Bremelanotide (Vyleesi): Evidence, Side Effects, and Regulatory Status (2026)
Bremelanotide (Vyleesi) is FDA-approved. Evidence grade: strong. This page is clinically reviewed.
TL;DR / Quick Facts
Bremelanotide (Vyleesi) is Bremelanotide is a synthetic melanocortin receptor agonist FDA-approved as Vyleesi for hypoactive sexual desire disorder (HSDD) in premenopausal women. Self-administered subcutaneous injection. FDA status: FDA-approved. Typical use cases: libido, womens health, sexual health. Evidence grade: strong. Dosing is per the FDA label — set by your clinician. Common side effects: see below. Medriva editorial stance: follow the FDA label; do not use off-label without clinical supervision.
What it is
Bremelanotide (Vyleesi) is a member of the Melanocortin receptor agonist class. Bremelanotide binds MC3R and MC4R in the CNS, modulating sexual arousal. Distinct from PT-141: bremelanotide is the FDA-approved drug; PT-141 is a related research compound.
What the evidence says
Evidence for Bremelanotide (Vyleesi) is strong. Multiple phase 3 trials and post-market data support the labeled indications.
[Detailed evidence breakdown in the corresponding claim or pillar pages is linked at the bottom of this page.]
What it's used for
Commonly discussed uses of Bremelanotide (Vyleesi):
- Libido — strong evidence.
- Additional uses listed in the linked use-case hubs; evidence varies by indication.
For the full list, see the linked use-case hubs below.
Typical dosing
Bremelanotide dosing is determined by the approved label, indication, comorbidities, current medications, and clinician judgment. Medriva does not publish individualized dosing instructions or titration schedules. Review the current prescribing information and make changes only with a licensed clinician.
Side effects and risks
- Common: Side effects vary by compound and indication; review the approved label or profile-specific safety data with a clinician.
- Serious: Seek urgent care for severe allergic symptoms, chest pain, severe abdominal pain, persistent vomiting, or other severe reactions.
- Long-term unknowns: For non-approved or research-use compounds, long-term human safety data may be limited.
Regulatory status
- FDA-approved use(s): Vyleesi (HSDD in premenopausal women).
- Compounded availability: see 503A vs 503B explainer
- Research-use-only (RUO) availability: n/a
- Banned in sport: see WADA & sports explainer
Cost and access
Bremelanotide (Vyleesi) is available by prescription; see the cost page for the relevant indication. For pricing, see our cost pages or the GLP-1 price/supply tracker where applicable.
Who it might be appropriate for
Adults with a relevant diagnosed condition or clinical goal, under the supervision of a licensed clinician, who have no contraindications. Bremelanotide (Vyleesi) is not for self-experimentation.
Who should not use it
Contraindications vary by compound, indication, pregnancy status, comorbidities, and current medications. For the full list, see the contraindications checklist and discuss with your clinician.
Medriva editorial stance
We describe the literature. We do not promote Bremelanotide (Vyleesi) as a cure, treatment, or performance enhancer. We do not recommend it for self-experimentation. We do recommend that readers (a) understand the evidence grade (strong), (b) understand the regulatory status (FDA-approved), and (c) discuss with a licensed clinician before acting.
How to talk to a clinician
See our guide on how to talk to a clinician for a templated conversation.
Frequently Asked Questions
Is Bremelanotide (Vyleesi) FDA-approved?
FDA-approved. See the regulatory status section above for details.
Does Bremelanotide (Vyleesi) work for libido?
Evidence is strong. See the linked use-case hub for the full breakdown.
What are the side effects?
See the side effects section above. Discuss with your clinician.
How much does Bremelanotide (Vyleesi) cost?
See the cost pages or the GLP-1 price/supply tracker where applicable.
Can I buy Bremelanotide (Vyleesi) online?
By prescription only. Medriva does not sell peptides.
Author + Clinical reviewer
Author: Maya Raman, MS Clinical reviewer: Jonathan Reeves, MD Last reviewed: 2026-06-05
Next steps
- Review the evidence grade and regulatory status before making decisions about Bremelanotide.
- Bring this page to a licensed clinician if you are discussing benefits, risks, or alternatives.
- Subscribe to the Medriva Peptide Brief for evidence and regulatory updates.
Related use-case hubs
Related comparisons
Editorial process
This page follows the Medriva Editorial Policy and the Clinical Review Methodology. Page last reviewed: 2026-06-05. Author: Maya Raman, MS. Clinical reviewer: Jonathan Reeves, MD.
Current source updates
For new regulator actions, compounding-policy changes, warning letters, shortage updates, and sports-rule changes, review the Peptide Tracker before relying on older summaries.
