Reviewed & approved by Dr. Nova Reyes · Last checked 2026-10-15. ← Back to Evidence Library
PT-141 (bremelanotide): what the evidence says
At a glance
What it is: a lab-made 7-amino-acid ring-shaped peptide that switches on melanocortin receptors (molecular "locks" involved in skin color, appetite and sexual function) in the brain. "PT-141" was its development code. Under the name bremelanotide, it is the active ingredient of Vyleesi, an FDA-approved prescription autoinjector. Gray-market "PT-141" vials and nasal sprays are sold online for libido and sexual performance in men and women. R1, R2
What the evidence says: in two large trials in premenopausal women with HSDD, desire scores rose and distress fell slightly more than on placebo (a dummy treatment), while nausea and other side effects were common (see below). The number of satisfying sexual events did not improve. For men, the only placebo-controlled trial we found is under an editorial "expression of concern." R3, R4, R7, R8
Biggest risks: nausea (40% in the trials), flushing, headache, a short rise in blood pressure after every dose, and dark skin patches that may not fade, especially with frequent use. A gray-market vial is not Vyleesi. R2, R5
| Claim | Rating |
|---|---|
| Human Low sexual desire (HSDD) in premenopausal women: the approved use | Moderate: two phase 3 RCTs (1,247 women in the safety population); benefits statistically significant but small, and a secondary outcome (satisfying sexual events) showed no difference R2, R3, R6 |
| Human Erectile dysfunction / sexual function in men | Very limited: one placebo-controlled trial, now under an editorial expression of concern; a related trial by the same author was retracted R7, R8 |
| Unknown Postmenopausal women, "performance," tanning, other uses | No human data that we could find for these gray-market uses (nothing at all in published trials we reviewed). The only nasal-spray trial we found is the men's trial under an expression of concern. Caution [UNVERIFIED: not an exhaustive search for older phase 2 nasal studies] |
| Animal Animal evidence | Unknown Not reviewed for this page (human trial data take precedence) |
| Regulatory | FDA-approved (Vyleesi, premenopausal HSDD only) · not in any FDA 503A nomination category · WADA 2026: not named R1, R9, R10 |
| Established human dose | Only for the approved use, under prescription: see the FDA label in R2. Unknown No established dose for any other use |
Evidence verdict: HSDD in premenopausal women (approved use): Moderate · Men: Very limited · Postmenopausal women, performance, tanning and other uses: No human data Card verdict: Moderate (HSDD in premenopausal women, FDA-approved as Vyleesi) · Men: Very limited · Postmenopausal women, performance, tanning: No human data Card note: Varies by use, see page
This page reports what studies and the approved label used. It is not dosing advice.
Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source
What "No human data" means here: for the gray-market uses listed above, we found nothing at all in published human trials. We did not review animal studies for this page.
What is it?
Bremelanotide is a short ring-shaped peptide that activates melanocortin receptors, mainly one called MC4R in the brain. The FDA label says "the mechanism by which VYLEESI improves HSDD in women is unknown." It also activates MC1R on pigment cells, which is why it can darken skin. R2
The approved medicine: what the approval trials showed
This section covers only Vyleesi, used as labeled, in the people it was tested in.
Human RECONNECT (two identical phase 3 trials, 2015–2016): these were large studies confirming benefit and safety before approval. 1,267 premenopausal women with HSDD were randomized to bremelanotide or placebo (a dummy treatment) for 24 weeks, used as needed before sexual activity. R3 - Desire score (FSFI-desire, a questionnaire scale) rose by 0.35 points more than placebo, pooled across both trials. - Distress about low desire fell by 0.33 points more than placebo. - The number of satisfying sexual events did not differ from placebo. R2, R3 - An independent re-analysis found that 8 of 11 registered efficacy outcomes (the results the trials said in advance they would measure) had not been published, that effect sizes on those ranged "from nil to small," and that the questionnaires have limited validation in women with HSDD. R6 - A score change on a questionnaire is not the same as a better sex life. The trial measured feelings of desire and distress, not relationships or wellbeing.
Human 52-week open-label extension: no new safety signals were reported. Scores stayed improved, but there was no placebo group to compare against. R4
Who paid: both phase 3 trials and the extension were funded by Palatin Technologies and AMAG Pharmaceuticals, the companies developing and selling the drug. Several authors were company employees. R3, R4, R5
Does it work for other uses?
