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Prostatic Hyperplasia

29
Pipeline Programs
9
Companies
50
Clinical Trials
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
14
0
2
0
4
9
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

9 companies ranked by most advanced pipeline stage

ViiV Healthcare
ViiV HealthcareNC - Durham
32 programs
13
4
5
Benign prostatic enlargementPhase 4
DutasteridePhase 4
Dutasteride plus tamsulosinPhase 4
Dutasteride plus tamsulosinPhase 4
Dutasteride/TamsulosinPhase 4
+27 more programs
Prevail Therapeutics
2 programs
1
1
TadalafilPhase 41 trial
tadalafilPhase 21 trial
Active Trials
NCT00547625Completed275Est. Jul 2005
NCT02252367Completed86Est. Jun 2020
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
1 program
1
CIALIS(tadalafil)PHASE_2
Handok
HandokKorea - Seoul
1 program
1
ALFUZOSINPhase 41 trial
Active Trials
NCT00427882Completed125Est. May 2007
Pfizer
PfizerNEW YORK, NY
3 programs
1
1
TamsulosinPhase 21 trial
UK369,003Phase 11 trial
Doxazosin mesylate GITSN/A1 trial
Active Trials
NCT01003886Completed989Est. Jan 2011
NCT00814736Completed22Est. Sep 2008
NCT00457457Completed609Est. Apr 2008
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
15 programs
ALNA®N/A1 trial
ALNA®N/A1 trial
ALNA®OCAS®N/A1 trial
Secotex®N/A1 trial
TamsulosinN/A1 trial
+10 more programs
Active Trials
NCT02244333Completed4,575
NCT02244268Completed3,629
NCT02245542Completed5,775
+12 more trials
GSK
GSKLONDON, United Kingdom
14 programs
5-alpha Reductase InhibitorN/A1 trial
5-alpha reductase inhibitorsN/A1 trial
5ARIN/A1 trial
5ARIN/A1 trial
5ARIN/A1 trial
+9 more programs
Active Trials
NCT01381510Completed54,459Est. Aug 2010
NCT01767363Completed1Est. Mar 2016
NCT01376258Completed28,903Est. Dec 2010
+11 more trials
Boston Scientific
Boston ScientificCA - Valencia
1 program
Rezum SystemN/A1 trial
Active Trials
NCT02943070Completed50Est. Dec 2018
Sanofi
SanofiPARIS, France
1 program
AlfuzosinPHASE_45 trials
Active Trials
NCT00893113Completed74Est. Oct 2012
NCT00576823Completed25Est. Oct 2009
NCT00688948Terminated20Est. Nov 2009
+2 more trials

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
GSKBenign prostatic enlargement
Prevail TherapeuticsTadalafil
HandokALFUZOSIN
SanofiAlfuzosin
SanofiAlfuzosin
SanofiAlfuzosin
SanofiAlfuzosin
SanofiAlfuzosin
Boehringer IngelheimTamsulosin HCl controlled release capsules
Boehringer IngelheimFLOMAX® capsules
Boehringer IngelheimTamsulosin hydrochloride
Boehringer IngelheimTamsulosin
SanofiAlfuzosin
SanofiAlfuzosin
SanofiAlfuzosin

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 178,591 patients across 50 trials

NCT02757963GSKBenign prostatic enlargement

Benign Prostatic Hyperplasia (BPH) Screening Tool Case Finding Study in Subjects >=50 Years

Start: May 2016Est. completion: Feb 20171,679 patients
Phase 4Completed

Effect of 12 Weeks Treatment With Tadalafil vs Placebo on Lower Urinary Tract Symptoms

Start: Dec 2015Est. completion: Jun 202086 patients
Phase 4Completed

Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study

Start: Sep 2006Est. completion: May 2007125 patients
Phase 4Completed

Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

Start: Jun 2006110 patients
Phase 4Completed

SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

Start: Apr 2006Est. completion: Mar 2008431 patients
Phase 4Completed

ALF-ONE : ALFuzosin ONcE Daily

Start: Aug 2005Est. completion: Feb 2006200 patients
Phase 4Completed

Once Daily Given Alfuzosin in the Treatment of BPH

Start: Oct 2003Est. completion: Dec 200460 patients
Phase 4Completed

Alfuzosin XL Lower Urinary Tract Symptoms Efficacy and Sexuality Study

Start: Sep 2003Est. completion: Mar 2005118 patients
Phase 4Completed
NCT02245490Boehringer IngelheimTamsulosin HCl controlled release capsules

