Benign Prostatic Hyperplasia
Society of Interventional Radiology Foundation n=108
NCT04185441 COMPLETED
Efficacy and Safety of Tanzânia Association in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia
EMS n=295
NCT01018511 COMPLETED
Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms
Astellas Pharma Europe B.V. n=1,334
NCT01021332 COMPLETED
Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms
Astellas Pharma Europe B.V. n=1,067
NCT06466369 COMPLETED
Administration of Tadalafil in Patients With Benign Prostatic Hyperplasia
Al-Azhar University n=306
NCT04947631 COMPLETED
Efficacy and Safety of DKF-313 in Patients With Benign Prostatic Hyperplasia
Dongkook Pharmaceutical Co., Ltd. n=667
NCT05222841 COMPLETED
The Effectiveness of Spermotrend Food Supplement in the Treatment of Male Infertility
Catalysis SL n=150
NCT05531344 COMPLETED
Composite Steep-pulseTreatment Device Used in Patients With Benign Prostatic Hyperplasia
REMD Medical Technology n=160
NCT04032067 COMPLETED
Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH)
GemVax & Kael n=423
NCT02869971 COMPLETED
Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia
Assistance Publique - Hôpitaux de Paris n=90
NCT04263987 COMPLETED
A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial
Vanderbilt University Medical Center n=60
NCT02972268 COMPLETED
Clinical Trial to Compare the Solifenacin/Tamsulosin Combination Therapy With Tamsulosin Monotherapy for LUTS Due to BPH
Jeil Pharmaceutical Co., Ltd. n=780
NCT01716104 COMPLETED
Clinical Trial of Safety and Efficacy of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression
Materia Medica Holding n=260
NCT01534351 TERMINATED
Comparison of Finasteride and Tamsulosin for Treatment of Benign Prostatic Hyperplasia (BPH) (MK-0906A-149 AM2)
Merck Sharp & Dohme LLC n=1
NCT01002664 COMPLETED
Efficacy and Safety of MCS-2 in the Treatment of Lower Urinary Tract Symptoms
Health Ever Bio-Tech Co., Ltd. n=272
NCT00564460 WITHDRAWN
On Label, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Finasteride in Patients Undergoing Transurethral Resection of the Prostate (TURP)
University of Alberta
NCT03246880 COMPLETED
Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients
Chong Kun Dang Pharmaceutical n=455
NCT01966614 COMPLETED
Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH
Sophiris Bio Corp n=479
NCT00945490 COMPLETED
Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH) NX02-0018
Nymox Corporation n=500
NCT01846793 COMPLETED
Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)(NX02-0022)
Nymox Corporation n=160
NCT01002274 COMPLETED
Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms
Health Ever Bio-Tech Co., Ltd. n=180
NCT02667938 COMPLETED
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HCP1303 Capsules
Hanmi Pharmaceutical Company Limited n=510
NCT02303769 COMPLETED
Study to Investigate the Efficacy and Safety of GL2702 GLARS-NF1tablet and Harnal-D - Tablet in BPH Patients With LUTS
GL Pharm Tech Corporation n=309
NCT00542243 COMPLETED
A Trial of PROSCAR (Finasteride) Versus Placebo in Men With an Initial Negative Prostate Biopsy
University Health Network, Toronto n=19
NCT01931605 TERMINATED
Results of Selective Prostatic Arterial Embolization in Patients With Indwelling Urinary Catheter Due to Benign Prostatic Hyperplasia Refractory to Medical Treatment.
University Hospital, Rouen n=2
NCT01002222 COMPLETED
Open-Label Extension Study of MCS-2 in the Treatment of Lower Urinary Tract Symptoms (MCS-2-US-c)
Health Ever Bio-Tech Co., Ltd. n=200
NCT01002417 COMPLETED
MCS in the Treatment of Lower Urinary Tract Symptoms
Health Ever Bio-Tech Co., Ltd. n=274
NCT01830829 TERMINATED
JALYN for Benign Prostatic Hyperplasia (BPH) and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Dr. J. Curtis Nickel n=1
NCT01438775 COMPLETED
Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
Nymox Corporation n=192
NCT00918983 COMPLETED
Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
Nymox Corporation n=500
NCT01460342 COMPLETED
Phase 3 Study of Tadalafil Once-Daily in Asian Men With Benign Prostatic Hyperplasia (BPH)
Eli Lilly and Company n=610
NCT01139762 COMPLETED
A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms
Eli Lilly and Company n=696
NCT01566292 COMPLETED
Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy
Catholic University of the Sacred Heart n=33
NCT00970632 COMPLETED
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia
Eli Lilly and Company n=511
NCT00855582 COMPLETED
A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia
Eli Lilly and Company n=606
NCT00861757 COMPLETED
Multinational Study to Evaluate Tadalafil in Asian Men With Signs and Symptoms of Benign Prostatic Hyperplasia
Eli Lilly and Company n=612
NCT00827242 COMPLETED
Study to Treat Patients Who Have Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) With Tadalafil Daily
Eli Lilly and Company n=325
NCT00848081 COMPLETED
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers
Eli Lilly and Company n=318
Data: ClinicalTrials.gov · Trials registered 2008 onwards · Industry sponsors only