Bremelanotide
What 127 indexed publications and 14 randomized trials actually state about bremelanotide, sentence by sentence, each tied to its source and labeled by the kind of evidence it is.
Approved label 27 sources Updated Also: Vyleesi, Vyleesi (autoinjector)
At a glance
Evidence availability
Approved label
Regulator-reviewed label exists
Indexed publications
127
Europe PMC, title or abstract, 2026-09-14
Human studies in ledger
14
10 randomized; study count, not efficacy proof
Approval
2019
ChEMBL phase 4
Routes reported
intranasal, subcutaneous
from studies in this ledger
Studied in
Dogs, Humans, Swine
21 primary studies in the evidence table
Compiled from 27 indexed sources, updated . Cited findings carry an evidence tier; passages written from general knowledge are marked editorial synthesis. Nothing here is medical or dosing advice. What changed
What it is
Bremelanotide is a peptide in the melanocortin agonists class (MC4 receptor agonist). Europe PMC indexes 127 publications naming it or a listed alias in a title or abstract, including 14 randomized controlled trials and 9 clinical trials of any design, as of . The strongest evidence tier in that literature is an approved medicine with a regulator-reviewed label.
This page reports what those studies state, sentence by sentence, with each statement tied to its source and labeled by the kind of evidence it is. It does not recommend use, and it does not translate study doses into anything personal.
What the evidence level means
Publication counts show what is indexed, not how strong the evidence is. The ledger below separates human clinical records from preclinical, analytical, and in-vitro work.
Human clinical studies in this ledger1410 randomized · 4 other human clinical
Evidence strengthNot yet assessedSeparate from evidence availability
Efficacy signalNot yet assessedRead the study result, not the tier alone
Interpretation boundary: An indexed publication count is a discovery measure. It does not establish efficacy, safety, approval, or a personal treatment plan.
What the evidence shows
One row per primary study in this record's ledger. Fields are read from each paper's indexing and abstract. "Analytical method" marks papers about detecting or measuring the compound rather than about its effects.
| Study | Design | n | Species | Dose | Route | Duration | Reported outcome | Tier |
|---|---|---|---|---|---|---|---|---|
| Simon 2022 | Randomized controlled trial | 1,202 | Humans | 1.75 mg | subcutaneous | 52 week; 24 weeks | Among 1202 patients included in the integrated and subgroup analyses, bremelanotide achieved statistically significant improvements in measures of increased desire and decreased distress associated with low desire… | Human clinical trial |
| Clayton 2022 | Randomized controlled trial | 1,247 | Humans | — | — | — | Small and transient but statistically significant blood pressure increases were observed during ambulatory blood pressure monitoring. | Human clinical trial |
| Derogatis 2021 | Clinical trial | 325 | Humans | — | — | — | Acceptable construct validity was demonstrated by significant correlations with related PRO scales in the expected directions and magnitude. | Human clinical trial |
| Revicki 2020 | Clinical trial | 676 | Humans | — | — | — | After 6 months, there was a significantly greater improvement for bremelanotide versus placebo in both the monthly and daily recall versions (both P Conclusions The results demonstrated that EDQ exhibited good… | Human clinical trial |
| Kingsberg 2019 | Randomized controlled trial | 267 | Humans | 1.75 mg | subcutaneous | 24 weeks | From baseline to end-of-study, women taking bremelanotide had statistically significant increases in sexual desire (study 301: 0.30, P Conclusions Both studies demonstrated that bremelanotide significantly improved… | Human clinical trial |
| Althof 2019 | Randomized controlled trial | — | Humans | 1.75 mg | subcutaneous | — | Bremelanotide was safe and well tolerated and demonstrated significant improvement in efficacy vs placebo in the phase 2b trial. | Human clinical trial |
| White 2017 | Randomized controlled trial | — | Humans | — | subcutaneous | — | Increases in BP were accompanied by reductions in HR during the 0-4-h interval for the 1.75-mg dose (-4.6 to -4.7 bpm; P Conclusion These data show that ambulatory monitoring was a useful methodology to detect small,… | Human clinical trial |
| Clayton 2017 | Randomized controlled trial | 24 | Humans | — | — | — | No clinically significant pharmacokinetic interactions were found between ethanol and BMT either overall or by sex. | Human clinical trial |
