myPeptides
English

All content is for general information only — not medical advice, not a dosing or usage recommendation, and not a claim of efficacy. Many substances are not approved as medicines or are prescription-only; whether possession and use are legal depends on the law of your country of residence and is your own responsibility. myPeptides does not sell or supply any substances — it is an information and organization tool. For health questions, consult a licensed physician or pharmacist.

PT-141: what the trials show, status and safety

Status at a glance

MarketStatusDate
United StatesApproved, prescription only2019-06-21
European UnionNot approved—
GermanyNot approved—
United KingdomNot approved—
AustraliaNot established—
CanadaNot approved—
SwitzerlandNot approved—
Development stage
Approved
Strongest evidence
Phase 3 randomised trial
WADA status
Not listed
Last verified
2026-09-17
Version
1.0

This page lists no doses.

PT-141: what the trials show, status and safety

Summary

PT-141, known by its international name bremelanotide, is a melanocortin receptor agonist approved in the United States in 2019 for premenopausal women with distressing low sexual desire. It is licensed nowhere else, and the European Union has never granted or even been asked for an approval. The two approval trials met their targets with a gain of about a third of a point on a six-point desire scale, while dropout for side effects was roughly twelve times higher than on placebo.

Key findings at a glance

  • The gain over placebo was 0.35 points on a scale from 1.2 to 6.0. Across the two phase 3 trials the difference in desire score was 0.30 points in one and 0.42 in the other, both at p < 0.001. The scale spans 4.8 points, so the gain amounts to about a fourteenth of its width [1].
  • Dropout for side effects was about twelve times more likely than on placebo. An independent re-analysis of the submission files put the odds ratio at 11.98 (95 per cent confidence interval 3.74 to 38.37). That is one extra dropout for every six women treated [2].
  • Asked to choose, women preferred placebo. Measured by who finished the trial and entered the voluntary extension, the odds favoured the placebo group at 0.30 (95 per cent confidence interval 0.24 to 0.38). That is one extra unfavourable outcome for every four women treated [2].
  • The most intuitive outcome did not move. A review of the regulator's files found no additional sexual event experienced as satisfying, on average [3].
  • Nausea affected roughly four women in ten. 40.0 per cent against 1.3 per cent on placebo in the approval trials, and 40.4 per cent over 52 weeks of open use [4], [5].
  • One approval exists worldwide, in the United States. Granted 21 June 2019 under NDA 210557, prescription-only, and still actively marketed [6].
  • There was never a European approval, and never a withdrawn application. Four independent register checks on 17 September 2026 returned nothing, each with control substances found in the same file [7], [8], [9], [10].
  • The grey market is documented, not theoretical. An American warning letter names the substance, several firms have registered it as a bulk ingredient, and forensic chemists found it in police-seized material [11], [12], [13].

What it is

PT-141 is a cyclic heptapeptide: a chain of seven amino-acid building blocks closed into a ring. It was designed as a synthetic copy of alpha-melanocyte-stimulating hormone (alpha-MSH), a body signal involved in pigmentation and in several brain functions [1], [14].

Two details of the design matter: the ring is closed by a bridge between two side chains, and one building block sits in its mirror-image form. Both make the molecule far harder for the body's peptide-splitting enzymes to break down than an ordinary peptide would be [14], [15].

Palatin Technologies in New Jersey developed it and gave it the code PT-141; AMAG Pharmaceuticals later took North American rights and filed the American application. The licensed product is sold in the United States as VYLEESI, now by Cosette Pharmaceuticals [6], [16].

Quick facts

FieldValueRef
International nameBremelanotide[15]
Development codePT-141, also written PT 141 and PT141[15]
ClassMelanocortin receptor agonist; synthetic analogue of alpha-MSH[1]
StructureCyclic heptapeptide, ring closed by a side-chain bridge, acetylated at one end[1], [15]
SequenceAc-Nle-cycloAsp-His-D-Phe-Arg-Trp-Lys-OH[1]
Formula and massC50H68N14O10, 1025.2 g/mol, free base[1], [15]
Half-lifeAbout 2.7 hours, range 1.9 to 4.0 hours[1]
Time to peak levelAbout 1.0 hour, range 0.5 to 1.0 hours[1]
BioavailabilityAbout 100 per cent after injection under the skin[1]
Route in trialsSubcutaneous injection; intranasal in the earliest programme[1], [17]
StatusApproved and prescription-only in the United States; unapproved elsewhere[6], [7]
Developed byPalatin Technologies, Cranbury, New Jersey[16]
CAS registry number189691-06-3, free base[15]
PubChem CID9941379[15]
UNII6Y24O4F92S[15]
InChIKeyFFHBJDQSGDNCIV-MFVUMRCOSA-N[15]
Other identifiersDrugBank DB11653, ChEMBL CHEMBL2070241, ChEBI 177849, KEGG D06569, Wikidata Q415353[15]

PT-141: what the trials show, status and safety

How it works

PT-141 switches on melanocortin receptors, a family of five docking points spread across pigment cells, nerve cells and the adrenal gland. It is not selective and activates several of them at once.

