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Benign Prostatic Hyperplasia

49
Pipeline Programs
30
Companies
50
Clinical Trials
3 recruiting
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
5
2
9
1
22
10
Early DiscoveryClinical DevelopmentMarket

On Market (2)

Approved therapies currently available

Eli Lilly and Company
ADCIRCAApproved
tadalafil
Eli Lilly and Company
Phosphodiesterase 5 Inhibitor [EPC]oral2009
29M Part D
Eli Lilly and Company
CIALISApproved
tadalafil
Eli Lilly and Company
Phosphodiesterase 5 Inhibitor [EPC]oral2003
6M Part D

Competitive Landscape

38 companies ranked by most advanced pipeline stage

ViiV Healthcare
ViiV HealthcareNC - Durham
12 programs
1
2
5
DutasteridePhase 4
DutasteridePhase 4
DutasteridePhase 4
TamsulosinPhase 4
dutasteridePhase 4
+7 more programs
Prevail Therapeutics
12 programs
1
4
1
5
1
TadalafilPhase 4
TadalafilPhase 3
TadalafilPhase 3
TadalafilPhase 3
TadalafilPhase 3
+7 more programs
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
3 programs
1
TadalafilPHASE_11 trial
TadalafilPHASE_21 trial
TadalafilPHASE_31 trial
Active Trials
NCT01183650Completed24Est. Apr 2011
NCT00540124Completed151Est. Jun 2008
NCT01460342Completed610Est. Oct 2012
JW Pharmaceutical
1
SilodosinPhase 41 trial
Active Trials
NCT01259531Completed100Est. Sep 2011
Nippon Shinyaku
1
TadalafilPhase 4
Chong Kun Dang Pharmaceutical
3
1
Tamsulosin 0.2mgPhase 31 trial
CKD-397Phase 11 trial
Harnal-D Tab.Phase 11 trial
Harnal-D Tab.Phase 11 trial
Active Trials
NCT02645890Completed36Est. Dec 2015
NCT03887871Completed30Est. Apr 2019
NCT03887858Completed30Est. May 2019
+1 more trials
Biocorp
4 programs
1
1
2
MCSPhase 3
PRX302Phase 31 trial
PRX302Phase 21 trial
PRX302Phase 1/21 trial
Active Trials
NCT01454349Completed40Est. Aug 2013
NCT00889707Completed92Est. Sep 2010
NCT01966614Completed479Est. Dec 2015
MSD
MSDIreland - Ballydine
2 programs
2
FinasteridePhase 31 trial
Transurethral Microwave ThermotherapyPhase 31 trial
Active Trials
NCT01534351Terminated1Est. Nov 2013
NCT00064649Terminated49Est. Jun 2006
Sharp Therapeutics
2
FinasteridePhase 3
Transurethral Microwave ThermotherapyPhase 3
Medica Corp
Medica CorpMA - Bedford
1 program
1
AfalazaPhase 31 trial
Active Trials
NCT01716104Completed260Est. Nov 2016
Ache Laboratorios Farmaceuticos
1
DNN.65.21.005Phase 31 trial
Active Trials
NCT07270432Not Yet Recruiting218Est. Apr 2027
Hanmi Pharmaceutical
1 program
1
HCP1303 capsule 5/0.2mgPhase 31 trial
Active Trials
NCT02667938Completed510Est. May 2016
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
1 program
1
JalynPhase 31 trial
Active Trials
NCT01830829Terminated1Est. Oct 2014
Health Ever Bio-Tech
1
MCSPhase 31 trial
Active Trials
NCT00501371Terminated85Est. Oct 2009
Ildong Pharmaceutical
1 program
1
Tamsulosin 0.2mgPhase 31 trial
Active Trials
NCT02862483Unknown330Est. Mar 2017
Urologix
UrologixMN - Plymouth
1 program
1
Transurethral Microwave ThermotherapyPhase 3
Medtronic
MedtronicNJ - Phillipsburg
1 program
