Data edition of
Residue An evidence-graded reference for peptide science

Monograph in Melanocortin peptides

Bremelanotide (PT-141)

A melanocortin-receptor agonist approved in 2019 as an on-demand injection for low sexual desire in premenopausal women. The benefit in trials was statistically significant but modest.

Also called PT-141 · Vyleesi

A

Best evidence: Approved / regulatory-grade

FDA-approved (Vyleesi, NDA 210557) for acquired, generalized hypoactive sexual desire disorder in premenopausal women, on the basis of two randomized phase 3 trials. Other uses are graded separately.

FDA-approved (Vyleesi) · Prescription

Residue Editorial Team · updated

What is Bremelanotide?

Bremelanotide (PT-141) is a synthetic α-MSH analog with high affinity for the melanocortin type 4 receptor1PubMedBremelanotide: First Approval. Dhillon S & Keam SJ Drugs. 2019.. In two phase 3 trials of 1,267 premenopausal women with hypoactive sexual desire disorder, 1.75 mg as needed improved desire and related distress versus placebo2PubMedBremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Kingsberg SA et al. Obstet Gynecol. 2019.. FDA approved it as Vyleesi in 20193FDADrugs@FDA: VYLEESI (AUTOINJECTOR) (NDA210557). COSETTE; original approval 2019-06-21; Prescription.. Nausea was the commonest side effect4PubMedSafety Profile of Bremelanotide Across the Clinical Development Program. Clayton AH et al. J Womens Health (Larchmt). 2022..

PubMed records
11357 reviews
Trial publications
1614 tagged RCT
Registered studies
101 active · 3 phase 3
Molecular weight
1,025.2g/mol · PubChem
Evidence grade
AApproved / regulatory-grade

Key findings

  1. Across the two RECONNECT trials, the desire score rose by 0.35 points more than placebo and distress about low desire fell by 0.33 points more (both P<.001)2.
  2. In the integrated phase 3 data (N=1,247), nausea occurred in 40.0% versus 1.3% on placebo, flushing in 20.3% versus 1.3%, and headache in 11.3% versus 1.9%4.
  3. Small, transient but statistically significant blood-pressure increases were seen on ambulatory monitoring4.
  4. Focal hyperpigmentation was rare at labeled dosing but occurred in more than a third of subjects given up to 16 consecutive daily doses4.
  5. A 2024 reanalysis argued the trial outcome measures have limited validity evidence and that effect sizes on unpublished endpoints ranged from nil to small5PubMedSmall Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder. Spielmans GI & Ellefson EM J Sex Res. 2024..

Written by Residue Editorial Team

Reviewed by Residue Editorial Team · source-by-source check,

First published

Last updated

Registry data · How we grade · Markdown + sources

What is Bremelanotide, chemically?

Identifiers retrieved from PubChem.
PubChem CID9941379 “Bremelanotide”
FormulaC50H68N14O10
Molecular weight1,025.2 g/mol
CAS (as listed)189691-06-3
FDA UNII6Y24O4F92S
InChIKeyFFHBJDQSGDNCIV-MFVUMRCOSA-N
Length7 residues
Route in trialsSubcutaneous autoinjector, as needed
OriginatorPalatin Technologies (originator)
MechanismMelanocortin receptor agonist, high affinity for MC4R
  • Hydrophobic
  • Basic (+)
  • Acidic (−)
  • Non-standard
Figure 1. Residue sequence of Bremelanotide (7 positions) as recorded in PubChem CID 9941379 — Ac-Nle-Asp(1)-His-D-Phe-Arg-Trp-Lys(1)-OH. “X” marks 1 non-standard, D-form or chemically modified position; see the condensed notation.

What is bremelanotide?

Bremelanotide is a synthetic peptide analog of α-MSH1. Its PubChem record lists the same seven-residue sequence as melanotan II, with the formula C50H68N14O106PubChemPubChem compound record: Bremelanotide. C50H68N14O10 · MW 1025.2 g/mol.,7PubChemPubChem compound record: melanotan-II. C50H69N15O9 · MW 1024.2 g/mol.. It is a self-administered, on-demand subcutaneous therapy, developed by Palatin Technologies and licensed to AMAG Pharmaceuticals for North America1.