Study to Characterise the Effect of Tamsulosin on Lower Urinary Tract Symptoms (LUTS) and Detrusor Motor Activity in Patients Affected by Benign Prostatic Hyperplasia (BPH) and Storage Urinary Symptoms

Start: Jan 2003153 patients
Phase 4Completed

FLOMAX® Versus HYTRIN® in Patients With the Signs and Symptoms of Benign Prostatic Hyperplasia

Start: Aug 19981,993 patients
Phase 4Completed
NCT02244242Boehringer IngelheimTamsulosin hydrochloride

Study to Evaluate the Symptomatic Relief Effects of FLOMAX® in Patients With Signs and Symptoms of Benign Prostatic Hyperplasia

Start: Jul 1998493 patients
Phase 4Completed

Study to Evaluate the Therapeutic Action of Tamsulosin and Finasteride in Symptomatic Benign Prostatic Hyperplasia (BPH) Patients

Start: Apr 1998403 patients
Phase 4Completed

An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms

Start: Jun 2009Est. completion: Oct 201274 patients
Phase 3Completed

Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology

Start: Dec 2007Est. completion: Oct 200925 patients
Phase 3Completed

Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction

Start: Oct 2007Est. completion: Dec 2009172 patients
Phase 3Completed

Efficacy and Safety of SL77.0499-10 (Alfuzosin) Versus Placebo and Tamsulosin in Japanese Patients With Benign Prostatic Hyperplasia

Start: Nov 2006Est. completion: Oct 20071,177 patients
Phase 3Completed

Use of Alfuzosin in Stone Treatment With ESWL

Start: Oct 2006Est. completion: Dec 20070
Phase 3Withdrawn

ALF-STONE: Alfuzosin in Uretheric Stones

Start: Aug 2006Est. completion: Jul 2007220 patients
Phase 3Terminated

Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology

Start: Jul 2006Est. completion: Feb 200729 patients
Phase 3Completed

Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH

Start: May 2006Est. completion: Oct 2007148 patients
Phase 3Completed
NCT00169585GSKLevofloxacin oral tablets

Levofloxacin For The Management Of Patients With Abnormal Prostate Specific Antigen (PSA)

Start: Mar 2005Est. completion: Apr 2007240 patients
Phase 3Completed

Alfuzosin Versus Placebo in Acute Urinary Retention

Start: May 2004160 patients
Phase 3Terminated

The Efficacy, Onset of Effect, and Safety of Alfuzosin Once Daily in the Treatment of Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: A Randomized, Placebo-Controlled Trial Using an Acute International Prostate Score

Start: Feb 2003Est. completion: Oct 2004372 patients
Phase 3Completed

Clinical Trial in Males With BPH (Enlarged Prostate)

Start: May 2001Est. completion: Mar 20051,522 patients
Phase 3Completed

ALFAURUS : A DB Randomized Parallel Group Study of Alfuzosin 10mg OD vs Placebo in the Management of AUR in Patients With a 1st Episode Due to BPH

Start: May 2001Est. completion: Oct 2004800 patients
Phase 3Completed

Alfuzosin for Voiding Dysfunction in Multiple Sclerosis (MS)

Start: Nov 2007Est. completion: Nov 200920 patients
Phase 2/3Terminated

Study the Effects of Different Doses of UK-369,003 in Men With Lower Urinary Tract Symptoms.

Start: May 2007Est. completion: Apr 2008609 patients
Phase 2Completed

Alfuzosin for Treating Acute Urinary Retention

Start: Feb 2006156 patients
Phase 2Completed

Study to Determine Safety and Effectiveness of Tadalafil on Prostate Related Sex Organ/Urinary Tract Problems

Start: Oct 2004Est. completion: Jul 2005275 patients
Phase 2Completed

Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fasted Male.

