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Erectile Dysfunction

141
Pipeline Programs
30
Companies
50
Clinical Trials
4
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
31
1
10
2
48
49
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
5100%
+ 182 programs with unclassified modality

On Market (4)

Approved therapies currently available

Viatris
REVATIOApproved
sildenafil citrate
Viatris
intravenous2009
8M Part D
Viatris
VIAGRAApproved
sildenafil citrate
Viatris
oral1998
334K Part D
Viatris
VYBRIQUEApproved
sildenafil citrate
Viatris
oral2025
Viatris
LIQREVApproved
sildenafil citrate
Viatris
oral2023

Competitive Landscape

42 companies ranked by most advanced pipeline stage

Bayer
BayerLEVERKUSEN, Germany
49 programs
2
2
1
22
16
LevitraPhase 41 trial
LevitraPhase 4
LevitraPhase 41 trial
LevitraPhase 4
LevitraPhase 41 trial
+44 more programs
Active Trials
NCT00470873Completed2,471Est. Feb 2008
NCT00874679Completed7,293Est. Apr 2010
NCT01106118Completed2,289Est. Aug 2013
+29 more trials
ViiV Healthcare
ViiV HealthcareNC - Durham
18 programs
1
1
8
8
LEVITRAPhase 4
LevitraPhase 4
LevitraPhase 4
LevitraPhase 4
LevitraPhase 4
+13 more programs
Prevail Therapeutics
14 programs
1
1
5
7
TadalafilPhase 4
TadalafilPhase 4
TadalafilPhase 4
TadalafilPhase 4
TadalafilPhase 4
+9 more programs
Pfizer
PfizerNEW YORK, NY
13 programs
4
1
1
4
sildenafilPhase 4
sildenafilPhase 41 trial
sildenafilPhase 4
tadalafilPhase 4
delivery systemPhase 31 trial
+8 more programs
Active Trials
NCT00743613Completed175Est. May 2008
NCT03356353Unknown24Est. Jan 2022
NCT01054001Unknown124Est. Jan 2013
+6 more trials
Viatris
ViatrisCANONSBURG, PA
13 programs
5
6
Sildenafil CitratePhase 41 trial
sildenafilPhase 41 trial
sildenafilPhase 41 trial
sildenafilPhase 41 trial
sildenafil citratePhase 41 trial
+8 more programs
Active Trials
NCT00874185Completed720Est. May 2008
NCT01108900Completed100Est. Oct 2011
NCT01254396Completed12Est. Jan 2011
+10 more trials
VIVUS
VIVUSCA - Campbell
11 programs
9
1
1
avanafilPhase 41 trial
avanafilPhase 31 trial
200 mg AvanafilPhase 11 trial
OmeprazolePhase 1Small Molecule1 trial
RitonavirPhase 1Small Molecule1 trial
+6 more programs
Active Trials
NCT01095588Completed24Est. May 2010
NCT01415128Completed60Est. May 2010
NCT00770042Completed44Est. Dec 2008
+8 more trials
Hanmi Pharmaceutical
6 programs
4
1
1
TadalafilPhase 41 trial
HCP1302Phase 31 trial
HCP1303Phase 11 trial
HCP1303Phase 11 trial
HIP0908Phase 11 trial
+1 more programs
Active Trials
NCT02712411Completed30Est. Sep 2015
NCT02715401Completed36Est. Nov 2015
NCT01514903Completed54Est. Dec 2011
+3 more trials
Martin Pharmaceuticals
1 program
1
NebivololPhase 4Small Molecule1 trial
Active Trials
NCT01885988Unknown70Est. Jun 2014
Human BioSciences
Human BioSciencesWV - Martinsburg
1 program
1
Sildenafil citratePhase 41 trial
Active Trials
NCT00512707Completed140Est. May 2010
Futura Medical
4 programs
1
1
2
MED2005Phase 31 trial
MED3000Phase 31 trial
Glyceryl trinitratePhase 21 trial
MED2005Phase 11 trial
Active Trials
NCT04008732Completed40Est. Apr 2018
NCT02495467Completed232Est. Jul 2016
NCT03813992Completed1,005Est. Jan 2020
+1 more trials
JW Pharmaceutical
JW PharmaceuticalKorea - Seoul
2 programs
2
AvanafilPhase 31 trial
Avanafil 100 or 200mgPhase 31 trial
Active Trials
NCT00903981Completed208Est. Nov 2009
NCT01705197Completed195Est. Nov 2013
Dong-A ST
2 programs
2
DA-8159Phase 31 trial
DA-8159Phase 31 trial
Active Trials
NCT01901640Completed302Est. Nov 2012
NCT01774864Completed349Est. May 2012
EMS
EMSBrazil - Hortolândia
2 programs
2
Tanzânia associationPhase 31 trial
Toronto associationPhase 31 trial
Active Trials
NCT04185441Completed295Est. Jul 2024
NCT05052879Unknown232Est. Aug 2026
Amgen
AmgenTHOUSAND OAKS, CA
1 program
1
LevitraPhase 3
Abdi Ibrahim
1 program
1
udenafilPhase 31 trial
Active Trials
NCT01305083Completed118Est. Aug 2011
Dicot
DicotSweden - Uppsala
2 programs
1
1
LIB-01Phase 21 trial
LIB-01Phase 11 trial
Active Trials
NCT06324006Completed64Est. May 2024
NCT06703840Completed156Est. Aug 2025
Medica Corp
Medica CorpMA - Bedford
2 programs
1
1
TPN171HPhase 21 trial
TPN171HPhase 11 trial
Active Trials
NCT05185011Completed24Est. Feb 2022
NCT04479917Completed255Est. Jul 2021
Initiator Pharma
Initiator PharmaDenmark - Copenhagen
2 programs
2
IP2018Phase 21 trial
IPED2015Phase 21 trial
Active Trials
NCT04686916Unknown24Est. Aug 2023
NCT04969666Unknown120Est. Nov 2022
Channel Therapeutics
Channel TherapeuticsNJ - North Brunswick
1 program
1
hMaxi-K Single Treatment/ 2 escalating dose levelsPhase 21 trial
Active Trials
NCT02713789Completed26Est. Aug 2017
Tritech Biopharmaceuticals
1
TR-399Phase 1/21 trial
Active Trials
NCT03102398Unknown26Est. Mar 2018
MSD
MSDIreland - Ballydine
1 program
1
Vardenafil ODT,Phase 11 trial
Active Trials
NCT01348880Completed42Est. Dec 2011
Sharp Therapeutics
1
Vardenafil ODT,Phase 1
Vigonvita
8 programs
TPN171HPHASE_11 trial
TPN171HPHASE_1
TPN171HPHASE_11 trial
TPN171H 10mgPHASE_11 trial
TPN171HPHASE_2
+3 more programs
Active Trials
NCT06090136Completed12Est. Jul 2022
NCT06090123Completed24Est. Sep 2020
NCT05585931Completed18Est. Dec 2022
+3 more trials
Boston Scientific
AMS Penile Prosthesis DevicesN/A1 trial
Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile DysfunctionN/A1 trial
Tactra MalleableN/A1 trial
Active Trials
NCT01383018Completed1,457Est. Jul 2018
NCT03849586Active Not Recruiting1,076Est. Feb 2032
NCT04200937Enrolling By Invitation450Est. Dec 2031
Coloplast
3 programs
Inflatable Penile ProsthesisN/A1 trial
Inflatable Penile ProsthesisN/A1 trial
Registry for Patients Undergoing Penile Prosthesis Implantation for Male Erectile DysfunctionN/A
Active Trials
NCT00731666Completed40Est. May 2011
NCT00731939Completed124Est. Apr 2010
GSK
GSKLONDON, United Kingdom
3 programs
LevitraPHASE_41 trial
LevitraPHASE_41 trial
LevitraPHASE_41 trial
Active Trials
NCT00662441Completed102Est. Jun 2004
NCT00681772Completed333Est. Nov 2003
NCT00663130Completed759Est. Jul 2004
Dornier MedTech
Dornier MedTechFrance - Sillingy
2 programs
Dornier Aries 2N/A1 trial
ARIESPHASE_11 trial
Active Trials
NCT03039218Terminated54Est. Mar 2018
NCT02620982Completed23Est. Sep 2016
Genesis Therapeutics
Injection of adipose derived cells into penisN/A
Tissue Genesis Cell Isolation SystemN/A
Tissue Genesis
Tissue GenesisTX - Leander
2 programs
Injection of adipose derived cells into penisN/A1 trial
Tissue Genesis Cell Isolation SystemN/A1 trial
Active Trials
NCT03518333Unknown60Est. Sep 2023
NCT01601353Unknown30Est. Aug 2021
Eli Lilly and Company
Eli Lilly and CompanyINDIANAPOLIS, IN
2 programs
LY2452473PHASE_11 trial
LY2452473PHASE_21 trial
Active Trials
NCT01401543Completed24Est. Sep 2011
NCT01160289Completed410Est. Nov 2011

