PT-141 (Bremelanotide)
Also sold as: PT-141, Bremelanotide, Bremelanotide acetate, Vyleesi, PT 141
PT-141 (bremelanotide) is an FDA-approved prescription drug — VYLEESI, NDA 210557, approved 21 June 2019, and shown on Drugs@FDA with marketing status 'Prescription' — but solely for premenopausal women with acquired, generalized hypoactive sexual desire disorder, and its FDA label states verbatim that it is 'not indicated for the treatment of HSDD in postmenopausal women or in men' and 'not indicated to enhance sexual performance'. In the two pivotal Phase 3 trials behind that approval, FDA reports no significant difference between VYLEESI and placebo in the number of satisfying sexual events, a secondary endpoint; the two co-primary endpoints that did separate from placebo were both questionnaires — self-rated sexual desire and self-rated distress about low desire — and nausea was reported in 40% of VYLEESI-treated patients versus 1% on placebo.
Which molecule this is. Per the FDA label's Description section: bremelanotide acetate is a synthetic, cyclic heptapeptide, Ac-Nle-cyclo-(Asp-His-D-Phe-Arg-Trp-Lys-OH), molecular weight 1025.2 (free base). It is a melanocortin receptor agonist that NONSELECTIVELY activates several receptor subtypes, in the label's stated order of potency: MC1R, MC4R, MC3R, MC5R, MC2R. That nonselectivity is not trivia — MC1R is expressed on melanocytes, and the label draws the causal line itself: binding there 'leads to melanin expression and increased pigmentation'. The hyperpigmentation signal below is the mechanism working as designed, not an idiosyncratic reaction. The label does not describe bremelanotide as a metabolite or derivative of melanotan II; that widely repeated lineage claim is not sourced here because it was not verified against a primary document.
FDA status
FDA has approved this as a drug. Approval is always for a specific indication and a specific population — check which one, because it is frequently not the use it is marketed for.
FDA-approved. Approval is always for a specific indication and population — see the approval record below, because it is routinely not the use this is marketed for.
Evidence
Efficacy established by adequate, well-controlled trials in humans.
ADMINISTRATION CHECK PASSED, and passed decisively — this is the rare record where it does. Both pivotal trials are interventional studies in which bremelanotide was self-administered by subcutaneous injection against placebo. Neither measures an endogenous peptide as a biomarker, which is the failure mode that reduces MOTS-c's and TB-500's apparent human trial counts to zero. Both were checked against the ClinicalTrials.gov v2 API on 2026-07-16: NCT02333071 (n=723 actual) and NCT02338960 (n=714 actual), lead sponsor Palatin Technologies, both COMPLETED with results posted. None of the contamination markers in this vertical are present — not the single research-peptide vendor sponsor, not the Feb-2026 start, not the perpetual RECRUITING status, not the zero-results registrations. THE TIER IS EARNED, AND IT IS ALSO NARROW. Scope: efficacy is established for premenopausal women with acquired, generalized HSDD and for nothing else. There is no tier here for men, for postmenopausal women, or for sexual performance — the label excludes all three, and absence of an approved indication is not evidence of efficacy awaiting discovery. Magnitude: in FDA's own Clinical Studies section, the co-primary FSFI-Desire endpoint (scale 1.2-6.0) improved by a mean of 0.5 vs 0.2 for placebo in Study 1 and 0.6 vs 0.2 in Study 2 — a placebo-subtracted difference of roughly 0.3-0.4 points on a 4.8-point scale. Statistically significant (p=0.0002 and p<0.0001, unadjusted Wilcoxon rank-sum) and small. 'Proven in humans' here means 'beat placebo on a questionnaire by a modest margin in two adequate trials', which is what drug approval means and is less than what the word 'proven' is doing in vendor copy.
What FDA actually approved
- Application
- NDA 210557 — VYLEESI
- Approved indication
- VYLEESI is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to: A co-existing medical or psychiatric condition, Problems with the relationship, or The effects of a medication or drug substance.
