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Disease
Erectile Dysfunction
Late-stage therapeutic developmentEmerging researchRising momentum
3
Publications
22
Clinical trials
2024
Latest publication
Latest activity
betaRecent clinical, regulatory, research and industry developments relating to this disease.
Princeton IV consensus guidelines: PDE5 inhibitors and cardiac health.
Research2024-01-01The journal of sexual medicine
Approval: Tadalafil Lilly (EMA)
Regulatory2017-03-22EMA
Approval: Tadalafil Mylan (EMA)
Regulatory2014-11-21EMA
Organic causes of erectile dysfunction in men under 40.
Research2013-11-21Urologia internationalis
Regulatory2013-06-21EMA
Approval: Sildenafil Actavis (EMA)
Regulatory2009-12-10EMA
Regulatory2003-03-06EMA
Regulatory2002-11-12EMA
Regulatory1998-09-13EMA
Impotence following radical prostatectomy: insight into etiology and prevention.
Research1982-09-01The Journal of urology
What's happening now
An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.
Executive briefingUpdating summary…Momentum: Moderate
Key developments
- 3 clinical trials expected to report results, the earliest in Q4 2026.
Upcoming Milestones
- Q4 2026Daily Tadalafil 5 mg Combined With On-Demand Sildenafil 100 mg for Treatment of Erectile Dysfunction in PDE-5I Non Responder Patients: A Multicenter Randomized, Double-Blind, Placebo-Controlled Trial
- Q4 2026L-Citrulline Versus Tadalafil Versus Combination Therapy in Mild to Moderate Erectile Dysfunction: A Prospective Randomized Trial
- Q4 2027Safety and Efficiacy of Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction: A Randomized Placebo-Controlled Clinical Trial
Major developments
Upcoming trial readoutHigh impact
Results expected Q4 20262026-06-12
Upcoming trial readoutHigh impact
Results expected Q4 20272026-03-18
Clinical MilestonesViewHide
Results expected
- 2026-06-12L-Citrulline Versus Tadalafil Versus Combination Therapy in Mild to Moderate Erectile Dysfunction: A Prospective Randomized TrialResults expected Q4 2026
- 2026-03-18Safety and Efficiacy of Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction: A Randomized Placebo-Controlled Clinical TrialResults expected Q4 2027
- 2026-02-06Daily Tadalafil 5 mg Combined With On-Demand Sildenafil 100 mg for Treatment of Erectile Dysfunction in PDE-5I Non Responder Patients: A Multicenter Randomized, Double-Blind, Placebo-Controlled TrialResults expected Q4 2026
Recently completed
- 2026-06-01Effect of Testofen on Erectile Function in an Adult Male Population - A Double Blind, Randomised Controlled Trial.Primary completion
- 2026-05-31Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement: A Prospective Non-inferiority TrialPrimary completion
- 2026-03-17A Randomized, Allocation-concealed, Assessor-blinded, Parallel-group Trial Evaluating the Association Between Erectile Dysfunction and Left Ventricular Diastolic Dysfunction and Comparing the Effects of Tadalafil, SGLT2 Inhibitors, and Their Combination in Patients With Metabolic Syndrome.Completed
- 2026-03-01Efficacy of Transcutaneous Electrical Neural Stimulation and Tadalafil in Men With Erectile Dysfunction: A Randomized, Double-Blind, Bi-centric, Placebo- and Sham-Controlled TrialCompleted
- 2025-12-16Efficacy of Intracavernosal Injection of Platelet-Rich Plasma Alone Versus Combined With Oral Tadalafil in The Management of Erectile Dysfunction; A Prospective Randomized StudyCompleted
Activity timeline8
- 2026-06-12ClinicalL-Citrulline Versus Tadalafil Versus Combination Therapy in Mild to Moderate Erectile Dysfunction: A Prospective Randomized TrialResults expected Q4 2026
- 2026-06-01ClinicalEffect of Testofen on Erectile Function in an Adult Male Population - A Double Blind, Randomised Controlled Trial.Primary completion
- 2026-05-31ClinicalIrrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement: A Prospective Non-inferiority TrialPrimary completion
- 2026-03-18ClinicalSafety and Efficiacy of Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction: A Randomized Placebo-Controlled Clinical TrialResults expected Q4 2027
