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Disease

Sexual dysfunction

Late-stage therapeutic development
17
Clinical trials
1
Associated genes
1
Related proteins

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Low
Key developments
  • 2 clinical trials expected to report results, the earliest in Q4 2026.
  • 4 industry developments reported.
Upcoming Milestones
Major developments
Upcoming trial readoutHigh impact
Postpartum Vaginal Estrogen for Sexual Function in Breastfeeding Patients: A Randomized Controlled Trial
Results expected Q4 20262026-07-23
Upcoming trial readoutImportant
Noninvasive Spinal Cord Neuromodulation to Improve Lower Urinary Tract Function After Spinal Cord Injury in Ukrainian War Veterans
Results expected Q4 20272026-02-27
Clinical Milestones2View
Results expected 2
Industry & Market4View
Activity timeline6

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

Original application approval — Treatment of erectile dysfunction in adult males.In order for tadalafil to be effective,… (2017)

Avanafilapproved

Original application approval — Treatment of erectile dysfunction in adult men. In order for Spedra to be effective, sexu… (2013)

Sildenafilapproved

Generic approval — Treatment of men with erectile dysfunction, which is the inability to achieve or maintain… (2009)

Vardenafilapproved

Original application approval — Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to… (2003)

Clinical trials

14 sponsors · 0 new · 0 completed in the last 12 months (net +0)

The current development programme across all trial phases.

Clinical programme
17
All trials
4
Active
13
Late-stage
6
Completed
Late-stage studies

Postpartum Vaginal Estrogen for Sexual Function in Breastfeeding Patients: A Randomized Controlled Trial

Phase 4 · Recruiting · University Hospitals Cleveland Medical Center

Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Erectile Dysfunction (Phase 2 Study)

Phase 2/3 · Completed · Cairo University

A Double-Blind, Placebo Controlled Study of Maca Root for the Treatment of Antidepressant-Induced Sexual Dysfunction in Females

Phase 3 · Completed · Massachusetts General Hospital

Impact of Lactate-containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors: Prospective Randomized Controlled Trial

Phase 3 · Completed · Seoul National University Hospital

A Dose-Finding Study of the Tolerability and Efficacy of Maca Root in Patients With Antidepressant-Induced Sexual Dysfunction

Phase 3 · Completed · Massachusetts General Hospital

Statin Therapy is Associated With Low Testosterone and Sexual Function in Men With Type 2 Diabetes

Phase 4 · Completed · Chang Gung Memorial Hospital
Recently completed

Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Erectile Dysfunction (Phase 2 Study)

Phase 2/3 · Completed · Cairo University

Impact of Lactate-containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors: Prospective Randomized Controlled Trial

Phase 3 · Completed · Seoul National University Hospital

Statin Therapy is Associated With Low Testosterone and Sexual Function in Men With Type 2 Diabetes

Phase 4 · Completed · Chang Gung Memorial Hospital

A Double-Blind, Placebo Controlled Study of Maca Root for the Treatment of Antidepressant-Induced Sexual Dysfunction in Females

Phase 3 · Completed · Massachusetts General Hospital

A Dose-Finding Study of the Tolerability and Efficacy of Maca Root in Patients With Antidepressant-Induced Sexual Dysfunction

Phase 3 · Completed · Massachusetts General Hospital

A 14 Week Open-Label Study to Evaluate the Tolerability of Switching From an SSRI to Tiagabine(GABITRIL) in Order to Alleviate SSRI Induced Sexual Dysfunction in Generalized Anxiety Disorder Patients

Phase 4 · Completed · State University of New York - Upstate Medical University

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

Product approvals and authorisations
2017emaOriginal application approval — 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 ↗
2014emaGeneric approval — 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 ↗
2013emaOriginal application approval — Avanafil· Treatment of erectile dysfunction in adult men. In order for Spedra to be effective, sexual stimulation is required. source ↗
2009emaGeneric approval — 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 ↗
2003emaOriginal application approval — 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 ↗
2002emaOriginal application approval — 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 ↗
1998emaOriginal application approval — 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.

Associated genes

1 match

Genes associated with this disease in the canonical knowledge graph (Open Targets evidence). Number shows the association score.

MC4R0.49

Disease biology

1 match

Proteins whose encoding gene is associated with this disease, reached through the canonical gene→disease graph. Number shows the gene's association score.

Melanocortin receptor 4via MC4R0.49
References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.