The Limitations of Use are the whole record. PT-141 is sold as a general libido or sexual-performance compound, to men as readily as to women; the label forecloses every part of that in two lines, and has done so since the day of approval — the 2019 original label and the current SPL carry identical wording, checked line-by-line on 2026-07-16. 'Acquired, generalized' is also load-bearing and is defined on the label: acquired means HSDD that developed in a patient who previously had no problems with sexual desire; generalized means it occurs regardless of the type of stimulation, situation or partner. A vendor citing 'FDA-approved' for a male customer, or for performance, is citing an approval whose own text excludes that customer and that use. discontinued: false is a live check, not an assumption — the current SPL (effective 2025-11-13) lists Cosette Pharmaceuticals as manufacturer, and Drugs@FDA still shows marketing status 'Prescription'. The application has changed hands since approval; secondary sources still naming AMAG or Palatin as the current sponsor are stale.
“Limitations of Use: VYLEESI is not indicated for the treatment of HSDD in postmenopausal women or in men. VYLEESI is not indicated to enhance sexual performance.”Checked against the source on .
What FDA found
FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.
FDA states on the approved label that the mechanism by which VYLEESI improves HSDD in women is unknown.
Approval establishes that a drug worked in trials, not that anyone knows why. This sits directly against the mechanistic storytelling the compound is marketed with — an approved drug whose own label declines to claim a mechanism is a poor foundation for a vendor's mechanistic extrapolation to populations and uses the label excludes.
VYLEESI (bremelanotide) injection — Highlights of Prescribing Information, original approval — FDA, 21 June 2019“The mechanism by which VYLEESI improves HSDD in women is unknown.”
Checked against the source on .FDA reports on the approved label that the two pivotal Phase 3 trials found no significant difference between VYLEESI and placebo in the number of satisfying sexual events.
THE MOST CITABLE SENTENCE ON THIS RECORD, and the one the compound's marketing cannot survive. PT-141 is sold on the promise of more and better sex. In the trials that won the approval that marketing invokes, the endpoint that counts sexual events did not separate from placebo. What did separate were two questionnaire endpoints — self-rated desire and self-rated distress about low desire. That is the approved effect: patients reported wanting sex more and being less bothered by not wanting it, without the trial detecting more satisfying sex. Re-verified verbatim against the current SPL via the openFDA label API on 2026-07-16 (effective_time 20251113); the sentence is unchanged since approval. It is a secondary endpoint and a null result on one is not proof of absence — but it is FDA's own reported result on the outcome the customer is actually buying, and no vendor citing 'FDA-approved' will ever reproduce it.
VYLEESI (bremelanotide) injection — Highlights of Prescribing Information, original approval — FDA, 21 June 2019“There was no significant difference between treatment groups in the change from baseline to end of study visit in the number of satisfying sexual events (SSEs), a secondary endpoint.”
Checked against the source on .FDA reports on the approved label that in both pivotal trials VYLEESI showed a statistically significant increase in the FSFI Desire Domain score and a statistically significant decrease in the FSDS-DAO Q13 score — the two co-primary endpoints, both patient questionnaires — from baseline to the end-of-study visit compared to placebo.
This is the positive finding, recorded as carefully as the negative one above it, and it is what the approval rests on. Read the endpoints for what the label says they are. FSFI-Desire is two questions — the label quotes them: 'Over the past 4 weeks, how often did you feel sexual desire or interest?' and a rating of the level of that desire. FSDS-DAO Q13 is one question: 'How often did you feel: Bothered by low sexual desire?' So both co-primary endpoints are self-report about desire, and the endpoint that counted sexual events did not separate (see the finding above). That is not a criticism of the trials — HSDD is a disorder of desire and distress, so measuring desire and distress is the correct design. It is a caution against reading 'two positive Phase 3 trials' as evidence of anything a customer buying a sexual-performance compound is trying to buy.