  • It hits all five subtypes, in a fixed order of strength. The American label gives the order as MC1R, MC4R, MC3R, MC5R, MC2R, and names the first two as the ones that matter therapeutically [1].
  • MC4R sits mainly in the brain. In animals the substance switched on nerve cells in the hypothalamus, a control centre for appetite, hormones and arousal, in a region traceably wired to the genital tissue [18].
  • MC1R explains the skin effect. This receptor drives pigment production, which is why repeated use darkens patches of skin [1].
  • The nearest chemical relative is Melanotan II. It shares the ring and differs at a single position — a chemical difference only, since the two sit in completely different legal worlds [19], [20].
  • Why it works for the licensed use is openly unknown. The label itself says the mechanism by which the substance improves the symptoms is not known — the manufacturer's own wording, not a critic's [1].
  • Nothing here is a sex hormone. It does not act on oestrogen, testosterone or their receptors, which sets it apart from hormonal approaches to the same complaint [1].

What the trials found

Ten trials are registered, run by five sponsors. Two identical phase 3 trials carried the approval, and the sharpest analyses of them came afterwards from people outside the manufacturer's chain [21].

Sexual desire, the approval endpoint

Phase 3 RCT The two RECONNECT trials randomised 1,267 premenopausal women with acquired, generalised low sexual desire that caused them distress. Both ran 24 weeks against placebo, and 1,202 of those women were counted in the efficacy analysis. Desire was measured on a questionnaire domain running from 1.2 to 6.0 points [1].

Both met the target: 0.30 points over placebo in study 301 and 0.42 in study 302, both at p < 0.001, and 0.35 combined. The registry figures for study 301 show treated women improving by 0.54 points (standard deviation 1.106) against 0.24 points (standard deviation 0.994) on placebo [1], [22].

Difference from placebo on the two approval endpoints
Desire, study 301
0.3 points
Desire, study 302
0.42 points
Desire, both trials combined
0.35 points
Distress, study 301
−0.37 points
Distress, study 302
−0.29 points
Distress, both trials combined
−0.33 points

RECONNECT studies 301 and 302, 1,267 premenopausal women randomised, 24 weeks. Desire is scored 1.2 to 6.0, where higher is more; distress is scored 0 to 4, where lower is less, so negative is the improvement. All values p < 0.001 except distress in study 302 (p = 0.005). Sources [1], [22].

Distress about low desire, the second approval endpoint

Phase 3 RCT Distress was measured on a single question scored from 0 to 4, where a fall is an improvement. It fell 0.37 points further than on placebo in study 301 (p < 0.001) and 0.29 points further in study 302 (p = 0.005), 0.33 points combined — again well under a tenth of the scale [1]. The registry figures for study 301 give the raw movement: -0.73 points (standard deviation 1.203) on the substance against -0.36 points (standard deviation 1.082) on placebo [22].

Satisfying sexual events, the endpoint that was dropped

Independent re-analysis This is the outcome a reader would find most tangible, and it is the one that went missing: it had been the main endpoint of the earlier dose-finding trial and was replaced for phase 3 by the two questionnaire scores [23]. A review of the American submission files put it bluntly, in the authors' own phrase delivering "bremelanotide to none": no additional sexual event experienced as satisfying, on average [3].

Phase 2b RCT The dose-finding trial in 612 women shows why. Over four weeks the number of such events rose by 0.2 on placebo (standard deviation 2.29) and by 0.6 at the lowest tested dose level (standard deviation 3.55).

The middle level gave 0.7 (standard deviation 1.81) and the highest 0.8 (standard deviation 2.86). The highest level beat placebo, and the test across all four groups was significant; the registry gives p < 0.05 for both [23].

That is a difference of roughly half an extra event in four weeks. A responder analysis of the same trial did find all seven of its defined response measures significant at the highest tested level (p ≤ 0.03) [24].

Dropout, preference and what was left unreported

Independent re-analysis The most consequential finding was published two years after the approval. Dropout because of side effects was far more common than on placebo: odds ratio 11.98, with a 95 per cent confidence interval from 3.74 to 38.37, or one extra woman dropping out for every six treated [2].

The same analysis used a blunter measure of preference: who completed the trial and chose to enter the voluntary open extension. On that measure the odds favoured placebo, at 0.30 with a confidence interval from 0.24 to 0.38, or one extra unfavourable outcome for every four women treated. Neither figure appeared in the main publication, and 72.72 per cent of the endpoints laid down in the trial plans were never reported at all [2].

The year-long extension

Open-label extension After the 24-week core phase, 856 women were eligible to continue without a placebo group; 684 entered and 272 finished, and attrition on that scale limits what the results can carry. Among those treated throughout, desire rose 1.25 to 1.30 points from baseline and distress fell 1.4 to 1.7 points; women switched over from placebo moved less, 0.70 to 0.77 points and about 0.9 points respectively [5].

