Erectile Dysfunction

30
Pipeline Programs
17
Companies
50
Clinical Trials
1 recruiting
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
7
1
5
0
13
4
Early DiscoveryClinical DevelopmentMarket

On Market (2)

Approved therapies currently available

Bayer
LEVITRAApproved
vardenafil hydrochloride
Bayer
oral2003
Astellas
PROGRAFApproved
tacrolimus
Astellas
oral2018

Competitive Landscape

17 companies ranked by most advanced pipeline stage

Bayer
BayerLEVERKUSEN, Germany
6 programs
1
4
1
Testosterone Undecanoate and/or PDE-5Phase 41 trial
LevitraPhase 31 trial
LevitraPhase 31 trial
LEVITRA(Levitra)Phase 35 trials
Testosterone gelPhase 32 trials
+1 more programs
Active Trials
NCT01168817Completed140Est. May 2011
NCT00661596Completed129Est. Jan 2004
NCT00661700Completed611Est. May 2004
+8 more trials
Astellas
AstellasChina - Shenyang
2 programs
1
1
TacrolimusPhase 41 trial
MirabegronPhase 1/21 trial
Active Trials
NCT02916693Completed20Est. Jan 2020
NCT00106392Completed131Est. Nov 2008
Vigonvita
VigonvitaChina - Suzhou
8 programs
4
2
2
TPN171HPhase 31 trial
TPN171H 2.5mg groupPhase 31 trial
TPN171HPhase 21 trial
TPN171H 2.5mgPhase 21 trial
TPN171HPhase 11 trial
+3 more programs
Active Trials
NCT06090136CompletedEst. Jul 2022
NCT05185011CompletedEst. Feb 2022
NCT06090123CompletedEst. Sep 2020
+5 more trials
Pfizer
PfizerNEW YORK, NY
3 programs
1
delivery systemPhase 31 trial
Satisfaction With Phosphodiesterase 5 Inhibitors Treatment In Patients With Cardiovascular RiskN/A1 trial
Sexual Health Inventory for MenN/A1 trial
Active Trials
NCT00874185Completed720Est. May 2008
NCT00743613Completed175Est. May 2008
NCT01008605Completed48Est. Feb 2011
Sanofi
SanofiPARIS, France
2 programs
1
1
Tadalafil 5 mg tablets with a digital tool.Phase 31 trial
SAR407899Phase 21 trial
Active Trials
NCT00914277Completed24Est. Oct 2009
NCT06805513Recruiting2,250Est. Feb 2026
J&
Johnson & JohnsonNEW BRUNSWICK, NJ
2 programs
2
DapoxetinePhase 31 trial
dapoxetinePhase 35 trials
Active Trials
NCT00210704Completed1,067Est. Jun 2006
NCT01366664Completed24Est. Apr 2012
NCT01063881Completed285Est. Jun 2011
+3 more trials
Amgen
AmgenTHOUSAND OAKS, CA
1 program
1
LevitraPhase 31 trial
Active Trials
NCT00657644Completed130Est. Mar 2004
IBSA Institut Biochimique
IBSA Institut BiochimiqueSwitzerland - Lugano-Pazzallo
1 program
1
Sildenafil Oral Film 25 mg, 50 mg, 75 mg or 100 mgPhase 31 trial
Active Trials
NCT05490680CompletedEst. Dec 2024
T-Therapeutics
T-TherapeuticsUK - Cambridge
1 program
1
intracavernous platelet rich plasma therapyPhase 31 trial
Active Trials
NCT06942988Active Not RecruitingEst. Jul 2025
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
2 programs
1
1
LY2452473Phase 21 trial
LY2452473Phase 11 trial
Active Trials
NCT01401543Completed24Est. Sep 2011
NCT01160289Completed410Est. Nov 2011
Dornier MedTech
Dornier MedTechFrance - Sillingy
2 programs
1
ARIESPhase 11 trial
Dornier Aries 2N/A1 trial
Active Trials
NCT03039218TerminatedEst. Mar 2018
NCT02620982CompletedEst. Sep 2016
Takeda
TakedaTOKYO, Japan
1 program
1
UdenafilPhase 11 trial
Active Trials
NCT01967264Completed83Est. Aug 2013
C
ColoplastAustralia - Mulgrave
3 programs
Inflatable Penile ProsthesisN/A1 trial
Inflatable Penile ProsthesisN/A1 trial
Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile DysfunctionN/A1 trial
Active Trials
NCT00731939CompletedEst. Apr 2010
NCT00731666CompletedEst. May 2011
NCT03849586Active Not RecruitingEst. Feb 2032
Genesis Therapeutics
Genesis TherapeuticsCA - Burlingame
2 programs
Injection of adipose derived cells into penisN/A1 trial
Tissue Genesis Cell Isolation SystemN/A1 trial
Active Trials
NCT03518333UnknownEst. Sep 2023
NCT01601353UnknownEst. Aug 2021
Rigicon
RigiconNY - Ronkonkoma
1 program
Rigicon Infla 10® Three-Piece Inflatable Penile ProsthesisN/A1 trial
Active Trials
NCT05574868RecruitingEst. May 2026
Fusion Pharmaceuticals Inc.
1 program
Utilization of Serenita for RelaxationN/A1 trial
Active Trials
NCT02757807UnknownEst. Dec 2016
Vivex Biologics
Vivex BiologicsGA - Atlanta
1 program
VIAGENEX MaxN/A1 trial
Active Trials
NCT05196191Terminated32Est. Dec 2023

