Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk
Cosette Pharmaceuticals, Inc.n = 1011 Jul 2025 to 15 Nov 2025
Lactating Mother
PepBank has 32 PT-141 studies with results. 28 of them gave PT-141, with 128 results, grouped by what the studies measured. In each group, results from studies in people come first. Data as of 2026-10-30.
Searches 128 results and 109 papers. Newer studies from Europe PMC
Identifiers, parent molecule, targets and development stage, from curated data.
Bremelanotide (PT-141) is the synthetic cyclic heptapeptide Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH, with a side-chain lactam between Asp and Lys. It has the same ring as Melanotan II but a free C-terminal acid instead of an amide. The FDA label describes it as a non-selective melanocortin receptor agonist (potency order MC1R, MC4R, MC3R, MC5R, MC2R) and states that its mechanism in HSDD is unknown. FDA approved it in 2019 as Vyleesi (bremelanotide acetate) for acquired, generalized HSDD in premenopausal women.
| Target | Action | Evidence |
|---|---|---|
| Melanocortin receptor 4MC4RP32245 (opens in a new tab) | Agonist | approved-drug labelSource (opens in a new tab) |
| Melanocyte-stimulating hormone receptorMC1RQ01726 (opens in a new tab) | Agonist | approved-drug labelSource (opens in a new tab) |
| Melanocortin receptor 3MC3RP41968 (opens in a new tab) | Agonist | approved-drug labelSource (opens in a new tab) |
| Melanocortin receptor 5MC5RP33032 (opens in a new tab) | Agonist | approved-drug labelSource (opens in a new tab) |
| Adrenocorticotropic hormone receptorMC2RQ01718 (opens in a new tab) | Agonist | approved-drug labelSource (opens in a new tab) |
Residues, differences from the parent, calculated properties and 3D structure. Source values and calculated values are shown separately.
7 amino acids · 4 modifications
Calculated from the two sequences. Curated notes are shown as given.
3 of 7 aligned residues identical (43%) · 2 substitutions · 2 non-canonical residues · Alpha-melanocyte-stimulating hormone (alpha-MSH) 4–10
Differences from the parent
Basis: GSRS bremelanotide lists INTERMEDINE (alpha-MSH, UNII OVF025LA77) as PARENT->DERIVATIVE. Same core as Melanotan II, which PubChem names 'Acetyl-(Nle4,Asp5,D-Phe7,Lys10)-cyclo-alpha-MSH (4-10) amide'; bremelanotide has a free C-terminal acid instead. alpha-MSH = POMC 138-150 (UniProt P01189).
Calculated from the two sequences with @pepdb/chem alignToParent (ungapped unless a gap scores higher). The record’s curated notes are shown as given.
Some values cannot be calculated. The sequence has a non-canonical residue (X). Residue tables cover only the 20 standard amino acids.
@pepdb/chem 0.2.0 · EMBOSS pKa set · ExPASy residue masses
No charge curve
The sequence has a non-canonical residue (X). Residue tables cover only the 20 standard amino acids.
7 residues. Each residue counts in one class; F and W count as aromatic.
Loads the 3D viewer (3Dmol.js, about 150 KB) and the model file from RCSB PDB.
Draws the structure in your browser with RDKit (about 2.3 MB, loaded once).
SMILES fromPubChem CID 9941379(opens in a new tab)
CCCC[C@@H](C(=O)N[C@H]1CC(=O)NCCCC[C@H](NC(=O)[C@@H](NC(=O)[C@@H](NC(=O)[C@H](NC(=O)[C@@H](NC1=O)CC2=CN=CN2)CC3=CC=CC=C3)CCCN=C(N)N)CC4=CNC5=CC=CC=C54)C(=O)O)NC(=O)CPeople first in each area, then animals, then lab cells. Counts are exact and come from studies that gave the peptide.
PepBank reads each paper before it shows the results. This search looks in Europe PMC for newer papers that PepBank has not read yet.
Counts are exact and come from studies that gave the peptide.
Studies by year
32 of 109 studies have results (29%), published 2003 to 2026. Top row: every study. Bottom row: studies with results about Bremelanotide (PT-141), by class. The rows use different scales.
Studies109 in all, 2003 to 2026
Studies with results32 in all, 2003 to 2026
Retracted studies are left out. A study with results in two classes counts in both.