Side effects rated as related to the substance were nausea in 40.4 per cent, flushing in 20.6 per cent and headache in 12.0 per cent [5].

Blood pressure and pulse

Phase 1 RCT A dedicated trial in 397 women with 24-hour ambulatory monitoring measured the cardiovascular effect. In the first four hours the systolic pressure rose 2.4 and 3.0 mmHg above placebo at the middle tested dose level (p = 0.029 and p = 0.076) and 3.1 and 3.2 mmHg at the highest (p = 0.006 and p = 0.027); peak rises usually lasted under 15 minutes. At the highest level the pulse slowed at the same time, by 4.6 to 4.7 beats per minute (p < 0.001). 26 women left the trial after randomisation because of predefined blood pressure rises, spread roughly evenly across all four groups [25].

The earlier programme in men

Phase 1 RCT The substance began as a nasal spray for erectile difficulty. Above a threshold dose level the erectile response measured by an instrument beat placebo, with the first response after about 30 minutes; no maximum tolerated level was established, and flushing and nausea were the commonest complaints [17]. A crossover trial in 19 men then combined sub-threshold levels of the nasal form with sildenafil and measured a stronger response over six hours than sildenafil alone, with no new side effects. The programme was abandoned nonetheless and never entered phase 3 [26].

Other measured outcomes

Phase 1 RCT An early crossover trial in 18 premenopausal women with arousal difficulty found more of them reporting moderate or high desire after the substance than after placebo (p = 0.0114), and more satisfaction with arousal among those who had intercourse within 24 hours (p = 0.0256). The objectively measured vaginal blood flow did not change significantly [27].

What is still unknown

  • Whether the nausea can be prevented at all. The one attempt on record, a trial in 228 healthy women, gave ondansetron beforehand. The label states plainly that it did not reduce the nausea, and nothing else has been tried [1], [21].
  • What happens beyond a year. No controlled data exist past 24 weeks, and only 272 of the 684 women who entered the 52-week extension finished it [5].
  • Anything about men, or about women after the menopause. The male programme stopped before phase 3, and the licence covers premenopausal women only [1], [17].
  • Whether the newer uses work at all. A 16-patient open study in diabetic kidney disease and a 108-patient trial combining the substance with tirzepatide in obesity have both ended recruitment without posting results [28], [29]; the South Korean bridging trial, completed in May 2023 with 193 women, has posted none either [30].
  • How the substance behaves in impaired kidneys or liver. Not covered by the sources used here.

Side effects and safety

The safety record is unusually well documented for a peptide traded online, because it comes from a licensed product. One side effect dominates, and one warning sets the boundary of who may use it at all.

  • Nausea in 40.0 per cent against 1.3 per cent on placebo. In study 301 that was 138 of 324 treated women against 7 of 319, and pre-treatment with ondansetron did not fix it [1], [22].
  • Flushing in 20.3 per cent against 0.3 per cent. 84 of 324 against 2 of 319 in the registry figures for study 301 [1], [22].
  • Reactions at the injection site in 13.2 per cent against 8.4 per cent [1].
  • Headache in 11.3 per cent against 1.9 per cent, and 32 of 324 against 8 of 319 in study 301 [1], [22].
  • Vomiting in 4.8 per cent against 0.2 per cent, 17 of 324 against none of 319 [1], [22].
  • A brief rise in blood pressure with a slower pulse. The label puts the average rise at about 6 mmHg systolic and 3 mmHg diastolic, and the fall in pulse at up to 5 beats per minute. Both usually settle within 12 hours [1], [25].
  • Patchy darkening of the face, gums and breasts. About 1 per cent under the licensed pattern of use, but 38 per cent when the substance was given daily in one investigation. People with darker skin were affected more often, and not every case faded after stopping [1].
  • Serious events were rare. Study 301 recorded 4 of 324 treated women against 1 of 319 on placebo, the extension none of 124 against 2 of 239, and no deaths [22].

Contraindication. The American label bars the substance outright for anyone with uncontrolled high blood pressure or known cardiovascular disease, a restriction that follows directly from the blood-pressure trial [1], [25].

The dropout figure belongs here as much as in the trial results: being roughly twelve times more likely to stop for side effects is a safety statement, and it was missing from the main publication [2].

Side effects reported in the approval trials, substance against placebo
Nausea, on the substance
40% of women
Nausea, on placebo
1.3% of women
Flushing, on the substance
20.3% of women
Flushing, on placebo
0.3% of women
Injection-site reaction, on the substance
13.2% of women
Injection-site reaction, on placebo
8.4% of women
Headache, on the substance
11.3% of women
Headache, on placebo
1.9% of women
Vomiting, on the substance
4.8% of women
Vomiting, on placebo
0.2% of women

Pooled approval trials for the American label; registry figures for study 301 give 138 of 324 against 7 of 319 for nausea. Bars pair each effect on the substance with the same effect on placebo. Sources [1], [22].

