P Palthera
Signalling Peptides

PT-141

Bremelanotide / Vyleesi / MT-II derivative

PT-141 (bremelanotide) is a cyclic melanocortin derived from α-melanocyte-stimulating hormone (α-MSH). It is FDA-approved as Vyleesi for acquired, generalised hypoactive sexual desire disorder (HSDD) in premenopausal women. Approval is indication-specific.

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Signalling Peptides
Classification
Melanocortin receptor agonist · FDA-approved (Vyleesi, as bremelanotide)
Research stage
Phase III clinical evidence; FDA-approved (Vyleesi) for hypoactive sexual desire disorder in premenopausal women
Sequence
Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH
Molecular weight
1025.2 Da

Snapshot

Key takeaways

A three-bullet snapshot before reading the full dossier.

  1. 01

    Cyclic melanocortin (active at MC1R, MC3R, MC4R).

  2. 02

    FDA-approved (2019) as Vyleesi for premenopausal acquired HSDD.

  3. 03

    Early intranasal pharmacology research preceded the subcutaneous formulation used in the approved indication.

Dossier overview

4

research areas

3

references

3

handling notes

01

Mechanism of action

PT-141 activates melanocortin in the central nervous system — particularly MC4R — implicated in sexual response pathways. The mechanism contrasts with PDE5-inhibitor approaches by targeting central rather than peripheral pathways.

02

Research applications

  • Melanocortin pharmacology
  • Female sexual dysfunction clinical research
  • Central nervous system peptide signalling
  • Metabolic-disorder research (MC4R pathway, separate from approved indication)

Evidence at a glance

What's behind this profile

3 citations · 2006–2023

Human
1

Studies in human volunteers or patients (incl. early-phase trials).

Review
2

Narrative or systematic reviews; no primary data.

Publication years

  1. 06
  2. 07
  3. 08
  4. 09
  5. 10
  6. 11
  7. 12
  8. 13
  9. 14
  10. 15
  11. 16
  12. 17
  13. 18
  14. 19
  15. 20
  16. 21
  17. 22
  18. 23
20062023

Counts are derived from the cited studies below. A study covering both in vivo and in vitro work is counted by its primary model. Sample size is reported in 1 of 3 citations. Findings remain model-specific and are not extrapolated to therapeutic use.

03

Study references

Each profile cites a minimum of two peer-reviewed sources, with model type and reported sample size where the source provides it. Findings are model-specific and must not be extrapolated to therapeutic use.

Bremelanotide: First Approval

2019

Dhillon S et al. · Drugs

Model
Drug approval review
Sample
N/A (review)

Reviewed the regulatory evidence and Phase III trial data supporting FDA approval of bremelanotide for premenopausal acquired HSDD.

PMID 31429064 DOI 10.1007/s40265-019-01187-w

An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT-141)

2006

Diamond LE et al. · Journal of Sexual Medicine

Model
Double-blind crossover clinical trial (intranasal formulation)
Sample
n=18

A single intranasal dose was associated with increased reported sexual desire and arousal satisfaction versus placebo in women with sexual arousal disorder.

PMID 16839319 DOI 10.1111/j.1743-6109.2006.00268.x

Targeting the central melanocortin system for the treatment of metabolic disorders

2023

Sweeney P et al. · Nature Reviews Endocrinology

Model
Narrative review
Sample
N/A (review)

Reviewed melanocortin pathway pharmacology including bremelanotide and setmelanotide, with focus on metabolic and behavioural disorder applications.

PMID 37365323 DOI 10.1038/s41574-023-00855-y

Evidence caveats

  • FDA approval is restricted to premenopausal acquired HSDD. Use outside the approved indication is investigational and is not endorsed here.
  • Reported adverse effects in trials include transient blood pressure increases. Clinical use requires a qualified healthcare professional.

04

Storage and handling

Approved product follows manufacturer instructions. Research-grade material must be stored under controlled laboratory conditions per protocol.

  • Approved product follows the manufacturer label.
  • Research-grade material requires controlled storage and batch documentation.
  • Clinical use is a medical decision with a qualified healthcare professional.