VYLEESI (bremelanotide) injection — Highlights of Prescribing Information, original approval — FDA, 21 June 2019“In both studies, VYLEESI showed a statistically significant increase in the FSFI Desire Domain score and a statistically significant decrease in the FSDS-DAO Q13 score from baseline to the EOS visit compared to placebo.”
Checked against the source on .Drugs@FDA shows NDA 210557 with original submission ORIG-1 approved 21 June 2019, sponsor Cosette, and VYLEESI (autoinjector) with marketing status 'Prescription'.
Recorded as its own finding rather than asserted inside a note, because two facts this record leans on are not in the label and cannot be: that the product is still marketed, and that the application now sits with Cosette Pharmaceuticals rather than the AMAG or Palatin sponsors the secondary corpus still names. The query returns exactly one result — there is no second bremelanotide application, and no generic. 'Prescription' is the whole of the drug's lawful supply route: every unit lawfully in the United States is dispensed by a pharmacy against a prescription for this one product. Re-run the URL to re-verify; it is a live query, not a PDF.
Drugs@FDA — approved drug products database, queried for bremelanotide (openFDA) — FDA, 16 July 2026“"application_number": "NDA210557", "sponsor_name": "COSETTE" … "brand_name": "VYLEESI (AUTOINJECTOR)" … "marketing_status": "Prescription"”
Checked against the source on .FDA reports that 40% of VYLEESI patients prematurely discontinued the 24-week double-blind period in Study 1 versus 13% on placebo, and 39% versus 25% in Study 2.
Read this against the effect size in `evidence`. Four in ten participants on drug did not finish the trial — three times the placebo rate in Study 1 — and FDA says so while explaining why an extra analysis was needed. Differential dropout of that magnitude, concentrated in the treated arm and driven substantially by tolerability (18% discontinued for adverse reactions vs 2% on placebo, see safetySignals), is a known source of bias in the surviving completers' self-reported scores. FDA approved the drug on these trials, so this is not an argument that the result is invalid. It is the texture that 'two positive Phase 3 trials' erases. Confirmed present verbatim in the current SPL (openFDA label API, 2026-07-16).
VYLEESI (bremelanotide) injection — Highlights of Prescribing Information, original approval — FDA, 21 June 2019“Because a greater percentage of MITT patients in the VYLEESI group prematurely discontinued the 24-week double-blind treatment period compared to placebo patients (40% vs. 13% for Study 1 and 39% vs. 25% for Study 2), an exploratory analysis was performed examining the percentages of patients who were able to complete the treatment period and improved from baseline.”
Checked against the source on .The label directs patients to avoid using VYLEESI with an orally administered naltrexone-containing product intended to treat alcohol or opioid addiction, citing the severe consequence of naltrexone treatment failure.
A documented interaction in which the failure mode is not a side effect of bremelanotide but the silent failure of a different, load-bearing drug — one whose failure means relapse. It is here because it is the interaction least likely to be caught outside a prescription: the label surfaces it in Highlights, and a person buying a research chemical has no prescriber cross-checking their naltrexone. Still present in the current SPL's Drug Interactions section (openFDA label API, 2026-07-16).
VYLEESI (bremelanotide) injection — Highlights of Prescribing Information, original approval — FDA, 21 June 2019“As VYLEESI may significantly decrease the systemic exposure of orally-administered naltrexone, patients should avoid using VYLEESI with an orally administered naltrexone-containing product that is intended to treat alcohol and opioid addiction due to the severe consequence of naltrexone treatment failure.”
Checked against the source on .FDA states on the label that the safety and effectiveness of VYLEESI have not been established in pediatric patients or in geriatric patients.
The label carries the identical sentence for geriatric patients. Together with the Limitations of Use, the population in which anything is established narrows to exactly one: premenopausal adult women with acquired, generalized HSDD. Everyone else buying this compound is outside the evidence base, not merely outside the marketing approval.
VYLEESI (bremelanotide) injection — Highlights of Prescribing Information, original approval — FDA, 21 June 2019“The safety and effectiveness of VYLEESI have not been established in pediatric patients.”