1
Transurethral Microwave ThermotherapyPhase 3
AbbVie
AbbVieNORTH CHICAGO, IL
3 programs
1
2
botulinum toxin Type APhase 21 trial
botulinum toxin Type APhase 21 trial
Botulinum Toxin Type APhase 1/21 trial
Active Trials
NCT00894517Completed61Est. Aug 2012
NCT00284518Completed380Est. May 2010
NCT01107392Completed315Est. Jun 2012
Bayer
BayerLEVERKUSEN, Germany
1 program
1
LevitraPhase 21 trial
Active Trials
NCT00657839Completed222Est. Jun 2006
Yuyu Pharma
Yuyu PharmaKorea - Seoul
1 program
1
Dutasteride 0.5 mgPhase 11 trial
Active Trials
NCT03240939Completed36Est. Oct 2017
Boston Scientific
Embozene MicrospheresN/A1 trial
GreenLight XPS Laser SystemN/A1 trial
Photoselective Vaporization of the ProstateN/A1 trial
RezumN/A1 trial
Rezum SystemN/A1 trial
+2 more programs
Active Trials
NCT02206243Completed300Est. Feb 2019
NCT02139969Completed956Est. Nov 2014
NCT01218672Completed291Est. Dec 2014
+4 more trials
Procept BioRobotics
Procept BioRoboticsCA - San Jose
6 programs
AQUABEAM Robotic SystemN/A1 trial
AQUABEAM System followed by catheter without hemostatic agentN/A1 trial
AquaBeam SystemN/A1 trial
AquaBeam SystemN/A1 trial
AquaBeam SystemN/A1 trial
+1 more programs
Active Trials
NCT05157529Recruiting50Est. Dec 2024
NCT04308070Completed26Est. Jun 2018
NCT03167294Completed47Est. Apr 2017
+3 more trials
Zenflow
ZenflowCA - South SF
4 programs
Zenflow Spring SystemN/A1 trial
Zenflow Spring SystemN/A1 trial
Zenflow Spring SystemN/A1 trial
Zenflow Spring SystemN/A1 trial
Active Trials
NCT02786290Unknown30Est. Jan 2020
NCT04309695Unknown40Est. Jan 2026
NCT03577236Unknown50Est. May 2024
+1 more trials
GSK
GSKLONDON, United Kingdom
3 programs
Early combination therapyN/A1 trial
Pharmacovigilance Study To Evaluate Safety Of AVODART In Subjects With Benign Prostate HyperplasiaN/A1 trial
GI198745 0.05mgPHASE_21 trial
Active Trials
NCT01435954Completed13,551Est. Mar 2011
NCT00593593Completed1,000
NCT00969072Completed121Est. Feb 2005
Merit Medical
Merit MedicalSOUTH JORDAN, UT
2 programs
Embosphere MicrospheresN/A1 trial
Prostate artery embolizationN/A1 trial
Active Trials
NCT01789840Terminated59Est. Dec 2017
NCT03527589Completed499Est. Jan 2022
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
2 programs
Real World Data on Management of Male LUTSN/A1 trial
Tamsulosin OCASPHASE_41 trial
Active Trials
NCT03075449Completed201Est. Dec 2016
NCT00379067Completed882Est. Nov 2006
Recordati
RecordatiFrance - Saint-Victor
2 programs
SilodosinPHASE_31 trial
SilodosinPHASE_41 trial
Active Trials
NCT00359905Completed1,228Est. Jan 2008
NCT01757769Completed1,036Est. Aug 2013
Andromeda Surgical
Beacon PlatformN/A1 trial
Active Trials
NCT06668142Recruiting54Est. Dec 2026
Lumenis
LumenisAustralia - Chatswood
1 program
Comparison study between KTP and HoLAP for BPHN/A1 trial
Active Trials
NCT00169767Terminated18Est. Apr 2008
HistoSonics
HistoSonicsMI - Ann Arbor
1 program
HistoSonics Edison SystemN/A1 trial
Active Trials
NCT07214675Recruiting80Est. Oct 2027