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
BayerLevitra
BayerTestosterone Undecanoate and/or PDE-5
BayerLevitra
BayerLevitra
BayerLevitra
BayerLevitra
AstellasTacrolimus
BayerLevitra
BayerTestosterone gel
BayerLevitra
BayerLevitra
BayerLevitra
BayerLevitra
BayerLevitra
BayerLevitra

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 49,962 patients across 50 trials

NCT00738400BayerLevitra

Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome

Start: Nov 2008Est. completion: Oct 2009150 patients
Phase 4Completed
NCT00555087BayerTestosterone Undecanoate and/or PDE-5

Treatment of Erectile Dysfunction in Hypogonadal Men With Testosterone Undecanoate

Start: May 2007Est. completion: Jan 200850 patients
Phase 4Unknown
NCT00377793BayerLevitra

Levitra (Vardenafil, BAY38-9456) Partner Satisfaction Study II

Start: Jul 2006Est. completion: Aug 2007352 patients
Phase 4Completed
NCT00663845BayerLevitra

Assessing Efficacy and Safety of Flexible Dosing With Vardenafil in Subjects With Erectile Dysfunction and Hyperlipidemia

Start: May 2006Est. completion: Apr 2007395 patients
Phase 4Completed
NCT00667966BayerLevitra

Assess Efficacy in Subjects With Traumatic Spinal Cord Injury

Start: Jul 2005Est. completion: Feb 200745 patients
Phase 4Completed
NCT00461565BayerLevitra

FDA Phase IV - Commitment - Retinal Function Study

Start: Feb 2005Est. completion: Oct 200663 patients
Phase 4Completed
NCT00106392AstellasTacrolimus

A Safety and Efficacy Study of Prograf in the Prevention of Erectile Dysfunction After Radical Prostatectomy

Start: Feb 2005Est. completion: Nov 2008131 patients
Phase 4Completed
NCT00655590BayerLevitra

Assess the Effect of Daily Treatment of Vardenafil 20mg or Sildenafil 100mg and Placebo on Sperm Function

Start: Jan 2005Est. completion: Jun 2006200 patients
Phase 4Completed
NCT00190060BayerTestosterone gel

Study of The Effects of Testosterone in Frail Elderly Men

Start: Oct 2004Est. completion: Dec 2008262 patients
Phase 4Completed
NCT00663728BayerLevitra

Assessment of Duration of Erection With Vardenafil 10 mg

Start: Sep 2004Est. completion: Apr 2005201 patients
Phase 4Completed
NCT00667979BayerLevitra

Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse

Start: Sep 2004Est. completion: Dec 2004264 patients
Phase 4Completed
NCT00665054BayerLevitra

BAY38-9456, 5/10/20mg, vs.Placebo in Erectile Dysfunction

Start: Aug 2004Est. completion: Aug 2005160 patients
Phase 4Completed
NCT00665340BayerLevitra

Investigate the Responsiveness of the Erectile Quality Scale to Vardenafil Flexible Dose vs Placebo in Males With Erectile Dysfunction (ED)

Start: Jul 2004Est. completion: Jan 2005219 patients
Phase 4Completed
NCT00668096BayerLevitra

A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy.

Start: May 2004Est. completion: Jan 2005260 patients
Phase 4Completed
NCT00664833BayerLevitra

Evaluation of LEVITRA to Advance the Treatment of Erectile Dysfunction

Start: May 2004Est. completion: Oct 20051,029 patients
Phase 4Completed
NCT00663130BayerLevitra

Evaluating the Efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in Subjects With Erectile Dysfunction (ED)

Start: Apr 2004Est. completion: Jul 2004759 patients
Phase 4Completed
NCT00663598BayerLevitra

Levitra® - Real Life Safety and Efficacy of Levitra

Start: Oct 2003Est. completion: Sep 200430,825 patients
Phase 4Completed
NCT00662441BayerLevitra

Evaluating of the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

Start: Sep 2003Est. completion: Jun 2004102 patients
Phase 4Completed
NCT00681772BayerLevitra

Evaluation of the Safety and Efficacy of Vardenafil in Subjects With Erectile Dysfunction

Start: Mar 2003Est. completion: Nov 2003333 patients
Phase 4Completed
NCT00668135BayerLevitra

Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia

Start: Mar 2003Est. completion: Apr 2004348 patients
Phase 4Completed
NCT00660998BayerLevitra

Evaluation of Efficacy and Safety of Vardenafil in Patients With Erectile Dysfunction and Type 1 Diabetes

Start: Feb 2003Est. completion: Jan 2004318 patients
Phase 4Completed
NCT06805513SanofiTadalafil 5 mg tablets with a digital tool.

Actual Use Trial of Tadalafil 5 mg

Start: Jan 2025Est. completion: Feb 20262,250 patients
Phase 3Recruiting
NCT06301854VigonvitaTPN171H

Long-term Safety of TPN171H Tablet in Erectile Dysfunction.

Start: Apr 2024Est. completion: Jun 2025
Phase 3Completed
NCT05490680IBSA Institut BiochimiqueSildenafil Oral Film 25 mg, 50 mg, 75 mg or 100 mg

A New Sildenafil Oral Film in Patients With Erectile Dysfunction

Start: Jan 2024Est. completion: Dec 2024
Phase 3Completed
NCT06942988T-Therapeuticsintracavernous platelet rich plasma therapy

Efficacy of Intracavernous Platelet-rich Plasma Injection in the Treatment of Erectile Dysfunction

Start: Dec 2023Est. completion: Jul 2025
Phase 3Active Not Recruiting
NCT05188989VigonvitaTPN171H 2.5mg group

Efficacy and Safety Study of TPN171H Tablets in Erectile Dysfunction.

Start: Dec 2021Est. completion: Feb 2023
Phase 3Completed
NCT01008605Pfizerdelivery system

Caverject User Study

Start: Feb 2011Est. completion: Feb 201148 patients
Phase 3Completed
NCT01063881Johnson & Johnsondapoxetine

The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy

Start: May 2010Est. completion: Jun 2011285 patients
Phase 3Completed
NCT01063855Johnson & Johnsondapoxetine

Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction

Start: Apr 2010Est. completion: Sep 2011495 patients
Phase 3Completed
NCT00244023BayerTestosterone gel

Co-Administering Testosterone With PDE5 Inhibitors in ED Patients Non Responders to PDE5 Inhibitors Alone