Checked against the source on .Bremelanotide appears nowhere in Categories 1, 2 or 3 of FDA's 503A bulk drug substances list (updated 2026-05-14).
READ THIS ABSENCE THE OPPOSITE WAY FROM BPC-157's. Verified by fetching and text-extracting the document directly on 2026-07-16 (Category 2 contains exactly six substances, and bremelanotide is not among them). For BPC-157, absence means the nominations were withdrawn. For bremelanotide, absence means the 503A nomination pathway was never the relevant one: that pathway exists for bulk substances that are NOT components of approved drugs, and bremelanotide is the active ingredient of an approved drug. Mapping 'not on the list' to withdrawn-from-nomination or never-nominated here would be mechanically consistent and completely wrong. This record does NOT adjudicate whether bremelanotide may lawfully be compounded — that turns on other 503A conditions, including the restriction on compounding drugs that are essentially copies of commercially available approved products, which we have not verified and therefore do not assert.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on .
Documented safety signals
Nausea was reported in 40% of VYLEESI-treated patients in the pooled Phase 3 placebo-controlled trials versus 1% on placebo, requiring anti-emetic therapy in 13% and causing 8% to discontinue.
The overall discontinuation rate due to adverse reactions was 18% on VYLEESI versus 2% on placebo. Roughly one in five trial participants stopped because of how the drug made them feel — in a trial population that had been screened and consented. The 2019 label's guidance on this is to consider discontinuing VYLEESI for persistent or severe nausea, or initiating anti-emetic therapy for patients who are bothered by nausea but wish to continue.
VYLEESI (bremelanotide) injection — Highlights of Prescribing Information, original approval — FDA, 21 June 2019“In the phase 3 placebo-controlled trials, nausea was the most commonly reported adverse reaction, reported in 40% of VYLEESI-treated patients, requiring anti-emetic therapy in 13% of VYLEESI-treated patients and leading to premature discontinuation from the trials for 8% of VYLEESI-treated patients.”
Checked against the source on .A Phase 4 study reported that pre-treatment with oral ondansetron did not reduce the incidence of nausea associated with VYLEESI, and the current label states such pre-treatment is not recommended.
This finding is cited to the CURRENT SPL, not to the 2019 approval label: the Phase 4 study postdates the 2019 label, and the word 'ondansetron' does not appear anywhere in that document (checked by extracting all 19 pages on 2026-07-16). We do not characterise the study as a postmarketing requirement or commitment — the approval letter's only 505(o) requirements are two pregnancy registry studies, and it never mentions ondansetron. Who asked for the study is not something we can source, so we do not say. The intuitive workaround was tested and failed. Note the distinction the label preserves and that summaries tend to flatten: what is not recommended is ondansetron PRE-treatment. The label states separately that treatment with ondansetron after VYLEESI administration, or after the onset of nausea, has not been formally studied — that is an absence of evidence, not a finding either way.
VYLEESI (bremelanotide) injection, solution — Prescribing Information (current SPL) — DailyMed (U.S. National Library of Medicine), 13 November 2025“In a phase 4, single-dose, placebo-controlled clinical study, pre-treatment with oral ondansetron (a 5-HT3 receptor antagonist) did not reduce the incidence of nausea associated with VYLEESI treatment. In this study, 228 healthy women were randomized (1:1) … Therefore, pre-treatment with oral ondansetron … does not reduce the incidence of VYLEESI-associated nausea and is not recommended.”
Checked against the source on .Focal hyperpigmentation — including of the face, gingiva and breasts — was reported in 1% of Phase 3 patients receiving up to eight doses per month, versus no placebo patients. In a separate study, 38% developed focal hyperpigmentation after daily use for eight days.
