Bremelanotide (PT-141)
Melanocortin receptor agonist.
Editorial review: August 13, 2026Evidence snapshot
This drawer marks papers. It is not a plan, a dose, or a source. A paper is a bounded report. It is not a protocol. Grades name the object. They are not a safety rating.
Labeled object. Bremelanotide (developmental name PT-141) is FDA-approved in the United States as Vyleesi for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, as characterized on the labeled claim. PubChem CID 9941379; formula C50H68N14O10 / MW 1025.2; CAS 189691-06-3. Papers below that test the approved subcutaneous HSDD program are about that labeled product–use pair. They do not travel to Melanotan II, unlabeled melanocortin “tanning” peptides, male erectile-dysfunction products, or a vial that is not the trial/approved object. Melanotan II is a separate drawer — related chemistry does not make them the same labeled object.
Bottom line
Pivotal RECONNECT Phase 3 trials and related HSDD development support the approved premenopausal HSDD object. Earlier intranasal/subcutaneous PT-141 work in men or in female arousal populations is a different developmental object and route history. Critiques of effect size exist; they do not erase the labeled indication, and they do not expand it. Do not blur bremelanotide into Melanotan II.
Papers
Approved indication — premenopausal HSDD (Vyleesi-class / RECONNECT object)
PMID 31599840 — Kingsberg 2019 (RECONNECT Phase 3)
Tested: subcutaneous bremelanotide versus placebo in two randomized Phase 3 trials for HSDD in premenopausal women (RECONNECT).
Does not show: a Melanotan II result, a male ED label, or efficacy of a non-trial preparation.
PMID 31599847 — Simon 2019
Tested: longer-term safety and efficacy follow-on for bremelanotide in the HSDD development program.
Does not show: use outside the studied HSDD population, or interchangeability with other melanocortin peptides.
PMID 35230162 — Simon 2022
Tested: prespecified and integrated subgroup analyses from the RECONNECT Phase 3 studies.
Does not show: a new pivotal indication beyond the parent trials’ object.
PMID 35147466 — Clayton 2022
Tested: pooled safety profile of bremelanotide across the clinical development program.
Does not show: efficacy outside the labeled HSDD object, or safety of unapproved melanocortin analogs.
PMID 27181790 — Clayton 2016
Tested: randomized, placebo-controlled dose-finding trial of bremelanotide for female sexual dysfunctions in premenopausal women (Phase 2b–style program preceding confirmatory Phase 3).
Does not show: the later RECONNECT confirmatory package by itself.
PMID 31277966 — Althof 2019
Tested: responder analyses from a Phase 2b dose-ranging bremelanotide study.
Does not show: a substitute for the Phase 3 primary reports.
PMID 31429064 — Dhillon 2019
Tested: regulatory first-approval review summarizing the approved HSDD indication and development context.
Does not show: approval of Melanotan II, or of unlabeled research vials.
Mechanism / neurobiology context for the labeled object
PMID 33455598 — Pfaus 2022
Tested: review of neurobiology of bremelanotide relevant to HSDD in premenopausal women.
Does not show: a new pivotal efficacy trial, or a tanning-peptide claim.
Critical re-analysis (context — does not expand or erase the label)
PMID 33678061 — Spielmans 2021
Tested: critical re-analysis of Phase 3 bremelanotide HSDD reporting and effect-size framing.
Does not show: a Melanotan II result. Marks debate over how large the clinical effect is; it is not a protocol and not a different indication.
Earlier PT-141 developmental objects (not the Vyleesi HSDD label)
PMID 14963471 — Diamond 2004
Tested: double-blind, placebo-controlled safety/PK/PD of intranasal PT-141 in healthy men and in erectile-dysfunction patients (RigiScan endpoints).
Does not show: the approved female HSDD subcutaneous label, or Melanotan II interchangeability.
PMID 14999221 — Rosen 2004
Tested: safety, pharmacokinetics, and pharmacodynamic erectile effects of subcutaneous PT-141 in healthy men and men with erectile dysfunction.
Does not show: an approved male ED indication for bremelanotide, or a tanning claim.
PMID 16839319 — Diamond 2006
Tested: effect of bremelanotide (PT-141) on subjective sexual response in premenopausal women with sexual arousal disorder (developmental female object, not the later HSDD label alone).
Does not show: that every female sexual dysfunction equals the approved HSDD indication.
PMID 18206919 — Safarinejad 2008
Tested: randomized, double-blind, placebo-controlled study of bremelanotide as salvage after sildenafil failure in men with erectile dysfunction.
Does not show: an FDA-approved male ED claim for bremelanotide, or relevance to Melanotan II retail products.
What is not established
Use of bremelanotide as Melanotan II, or the reverse. An approved male erectile-dysfunction indication for bremelanotide. Efficacy of compounding or research-labeled melanocortin vials as if they were Vyleesi. Expansion of the HSDD label to postmenopausal women, men, or “general libido” without a matching labeled object. Tanning or pigmentation claims are not what the HSDD program grades.
Selected sources
31599840 31599847 35230162 35147466 27181790 31277966 31429064 33455598 33678061 14963471 14999221 16839319 18206919
Reported experiences
Sexual desire and arousal
Reported topics are not established benefits.Risks and unknowns
Nausea, flushing, headache, blood-pressure changes, skin darkening
Compare experiences with care.
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