+12 more companies

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Hanmi PharmaceuticalTadalafil
Martin PharmaceuticalsNebivolol
VIVUSavanafil
BayerVardenafil
Viatrissildenafil citrate
BayerTestosterone Undecanoate and/or PDE-5
Human BioSciencesSildenafil citrate
Pfizersildenafil
BayerVardenafil
ViatrisSildenafil Citrate
BayerLevitra
BayerLevitra
BayerLevitra
GSKLevitra
PfizerSildenafil

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 48,591 patients across 50 trials

Effect of Tadalafil on Erectile Dysfunction Treatment and QOL Improvement Effect (by SF-12) in Andropause Patients With Erectile Dysfunction

Start: Jul 2016Est. completion: Jul 201740 patients
Phase 4Unknown

Nebivolol Effects on Endothelial Function and Erectile Function

Start: Mar 2013Est. completion: Jun 201470 patients
Phase 4Unknown

Study Evaluating the Effects of Avanafil on Semen Parameters

Start: Dec 2012Est. completion: Aug 2014181 patients
Phase 4Completed

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

Start: Nov 2008Est. completion: Oct 2009150 patients
Phase 4Completed
NCT00468650Viatrissildenafil citrate

A Multicenter, Open Label, To Evaluate The Efficacy And Satisfaction Of Patrex® In Men With Erectile Dysfunction.