- Human Men: one 2008 randomized trial (342 men who didn't respond to sildenafil/Viagra; nasal spray) reported benefit, but the journal issued an expression of concern about it in January 2023. A 2008 trial in women by the same author was retracted by the Journal of Sexual Medicine after he did not provide his original data. We don't treat either as reliable evidence. R7, R8
- Unknown Postmenopausal women, "performance," tanning, nasal sprays: we found no published trial supporting these uses. The FDA label says it is not for postmenopausal women or men, and not for enhancing sexual performance. R2
Is it safe?
From the FDA label and the companies' pooled safety review (approved product, used as labeled): - Human Nausea: 40% on bremelanotide vs 1.3% on placebo; 13% needed anti-nausea medicine. It was worst after the first dose. R2, R5 - Human Flushing 20% vs under 1%; headache 11% vs 2%; injection site reactions 13.2% vs 8.4%. R2, R5 - Caution Blood pressure: after each dose, blood pressure rose (up to 6 mmHg systolic) and heart rate fell, usually back to normal within 12 hours. The label says not to use it with uncontrolled high blood pressure or known heart disease. R2 - Caution Dark skin patches (focal hyperpigmentation) of the face, gums and breasts: 1% in the phase 3 trials, but 38% in another study with more frequent use (see study table). More likely with darker skin. Some patches didn't fade after stopping. R2 - Caution Liver: one case of acute hepatitis (liver inflammation) in the open-label extension. The label says the drug's role "could not definitively be excluded." R2 - Caution Drug interactions: it may slow stomach emptying and lower blood levels of oral medicines, including naltrexone used for alcohol or opioid addiction. R2 - Caution Pregnancy: the label advises effective contraception and stopping if pregnancy is suspected (fetal harm in animal studies). R2 - Stopping because of side effects: 18% on bremelanotide vs 2% on placebo, mostly nausea (8%). R2 - Serious adverse events (problems reported after use, which may or may not have been caused by the drug): 1.1% vs 0.5% on placebo. R2
Its half-life (the time it takes for half of the drug to be cleared from the body) is about 2.7 hours. R2
What we don't know
- Unknown Whether it helps men, postmenopausal women, or people without HSDD
- Unknown Safety of frequent or daily use outside the label's limits (the label warns this raises the risk of skin darkening)
- Unknown Anything about gray-market nasal sprays (the only nasal trial is under an expression of concern)
Is it legal?
- FDA / elsewhere: Vyleesi (NDA 210557) was approved June 21, 2019 and is a prescription drug (current holder: Cosette). Not in the EMA's list of centrally authorised medicines (checked Oct 15, 2026). Caution [UNVERIFIED: Russia, China and Japan registries not searched directly] R1, R2
- Compounding: bremelanotide is the active ingredient of an approved drug. It does not appear in any category of FDA's 503A nominations list (updated May 14, 2026). Pharmacies generally may not make copies of an approved drug. Caution [UNVERIFIED: our reading of the "essentially a copy" rule; no FDA statement specific to bremelanotide checked] R9
- Athletes: bremelanotide is not named on WADA's 2026 Prohibited List. Because it is approved in the US, the S0 "non-approved substances" catch-all likely does not apply. Unknown This is our reading, not a WADA ruling. R10
What's in the vial?
Vyleesi is made under FDA oversight, with identity, strength and sterility controls. A gray-market "PT-141" vial is not the approved product. It has no quality control and no guarantee of identity. It could contain the wrong compound, the wrong amount, impurities or bacterial toxins, or be fake (counterfeit). The Vyleesi trial results above don't transfer to it. We test retail vials blind under the Open Peptide Standard. See results at /tests/. A passing test covers one batch, tested on one date. It does not mean the compound itself is safe.
What do users report?
Self-report, not evidence.
Unknown TBD. We'll only list this once we can cite a public source.