+8 more companies

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
RecordatiSilodosin
JW PharmaceuticalSilodosin
Boehringer IngelheimTamsulosin OCAS
Ache Laboratorios FarmaceuticosDNN.65.21.005
Ildong PharmaceuticalTamsulosin 0.2mg
Chong Kun Dang PharmaceuticalTamsulosin 0.2mg
Hanmi PharmaceuticalHCP1303 capsule 5/0.2mg
BiocorpPRX302
MSDFinasteride
Angeles TherapeuticsJalyn
Medica CorpAfalaza
Eli Lilly and CompanyTadalafil
Health Ever Bio-TechMCS
RecordatiSilodosin
MSDTransurethral Microwave Thermotherapy

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 10,183 patients across 50 trials

Effectiveness and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia

Start: May 2011Est. completion: Aug 20131,036 patients
Phase 4Completed

Study of a α1A Adrenoceptor Selective Antagonist Silodosin to Treat Severe Benign Prostatic Hyperplasia(BPH)

Start: Dec 2010Est. completion: Sep 2011100 patients
Phase 4Completed

A Phase 4 Study With Tamsulosin OCAS to Assess Nighttime Voiding.

Start: Oct 2005Est. completion: Nov 2006882 patients
Phase 4Completed

Efficacy/ Safety of Product DNN.65.21.005 in Patients With Benign Prostatic Hyperplasia

Start: Jan 2026Est. completion: Apr 2027218 patients
Phase 3Not Yet Recruiting

The Efficacy and Safety of the Combination of Tamsulosin and Tadalafil in Men With Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia and Erectile Dysfunction

Start: Mar 2016Est. completion: Mar 2017330 patients
Phase 3Unknown

Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients

Start: Sep 2015Est. completion: May 2016455 patients
Phase 3Completed
NCT02667938Hanmi PharmaceuticalHCP1303 capsule 5/0.2mg

A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of HCP1303 Capsules

Start: Mar 2015Est. completion: May 2016510 patients
Phase 3Completed

Randomized, Double-Blind, Vehicle-Controlled, Multicenter Safety and Efficacy Study of Intraprostatic PRX302 for LUTS BPH

Start: Oct 2013Est. completion: Dec 2015479 patients
Phase 3Completed
NCT01534351MSDFinasteride

Comparison of Finasteride and Tamsulosin for Treatment of Benign Prostatic Hyperplasia (BPH) (MK-0906A-149 AM2)

Start: Aug 2013Est. completion: Nov 20131 patients
Phase 3Terminated

JALYN for Benign Prostatic Hyperplasia (BPH) and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

Start: Apr 2013Est. completion: Oct 20141 patients
Phase 3Terminated

Clinical Trial of Safety and Efficacy of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression

Start: Nov 2012Est. completion: Nov 2016260 patients
Phase 3Completed

Phase 3 Study of Tadalafil Once-Daily in Asian Men With Benign Prostatic Hyperplasia (BPH)

Start: Dec 2011Est. completion: Oct 2012610 patients
Phase 3Completed

MCS in Treating Lower Urinary Tract Symptoms (LUTS) Suggestive of Benign Prostatic Hyperplasia

Start: Jul 2007Est. completion: Oct 200985 patients
Phase 3Terminated

Evaluation of the Efficacy and Safety of Silodosin in the Treatment of the Signs and Symptoms of BPH

Start: May 2006Est. completion: Jan 20081,228 patients
Phase 3Completed
NCT00064649MSDTransurethral Microwave Thermotherapy

Minimally Invasive Surgical Therapy for BPH

Start: Apr 2004Est. completion: Jun 200649 patients
Phase 3Terminated

Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH)

Start: Feb 2018Est. completion: Jun 2019114 patients
Phase 2Terminated
NCT01107392AbbViebotulinum toxin Type A

Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

Start: Aug 2010Est. completion: Jun 2012315 patients
Phase 2Completed

Transperineal Intraprostatic Injection of PRX302 Under Ultrasound Guidance for Management of Prostatic Hyperplasia

Start: Jan 2009Est. completion: Sep 201092 patients
Phase 2Completed

Pilot Study Investigating Safety and Efficacy of Tadalafil as Treatment for Benign Prostatic Hyperplasia (BPH) in Asian Men

Start: Oct 2007Est. completion: Jun 2008151 patients
Phase 2Completed
NCT00284518AbbViebotulinum toxin Type A

Safety and Efficacy Study of Botulinum Toxin Type A to Treat Lower Urinary Symptoms Due to Benign Prostatic Hyperplasia

Start: Dec 2005Est. completion: May 2010380 patients
Phase 2Completed

Assessment of Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia

Start: Oct 2005Est. completion: Jun 2006222 patients
Phase 2Completed
NCT00409357SanofiSL77.0499-10

Dose Ranging Study of Alfuzosin in Patients With Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia

Start: Nov 2004Est. completion: Aug 2005473 patients
Phase 2Completed
NCT00969072GSKGI198745 0.05mg

Extension Study of GI198745 to Treat Benign Prostatic Hyperplasia

Start: Aug 2003Est. completion: Feb 2005121 patients
Phase 2Completed

Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)

Start: Sep 2011Est. completion: Aug 201340 patients
Phase 1/2Completed
NCT00894517AbbVieBotulinum Toxin Type A

A Study Evaluating the Effect of Botulinum Toxin Type A on Semen Quality in Patients With Benign Prostatic Hyperplasia

Start: Aug 2009Est. completion: Aug 201261 patients
Phase 1/2Completed
NCT04243824EmbolxGallium 68 Macro-aggregated albumin

Ga-68 MAA Distribution in PAE Patients

Start: May 2021Est. completion: May 20220
Phase 1Withdrawn

Study to Evaluate the Bioequivalence of Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers After Meal

Start: Mar 2019Est. completion: Apr 201930 patients
Phase 1Completed

Study to Evaluate the Bioequivalence of Astellas Phama Korea Inc. "Harnal-D" in Healthy Volunteers