Data gaps. Nothing is known about use outside medical care, which is exactly the grey-market situation. The only related warning is a documented poisoning case involving Melanotan II, a different substance [19].

Why this page lists no doses

This page gives no amounts for PT-141 in any unit and no instructions for its use. The substance is a prescription-only medicine, and European advertising law keeps dosing information for prescription medicines out of material written for the general public.

The reason is not only formal. The label makes its use conditional on a medical assessment of cardiovascular risk and on blood pressure being well controlled. Set down on a reference page, outside a prescription and outside those checks, such figures would read as an instruction rather than as a citation [1].

Where the sections above had to tell trial arms apart, they name them only as the lowest, middle or highest tested level.

Development and approval status

One approval exists, granted by the United States on 21 June 2019 under NDA 210557 for a single narrow diagnosis in premenopausal women; a label supplement followed on 23 October 2020. Every other register checked on 17 September 2026 returned nothing [6], [7].

From a nasal spray for men to one American licence

  1. 2003First descriptionPalatin publishes the melanocortin agonist PT-141, with nerve-cell activation in the hypothalamus of animals, ref [18]
  2. 2004The nasal programme in menPlacebo-controlled trials in erectile difficulty show an instrument-measured response; no maximum tolerated level is found, ref [17]
  3. 2011 to 2012Switch to women and to injectionThe dose-finding trial in 612 women with arousal or desire difficulty runs, ref [23]
  4. 2015 to 2016The RECONNECT trialsTwo identical 24-week trials randomise 1,267 premenopausal women, followed by a 52-week open extension, refs [1], [5]
  5. 2019Approved in the United StatesFDA approval on 21 June under NDA 210557, prescription-only; the trials are published in October, refs [6], [1]
  6. 2021The independent re-analysesTwo outside groups report the dropout odds ratio of 11.98 and the absence of any extra satisfying event, refs [2], [3]
  7. August 2023Hainan and SeoulFirst commercial sale in the Chinese free-trade port of Hainan without national registration; the South Korean bridging trial completes, refs [31], [30]
  8. 2025New owner, new fieldsCosette Pharmaceuticals takes over American marketing in November; trials in kidney disease and obesity report nothing, refs [6], [28], [29]
MarketStatusSince or note
United StatesApproved2019, prescription-only
European UnionUnapprovedNever applied
GermanyUnapprovedNo national licence
United KingdomUnapprovedRegister empty
AustraliaUnverifiedRegister unreachable
CanadaUnapprovedNo product number
SwitzerlandUnapprovedNot listed

Five of these entries rest on register queries run with control substances in the same database, so a blank means absence, not a broken query [7], [8], [32], [33], [34]. The Australian entry is the exception: the register could not be reached on 17 September 2026, so no finding is claimed [35].

Two markets sit outside the table. South Korea has no entry in its medicines database despite a completed bridging trial [36]. China has no national registration either, yet since August 2023 the product has been dispensed through a medical institution in the Hainan free-trade port, on a route that does not require one — a company statement, not a regulator's [31].

Germany deserves one clarification. The substance is not named in the annex to the prescription-only regulation, which sounds permissive and is not: without an approval there is no lawful finished medicine to sell, and importing one requires a doctor's prescription [37].

The grey market is documented. Seven firms had registered the substance as a bulk ingredient with the American regulator by 2026, several explicitly for pharmacy compounding [12], although it appears in none of the three categories of substances nominated for that purpose [38]. A warning letter of 1 April 2020 names it directly, listing "Bremelanotide (PT-141)" among 21 substances a compounding pharmacy had used [11], and in 2021 forensic chemists identified it, alongside Melanotan II, in eight police-seized samples from the market in performance and image enhancing drugs [13].

The wider legal picture is under are peptides legal and FDA-approved peptides.

Anti-doping

PT-141 is not prohibited in sport. A full-text search of the 2026 prohibited list on 17 September 2026 found no match for bremelanotide, PT-141, melanotan, melanocortin or MSH, while control terms in the same file were found [39].

The catch-all class S0 does not reach it either. That class covers "any pharmacological substance … with no current approval by any governmental regulatory health authority for human therapeutic use", and the American approval is exactly such an approval [39].

This is the sharpest practical difference from Melanotan II, which has no approval anywhere and is therefore caught by S0. The German anti-doping statute lists no melanocortins at all [40]. The full picture is at peptides banned in sport.

Compared with related peptides

SubstanceHow it actsStatusStrongest own resultRef
PT-141Melanocortin receptors, non-selectiveApproved in the United States onlyDesire +0.35 points over placebo, 1,267 women, 24 weeks[1]
Melanotan IISame ring, amide instead of free acidApproved nowhere; caught by class S0See its own page[19]
Melanotan IMelanocortin receptors, pigmentationSee its own pageSee its own page—
Kisspeptin-10Kisspeptin receptor, upstream of sex hormonesInvestigationalSee its own page—
TirzepatideTwo metabolic receptorsApproved medicineSee its own page—

PT-141 is the only one of these with a licence anywhere, and it covers one diagnosis in one country [6]. Kisspeptin-10 is also studied in low sexual desire, though it works through the hormonal axis rather than directly on brain receptors, and tirzepatide appears because the two are being tested together in obesity [29].