AI wrote and checked these results. AI can make mistakes, so check important results against the source.
Registered trials that test the peptide, with phase, status and dates. A dot marks trials with posted results.
10 trials match. Highest phase first. Data from ClinicalTrials.gov.
10 trials · 1 ongoing · 9 completed · 4 with posted results
Evaluate the Safety and Efficacy of Bremelanotide in Women With Female Sexual Arousal Disorder (FSAD)
NCT00425256Feb 2006 to May 2007
Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder
NCT01382719Jun 2011 to Sept 2012
Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran
NCT0397304717 Jun 2019 to 20 Jul 2019
Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder
NCT041797347 Oct 2019 to 6 Oct 2020
A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal)
NCT0494306810 May 2021 to 16 May 2023
Single Dose of Vyleesi in Lactating Female Subjects to Measure the Concentration of Bremelanotide in Breast Milk
NCT0686783511 Jul 2025 to 15 Nov 2025
10 trials · 1 ongoing · 9 completed · 4 with posted results · source ClinicalTrials.gov (opens in a new tab)
Cosette Pharmaceuticals, Inc.n = 1011 Jul 2025 to 15 Nov 2025
Lactating Mother
Imperial College Healthcare NHS Trustn = 407 Oct 2019 to 6 Oct 2020
Hypoactive Sexual Desire Disorder
Kwang Dong Pharmaceutical co., ltd.n = 19310 May 2021 to 16 May 2023
Hypoactive Sexual Desire Disorder
Palatin Technologies, Incn = 723Dec 2014 to 30 Jun 2017
Hypoactive Sexual Desire Disorder
Palatin Technologies, Incn = 714Jan 2015 to 29 Jun 2017
Hypoactive Sexual Desire Disorder
Palatin Technologies, Incn = 1085 Aug 2024 to est. 31 Mar 2025
Obesity
Palatin Technologies, Incn = 1626 Dec 2022 to 26 Apr 2024
Kidney Disease
Palatin Technologies, Incn = 612Jun 2011 to Sept 2012
Female Sexual Arousal Disorder · Hypoactive Sexual Desire Disorder
Palatin Technologies, IncFeb 2006 to May 2007
Sexual Arousal Disorder
AMAG Pharmaceuticals, Inc.n = 22817 Jun 2019 to 20 Jul 2019
Nausea
Studies on this peptide. Some have results. The others have none yet.
109 studies match. Retracted studies are left out.
Showing 12 of 109 studiesquery qry_c4060478bc89322824ddef58
32 studies in all, 11 on this page
Randomized controlled trial · 2019
Kingsberg et al. 2019Obstetrics and gynecologyn = 1,247cited by 95
PMID 31599840PMC6819021DOI 10.1097/aog.0000000000003500PUB-31599840
Animal study (in vivo) · rat · 2004
Pfaus et al. 2004Proceedings of the National Academy of Sciences of the United States of Americacited by 83
PMID 15226502PMC454387DOI 10.1073/pnas.0400491101PUB-15226502
Randomized controlled trial · 2004
Diamond et al. 2004International journal of impotence researchcited by 80
PMID 14963471DOI 10.1038/sj.ijir.3901139PUB-14963471
Other design · 2003
Molinoff et al. 2003Annals of the New York Academy of Sciencescited by 75
PMID 12851303DOI 10.1111/j.1749-6632.2003.tb03167.xPUB-12851303
Randomized controlled trial · 2006
Diamond et al. 2006The journal of sexual medicinen = 18cited by 65
PMID 16839319DOI 10.1111/j.1743-6109.2006.00268.xPUB-16839319
Animal study (in vivo) · rat · 2007
Pfaus et al. 2007The journal of sexual medicinecited by 65
PMID 17958619DOI 10.1111/j.1743-6109.2007.00610.xPUB-17958619
Not a test of Bremelanotide (PT-141) alone · 2021
Zhang et al. 2021Cell researchcited by 59
PMID 34433901PMC8563965DOI 10.1038/s41422-021-00552-3PUB-34433901
Randomized controlled trial · 2004
Rosen et al. 2004International journal of impotence researchcited by 58
PMID 14999221DOI 10.1038/sj.ijir.3901200PUB-14999221
Randomized controlled trial · 2016
Clayton et al. 2016Women's health (London, England)cited by 58
PMID 27181790PMC5384512DOI 10.2217/whe-2016-0018PUB-27181790
Randomized controlled trial · 2005
Diamond et al. 2005Urologyn = 19cited by 33
PMID 15833522DOI 10.1016/j.urology.2004.10.060PUB-15833522
Non-randomized trial · 2019
Simon et al. 2019Obstetrics and gynecologyn = 684cited by 30
PMID 31599847PMC6819023DOI 10.1097/aog.0000000000003514PUB-31599847
11 studies in all, 1 on this page
PubMed tag: Randomized Controlled Trial · 2008
Safarinejad et al. 2008The Journal of urologycited by 28
PMID 18206919DOI 10.1016/j.juro.2007.10.063PUB-18206919
These studies name Bremelanotide (PT-141) but give no result for it (for example, the results concern another peptide in the study).
