FDA-approved, prescription onlyVyleesi is approved for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). The label says it is not for postmenopausal women or men, and not "to enhance sexual performance".[2] The autoinjector holds exactly one dose, so a calculator is not needed to use it. "PT-141" sold online as a research chemical is not Vyleesi.
PT-141 peptide dosage chart: what the label says
The Vyleesi label sets a single 1.75 mg dose, at most once in 24 hours, with more than 8 doses a month not recommended.
| Item | Label |
|---|---|
| Product | 1.75 mg/0.3 mL single-dose prefilled autoinjector |
| How it is given | 1.75 mg under the skin of the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity |
| Limit per day | "Do not administer more than one dose within 24 hours." |
| Limit per month | "More than 8 doses per month is not recommended." |
| When to stop | Discontinue after 8 weeks if there is no improvement |
| Do not use with | Uncontrolled high blood pressure or known cardiovascular disease |
| Storage | At or below 25 °C; do not freeze; protect from light |
The calculator above reproduces the autoinjector: 1.75 mg in 0.3 mL is 5.833 mg/mL, and the full 0.3 mL equals 30 units on a U-100 scale. One unit of that solution would hold 58.3 mcg. These are arithmetic checks; the autoinjector delivers its fixed dose without any measuring.[2]
What the trials showed
The label reports two identical 24-week phase 3 trials, known as RECONNECT, with 1,267 women randomized. Participants used 1.75 mg as needed, and the trials allowed up to 12 doses a month.[3][2]
| Measure | Result |
|---|---|
| Desire score (FSFI-D) | +0.30 and +0.42 more than placebo in the two trials[3] |
| Distress about low desire | −0.37 and −0.29 versus placebo |
| Number of satisfying sexual events | Not different from placebo[2] |
PT-141 side effects on the Vyleesi label
Nausea is the main side effect: 40% of women on bremelanotide had it, against 1.3% on placebo, and 18% stopped treatment because of side effects.[2]
| Side effect | Bremelanotide | Placebo |
|---|---|---|
| Nausea | 40.0% | 1.3% |
| Flushing | 20.3% | 0.3% |
| Injection-site reactions | 13.2% | 8.4% |
| Headache | 11.3% | 1.9% |
| Vomiting | 4.8% | 0.2% |
18% stopped because of side effects, against 2% on placebo. Blood pressure rose briefly by up to 6/3 mmHg after a dose, and focal darkening of the skin occurred in 1%.[2] In the open-label extension, 272 of 684 women completed 52 weeks, with "no new safety signals".[4]
"Research" PT-141 and the FDA
In August 2026 the FDA sent warning letters to five online sellers that offered "PT-141" as a research peptide, treating it as an unapproved new drug.[7][8][9][10][11] PT-141 also has an entry on FDA Import Alert 66-41 for unapproved drugs.[12] Bremelanotide is not on the FDA's 503A compounding category lists, and we found no FDA statement on compounding it specifically.[5] A 2020 warning letter to a compounder, written before Vyleesi was approved, listed it as ineligible.[6]
What is PT-141? Molecule and sport
Bremelanotide is a cyclic 7-amino-acid melanocortin receptor agonist, Ac-Nle-cyclo(Asp-His-D-Phe-Arg-Trp-Lys)-OH, 1,025.2 g/mol.[2][14] The 1.75 mg dose is about 1,707 nmol. It is not named on the WADA 2026 Prohibited List.[13]
Other peptide pages
The peptides most often looked up alongside this one. Each page gives that peptide's FDA status, compounding status and published human evidence, with sources; the status table has all 23 in one place.
- SemaxNot approved ACTH-based heptapeptide. Intranasal studies only.
- SelankNot approved TP-7 heptapeptide. Never reviewed by the FDA committee.
- MT2 (melanotan II)Not approved Melanotan II. Never approved; FDA cites melanoma reports.
- DSIP (emideltide)Not approved Delta sleep-inducing peptide. Small IV studies, 1981–1998.
- BPC-157Not approved 15-amino-acid peptide. Human data: a few tiny, uncontrolled studies.
- TB-500Not approved A 7-amino-acid fragment of thymosin beta-4. No human trials of TB-500 itself.
Frequently asked questions
Is PT-141 the same as Vyleesi?
What is the dose of bremelanotide?
The Vyleesi label dose is 1.75 mg under the skin, as needed, at least 45 minutes before anticipated sexual activity, no more than once in 24 hours, with more than 8 doses a month not recommended.[2]
How many units is 1.75 mg of PT-141?
In the Vyleesi autoinjector, 1.75 mg is the whole 0.3 mL, which equals 30 units on a U-100 scale. The autoinjector delivers it without measuring.[2]
Is bremelanotide approved for men?
No. The label says Vyleesi is not indicated for men or for postmenopausal women.[2]
Sources
- Drugs@FDA: Vyleesi (bremelanotide), NDA 210557
- Vyleesi (bremelanotide) prescribing information
- Kingsberg SA et al. Bremelanotide for HSDD: two randomized phase 3 trials (Obstet Gynecol 2019;134:899–908)
- Simon JA et al. Long-term safety and efficacy of bremelanotide (open-label extension) (Obstet Gynecol 2019;134:909–17)
- Bulk drug substances nominated for use in compounding under section 503A (category lists)
- Warning letter: Tailor Made Compounding LLC
- Warning letter: Royal Peptides LLC
- Warning letter: NuScience Peptides LLC
- Warning letter: Peak Performance Peptides
- Warning letter: TXP Innovations LLC dba Tex Peptides
- Warning letter: Peptide Partners LLC
- Import Alert 66-41: unapproved new drugs promoted in the U.S.
- World Anti-Doping Code: Prohibited List 2026
- PubChem CID 9941379: bremelanotide