Compound monograph
Bremelanotide
Also known as: PT-141, Vyleesi
§1 Definition
Bremelanotide is a synthetic melanocortin-receptor agonist, FDA-approved as Vyleesi for acquired, generalized hypoactive sexual desire disorder in premenopausal women. Administered as an as-needed subcutaneous injection, it activates the same receptor family as the unapproved research compound Melanotan II, from which it was pharmacologically derived, but bremelanotide alone has completed FDA review and carries an approved label.
Educational purposes only, not medical advice. Dosing figures below are documented ranges from cited literature, not a recommendation for any individual. Consult a qualified provider before administering anything.
§2 Evidence tier and regulatory status
Evidence tier
1 — FDA-approved
Approved by the FDA for at least one indication, backed by multiple randomized controlled trials.
FDA-approved as Vyleesi on June 21, 2019, for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women — specifically excluding cases due to a co-existing medical or psychiatric condition, relationship problems, or medication effects. Not approved for postmenopausal women, men, or general sexual-performance enhancement.
§3 Documented dosing
| Context | Range | Frequency | Source |
|---|---|---|---|
| Hypoactive sexual desire disorder, premenopausal women (Vyleesi) | 1.75–1.75 mg | as needed, at least 45 minutes before anticipated sexual activity; no more than 1 dose per 24 hours or 8 doses per month | [1] |
§4 Reconstitution math
Vyleesi is supplied as a ready-to-use prefilled autoinjector (1.75mg/0.3mL) — it does not require reconstitution, unlike lyophilized peptides. No published data exists on reconstituting a non-FDA lyophilized version, since none is part of the approved product line.
- Concentration
- 5000 mcg/mL
- Draw volume
- 0.05 mL
- Syringe units
- 5.0
- Doses per vial
- 40
§5 What the research shows
| Trial | Phase | n | Duration | Endpoint | Result | Source |
|---|---|---|---|---|---|---|
| RECONNECT trials | Phase 3 | 1247 | 24-week double-blind phase, with a 52-week open-label extension (684 participants continued) | Co-primary endpoints: change in Female Sexual Function Index desire-domain score, and Female Sexual Distress Scale-DAO item 13 (bother from low desire) | Two identically-designed trials both showed statistically significant improvement in desire score and distress score versus placebo (integrated analysis P<0.001 for both). | [1], [2] |
§6 Safety and reported adverse effects
| Effect | Incidence | Source |
|---|---|---|
| Nausea | 40.0% vs 1.3% placebo | [1] |
| Flushing | 20.3% vs 0.3% placebo | [1] |
| Injection site reactions | 13.2% vs 8.4% placebo | [1] |
| Headache | 11.3% vs 1.9% placebo | [1] |
| Vomiting | 4.8% vs 0.2% placebo | [1] |
| Focal hyperpigmentation | ~1% at label-recommended frequency (≤8 doses/month); reported up to 38% with off-label daily dosing in trial data | [1] |
| Transient blood pressure increase | up to +6 mmHg systolic / +3 mmHg diastolic, peaking 2-4 hours post-dose and resolving by approximately 12 hours | [1] |
Contraindications
- Uncontrolled hypertension
- Known cardiovascular disease
Known interactions
- No published drug-interaction data was located in this research pass beyond the cardiovascular contraindications above.
§7 Storage and handling
- Lyophilized
- Not applicable — the FDA-approved product is a ready-to-use solution, not a lyophilized powder.
- Reconstituted
- No published data located for a non-FDA lyophilized or reconstituted form.
§8 Sourcing considerations
- Confirm any product sold as bremelanotide or PT-141 is the FDA-approved Vyleesi autoinjector, not an unregulated compounded or research-chemical version.
- Do not confuse bremelanotide with Melanotan II — they are related but distinct molecules, and only bremelanotide (Vyleesi) is FDA-approved.
- Confirm cold-chain shipping and storage claims against the FDA label if handling a non-Vyleesi version, since the approved product has specific handling requirements.
§9 FAQ
Is PT-141 the same as Vyleesi?
Yes — PT-141 is the research name for bremelanotide, which is marketed as Vyleesi.
How is bremelanotide different from Melanotan II?
They activate related melanocortin receptors and bremelanotide was derived from the same line of research as Melanotan II, but they are different molecules — only bremelanotide has completed FDA review and is approved (as Vyleesi).
What are Vyleesi's side effects?
Nausea (40% of patients) and flushing (20%) are the most common. See the adverse effects table above for full trial-reported rates.
Does bremelanotide raise blood pressure?
Yes, transiently — up to about 6 mmHg systolic and 3 mmHg diastolic, peaking 2-4 hours after a dose and resolving by about 12 hours. It's contraindicated in uncontrolled hypertension and known cardiovascular disease.
Can bremelanotide cause skin darkening?
Focal hyperpigmentation was reported in about 1% of patients at the label-recommended frequency, but was much more common (up to 38%) in trial data using off-label daily dosing — a reason to stay within the labeled dosing limits.
How often can you use Vyleesi?
No more than one dose in 24 hours, and no more than 8 doses per month, per the FDA label.
§10 Sources
- [1] VYLEESI (bremelanotide injection) — Full Prescribing Information. U.S. Food and Drug Administration, 2019. FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210557s000lbl.pdf
- [2] Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials (RECONNECT). Obstetrics & Gynecology, 2019. Peer-reviewed. https://pubmed.ncbi.nlm.nih.gov/31599840/