PubMed tag: Review · 2015
Kingsberg et al. 2015CNS drugscited by 78
PMID 26519340DOI 10.1007/s40263-015-0288-1PUB-26519340
PubMed tag: Review · 2006
Hadley et al. 2006Peptidescited by 65
PMID 16412534DOI 10.1016/j.peptides.2005.01.029PUB-16412534
PubMed tag: Review · 2019
Dhillon et al. 2019Drugscited by 65
PMID 31429064DOI 10.1007/s40265-019-01187-wPUB-31429064
PubMed tag: Review · 2023
Sweeney et al. 2023Nature reviews. Endocrinologycited by 52
PMID 37365323DOI 10.1038/s41574-023-00855-yPUB-37365323
PubMed tag: review-article, Review · 2018
Clayton et al. 2018Sexual medicinecited by 42
PMID 29523488PMC5960024DOI 10.1016/j.esxm.2018.01.004PUB-29523488
PubMed tag: Meta-Analysis · 2018
Weinberger et al. 2018Obstetrics and gynecologycited by 38
PMID 29995725DOI 10.1097/aog.0000000000002733PUB-29995725
PubMed tag: Review · 2007
Shadiack et al. 2007Current topics in medicinal chemistrycited by 37
PMID 17584134DOI 10.2174/156802607780906681PUB-17584134
PubMed tag: Systematic Review · 2020
Mayer et al. 2020The Annals of pharmacotherapycited by 33
PMID 31893927DOI 10.1177/1060028019899152PUB-31893927
PubMed tag: none · 2007
King et al. 2007Current topics in medicinal chemistrycited by 31
PMID 17584130PMC2694735DOI 10.2174/156802607780906564PUB-17584130
PubMed tag: Review · 2022
Nappi et al. 2022The Urologic clinics of North Americacited by 28
PMID 35428435DOI 10.1016/j.ucl.2022.02.001PUB-35428435
PubMed tag: review-article, Review · 2022
Edinoff et al. 2022Neurology internationalcited by 24
PMID 35076581PMC8788464DOI 10.3390/neurolint14010006PUB-35076581
PubMed tag: none · 2021
Derogatis et al. 2021Journal of patient-reported outcomescited by 23
PMID 34559353PMC8463644DOI 10.1186/s41687-021-00359-1PUB-34559353
PubMed tag: Review · 2014
Ückert et al. 2014Expert opinion on investigational drugscited by 22
PMID 25096243DOI 10.1517/13543784.2014.934805PUB-25096243
Page 1 of 1
Kingsberg SA · Obstetrics and gynecology · 2019
Randomized controlled trial · 6 results
Clayton AH · Women's health (London, England) · 2016
Randomized controlled trial · 6 results
Revicki DA · Journal of patient-reported outcomes · 2020
Randomized controlled trial · 1 result
Clayton AH · Journal of women's health (2002) · 2022
Randomized controlled trial · 14 results
Simon JA · Journal of women's health (2002) · 2022
Randomized controlled trial · 6 results
White WB · Journal of hypertension · 2017
Randomized controlled trial · 5 results
Journal of the Endocrine Society · 2022
Randomized controlled trial · 10 results
Clayton AH · Clinical therapeutics · 2017
Randomized controlled trial · 7 results
Diamond LE · Urology · 2005
Randomized controlled trial · 2 results
Diamond LE · The journal of sexual medicine · 2006
Randomized controlled trial · 4 results
Diamond LE · International journal of impotence research · 2004
Randomized controlled trial · 11 results
Rosen RC · International journal of impotence research · 2004
Randomized controlled trial · 4 results
Spana C · Diabetes, obesity & metabolism · 2022
Randomized controlled trial · 4 results
Althof S · The journal of sexual medicine · 2019
Randomized controlled trial · 1 result
Spielmans GI · Journal of sex research · 2024
Randomized controlled trial · 3 results
Toledo RG · Journal of minimally invasive gynecology · 2026
Systematic review · 3 results
Simon JA · Obstetrics and gynecology · 2019
Non-randomized trial · 9 results
Koochaki P · Journal of women's health (2002) · 2021
Observational study · 3 results
Saffati G · Sexual medicine · 2023
Case report or series · 1 result
