Erectile dysfunction is a common condition, affecting tens of millions of American men. Some reports estimate that over half of American men between the ages of 40 and 70 experience some degree of erectile dysfunction. The condition can develop co-occurring with other conditions like diabetes and heart disease or it can result from pelvic surgery, radiation therapy, or from types of penile trauma. Erectile dysfunction can also be a side effect of medications or be associated with psychological conditions.

Today, we are taking a look at the latest information regarding erectile dysfunction in relation to clinical guidance, FDA approvals, and clinical trials. 

Current Erectile Dysfunction Guidelines

The European Association of Urology (EAU) released a guideline earlier this year that features a section on erectile dysfunction. The section, Management of Erectile Dysfunction, features 13 recommendations on the evaluation and treatment of erectile dysfunction. The American Urological Association's (AUA) 2018 guideline features 25 recommendations on erectile dysfunction separated into two sections: Evaluation and Diagnosis, and Treatment.

Recent FDA Approvals for Erectile Dysfunction

Below are the recent medications and therapies recently approved by the FDA that we anticipated being incorporated into future clinical guidelines: 

  • Vybrique (sildenafil)
    • IBSA
    • February 2026
    • A phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction
  • Eroxon
    • Futura Medical
    • June 2023
    • An OTC non-medicated hydro-alcoholic gel indicated for treatment of erectile dysfunction in adult males aged 22 years and over
Active Clinical Trials Related to Erectile Dysfunction

The following are ongoing, Phase 3 or Phase 4 clinical trials based in the United States that may impact future erectile dysfunction clinical guidelines.

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