Start: Jun 2007Est. completion: Feb 2008117 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

Effect of Testosterone in Men With Erectile Dysfunction

Start: Nov 2006Est. completion: May 2010140 patients
Phase 4Completed

Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males

Start: Sep 2005Est. completion: Jun 2007100 patients
Phase 4Unknown

Assess Efficacy in Subjects With Traumatic Spinal Cord Injury

Start: Jul 2005Est. completion: Feb 200745 patients
Phase 4Completed
NCT00159900ViatrisSildenafil Citrate

Quality of Erection Study

Start: May 2005Est. completion: Jan 2006300 patients
Phase 4Completed

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

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

Evaluation of LEVITRA to Advance the Treatment of Erectile Dysfunction

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

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

Blood Pressure Interaction Between Sildenafil and Sublingual Glyceryl Trinitrate (GTN) in Men With Angina

Start: Jan 2004Est. completion: Sep 200520 patients
Phase 4Completed

Levitra® - Real Life Safety and Efficacy of Levitra

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

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

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

A Multicenter, Randomized, Parallel Group, Double-Blind, Placebo Controlled, Flexible Dose Escalation Study To Evaluate Sexual And Relationship Satisfaction In The Female Partner Of Men With Erectile Dysfunction Treated With Sildenafil Citrate

Start: Jun 2003Est. completion: Apr 2004300 patients
Phase 4Completed

A Randomized, Open-Label, Crossover, Multicenter, Single Dose Comparator Study Evaluating Onset Of Penile Rigidity In Men With Erectile Dysfunction Who Are Treated With Sildenafil And Tadalafil

Start: Jun 2003Est. completion: Nov 200356 patients
Phase 4Completed

A Study to Evaluate Self-esteem and Relationships in Males With Erectile Dysfuntion

Start: May 2003Est. completion: May 2004780 patients
Phase 4Completed

Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia

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

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

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

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

A Multicenter, Double-blind Study to Evaluate the Effect of Pretreatment With a Daily Dose of Sildenafil on the As-Needed Efficacy of Viagra in Men With Erectile Dysfunction and Type 2 Diabetes

Start: Dec 2002Est. completion: Jan 2004300 patients
Phase 4Completed
NCT06805513SanofiTadalafil 5 mg tablets with a digital tool.

Actual Use Trial of Tadalafil 5 mg

Start: Jan 2025Est. completion: Apr 20262,212 patients
Phase 3Completed
NCT05052879EMSToronto association

Efficacy and Safety of Toronto Association in the Treatment of Erectile Dysfunction and Premature Ejaculation

Start: Jul 2024Est. completion: Aug 2026232 patients
Phase 3Unknown

Long-term Safety of TPN171H Tablet in Erectile Dysfunction.

Start: Apr 2024Est. completion: Jun 2025472 patients
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 2024488 patients
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 2023765 patients
Phase 3Completed

Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction

Start: Sep 2021Est. completion: Jul 2022116 patients
Phase 3Completed
NCT04185441EMSTanzânia association

Efficacy and Safety of Tanzânia Association in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia

Start: Mar 2021Est. completion: Jul 2024295 patients
Phase 3Completed

Clinical Trial Using Topically Applied Glyceryl Trinitrate (GTN) for the Treatment of Erectile Dysfunction

Start: Nov 2018Est. completion: Jan 20201,005 patients
Phase 3Completed

Sildenafil for the Prevention of Right Heart Failure Following LVAD Implantation

Start: Mar 2018Est. completion: Jan 202224 patients
Phase 3Unknown

Trial to Evaluate the Efficacy and Safety of HCP1302

Start: Sep 2014Est. completion: Aug 2015232 patients
Phase 3Completed
NCT01705197JW PharmaceuticalAvanafil 100 or 200mg

This Study is to Evaluate the Safety and Efficacy of Avanafil in the Treatment of Erectile Dysfunction.

Start: Feb 2012Est. completion: Nov 2013195 patients
Phase 3Completed

Safety Study of Once-a-Day Dosing of Udenafil to Treat Erectile Dysfunction

Start: Nov 2011Est. completion: Nov 2012302 patients
Phase 3Completed

Efficacy and Safety Study of Udenafil to Treat Erectile Dysfunction

Start: Apr 2011Est. completion: May 2012349 patients
Phase 3Completed
NCT01008605Pfizerdelivery system

Caverject User Study

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

Efficacy and Safety Study of Udenafil Tablets in Erectile Dysfunction.

Start: Oct 2010Est. completion: Aug 2011118 patients
Phase 3Completed

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

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

Concomitant Use of PriLigy in Men Treated for Erectile Dysfunction

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

Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Avanafil

Start: Mar 2009Est. completion: Nov 2009208 patients
Phase 3Completed

Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction

Start: Mar 2009Est. completion: Apr 2010712 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

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

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

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

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

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

BAY38-9456 - Supportive Trial for Spinal Injury

Start: Mar 2004Est. completion: Nov 200432 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

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