Common misconceptions

  • "PT-141 and bremelanotide are different substances." One substance, two names, both resolving to CAS 189691-06-3 and PubChem CID 9941379; the American regulator itself writes "Bremelanotide (PT-141)" [11], [15].
  • "Vyleesi was a European medicine that got withdrawn." Neither happened. Four registers were checked on 17 September 2026, each with control substances found in the same file [7], [8], [9], [10].
  • "The approval proves a meaningful effect." It proves a statistically reliable one: 0.35 points on a scale from 1.2 to 6.0, while the most tangible outcome did not move and dropout for side effects was roughly twelvefold [1], [2], [3].
  • "It is a treatment for erectile difficulty in men." Development began there and was abandoned before phase 3; the only licence worldwide covers premenopausal women [1], [17].
  • "It is on the doping list because it is an injected peptide." It is on neither the 2026 prohibited list nor the German annex, and being injectable is not a criterion [39], [40].
  • "PT-141 and Melanotan II are interchangeable." Transferring the Melanotan II poisoning case to PT-141 would be as wrong as claiming the two are unrelated [19], [20].
  • "It is not a prescription substance in Germany, so it is freely available." It is absent from the prescription-only annex because there is no approved product to regulate, and import requires a prescription [37].

Frequently asked questions

What is PT-141?

PT-141 is a small ring-shaped peptide of seven building blocks, built as a copy of a natural body signal called alpha-MSH. It switches on melanocortin receptors, a family of docking points found on nerve cells and pigment cells. Under the international name bremelanotide it is a licensed prescription medicine in the United States.

Is PT-141 the same substance as bremelanotide?

Yes. PT-141 is the development code used by Palatin Technologies, bremelanotide the international non-proprietary name. Both point to the same compound, the same registry number (CAS 189691-06-3) and the same PubChem entry (CID 9941379). The American regulator itself writes the pairing as Bremelanotide (PT-141).

Is PT-141 approved anywhere?

In one country. The United States approved it on 21 June 2019 under application NDA 210557, as a prescription-only medicine for a single narrow diagnosis. Register checks on 17 September 2026 found no approval in the European Union, Germany, the United Kingdom, Canada, Switzerland or South Korea. It is dispensed in the Chinese free-trade port of Hainan on a special route that skips national registration.

Was PT-141 ever approved in the European Union?

No, and this is widely reported wrongly. There was never a European approval, and no application was ever withdrawn either. Four separate registers were checked on 17 September 2026: the list of valid European approvals, the list of expired ones, the agency's assessment-report dataset and its dataset of withdrawn applications. All four returned nothing, with control substances found in the same files.

What did the phase 3 trials of PT-141 actually show?

Two identical 24-week trials in 1,267 premenopausal women met both of their targets. On a desire scale running from 1.2 to 6.0 the gain over placebo was 0.30 points in one trial and 0.42 in the other, 0.35 points combined. Distress about low desire fell by 0.33 points more than on placebo. Statistically solid, and very small in absolute terms.

What are the side effects of PT-141?

Nausea dominates: 40.0 per cent of treated women against 1.3 per cent on placebo, and 40.4 per cent over a year of open use. Flushing affected 20.3 per cent, headache 11.3 per cent, vomiting 4.8 per cent. Blood pressure rises briefly while the pulse slows, and patchy darkening of the face, gums and breasts occurs in about 1 per cent.

Is PT-141 the same as Melanotan II?

No, but they are close relatives. Both share the same ring structure and differ at one position: Melanotan II carries an amide group where PT-141 carries a free acid group. Their legal positions are opposite. PT-141 is a licensed American medicine; Melanotan II is approved nowhere, is caught by the anti-doping catch-all class, and is linked to documented poisoning cases.

Is PT-141 banned in sport?

No. A full-text check of the 2026 prohibited list on 17 September 2026 found no entry for bremelanotide, PT-141, melanotan or melanocortins. The catch-all class S0 for non-approved substances does not apply either, precisely because the American approval exists. It is also absent from the annex to the German anti-doping statute.

Why does this page list no doses for PT-141?

Because it is a prescription-only medicine. European advertising law bars consumer-facing material for prescription medicines from carrying dosing information. The label also makes the use of this substance conditional on a medical assessment of cardiovascular risk and on blood pressure being well controlled, so figures quoted outside a prescription would read as an instruction, not as a citation.