How does bremelanotide work?

It is a melanocortin receptor agonist with high affinity for the melanocortin type 4 receptor, thought to be important for sexual function, which may modulate brain pathways involved in sexual response1. MC4R also plays a central role in appetite, which is why it was tested for weight8PubMedEffect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials. Spana C et al. Diabetes Obes Metab. 2022..

What have studies found?

Hypoactive sexual desire disorder. RECONNECT comprised two identical randomized, double-blind trials in premenopausal women (mean age 39). Over 24 weeks, bremelanotide 1.75 mg as needed increased the Female Sexual Function Index desire score and reduced distress about low desire versus placebo in each study2. In the 52-week open-label extension, 684 women enrolled and 272 completed it9PubMedLong-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. Simon JA et al. Obstet Gynecol. 2019..

How large is the effect? A 2024 analysis of the RECONNECT data concluded that bremelanotide's benefits are statistically modest and limited to outcomes with scant validity evidence in HSDD, and that 8 of 11 registered efficacy outcomes had not previously been published5.

Weight. In two phase 1 randomized trials in women with obesity, bremelanotide reduced caloric intake by roughly 400 kcal/day and body weight by 1.3 kg more than placebo over 16 days8.

What is its safety record?

The development program covered 3,500 subjects in 43 studies. There were no deaths. Nausea was the most common adverse event and reason for discontinuation; the review advises caution in people at cardiovascular risk because of transient blood-pressure increases, and notes interactions that lowered plasma levels of indomethacin and naltrexone4.

Is Bremelanotide FDA-approved?

Table 1. Regulatory status of Bremelanotide in the United States — from Drugs@FDA (openFDA) and FDA’s bulk-substance compounding categories, as fetched.
RecordStatusSource
VYLEESI (AUTOINJECTOR)
NDA210557 · COSETTE		 FDA-approved original approval 2019-06-21
SOLUTION SUBCUTANEOUS		 3

Drugs@FDA lists Vyleesi (autoinjector), a subcutaneous solution with prescription status and an original approval on June 21, 20193. Approval covers its labeled use only. Bremelanotide is not on FDA's compounding-risk lists10FDACertain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. U.S. FDA, content current as of 04/22/2026..

What is still unknown?

  • Use outside the label, including in men and postmenopausal women; the phase 3 trials enrolled premenopausal women2.
  • Whether the measured gains are clinically meaningful, which a 2024 reanalysis disputes5.

What effects has Bremelanotide shown, by body system?

Each row is graded separately using the Residue evidence scale: a compound can carry an A for one use and a D for another.

Table 2. Research-observed effects of Bremelanotide by body system, with the strongest evidence available for each.
SystemWhat was observedGrade
Sexual desire (HSDD, premenopausal women)Improved desire and reduced distress versus placebo in two phase 3 RCTs2. A
Body weight (obesity)About 1.3 kg more weight loss than placebo over 16 days and roughly 400 kcal/day lower intake in phase 1 RCTs8. B
Blood pressureSmall, transient increases on ambulatory monitoring4. B
SkinFocal hyperpigmentation, rare at label dosing, common with daily dosing4. B

How much research is there on Bremelanotide?