Molinoff PB · Annals of the New York Academy of Sciences · 2003
Other design · 4 results
Pfaus JG · Proceedings of the National Academy of Sciences of the United States of America · 2004
Animal study (in vivo) · rat · 6 results
Pfaus J · The journal of sexual medicine · 2007
Animal study (in vivo) · rat · 5 results
Sauter M · Journal of pharmaceutical and biomedical analysis · 2020
Animal study (in vivo) · beagle dog · 6 results
Borland JM · Neuropharmacology · 2025
Animal study (in vivo) · syrian hamster · 2 results
Krupke H · Journal of Controlled Release · 2025
Animal study (in vivo) · 2 results
Aughton KL · British journal of pharmacology · 2008
Ex vivo tissue · rabbit · 4 results
Suzuki S · Anticancer research · 2024
In vitro (cells) · 7 results
Serilmez M · Turkish journal of biology = Turk biyoloji dergisi · 2025
In silico · 1 result
Yuvaraaj VK · Analytical methods : advancing methods and applications · 2026
Not a test of Bremelanotide (PT-141) alone · 9 results
Zhang H · Cell research · 2021
Not a test of Bremelanotide (PT-141) alone · 3 results
Pyke RE · Sexual medicine reviews · 2018
Not a test of Bremelanotide (PT-141) alone · 1 result
Mestria S · Drug testing and analysis · 2021
Not a test of Bremelanotide (PT-141) alone · 1 result
Approval and sport status, and the safety outcomes reported in study results. Laws and labels change, so check the regulator for the current status.
| Jurisdiction | Body | Status | As of | Source |
|---|---|---|---|---|
| US | FDA |
| 9 Oct 2026 | accessdata.fda.gov (opens in a new tab) |
| EU | EMA | No centrally authorised, withdrawn or refused medicine and no orphan designation for this substance in the EMA data files (medicines file, all statuses, timestamp 2026-10-09T06:23:44Z; orphan designations file timestamp 2026-10-09T06:32:20Z). National authorisations in EU member states were not checked. No EU marketing authorisation application found. | 9 Oct 2026 | ema.europa.eu (opens in a new tab) |
| Sport | WADA | Not listed as banned by WADA It is FDA-approved, so S0 (non-approved substances) does not apply by its wording. | 2026 List | wada-ama.org (opens in a new tab) |
| South Korea | Note | Kwang Dong Pharmaceutical holds Korean rights (licence from Palatin, 2017, per Korean trade press) and completed a Korean bridging phase 3 trial (NCT04943068, completed 2023-05-16, 193 participants). A Korean news report of 2024-12-09 says a marketing application to the regulator (MFDS) was planned. A marketing authorisation in Korea was not found. | 9 Oct 2026 | clinicaltrials.gov (opens in a new tab) |
42 safety results for Bremelanotide (PT-141).
In premenopausal women with hypoactive sexual desire disorder, nausea was more frequent with bremelanotide than with placebo, at 10% or more in both studies.
Randomized controlled trialn = 1,247
In premenopausal women with hypoactive sexual desire disorder, flushing was more frequent with bremelanotide than with placebo, at 10% or more in both studies.
Randomized controlled trialn = 1,247
In premenopausal women with hypoactive sexual desire disorder, headache was more frequent with bremelanotide than with placebo, at 10% or more in both studies.
Randomized controlled trialn = 1,247
In premenopausal women with hypoactive sexual desire disorder, most treatment-emergent adverse events with bremelanotide were related to tolerability and were mild or moderate in intensity.
Randomized controlled trialn = 1,247
In the integrated double-blind phase 3 studies, nausea was more frequent with bremelanotide than with placebo.