Start: Oct 2005Est. completion: Jul 2007173 patients
Phase 3Completed
NCT00210704Johnson & JohnsonDapoxetine

A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation

Start: Mar 2005Est. completion: Jun 20061,067 patients
Phase 3Completed
NCT00492635BayerLevitra

Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil vs Vardenafil PRN vs Placebo in Men Immediately After Nerve-sparing Prostatectomy for Improving ED

Start: Dec 2004Est. completion: Sep 2007628 patients
Phase 3Completed
NCT00229073Johnson & Johnsondapoxetine

A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation

Start: Dec 2004Est. completion: Oct 20061,116 patients
Phase 3Completed
NCT00210613Johnson & Johnsondapoxetine

A Study of Withdrawal Effects With Dapoxetine in the Treatment of Premature Ejaculation

Start: Nov 2004Est. completion: Aug 2005199 patients
Phase 3Completed
NCT00652262BayerLevitra

BAY38-9456 - Supportive Trial for Spinal Injury

Start: Mar 2004Est. completion: Nov 200432 patients
Phase 3Completed
NCT00678704BayerLevitra

BAY38-9456 - Pivotal Trial for Diabetes Patient

Start: Jan 2004Est. completion: Nov 2004790 patients
Phase 3Completed
NCT00668109BayerLevitra

Assessment of Efficacy of Vardenafil in Subjects With Erectile Dysfunction and Diabetes, Hypertension or Hyperlipidemia

Start: Dec 2003Est. completion: Jun 2004614 patients
Phase 3Completed
NCT00682019BayerLevitra

Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks

Start: Dec 2003Est. completion: Aug 2004383 patients
Phase 3Completed
NCT00657033BayerLevitra

Study to Investigate the Efficacy and Safety of Vardenafil Flexible Dose Versus Placebo in Males With Erectile Dysfunction

Start: Oct 2003Est. completion: Aug 2004229 patients
Phase 3Completed
NCT00657644AmgenLevitra

Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction

Start: Aug 2003Est. completion: Mar 2004130 patients
Phase 3Completed
NCT00665496BayerLevitra

A Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction

Start: Jun 2003Est. completion: Nov 2003732 patients
Phase 3Completed
NCT00658177BayerLevitra

Study Evaluating the Efficacy and Safety of Flexible-dose Vardenafil in Subjects With Erectile Dysfunction

Start: Jun 2003Est. completion: Feb 2004463 patients
Phase 3Completed
NCT00661297BayerLevitra

Study Evaluating the Efficacy, Safety, and Reliability of Vardenafil

Start: Jun 2003Est. completion: Jan 2004523 patients
Phase 3Completed
NCT00661596BayerLevitra

Assessment of Efficacy of Vardenafil, Influence on Self-esteem and Self-confidence in Subjects With Erectile Dysfunction

Start: May 2003Est. completion: Jan 2004129 patients
Phase 3Completed
NCT00661115BayerLevitra

To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction.

Start: May 2003Est. completion: Feb 2004173 patients
Phase 3Completed
NCT00654914BayerLevitra

A Study to Assess the Efficacy and Safety of Vardenafil in the Treatment of Male Patients With Erectile Dysfunction

Start: May 2003Est. completion: Feb 2004527 patients
Phase 3Completed
NCT00661700BayerLevitra

A Double-blind "Preferred" Vardenafil Dose Study of QoL and Functional Outcomes in Males With Erectile Dysfunction

Start: Apr 2003Est. completion: May 2004611 patients
Phase 3Completed
NCT00668005BayerLevitra

Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction and Hypertension

Start: Feb 2003Est. completion: Sep 2003388 patients
Phase 3Completed
NCT00668018BayerLevitra

Assess Efficacy of Vardenafil 10mg in Erectile Dysfunction Within Intake of 6 Hours

Start: Jan 2003Est. completion: Oct 2003887 patients
Phase 3Completed
NCT00668057BayerLevitra

BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.

Start: Dec 2002Est. completion: Sep 2003624 patients
Phase 3Completed

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

13 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 49,962 patients
17 companies competing in this space