Benign Prostatic Hyperplasia

19
Pipeline Programs
16
Companies
50
Clinical Trials
1 recruiting
8
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
2
0
3
0
2
12
Early DiscoveryClinical DevelopmentMarket

On Market (8)

Approved therapies currently available

Eli Lilly and Company
ADCIRCAApproved
tadalafil
Eli Lilly and Company
Phosphodiesterase 5 Inhibitor [EPC]oral2009
U
CHEWTADZYApproved
tadalafil
Unknown Company
oral2024
Eli Lilly and Company
CIALISApproved
tadalafil
Eli Lilly and Company
Phosphodiesterase 5 Inhibitor [EPC]oral2003
U
MIRABEGRONApproved
mirabegron
Unknown Company
beta3-Adrenergic Agonist [EPC]oral2022
U
MYRBETRIQApproved
mirabegron
Unknown Company
beta3-Adrenergic Agonist [EPC]oral2012
U
MYRBETRIQ GRANULESApproved
mirabegron
Unknown Company
beta3-Adrenergic Agonist [EPC]oral2021
U
TADLIQApproved
tadalafil
Unknown Company
Phosphodiesterase 5 Inhibitor [EPC]oral2022
U
TAMSULOSIN HYDROCHLORIDEApproved
tamsulosin hydrochloride
Unknown Company
oral2017

Competitive Landscape

13 companies ranked by most advanced pipeline stage

Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
3 programs
1
1
1
1
TadalafilPhase 31 trial
TadalafilPhase 21 trial
TadalafilPhase 11 trial
Active Trials
NCT01183650Completed24Est. Apr 2011
NCT00540124Completed151Est. Jun 2008
NCT01460342Completed610Est. Oct 2012
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
2 programs
1
Tamsulosin OCASPhase 41 trial
Real World Data on Management of Male LUTSN/A1 trial
Active Trials
NCT03075449Completed201Est. Dec 2016
NCT00379067Completed882Est. Nov 2006
Recordati
RecordatiFrance - Saint-Victor
2 programs
1
1
SilodosinPhase 41 trial
SilodosinPhase 31 trial
Active Trials
NCT00359905Completed1,228Est. Jan 2008
NCT01757769Completed1,036Est. Aug 2013
Astellas
AstellasChina - Shenyang
2 programs
2
MirabegronPhase 45 trials
Tamsulosin hydrochloridePhase 43 trials
Active Trials
NCT04562090Completed249Est. Mar 2022
NCT04501640Completed24Est. Oct 2020
NCT03572231Completed805Est. Mar 2020
+5 more trials
Opko Health
Opko HealthMIAMI, FL
1 program
1
Group-1Phase 21 trial
Active Trials
NCT03297398TerminatedEst. Jun 2019
Sanofi
SanofiPARIS, France
1 program
1
SL77.0499-10Phase 21 trial
Active Trials
NCT00409357Completed473Est. Aug 2005
Embolx
EmbolxCA - Sunnyvale
1 program
1
Gallium 68 Macro-aggregated albuminPhase 11 trial
Active Trials
NCT04243824WithdrawnEst. May 2022
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
NCT04309695Unknown40Est. Jan 2026
NCT02786290Unknown30Est. Jan 2020
NCT03595735Unknown40Est. Mar 2024
+1 more trials
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
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
AM-Pharma
AM-PharmaNetherlands - Utrecht
1 program
Optilume Catheter SystemN/A1 trial
Active Trials
NCT05567666UnknownEst. Dec 2024
Pierre Fabre
Pierre FabreFrance - Aignan
1 program
PhytotherapyN/A1 trial
Active Trials
NCT07144709Completed288Est. Jul 2024

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
AstellasMirabegron
AstellasMirabegron
AstellasMirabegron
AstellasMirabegron
AstellasMirabegron
AstellasMirabegron
AstellasMirabegron
AstellasMirabegron
AstellasMirabegron
AstellasMirabegron
AstellasMirabegron
RecordatiSilodosin
AstellasTamsulosin hydrochloride
Boehringer IngelheimTamsulosin OCAS
AstellasMirabegron

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 23,224 patients across 50 trials

A Study With Mirabegron 50 mg and 25 mg in Chinese Participants With Overactive Bladder

Start: Jan 2021Est. completion: Mar 2022249 patients
Phase 4Completed

A Study to Investigate the Effect of Food With Mirabegron in Healthy Chinese Participants

Start: Sep 2020Est. completion: Oct 202024 patients
Phase 4Completed

Mirabegron for the Treatment of Pain Motivated Urinary Frequency and Urgency in Women

Start: Dec 2017Est. completion: Jun 20180
Phase 4Withdrawn

A Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Men With OAB Symptoms While Taking Tamsulosin Hydrochloride for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)

Start: Jun 2016Est. completion: Sep 2018715 patients
Phase 4Completed

A Phase 4 Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Male Subjects With Overactive Bladder (OAB) Symptoms, While Taking the Alpha Blocker for Benign Prostatic Hypertrophy (BPH)

Start: Jan 2016Est. completion: Jul 2017568 patients
Phase 4Completed

Mirabegron and Urinary Urgency Incontinence

Start: Jan 2015Est. completion: Jan 201984 patients
Phase 4Completed

Postmarketing Study to Evaluate add-on Therapy With Anticholinergics in Patients With Overactive Bladder (OAB) on Mirabegron.