Randomized controlled trialn = 1,247
In the integrated double-blind phase 3 studies, flushing was more frequent with bremelanotide than with placebo.
Randomized controlled trialn = 1,247
In the integrated double-blind phase 3 studies, headache was more frequent with bremelanotide than with placebo.
Randomized controlled trialn = 1,247
In the integrated double-blind phase 3 studies, injection site reactions were more frequent with bremelanotide than with placebo.
Randomized controlled trialn = 1,247
The top 24 of 40 results.
The doses that these studies used. They are not recommendations.
1.75 mgHuman
1.25 and 1.75 mg pooledHuman
1.75 mgHuman
1.25 mgHuman
1.75 mgHuman
0.75, 1.25 and 1.75 mgHuman
6 of 17 shown
PepBank is a research reference. Talk to a doctor before you use any peptide.
Data version, change history and code for this peptide.
curl -s https:// pepbank.io/ v1/ briefs/ pt-141Evidence summary for Bremelanotide (PT-141): counts by class, key results with sources, notices, data version.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated
Top outcomes
The 8 outcome groups with the most study results, by evidence class.
Data version 308560. Bar length is the number of results, not the size of an effect.
Evidence matrix
Study results by outcome and evidence class. Arrows show how the measured outcome moved, not whether the change is good.
| Outcome group | Human | Animal | Lab | Computer model | Total |
|---|---|---|---|---|---|
| Sexual functionReproductive and sexual health | Human: 38 results from 16 studies: 26 increase, 6 decrease, 4 no significant change, 1 mixed, 1 not reported. Strongest design: Randomized controlled trial | Animal: 12 results from 4 studies: 4 increase, 8 no significant change. Strongest design: Animal study (in vivo) | Lab: 2 results from 1 study: 2 no significant change. Strongest design: Ex vivo tissue | No results | 52 |
| Adverse eventsWhole body | Human: 29 results from 9 studies: 6 increase, 8 no significant change, 15 not reported. Strongest design: Randomized controlled trial | No results | No results | No results | 29 |
| PharmacokineticsPharmacology | Human: 8 results from 3 studies: 2 increase, 2 decrease, 2 no significant change, 2 not reported. Strongest design: Randomized controlled trial | Animal: 2 results from 2 studies: 2 not reported. Strongest design: Animal study (in vivo) | No results | No results | 10 |
| Receptor activity and mechanismNervous system and cognition | Human: 5 results from 1 study: 4 increase, 1 decrease. Strongest design: Randomized controlled trial | Animal: 3 results from 3 studies: 2 increase, 1 no significant change. Strongest design: Animal study (in vivo) | Lab: 2 results from 1 study: 2 no significant change. Strongest design: In vitro (cells) | No results | 10 |
| Blood pressureCardiovascular | Human: 5 results from 3 studies: 4 increase, 1 no significant change. Strongest design: Randomized controlled trial | No results | No results | No results | 5 |
| Sex hormones and fertilityEndocrine and hormones | Human: 4 results from 1 study: 2 increase, 2 no significant change. Strongest design: Randomized controlled trial | No results | No results | No results | 4 |
| Appetite and food intakeMetabolic and weight | Human: 2 results from 1 study: 2 decrease. Strongest design: Randomized controlled trial | No results | No results | No results | 2 |
| Body weightMetabolic and weight | Human: 2 results from 1 study: 2 decrease. Strongest design: Randomized controlled trial | No results | No results | No results | 2 |
| Gastrointestinal adverse eventsGastrointestinal | Human: 2 results from 2 studies: 1 increase, 1 not reported. Strongest design: Randomized controlled trial | No results | No results | No results | 2 |
| PigmentationSkin and wound | Human: 2 results from 1 study: 1 increase, 1 not reported. Strongest design: Randomized controlled trial | No results | No results | No results | 2 |
| Heart functionCardiovascular | Human: 1 result from 1 study: 1 decrease. Strongest design: Randomized controlled trial | No results | No results | No results | 1 |
| MortalityWhole body | Human: 1 result from 1 study: 1 no significant change. Strongest design: Randomized controlled trial | No results | No results | No results | 1 |
12 outcome groups shown of 17 · 128 study results
Data version 308560. Shade grows with the number of results. Every cell shows the exact count.
Trials by phase
10 registered trials, grouped by phase and shown by status.
Source: ClinicalTrials.gov, data version 308560. Status is the registry status.