0714 2003: 2 records 2003 2004: 7 records 2005: 4 records 2005 2006: 5 records 2007: 7 records 2008: 7 records 2009: 0 records 2010: 0 records 2010 2011: 1 records 2012: 2 records 2013: 0 records 2014: 2 records 2015: 2 records 2015 2016: 2 records 2017: 5 records 2018: 4 records 2019: 6 records 2020: 7 records 2020 2021: 10 records 2022: 14 records 2023: 8 records 2024: 8 records 2025: 13 records 2025 2026: 11 records (year to date) 2026
Figure 2. PubMed records per publication year matching (bremelanotide[tiab] OR PT-141[tiab]) — 113 in total; peak 14 in 2022. The 2026 bar is year-to-date (hatched). Volume of literature is not evidence of efficacy. Run this query on PubMed.
Registered studies of Bremelanotide by phase and status
PhaseStudiesBreakdown
Phase 1 1
1 completed, 0 active or recruiting, 0 stopped, 0 other
Phase 2 4
3 completed, 1 active or recruiting, 0 stopped, 0 other
Phase 3 3
3 completed, 0 active or recruiting, 0 stopped, 0 other
Phase 4 2
2 completed, 0 active or recruiting, 0 stopped, 0 other
Figure 3. 10 studies on ClinicalTrials.gov match the registry search bremelanotide OR PT-141. Multi-phase studies are counted at their highest phase. Open the full trial feed

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Questions readers ask

Is PT-141 the same as bremelanotide?

Yes. PubChem lists PT-141 as a synonym of bremelanotide6, which is sold in the US as Vyleesi3.

Is bremelanotide FDA-approved?

Yes. Vyleesi (autoinjector) is listed in Drugs@FDA with an original approval on June 21, 20193, for premenopausal women with acquired, generalized hypoactive sexual desire disorder1.

What dose of bremelanotide was used in trials?

The phase 3 trials used 1.75 mg injected under the skin as needed2, the dose chosen from the phase 2b study11.

What are the side effects of bremelanotide?

In phase 3, nausea (40.0%), flushing (20.3%), headache (11.3%) and injection-site reactions (5.4%) were more common than on placebo; small transient blood-pressure rises were also seen4.

Does bremelanotide work for men?

Its approval and phase 3 trials are in premenopausal women2,1. The erection trials in men were of the related peptide melanotan II12.

References

Every source below was retrieved from its official API or page and cached on the data-edition date. Numbers match the margin notes.

  1. 1 PubMed Dhillon S, Keam SJ. Bremelanotide: First Approval. Drugs 2019. PMID 31429064; doi:10.1007/s40265-019-01187-w.
  2. 2 PubMed Kingsberg SA, Clayton AH, Portman D, et al. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol 2019. PMID 31599840; doi:10.1097/AOG.0000000000003500.
  3. 3 FDA Drugs@FDA: VYLEESI (AUTOINJECTOR) (NDA210557). COSETTE; original approval 2019-06-21; Prescription.
  4. 4 PubMed Clayton AH, Kingsberg SA, Portman D, et al. Safety Profile of Bremelanotide Across the Clinical Development Program. J Womens Health (Larchmt) 2022. PMID 35147466; doi:10.1089/jwh.2021.0191.
  5. 5 PubMed Spielmans GI, Ellefson EM. Small Effects, Questionable Outcomes: Bremelanotide for Hypoactive Sexual Desire Disorder. J Sex Res 2024. PMID 36809187; doi:10.1080/00224499.2023.2175192.
  6. 6 PubChem PubChem compound record: Bremelanotide. C50H68N14O10 · MW 1025.2 g/mol.
  7. 7 PubChem PubChem compound record: melanotan-II. C50H69N15O9 · MW 1024.2 g/mol.
  8. 8 PubMed Spana C, Jordan R, Fischkoff S. Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials. Diabetes Obes Metab 2022. PMID 35170192; doi:10.1111/dom.14672.
  9. 9 PubMed Simon JA, Kingsberg SA, Portman D, et al. Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder. Obstet Gynecol 2019. PMID 31599847; doi:10.1097/AOG.0000000000003514.
  10. 10 FDA Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. U.S. FDA, content current as of 04/22/2026.
  11. 11 PubMed Althof S, Derogatis LR, Greenberg S, et al. Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide. J Sex Med 2019. PMID 31277966; doi:10.1016/j.jsxm.2019.05.012.
  12. 12 PubMed Wessells H, Fuciarelli K, Hansen J, et al. Synthetic melanotropic peptide initiates erections in men with psychogenic erectile dysfunction: double-blind, placebo controlled crossover study. J Urol 1998. PMID 9679884.