Xeomin and Tadalafil Phase 2 ED Trial
ClinicalTrials.gov Studies
Summary
NIH registered a Phase 2 clinical trial (NCT07537855) evaluating intracavernosal incobotulinumtoxinA (Xeomin, 100 Units) combined with tadalafil for treating mild-moderate erectile dysfunction in approximately 30 million affected men. The randomized crossover pilot study enrolls male participants to assess efficacy where PDE5 inhibitors alone may be insufficient. ClinicalTrials.gov study record posted April 17, 2026.
What changed
NIH registered a Phase 2 clinical trial on ClinicalTrials.gov (NCT07537855) investigating the combination of incobotulinumtoxinA (Xeomin, 100 Units) administered intracavernosally with tadalafil for treatment of mild-moderate erectile dysfunction. The randomized crossover pilot study targets men who may be partial or non-responders to phosphodiesterase-5 inhibitors alone, a population representing approximately 30-40% of ED patients.
For sponsors and clinical investigators, this represents an active Phase 2 research program in the urology/sexual medicine space. Drug manufacturers producing botulinum toxin products or PDE5 inhibitors may find this trial relevant to their product development or competitive intelligence. Patients and healthcare providers seeking investigational ED treatments can access trial details via ClinicalTrials.gov.
Archived snapshot
Apr 18, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Efficacy of Intracavernosal Xeomin With Tadalafil for Mild-Moderate Erectile Dysfunction: A Randomized Crossover Pilot Study
Phase 2 NCT07537855 Kind: PHASE2 Apr 17, 2026
Abstract
Erectile dysfunction (ED) affects approximately 30 million men in the United States and is associated with factors such as aging, smoking, diabetes, hypertension, obesity, and sedentary lifestyle. ED can also negatively impact the quality of life of patients and their partners. Treatment decisions are typically made jointly between patients and their urologists, often starting with less invasive options. Oral phosphodiesterase-5 inhibitors (PDE5 inhibitors), including sildenafil, tadalafil, and vardenafil, are commonly used as first-line therapy. While these medications improve erectile function in many patients, approximately 30-40% do not respond adequately to PDE5 inhibitor therapy alone. Patients who do not achieve sufficient benefit may require additional or more invasive treatment options.
Conditions: Erectile Dysfunction
Interventions: IncobotulinumtoxinA (100 Units), Placebo
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