Start: Oct 2014Est. completion: Sep 2016649 patients
Phase 4Completed

A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB)

Start: Jul 2014Est. completion: Nov 2015376 patients
Phase 4Completed

Study of Behavioral Modification Program and Mirabegron to Improve Urinary Urgency in Multiple Sclerosis

Start: May 2014Est. completion: Jun 201928 patients
Phase 4Completed

A Pilot Study of Mirabegron and Behavioral Modification Including Pelvic Floor Exercise for Overactive Bladder in Parkinson's Disease (MAESTRO)

Start: Mar 2014Est. completion: Jul 201830 patients
Phase 4Completed

Post-marketing Study to Evaluate the Effect of Mirabegron on the Plasma Concentration of Tolterodine

Start: Jun 2013Est. completion: Aug 201324 patients
Phase 4Completed

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

Start: May 2011Est. completion: Aug 20131,036 patients
Phase 4Completed
NCT00771394AstellasTamsulosin hydrochloride

Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia

Start: Oct 2008Est. completion: Jan 2010638 patients
Phase 4Completed

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

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

This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder

Start: Nov 2013Est. completion: Oct 20153,527 patients
Phase 3Completed

A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)

Start: Jul 2013Est. completion: Nov 20142,174 patients
Phase 3Completed

A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.

Start: Jun 2012Est. completion: Apr 20131,887 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
NCT01021332AstellasTamsulosin hydrochloride

Long Term Study of Solifenacin Succinate and Tamsulosin Hydrochloride Oral Controlled Absorption System (OCAS) in Males With Lower Urinary Tract Symptoms

Start: Apr 2010Est. completion: Dec 20111,067 patients
Phase 3Completed

A Study to Assess Efficacy and Safety of the Beta-3 Agonist Mirabegron (YM178) in Patients With Symptoms of Overactive Bladder

Start: Mar 2008Est. completion: Apr 20092,149 patients
Phase 3Completed

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

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

Start: Feb 2018Est. completion: Jun 2019
Phase 2Terminated

A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder

Start: Mar 2011Est. completion: Jun 20121,307 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
NCT00507455AstellasTamsulosin hydrochloride

Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction

Start: Jun 2007Est. completion: Aug 2008222 patients
Phase 2Completed

A Study of Mirabegron (YM178) in Men With Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)

Start: Dec 2006Est. completion: Aug 2008200 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
NCT04243824EmbolxGallium 68 Macro-aggregated albumin

Ga-68 MAA Distribution in PAE Patients

Start: May 2021Est. completion: May 2022
Phase 1Withdrawn

Study to Evaluate the Effect of Solifenacin and Mirabegron on the Tamsulosin Hydrochloride (HCl) Concentrations in Blood in Healthy Male Subjects

Start: May 2014Est. completion: Aug 201420 patients
Phase 1Completed

A Study of Tadalafil in Benign Prostatic Hyperplasia

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

A Study to Evaluate the Effect of Oral Mirabegron on the Heart in Healthy Males and Females

Start: May 2010Est. completion: Nov 2010352 patients
Phase 1Completed

Study of the Effect of Food on the Pharmacokinetics of Mirabegron

Start: May 2009Est. completion: Jul 200976 patients
Phase 1Completed

Pharmacokinetics of Oral Mirabegron With Different Release Rates Versus Intravenous (IV) Mirabegron

Start: Apr 2009Est. completion: Jul 200991 patients
Phase 1Completed

A Clinical Study to Assess the Effect on Pharmacokinetics of Dosing Mirabegron (YM178) and Solifenacin Simultaneously

Start: Mar 2009Est. completion: Jul 200941 patients
Phase 1Completed

A Study to Evaluate How Mirabegron Enters and Leaves the Bloodstream According to Age and Sex

Start: Mar 2009Est. completion: Nov 200975 patients
Phase 1Completed

A Study to Investigate the Effect of Mirabegron (YM178) on Subjects With Mild or Moderate Hepatic Impairment Compared to Healthy Subjects

Start: Nov 2008Est. completion: Apr 200932 patients
Phase 1Completed

To Evaluate the Effect of Mirabegron (YM178) on Blood Levels of Desipramine When They Are Taken Together

Start: Oct 2008Est. completion: Jan 200928 patients
Phase 1Completed

A Study to Evaluate the Possible Effects of Taking Mirabegron While Taking a Contraceptive Pill

Start: Oct 2008Est. completion: Mar 200930 patients
Phase 1Completed

To Evaluate the Blood and Urine Concentration and the Safety and Tolerability of Increasing Repeated Doses of Mirabegron (YM178) OCAS in Healthy Young and Elderly Males and Healthy Young and Elderly Females

Start: May 2005Est. completion: Oct 200596 patients
Phase 1Completed

To Compare Blood and Urine Concentrations of Mirabegron (YM178) in Healthy Poor or Extensive Metabolizers for CYP2D6 and to Assess the Effect of Mirabegron on the Metabolism of Metoprolol

Start: Sep 2002Est. completion: Nov 200228 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
NCT05567666AM-PharmaOptilume Catheter System

Optilume BPH Catheter System in Benign Prostatic Hyperplasia (BPH)

Start: Nov 2022Est. completion: Dec 2024
N/AUnknown

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
NCT04309695ZenflowZenflow Spring System

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

Start: Feb 2021Est. completion: Jan 202640 patients
N/AUnknown
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

A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China

Start: Jul 2018Est. completion: Mar 2020805 patients
N/ACompleted
NCT03595735ZenflowZenflow Spring System

The Zenflow Spring System Safety, Performance and Effectiveness Study

Start: Jun 2018Est. completion: Mar 202440 patients
N/AUnknown
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

Phase Legend

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

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 23,224 patients
16 companies competing in this space