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Benign Prostatic Hyperplasia (BPH)

5
Pipeline Programs
10
Companies
14
Clinical Trials
1 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
1
0
2
2
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

10 companies ranked by most advanced pipeline stage

Pfizer
PfizerNEW YORK, NY
1 program
1
Tolterodine ER 4mgPhase 4
ViiV Healthcare
ViiV HealthcareNC - Durham
1 program
1
Tolterodine ER 4mgPhase 4
Gemvax & KAEL
Gemvax & KAELKorea - Seongnam
1 program
1
GV1001 placeboPhase 31 trial
Active Trials
NCT04032067Completed423Est. Mar 2022
Prevail Therapeutics
1 program
1
Tadalafil 5 mgPhase 31 trial
Active Trials
NCT00970632Completed511Est. Jan 2011
Kissei Pharmaceutical
Kissei PharmaceuticalJapan - Matsumoto City
1 program
1
KSO-0400Phase 21 trial
Active Trials
NCT01222650Completed400
Procept BioRobotics
Procept BioRoboticsCA - San Jose
3 programs
AQUABEAM SystemN/A1 trial
AQUABEAM SystemN/A1 trial
AquablationN/A1 trial
Active Trials
NCT02505919Completed184Est. Dec 2021
NCT03191734Completed30Est. Jan 2019
NCT03123250Completed101Est. Dec 2022
Boston Scientific
Boston ScientificCA - Valencia
3 programs
GreenLight XPS™ 532 nm Laser System with MoXy™ laser fiberN/A1 trial
REZŪMN/A1 trial
Rezūm SystemN/A1 trial
Active Trials
NCT03736512Completed30Est. Nov 2021
NCT04838769Active Not Recruiting155Est. Mar 2027
NCT04823221Completed22Est. Aug 2021
HistoSonics
HistoSonicsMI - Ann Arbor
2 programs
Vortx Rx - Histotripsy BPH DeviceN/A1 trial
Vortx Rx - Histotripsy BPH DeviceN/A1 trial
Active Trials
NCT01896973Terminated28Est. Dec 2016
NCT01775488Withdrawn0
Pierre Fabre
Pierre FabreFrance - Aignan
2 programs
Permixon® 160 mgPHASE_41 trial
Permixon® 160 mgPHASE_41 trial
Active Trials
NCT01604811Completed206Est. Oct 2013
NCT02121613Completed833Est. Jun 2016
Olympus
OlympusPA - Center Valley
1 program
iTindN/A1 trial
Active Trials
NCT04757116Recruiting206Est. Dec 2031

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Pierre FabrePermixon® 160 mg
Pierre FabrePermixon® 160 mg
Gemvax & KAELGV1001 placebo
Prevail TherapeuticsTadalafil 5 mg
OlympusiTind
Boston ScientificREZŪM
Boston ScientificRezūm System
Boston ScientificGreenLight XPS™ 532 nm Laser System with MoXy™ laser fiber
Procept BioRoboticsAQUABEAM System
Procept BioRoboticsAquablation
Procept BioRoboticsAQUABEAM System
HistoSonicsVortx Rx - Histotripsy BPH Device
HistoSonicsVortx Rx - Histotripsy BPH Device

Clinical Trials (14)

Total enrollment: 3,129 patients across 14 trials

NCT02121613Pierre FabrePermixon® 160 mg

PERmixon® in LUTS Evaluation Study (PERLES)

Start: Apr 2014Est. completion: Jun 2016833 patients
Phase 4Completed
NCT01604811Pierre FabrePermixon® 160 mg

Exploratory Study of L.S.E.S.r. (LipidoSterolic Extract of Serenoa Repens)(PERMIXON® 160 mg Hard Capsule) Versus Tamsulosine LP Activity on Inflammation Biomarkers in Urinary Symptoms Related to BPH (Benign Prostatic Hyperplasia)

Start: Jun 2012Est. completion: Oct 2013206 patients
Phase 4Completed
NCT04032067Gemvax & KAELGV1001 placebo

Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH)

Start: Oct 2019Est. completion: Mar 2022423 patients
Phase 3Completed
NCT00970632Prevail TherapeuticsTadalafil 5 mg

A Study of Tadalafil in Men With Benign Prostatic Hyperplasia

Start: Oct 2009Est. completion: Jan 2011511 patients
Phase 3Completed
NCT01222650Kissei PharmaceuticalKSO-0400

A Comparative Study of KSO-0400 in BPH Patients With LUTS

400 patients
Phase 2Completed
NCT04757116OlympusiTind

Post-Market Study to Assess iTind Safety in Comparison to UroLift

Start: Sep 2022Est. completion: Dec 2031206 patients
N/ARecruiting
NCT04838769Boston ScientificREZŪM

REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men

Start: Sep 2021Est. completion: Mar 2027155 patients
N/AActive Not Recruiting
NCT04823221Boston ScientificRezūm System

To Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China

Start: Jul 2021Est. completion: Aug 202122 patients
N/ACompleted
NCT03736512Boston ScientificGreenLight XPS™ 532 nm Laser System with MoXy™ laser fiber

China Greenlight Registry Study (Post-market)

Start: Feb 2019Est. completion: Nov 202130 patients
N/ACompleted
NCT03191734Procept BioRoboticsAQUABEAM System

French Aquablation Clinical Investigation Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue

Start: Sep 2017Est. completion: Jan 201930 patients
N/ACompleted
NCT03123250Procept BioRoboticsAquablation

Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue II

Start: Aug 2017Est. completion: Dec 2022101 patients
N/ACompleted
NCT02505919Procept BioRoboticsAQUABEAM System

Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue (WATER)

Start: Oct 2015Est. completion: Dec 2021184 patients
N/ACompleted
NCT01896973HistoSonicsVortx Rx - Histotripsy BPH Device

Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (US)

Start: Jul 2013Est. completion: Dec 201628 patients
N/ATerminated
NCT01775488HistoSonicsVortx Rx - Histotripsy BPH Device

Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (Canada)

Start: Jun 20130
N/AWithdrawn

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 3,129 patients
10 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.