The frequency gradient is the point, and it is the signal most likely to be understated for grey-market users. At the labeled intermittent frequency the rate is 1%; with daily use it was 38%, with a further 14% developing new pigmentary changes on continued daily use. FDA states that patients with dark skin were more likely to develop it and that resolution after stopping was not confirmed in all patients — meaning a potentially permanent cosmetic effect. This is mechanistically expected from MC1R agonism (see moleculeNote), not a surprise, and anyone using the compound more frequently than the label contemplates is sitting on the wrong end of that gradient.
VYLEESI (bremelanotide) injection — Highlights of Prescribing Information, original approval — FDA, 21 June 2019“Resolution of the focal hyperpigmentation was not confirmed in all patients after discontinuation of VYLEESI.”
Checked against the source on .VYLEESI transiently increases blood pressure and reduces heart rate after each dose, and is CONTRAINDICATED in patients with uncontrolled hypertension or known cardiovascular disease.
Reported maximal increases were 6 mmHg systolic and 3 mmHg diastolic, peaking 2-4 hours post-dose with a corresponding heart-rate reduction of up to 5 bpm, usually resolving within 12 hours. The magnitude is modest; the contraindication is not conditional. The label also states VYLEESI is not recommended in patients at high risk for cardiovascular disease. A contraindication presupposes a prescriber who screened for it — that screening step is precisely what is absent when the compound is bought as a research chemical, which makes this the signal that translates worst to grey-market use.
VYLEESI (bremelanotide) injection — Highlights of Prescribing Information, original approval — FDA, 21 June 2019“VYLEESI is contraindicated in patients who have uncontrolled hypertension or known cardiovascular disease.”
Checked against the source on .One patient in the Phase 3 trials experienced a serious headache event: intractable pain leading to hospitalization.
Headache occurred in 11% of VYLEESI patients versus 2% on placebo. Serious adverse reactions overall were reported in 1.1% of VYLEESI-treated patients versus 0.5% on placebo.
VYLEESI (bremelanotide) injection — Highlights of Prescribing Information, original approval — FDA, 21 June 2019Checked against the source on .
Questions people actually ask
Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.
- Is PT-141 FDA-approved?
Yes, but not for what it is sold for. PT-141 (bremelanotide) is approved by FDA as VYLEESI under NDA 210557, approved 21 June 2019, and only for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). The approved label's Limitations of Use state: 'VYLEESI is not indicated for the treatment of HSDD in postmenopausal women or in men. VYLEESI is not indicated to enhance sexual performance.' That wording has been on the label since the day of approval and is identical in the current prescribing information effective 13 November 2025. A seller invoking 'FDA-approved' to a male customer, or for sexual performance, is invoking an approval whose own text excludes that customer and that use.
VYLEESI (bremelanotide) injection, solution — Prescribing Information (current SPL) — DailyMed (U.S. National Library of Medicine), 13 November 2025“Limitations of Use: VYLEESI is not indicated for the treatment of HSDD in postmenopausal women or in men. VYLEESI is not indicated to enhance sexual performance.”
Checked against the source on .- Does PT-141 work for men?
FDA has not approved PT-141 (bremelanotide) for use in men, and the approved VYLEESI label states explicitly that it 'is not indicated for the treatment of HSDD in postmenopausal women or in men' and 'is not indicated to enhance sexual performance'. The only population in which FDA has found bremelanotide's efficacy established is premenopausal women with acquired, generalized hypoactive sexual desire disorder; the label separately states that safety and effectiveness have not been established in pediatric or in geriatric patients. Both pivotal Phase 3 trials enrolled premenopausal women only. The absence of an approved male indication is not evidence that the compound works in men and awaits paperwork — it means no such use has been demonstrated to FDA.
VYLEESI (bremelanotide) injection — Highlights of Prescribing Information, original approval — FDA, 21 June 2019“VYLEESI is not for the treatment of HSDD in women who have gone through menopause or in men.”
Checked against the source on .- Is there any human evidence that PT-141 works?