Study details
R3–R8 Human Human studies
| Study | People | Route | Dose used (study arm, not a recommendation) | Follow-up | Reported | Limitations | Citation |
|---|---|---|---|---|---|---|---|
| Kingsberg 2019, RECONNECT studies 301 + 302 | 1,267 randomized premenopausal women with HSDD (1,247 safety; 1,202 efficacy) | Subcutaneous autoinjector, as needed | 1.75 mg | 24 wk | FSFI-desire +0.35 vs placebo; FSDS-DAO item 13 −0.33 vs placebo; no difference in satisfying sexual events | Industry-funded; small effects; 85.6% white, 96.6% US sites | PMID 31599840 |
| Simon 2019, open-label extension | Women continuing from RECONNECT | Subcutaneous, as needed | 1.75 mg | 52 wk | No new safety signals; scores maintained | No placebo; completers only | PMID 31599847 |
| Clayton 2022, integrated safety | 3,500 people across 43 studies; 1,247 in phase 3 double-blind | Subcutaneous | Various | Up to 18 mo | Nausea 40.0% vs 1.3%; flushing 20.3% vs 1.3%; headache 11.3% vs 1.9% | Company-authored pooled review | PMID 35147466 |
| Spielmans 2024, independent re-analysis | RECONNECT data | n/a | n/a | n/a | 8 of 11 registered efficacy outcomes previously unpublished; effects "nil to small" | Secondary analysis | PMID 36809187 |
| FDA label, hyperpigmentation data | Women in the phase 3 trials; participants in a separate clinical study (label) | Subcutaneous | Phase 3: up to 8 doses a month; separate study: 8 consecutive daily doses | Phase 3: 24 wk | Focal hyperpigmentation 1% (phase 3) vs 38% (separate study); some patches did not resolve | Label summary, not a full study report | R2 |
| Safarinejad 2008, men (sildenafil non-responders) | 342 randomized (172 drug, 170 placebo) | Intranasal | 10 mg | At least 16 attempts | "Positive clinical results" 33.5% vs 8.5% (p=0.03); more drug-related side effects | Expression of concern (2023) | PMID 18206919; EoC PMID 36626345 |
| Safarinejad 2008, women with arousal disorder | — | Intranasal | — | — | Not reported here | Retracted (journal could not verify methods or results) | PMID 18179455 |
Dropouts: in the phase 3 trials, 18% of people on bremelanotide vs 2% on placebo stopped because of side effects (label). In the integrated analysis, 70% of the bremelanotide group vs 87% of the placebo group went on to the open-label phase. R2, R5
R1, R2, R9, R10 Label and regulatory (as of Oct 15, 2026)
- R1 Drugs@FDA (openFDA query, Oct 15, 2026): NDA 210557, VYLEESI (bremelanotide acetate) autoinjector, original approval June 21, 2019 (Type 1, new molecular entity), marketing status Prescription, sponsor Cosette. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210557
- R2 FDA label (DailyMed; SPL effective Nov 13, 2025; label text checked Oct 15, 2026): indication, limitations of use, warnings 5.1–5.3, adverse reactions, drug interactions, half-life quoted above. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf
- R9 FDA 503A nominations list (updated May 14, 2026; no entry for bremelanotide): https://www.fda.gov/media/94155/download
- R10 WADA 2026 Prohibited List (official PDF text, saved copy; bremelanotide not named). https://www.wada-ama.org/en/resources/world-anti-doping-code-and-international-standards/prohibited-list
Full reference list (PMIDs verified on PubMed, Oct 15, 2026)
- R3 Kingsberg SA, et al. Obstet Gynecol. 2019;134(5):899-908. doi:10.1097/AOG.0000000000003500. PMID 31599840. Funded by Palatin Technologies and AMAG Pharmaceuticals.
- R4 Simon JA, et al. Obstet Gynecol. 2019;134(5):909-917. doi:10.1097/AOG.0000000000003514. PMID 31599847. Funded by Palatin and AMAG.
- R5 Clayton AH, et al. J Womens Health. 2022;31(2):171-182. doi:10.1089/jwh.2021.0191. PMID 35147466. Authors include AMAG and Palatin employees.
- R6 Spielmans GI, Ellefson EM. J Sex Res. 2024;61(4):540-561. doi:10.1080/00224499.2023.2175192. PMID 36809187.
- R7 Safarinejad MR, et al. J Urol. 2008;179(3):1066-71. doi:10.1016/j.juro.2007.10.063. PMID 18206919; Expression of Concern, J Urol, Jan 10, 2023, doi:10.1097/JU.0000000000003117, PMID 36626345.
- R8 Safarinejad MR. J Sex Med. 2008;5(4):887-897. doi:10.1111/j.1743-6109.2007.00698.x. PMID 18179455 (RETRACTED at the Editor-in-Chief's request; retraction notice on the article record).
Disclaimer
This page is for education and harm reduction. It is not medical advice and not a recommendation to use bremelanotide outside a prescription. Its safety is established only for its approved use, under medical supervision. Please talk to a clinician you trust, especially if you have high blood pressure or heart disease, take naltrexone, are pregnant or could become pregnant, or are a tested athlete. Seek care right away for a serious reaction, and report it to FDA MedWatch (https://www.fda.gov/safety/medwatch).