Sources

  1. US Food and Drug Administration (2025). VYLEESI (bremelanotide injection), prescribing information, label revision 13 November 2025. DailyMed setid f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf. Sections 1, 4, 5.1 to 5.3, 6.1, 11, 12.1 and 12.3 read. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf
  2. Spielmans GI (2021). Re-analyzing phase III bremelanotide trials for "hypoactive sexual desire disorder" in women. Journal of Sex Research 58(9):1085-1105. PMID 33678061. DOI 10.1080/00224499.2021.1885601. Source of the dropout odds ratio 11.98 (95 per cent CI 3.74 to 38.37), the placebo-preference odds ratio 0.30 (95 per cent CI 0.24 to 0.38) and the finding that 72.72 per cent of the endpoints laid down in the trial plans went unreported.
  3. Mintzes B, Tiefer L, Cosgrove L (2021). Bremelanotide and flibanserin for low sexual desire in women: the fallacy of regulatory precedent. Drug and Therapeutics Bulletin 59(12):185-188. PMID 34642243. DOI 10.1136/dtb.2021.000020. Re-analysis of the regulator's files; source of the phrase "bremelanotide to none".
  4. Kingsberg SA, Clayton AH, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Simon JA (2019). Bremelanotide for the treatment of hypoactive sexual desire disorder: two randomized phase 3 trials. Obstetrics and Gynecology 134(5):899-908. PMID 31599840. DOI 10.1097/AOG.0000000000003500.
  5. Simon JA, Kingsberg SA, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Clayton AH (2019). Long-term safety and efficacy of bremelanotide for hypoactive sexual desire disorder. Obstetrics and Gynecology 134(5):909-917. PMID 31599847. DOI 10.1097/AOG.0000000000003514. The 52-week open extension: 684 entries, 272 completions.
  6. US Food and Drug Administration (2026). Drugs@FDA dataset for bremelanotide, queried 17 September 2026: NDA 210557, original approval 21 June 2019, supplement 2 approved 23 October 2020, current applicant Cosette Pharmaceuticals, marketing status prescription. https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22bremelanotide%22
  7. European Commission (2026). Union Register of medicinal products for human use, list of valid authorisations, searched 17 September 2026: no entry for "Vyleesi" or "bremelanotide"; controls Mounjaro, Imcivree and Scenesse found in the same document. https://ec.europa.eu/health/documents/community-register/html/reg_hum_act.htm
  8. European Commission (2026). Union Register, list of authorisations no longer valid, searched 17 September 2026 — the list in which a withdrawn approval would appear: no entry; controls Zynteglo, Esmya and Raptiva found. https://ec.europa.eu/health/documents/community-register/html/reg_hum_nact.htm
  9. European Medicines Agency (2026). Dataset "Medicines output — European public assessment reports", 12,955 text cells searched 17 September 2026: no entry; controls tirzepatide, setmelanotide and afamelanotide found.
  10. European Medicines Agency (2026). Dataset "Medicines output — withdrawn applications", searched 17 September 2026: no entry; control Egrifta/tesamorelin found.
  11. US Food and Drug Administration (2020). Warning letter to Tailor Made Compounding LLC, CMS 594743, 1 April 2020. Section B names "Bremelanotide (PT-141)" among 21 bulk substances used in compounding. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020
  12. US Food and Drug Administration (2026). National drug code directory, queried 17 September 2026 for the generic name: the finished product NDC 0713-0897 plus seven bulk-ingredient registrations by seven different firms between 2020 and 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22bremelanotide%22
  13. Mestria S, Odoardi S, Frison G, Strano Rossi S (2021). LC-HRMS characterization of the skin pigmentation and sexual enhancers melanotan II and bremelanotide sold on the black market of performance and image enhancing drugs. Drug Testing and Analysis 13(4):876-882. PMID 33245851. DOI 10.1002/dta.2986. Eight police-seized samples.
  14. Dhillon S, Keam SJ (2019). Bremelanotide: first approval. Drugs 79(14):1599-1606. PMID 31429064. DOI 10.1007/s40265-019-01187-w. Development path from Palatin to AMAG.
  15. National Center for Biotechnology Information (2026). PubChem compound summary CID 9941379, bremelanotide, queried 17 September 2026: formula C50H68N14O10, 1025.2 g/mol, InChIKey FFHBJDQSGDNCIV-MFVUMRCOSA-N, CAS 189691-06-3, UNII 6Y24O4F92S, DrugBank DB11653, ChEMBL CHEMBL2070241, ChEBI 177849, KEGG D06569, Wikidata Q415353, 54 synonyms including PT-141, PT 141 and PT141. https://pubchem.ncbi.nlm.nih.gov/compound/9941379
  16. Palatin Technologies, Cranbury, New Jersey: originator and licensor, recorded in the approval dataset [6] and in the first-approval review [14]. North American rights were licensed to AMAG Pharmaceuticals, which filed the application.
  17. Diamond LE, Earle DC, Rosen RC, Willett MS, Molinoff PB (2004). Double-blind, placebo-controlled evaluation of the safety, pharmacokinetic properties and pharmacodynamic effects of intranasal PT-141, a melanocortin receptor agonist, in healthy males and patients with mild-to-moderate erectile dysfunction. International Journal of Impotence Research 16(1):51-59. PMID 14963471. DOI 10.1038/sj.ijir.3901139.
  18. Molinoff PB, Shadiack AM, Earle D, Diamond LE, Quon CY (2003). PT-141: a melanocortin agonist for the treatment of sexual dysfunction. Annals of the New York Academy of Sciences 994:96-102. PMID 12851303. DOI 10.1111/j.1749-6632.2003.tb03167.x. Activation of hypothalamic nerve cells in animals, traced to genital tissue.
  19. Nelson ME, Bryant SM, Aks SE (2012). Melanotan II injection resulting in systemic toxicity and rhabdomyolysis. Clinical Toxicology 50(10):1169-1173. PMID 23121206. DOI 10.3109/15563650.2012.740637. The case concerns Melanotan II, not bremelanotide; the paper describes bremelanotide as a variation of Melanotan II.
  20. Ückert S, Bannowsky A, Albrecht K, Kuczyk MA (2014). Melanocortin receptor agonists in the treatment of male and female sexual dysfunctions: results from basic research and clinical studies. Expert Opinion on Investigational Drugs 23(11):1477-1483. PMID 25096243. DOI 10.1517/13543784.2014.934805.