Yes — and it is real, narrow, and smaller than the marketing implies. FDA approved PT-141 (bremelanotide) on what its label describes as 'two identical, Phase 3, randomized, double-blind, placebo-controlled trials: NCT02333071 and NCT02338960', in premenopausal women with acquired, generalized hypoactive sexual desire disorder, in which the compound was actually administered by subcutaneous injection rather than merely measured. On FDA's own reported results, the co-primary FSFI-Desire score (scale 1.2 to 6.0) improved by a mean of 0.5 versus 0.2 for placebo in Study 1 and 0.6 versus 0.2 in Study 2 — a placebo-subtracted difference of roughly 0.3 to 0.4 points on a 4.8-point questionnaire, statistically significant and small. FDA also reports that there was no significant difference between VYLEESI and placebo in the number of satisfying sexual events, a secondary endpoint. The demonstrated effect is on self-rated desire and distress, not on how much satisfying sex participants had.
VYLEESI (bremelanotide) injection — Highlights of Prescribing Information, original approval — FDA, 21 June 2019“There was no significant difference between treatment groups in the change from baseline to end of study visit in the number of satisfying sexual events (SSEs), a secondary endpoint.”
Checked against the source on .- Is PT-141 safe?
PT-141 (bremelanotide) has documented harms serious enough that FDA contraindicates it outright in some patients: the approved VYLEESI label states it 'is contraindicated in patients who have uncontrolled hypertension or known cardiovascular disease', because each dose transiently raises blood pressure and lowers heart rate. In the Phase 3 trials FDA reports nausea in 40% of VYLEESI-treated patients versus 1% on placebo, requiring anti-emetic therapy in 13% and causing 8% to stop; 18% discontinued for adverse reactions overall versus 2% on placebo. Focal hyperpigmentation — including of the face, gingiva and breasts — occurred in 1% at the label's intermittent frequency but in 38% of subjects in a study using the drug daily for eight days, and FDA states that 'Resolution of the focal hyperpigmentation was not confirmed in all patients after discontinuation of VYLEESI', meaning the skin change may be permanent. A contraindication only protects a patient whose prescriber screened for it, which nobody does when the compound is bought as a research chemical.
VYLEESI (bremelanotide) injection — Highlights of Prescribing Information, original approval — FDA, 21 June 2019“VYLEESI is contraindicated in patients who have uncontrolled hypertension or known cardiovascular disease.”
Checked against the source on .- Is PT-141 legal in 2026?
PT-141 (bremelanotide) is lawful in the United States in exactly one form: VYLEESI, a prescription drug approved under NDA 210557, which Drugs@FDA shows as of 16 July 2026 with sponsor Cosette and marketing status 'Prescription' — the query returns one application and no generic. Being an approved prescription drug is not the same as being generally legal to sell or buy. The approval attaches to that specific product, made by that manufacturer, dispensed by a pharmacy against a prescription. 'FDA-approved' is a fact about VYLEESI; it is not a fact about bremelanotide powder sold as a research chemical, which is a different product with no approval of its own, and it says nothing about whether a given sale of one is lawful.
Drugs@FDA — approved drug products database, queried for bremelanotide (openFDA) — FDA, 16 July 2026“"application_number": "NDA210557", "sponsor_name": "COSETTE" … "marketing_status": "Prescription"”
Checked against the source on .- Is bremelanotide on FDA's 503A bulk drug substances list?
No. Bremelanotide appears in no category — 1, 2 or 3 — of FDA's 503A bulk drug substances list, updated 14 May 2026 and text-extracted directly on 16 July 2026. For bremelanotide that absence means something different from what it means for the unapproved peptides on this site, and reading it the same way would be mechanically consistent and completely wrong. The 503A nomination pathway exists for bulk substances that are NOT components of FDA-approved drugs; bremelanotide is the active ingredient of an approved drug, so that pathway was never the relevant one for it. Absence here is not withdrawal, not rejection, and not a safety finding. This record does not adjudicate whether bremelanotide may lawfully be compounded — that turns on other 503A conditions, including the restriction on compounding drugs that are essentially copies of a commercially available approved product, which we have not verified and therefore do not assert.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on .