- 2026-03-17ClinicalA Randomized, Allocation-concealed, Assessor-blinded, Parallel-group Trial Evaluating the Association Between Erectile Dysfunction and Left Ventricular Diastolic Dysfunction and Comparing the Effects of Tadalafil, SGLT2 Inhibitors, and Their Combination in Patients With Metabolic Syndrome.Completed
- 2026-03-01ClinicalEfficacy of Transcutaneous Electrical Neural Stimulation and Tadalafil in Men With Erectile Dysfunction: A Randomized, Double-Blind, Bi-centric, Placebo- and Sham-Controlled TrialCompleted
- 2026-02-06ClinicalDaily Tadalafil 5 mg Combined With On-Demand Sildenafil 100 mg for Treatment of Erectile Dysfunction in PDE-5I Non Responder Patients: A Multicenter Randomized, Double-Blind, Placebo-Controlled TrialResults expected Q4 2026
- 2025-12-16ClinicalEfficacy of Intracavernosal Injection of Platelet-Rich Plasma Alone Versus Combined With Oral Tadalafil in The Management of Erectile Dysfunction; A Prospective Randomized StudyCompleted
Therapeutic landscape
Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.
Approved & established therapies
Tadalafilapproved
Approval — Treatment of erectile dysfunction in adult males.In order for tadalafil to be effective,… (2017)
Avanafilapproved
Approval — Treatment of erectile dysfunction in adult men. In order for Spedra to be effective, sexu… (2013)
Sildenafilapproved
Approval — Treatment of men with erectile dysfunction, which is the inability to achieve or maintain… (2009)
Vardenafilapproved
Approval — Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to… (2003)
Clinical trials
The current development programme across all trial phases.
Clinical programme
22
6
15
6
Late-stage studies
Recruiting
Recently completed
Regulatory timeline
Drug regulatory events matched to this condition by indication — EMA.
First approvals
2017emaApproval — Tadalafil· Treatment of erectile dysfunction in adult males.In order for tadalafil to be effective, sexual stimulation is required. Tadalafil Lilly is not indicated for use by women. Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males. source ↗
2014emaApproval — Tadalafil· Treatment of erectile dysfunction in adult males. In order for tadalafil to be effective, sexual stimulation is required. Tadalafil Mylan is not indicated for use by women. source ↗
2013emaApproval — Avanafil· Treatment of erectile dysfunction in adult men. In order for Spedra to be effective, sexual stimulation is required. source ↗
2009emaApproval — Sildenafil· Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Sildenafil Actavis to be effective, sexual stimulation is required. source ↗
2003emaApproval — Vardenafil· Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Levitra to be effective, sexual stimulation is required. Levitra is not indicated for use by women. source ↗
2002emaApproval — Tadalafil· Treatment of erectile dysfunction. In order for tadalafil to be effective, sexual stimulation is required. Cialis is not indicated for use by women. source ↗
1998emaApproval — Sildenafil· Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. In order for Viagra to be effective, sexual stimulation is required. source ↗
European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.
Research activity
Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.
Publications over time
19822024
Most influential
Major themes3
- Cardiovascular Diseases1
- Erectile Dysfunction1
- Penile Erection1
Leading journals3
- The journal of sexual medicine1
- The Journal of urology1
- Urologia internationalis1
Leading researchers8
- Blaha MJ1
- Burnett AL1
- Donker PJ1
- Ganz P1
- Goldstein I1
- Kim NN1
- Kloner RA1
- Kohler T1
Affiliations (unnormalised)6
- Center for Male Health1
- Center for Sexual Health1
- Huntington Medical Research Institutes1
- Institute for Sexual Medicine1
- Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease1
- Johns Hopkins University1
Reference
Authoritative identity, definition & identifiers.
Defined in MeSH
The inability in the male to have a PENILE ERECTION due to psychological or organ dysfunction.
Identifiers
References & data sources
- Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
- Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
- Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
- Related entities are derived from literature co-mention (studied together) — associative, not causal.