  21. ClinicalTrials.gov (2026). API v2, query.intr=bremelanotide, 17 September 2026: ten registered trials across five sponsors, including the 228-participant ondansetron trial NCT03973047 and the 10-participant breast-milk trial NCT06867835. No trials by the sponsor "Hudson Biotech" appear in this dataset. https://clinicaltrials.gov/api/v2/studies?query.intr=bremelanotide
  22. ClinicalTrials.gov. NCT02333071, RECONNECT study 301, phase 3, registered enrolment 723, with results section. Co-primary endpoints with raw values and the adverse-event module. https://clinicaltrials.gov/study/NCT02333071 . The companion trial NCT02338960 (study 302, registered enrolment 714) is recorded at https://clinicaltrials.gov/study/NCT02338960 . Registry enrolment figures include the open extension and therefore exceed the 1,267 randomised women reported in the publication [4].
  23. ClinicalTrials.gov. NCT01382719, phase 2b dose-ranging trial in 612 women, with results section: satisfying sexual events 0.2, 0.6, 0.7 and 0.8, registered p < 0.05 both for the highest tested level against placebo and across all four groups. https://clinicaltrials.gov/study/NCT01382719
  24. Althof S, DeRogatis LR, Greenberg S, Clayton AH, Jordan R, Lucas J, Spana C (2019). Responder analyses from a phase 2b dose-ranging study of bremelanotide. Journal of Sexual Medicine 16(8):1226-1235. PMID 31277966. DOI 10.1016/j.jsxm.2019.05.012. All seven responder endpoints significant at p ≤ 0.03 at the highest tested dose level.
  25. White WB, Myers MG, Jordan R, Lucas J (2017). Usefulness of ambulatory blood pressure monitoring to assess the melanocortin receptor agonist bremelanotide. Journal of Hypertension 35(4):761-768. PMID 27977473. DOI 10.1097/HJH.0000000000001221. 397 participants; 26 withdrawals for predefined blood-pressure rises.
  26. Diamond LE, Earle DC, Garcia WD, Spana C (2005). Co-administration of low doses of intranasal PT-141, a melanocortin receptor agonist, and sildenafil to men with erectile dysfunction results in an enhanced erectile response. Urology 65(4):755-759. PMID 15833522. DOI 10.1016/j.urology.2004.10.060. Crossover trial in 19 men.
  27. Diamond LE, Earle DC, Heiman JR, Rosen RC, Perelman MA, Harning R (2006). An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT-141), a melanocortin receptor agonist. Journal of Sexual Medicine 3(4):628-638. PMID 16839319. DOI 10.1111/j.1743-6109.2006.00268.x. 18 participants; vaginal blood flow unchanged.
  28. ClinicalTrials.gov. NCT05709444, phase 2b in diabetic kidney disease, 16 participants, open-label and single-arm, completed 26 April 2024, no results posted. https://clinicaltrials.gov/study/NCT05709444
  29. ClinicalTrials.gov. NCT06565611, phase 2 combination with tirzepatide in obesity, 108 participants in four arms, active and no longer recruiting, no results posted. https://clinicaltrials.gov/study/NCT06565611
  30. ClinicalTrials.gov. NCT04943068, phase 3 bridging trial KD-BMT-301 by Kwang Dong Pharmaceutical, 193 premenopausal women at two centres in Seoul, completed 16 May 2023, no results posted. https://clinicaltrials.gov/study/NCT04943068
  31. Palatin Technologies (8 August 2023). Press release on the first commercial sale by its licensee in China and the completion of enrolment in South Korea. Company statement, not a regulator's: imported products "can be sold in Hainan without first receiving registration approval from the Chinese National Medical Products Administration". https://palatin.com/press_releases/palatins-vyleesi-licensee-fosun-pharma-reports-first-commercial-sale-in-china-and-south-korean-licensee-kwangdong-pharmaceuticals-completes-enrollment-in-phase-3-clinical-study/
  32. Medicines and Healthcare products Regulatory Agency (2026). MHRA products index, searched 17 September 2026: no result for "bremelanotide" or "vyleesi"; controls tirzepatide 106, semaglutide 269, setmelanotide 3 and afamelanotide 2. https://products.mhra.gov.uk/
  33. Health Canada (2026). Drug product database, active-ingredient and brand queries on 17 September 2026: both empty; controls tirzepatide, setmelanotide, Imcivree (DIN 02537745) and Egrifta (DIN 02423677 and 02438712) returned records. https://health-products.canada.ca/api/drug/activeingredient/?ingredientname=bremelanotide&lang=en&type=json
  34. Swissmedic (2026). Extended list of authorised human medicines, 29,625 text cells searched 17 September 2026: no entry; controls tirzepatide 19, setmelanotide 2 and somatropin 15.
  35. Therapeutic Goods Administration. Australian Register of Therapeutic Goods, full-text search attempted 17 September 2026 and unreachable (HTTP/2 connection reset, HTTP/1.1 timeout after 90 seconds, fetch service timeout after 60 seconds). No register extract exists, so no absence is claimed here. https://www.tga.gov.au/resources/artg
  36. Ministry of Food and Drug Safety, Republic of Korea (2026). Medicines database nedrug, searched 17 September 2026: "0 entries in total" for the Korean substance name and for "bremelanotide"; control "Mounjaro" returned 18 entries. https://nedrug.mfds.go.kr/searchDrug
  37. Federal Ministry of Justice, Germany (2026). Annex 1 to the regulation on prescription-only medicines (AMVV), searched 17 September 2026: no entry; controls afamelanotide, setmelanotide, somatropin and sermorelin found in the same document. https://www.gesetze-im-internet.de/amvv/anlage_1.html
  38. US Food and Drug Administration (2026). Bulk drug substances nominated for use in compounding under section 503A, version of 14 May 2026, all three categories searched: no entry for bremelanotide or PT-141; controls kisspeptin-10 and ibutamoren in category 2, GHRP-2, GHRP-6, mechano growth factor and cibinetide in category 3, GHK-Cu and vasoactive intestinal peptide in category 1. https://www.fda.gov/media/94155/download
  39. World Anti-Doping Agency (2026). The 2026 prohibited list, sections S0 and S2, full text searched 17 September 2026: no match for bremelanotide, PT-141, melanotan, melanocortin or MSH; controls "peptide hormones", somatropin, erythropoietin, GHRP and insulin found in the same file.
  40. Federal Ministry of Justice, Germany. Annex to section 2(3) of the anti-doping act, official citation BGBl. 2023 I no. 67, read 17 September 2026: no melanocortins listed; controls somatropin, sermorelin and tesamorelin found. https://www.gesetze-im-internet.de/antidopg/anlage.html