Start: Apr 2015Est. completion: May 201534 patients
Phase 1Completed

Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fed Male.

Start: Apr 2015Est. completion: May 201534 patients
Phase 1Completed
NCT01262989GSKTest formulation

SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fast Admin

Start: Jan 2010Est. completion: Jan 201040 patients
Phase 1Completed
NCT01330303GSKReference formulation

SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fed Admin

Start: Dec 2009Est. completion: Dec 200937 patients
Phase 1Completed

A Randomized, Double-Blinded, Placebo-Controlled, Two-Way Crossover Study to Investigate the Safety and Toleration of Single Dose Sildenafil in Subjects Receiving Chronic UK-369,0031

Start: Aug 2008Est. completion: Sep 200822 patients
Phase 1Completed

A Study To Compare 3 Different Formulations Of Tamsulosin At Steady State.

Start: Feb 2008Est. completion: Apr 200824 patients
Phase 1Completed
NCT00537654GSKTreatment sequence A

A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State

Start: Oct 2007Est. completion: Feb 200881 patients
Phase 1Completed
NCT01767363GSK5-alpha reductase inhibitors

WEUSKOP5723: Prostate Cancer Study

Start: Nov 2012Est. completion: Mar 20161 patients
N/ACompleted

Rezum I Pilot Study for Benign Prostatic Hyperplasia

Start: Mar 2012Est. completion: Dec 201850 patients
N/ACompleted

Benefits of Adherence to 5-alpha Reductase Inhibitor Treatment in Men With Enlarged Prostate: An Assessment of Medicare and Medicaid Patients Using the MarketScan Database

Start: Oct 2010Est. completion: Dec 201028,903 patients
N/ACompleted

Evaluating the Impact of Early Versus Delayed 5 Alpha Reductase Inhibitor Treatment on the Risk of Emergent Surgery in Men With Benign Prostatic Hyperplasia

Start: Aug 2010Est. completion: Aug 20104,068 patients
N/ACompleted
NCT01381510GSK5-alpha Reductase Inhibitor

Establishing the Benefits of Adherence to Enlarged Prostate Treatment: A Validation Study Linking Adherence to Outcomes Using the Market Scan Database

Start: Jun 2010Est. completion: Aug 201054,459 patients
N/ACompleted
NCT01334723GSKAdherent with 5-alpha-reductase inhibitor

Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia

Start: Apr 2010Est. completion: Jun 201035,032 patients
N/ACompleted

Benign Prostatic Hypertrophy Treatment Patterns & Outcomes: Marketscan

Start: Apr 2010Est. completion: Jun 201035,032 patients
N/ACompleted
NCT01003886PfizerDoxazosin mesylate GITS

A Post Marketing Surveillance Study Of Doxazosin Mesylate GITS Among Filipino Patients With Benign Prostatic Hyperplasia (BPH)

Start: May 2009Est. completion: Jan 2011989 patients
N/ACompleted
NCT01390870GSK5ARI or AB or Combination Therapy

Establishing Predictors of Enlarged Prostate Treatment Adherence: Linking Symptom Improvement to Adherence

Start: May 2009Est. completion: Sep 2010400 patients
N/ACompleted

Clinical and Economic Outcomes of Patients Utilizing Combination Therapy for Enlarged Prostates: A Henry Ford Database Assessment

Start: Mar 2009Est. completion: Jun 2010332 patients
N/ACompleted

Benign Prostatic Hyperplasia in Taiwan

Start: Sep 2006Est. completion: Sep 2008362 patients
N/ACompleted

Observational Study of Tamsulosin in Patients With Benign Prostatic Hyperplasia

Start: Apr 20061,060 patients
N/ACompleted

Uroxatral in Men With Benign Prostate Hypertrophy (BPH) and Erectile Dysfunction (ED)

Start: Nov 2005Est. completion: May 20076 patients
N/ACompleted

The Impact of Alna® Ocas® on Nocturia in Patients With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (LUTS/BPH)

Start: Apr 20055,775 patients
N/ACompleted

Phase Legend

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

Key Insights

4 late-stage (Phase 3) programs, potential near-term approvals
9 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.