PT-141 (Bremelanotide) for Erectile Dysfunction
PT-141 (bremelanotide) is FDA-approved exclusively for hypoactive sexual desire disorder (HSDD) in premenopausal women, NOT for erectile dysfunction in men, and should not be used for this indication. 1, 2
Current FDA Approval and Indication
- Bremelanotide received FDA approval in 2019 specifically for treating acquired, generalized HSDD in premenopausal women only 1, 3
- The drug is marketed as Vyleesi and administered as a 1.75 mg subcutaneous injection approximately 45 minutes before anticipated sexual activity 3, 4
- There is no FDA approval for bremelanotide in men with erectile dysfunction 1, 2
Limited Evidence in Male Erectile Dysfunction
- While bremelanotide is a melanocortin receptor agonist that was initially investigated in men with ED as a centrally acting agent, it has not progressed to FDA approval for this indication 5
- Early phase studies suggested potential utility in male sexual dysfunction, but no phase 3 trials or regulatory approval followed for men 5
- Current major erectile dysfunction guidelines (AUA 2018, EAU 2025) do not mention bremelanotide as a treatment option for men 1
Established First-Line Treatment for Male ED
Men with erectile dysfunction should be offered FDA-approved PDE5 inhibitors (sildenafil, tadalafil, vardenafil, or avanafil) as first-line therapy, which have robust evidence with approximately 60-65% success rates 1
PDE5 Inhibitor Recommendations:
- All four FDA-approved PDE5 inhibitors demonstrate similar efficacy in the general ED population 1
- Treatment should begin conservatively and be titrated to maximum dose if needed 6, 7
- At least 5 separate occasions at maximum dose constitute an adequate trial before declaring treatment failure 6, 7
- Absolute contraindication: Never prescribe with nitrates due to dangerous hypotension risk 6, 7, 8
Second-Line Options When PDE5 Inhibitors Fail
If PDE5 inhibitors are ineffective after adequate trial:
- Intracavernosal injection therapy with vasoactive drugs 1, 6
- Intraurethral alprostadil suppositories 6, 7
- Vacuum erection devices 1, 6
- Low-intensity shockwave therapy may be considered for mild vasculogenic ED 1
Third-Line Definitive Treatment
- Penile prosthesis implantation remains the definitive surgical option for refractory ED with high patient satisfaction rates 1, 6
Critical Cardiovascular Assessment
Before initiating any ED treatment, assess cardiovascular risk as ED is a strong independent risk marker for cardiovascular disease, equivalent to smoking or family history of myocardial infarction 1, 6
- Patients unable to walk 1 mile in 20 minutes or climb 2 flights of stairs in 20 seconds without symptoms require cardiology referral before treatment 6, 7
- High-risk patients should defer sexual activity until cardiac stabilization 6, 7
Common Pitfall to Avoid
Do not prescribe bremelanotide off-label for male erectile dysfunction when evidence-based, FDA-approved treatments with established efficacy and safety profiles are available 1. The lack of phase 3 trial data, regulatory approval, and guideline support for bremelanotide in men makes this an inappropriate choice that could delay effective treatment.