Cite this page

Every fact on this page was checked on 17 September 2026. Two points remain open: the Australian register could not be reached, and the South Korean position rests on a database that is currently empty.

myPeptides Research & Editing. (2026). PT-141: what the trials show, status and safety. Version 1.0, 17 September 2026. myPeptides Peptide Register. Retrieved from https://mypep.app/peptides/pt-141

How pages in this register are compiled and graded is described under methodology; the full register is at peptides.

VersionDateChange
1.02026-09-17Initial publication

Last verified: 17 September 2026. Next review: on any approval outside the United States, on results from the kidney or obesity trials, or on any change to the anti-doping classification.

Identifiers

IdentifierValue
CAS number189691-06-3
PubChem CID9941379
UNII6Y24O4F92S
InChIKeyFFHBJDQSGDNCIV-MFVUMRCOSA-N
DrugBankDB11653
ChEMBLCHEMBL2070241
WikidataQ415353
Molecular formulaC50H68N14O10
Molecular weight1025.2
SequenceAc-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH

Related peptides

Comparisons

Cite this page

Use this reference when you quote the page, and the JSON export when you process it automatically.

myPeptides Research & Editing (2026). PT-141: what the trials show, status and safety (Version 1.0). myPeptides. https://mypep.app/peptides/pt-141

Machine-readable version (JSON)

Last reviewed: September 2026

Tools and references

Free tools that turn the ideas above into real numbers — no sign-up.

Reconstitution calculatorMilligrams, vial strength and water become units on a U-100 scale.Open

Take myPeptides with you

Track doses, plans and progress on your phone — end-to-end encrypted.

Open in app App Store Join the beta

This article is for informational purposes only and does not replace medical advice. myPeptides gives no dosing recommendations.