Start: Mar 2019Est. completion: May 201930 patients
Phase 1Completed
NCT03240939Yuyu PharmaDutasteride 0.5 mg

Pharmacokinetics and Safety/Tolerability of YY-201 in Comparison to Dutasteride and Tadalafil

Start: Mar 2017Est. completion: Oct 201736 patients
Phase 1Completed

Study to Compare the Safety and Pharmacokinetics of CKD-397

Start: Nov 2015Est. completion: Dec 201536 patients
Phase 1Completed

A Study of Tadalafil in Benign Prostatic Hyperplasia

Start: Jul 2010Est. completion: Apr 201124 patients
Phase 1Completed
NCT07214675HistoSonicsHistoSonics Edison System

The Edison System for Treatment of Benign Prostatic Hyperplasia (BPH) Using Histotripsy

Start: Mar 2026Est. completion: Oct 202780 patients
N/ARecruiting

A Prospective, Multicenter, Open-label Study of the Beacon Platform for Holmium Laser Enucleation of the Prostate (HoLEP)

Start: Dec 2024Est. completion: Dec 202654 patients
N/ARecruiting
NCT05157529Procept BioRoboticsAQUABEAM Robotic System

AQUABEAM® Robotic System and Ultrasound Accessories

Start: Feb 2023Est. completion: Dec 202450 patients
N/ARecruiting

Moses Vaporization: Is Use of Moses 2.0 in Holmium Laser Ablation of the Prostate More Efficient

Start: Nov 2022Est. completion: Jul 202519 patients
N/ATerminated
NCT06051942Procept BioRoboticsRobotic Waterjet Treatment

PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

Start: Nov 2022Est. completion: Mar 2027125 patients
N/AActive Not Recruiting

Expander-2 Trial: Randomized Study to Evaluate Safety & Efficacy of the Urocross® Expander System & Retrieval Sheath

Start: Jul 2022Est. completion: Dec 2028240 patients
N/AActive Not Recruiting

A 6-months Observational Study to Evaluate the Quality of Life of Patients Treated With Phytotherapy or Alpha-blockers for Benign Prostatic Hyperplasia

Start: Jun 2022Est. completion: Jul 2024288 patients
N/ACompleted

Catheterless Water Vapor Therapy for the Treatment of BPH

Start: Oct 2021Est. completion: Jun 202720 patients
N/ASuspended
NCT04309695ZenflowZenflow Spring System

The Zenflow Spring System Safety and Performance Study (ZEST CAN)

Start: Feb 2021Est. completion: Jan 202640 patients
N/AUnknown
NCT03972371ProVerum MedicalThe ProVee Urethral Expander System

The ProVerum First in Man PROVE Study

Start: May 2019Est. completion: Nov 202310 patients
N/ACompleted
NCT03577236ZenflowZenflow Spring System

The Zenflow Spring System EU Safety and Performance Study

Start: Jan 2019Est. completion: May 202450 patients
N/AUnknown
NCT03527589Merit MedicalProstate artery embolization

Embosphere® PROstate Post Market Study

Start: Aug 2018Est. completion: Jan 2022499 patients
N/ACompleted
NCT03595735ZenflowZenflow Spring System

The Zenflow Spring System Safety, Performance and Effectiveness Study

Start: Jun 2018Est. completion: Mar 202440 patients
N/AUnknown
NCT04308070Procept BioRoboticsAQUABEAM System followed by catheter without hemostatic agent

Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia III

Start: Jul 2017Est. completion: Jun 201826 patients
N/ACompleted

Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia II

Start: Apr 2017Est. completion: Jul 201711 patients
N/ACompleted

Acute Hemostasis Following the Use of the AQUABEAM® System for the Treatment of Benign Prostatic Hyperplasia

Start: Aug 2016Est. completion: Jul 201721 patients
N/ACompleted
NCT03075449Boehringer IngelheimReal World Data on Management of Male LUTS

Real World Data on Management of Male LUTS

Start: May 2016Est. completion: Dec 2016201 patients
N/ACompleted
NCT02786290ZenflowZenflow Spring System

The Zenflow Spring System Feasibility and Safety Study

Start: Apr 2016Est. completion: Jan 202030 patients
N/AUnknown
NCT02509975IMBiotechnologiesProstate artery embolization.

Safety and Efficacy of OCL 503 in Prostate Artery Embolization

Start: Sep 2015Est. completion: May 201810 patients
N/ACompleted

Related Jobs

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

22 late-stage (Phase 3) programs, potential near-term approvals
3 actively recruiting trials targeting 10,183 patients
30 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.