| Clayton 2016 | Randomized controlled trial | 327 | Humans | — | — | 12 weeks | — | Human clinical trial |
| Diamond 2005 | Randomized controlled trial | — | Humans | 25 mg | intranasal | — | The erectile response induced by co-administration of PT-141 and sildenafil was significantly greater than the response elicited by administration of sildenafil alone. | Human clinical trial |
| Rosen 2004 | Randomized controlled trial | — | Humans | — | subcutaneous | — | The erectile response induced by PT-141 was statistically significant at both doses. | Human clinical trial |
| Diamond 2004 | Randomized controlled trial | — | Humans | — | intranasal | — | In both studies, an erectile response induced by PT-141 administration was statistically significant, compared to placebo, at doses greater than 7 mg, with the onset of the first erection occurring in approximately 30… | Human clinical trial |
| Molinoff 2003 | Clinical trial | — | Humans | — | — | — | Administration of PT-141 to normal men and to patients with erectile dysfunction resulted in a rapid dose-dependent increase in erectile activity. | Human clinical trial |
| Simon 2019 | Human study | — | Humans | — | — | 52 week | During the 52-week open-label extension of RECONNECT, no new safety signals were observed, and premenopausal women treated with bremelanotide exhibited sustained improvements in hypoactive sexual desire disorder… | Observational, human |
| Merlino 2026 | Animal study | — | — | — | — | — | — | Animal, preclinical |
| Krupke 2025 | Animal study | — | Dogs, Swine | — | subcutaneous | — | In beagle dogs, the bioavailability of semaglutide (4.11 kDa) was substantially improved compared to the commercially available tablet, with an application time of only 10 min. | Animal, preclinical |
| Borland 2025 | Animal study | — | — | — | — | — | — | Animal, preclinical |
| King 2007 | Animal study | — | — | — | — | — | Through their centrally mediated activity, melanocortin agonists have potential to treat erectile dysfunction as well as possible applications to the unmet medical needs of decreased sexual motivation and loss of libido. | Animal, preclinical |
| Yuvaraaj 2026 | In vitro study | — | — | — | — | — | Forced degradation studies revealed that BRM exhibited lower degradation under acidic conditions compared with basic conditions and showed significant susceptibility to oxidative conditions. | Mechanistic, in vitro |
| Spana 2022 | In vitro study | — | Humans | — | subcutaneous | 4 day | In Study A, 27 of 30 bremelanotide subjects (90.0%) completed the trial and exhibited a significantly greater reduction in body weight after 16 days versus placebo [least squares mean difference (95% CI), -1.3 (-1.9 to… | Mechanistic, in vitro |
| Zhang 2021 | In vitro study | — | Humans | — | — | — | — | Mechanistic, in vitro |
Doses reported in studies
Each entry is a sentence quoted from the study's abstract, with the study's design, sample size and year in front of it. Comparator doses in the same sentence are not attributed to bremelanotide.
- Doses stated in the abstract: 1.75 mg
Patients self-administered bremelanotide 1.75 mg or placebo subcutaneously using an autoinjector, as needed, before sexual activity for 24 weeks.
Sourcepmid-35230162· quoted verbatim from the abstract, emphasis added - Doses stated in the abstract: 1.75 mg
Two identical phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trials (RECONNECT) evaluated the safety and efficacy of bremelanotide 1.75 mg administered subcutaneously as needed in premenopausal women with hypoactive sexual desire disorder.
Sourcepmid-31599840· quoted verbatim from the abstract, emphasis added - Doses stated in the abstract: 1.75 mg
Clinical implications These responder definitions were subsequently used in the bremelanotide phase 3 registration studies (RECONNECT) that evaluated the safety and efficacy of the bremelanotide 1.75 mg subcutaneous dose in premenopausal women with HSDD.
Sourcepmid-31277966· quoted verbatim from the abstract, emphasis added - Doses stated in the abstract: 25 mg
Nineteen patients with erectile dysfunction who were responders to either Viagra or Levitra by self-report were given 25 mg sildenafil and 7.5 mg intranasal PT-141, 25 mg sildenafil and an intranasal placebo spray, and a placebo tablet and an intranasal placebo spray in a randomized cross-over design.
Sourcepmid-15833522· quoted verbatim from the abstract, emphasis added
Escalation schedules used in studies
How trials stepped doses, reported as study design.
-
Althof S, Derogatis LR, Greenberg S, et al. Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide.
Sourcepmid-31277966· quoted verbatim from the abstract
Adverse events and frequency
Events and their frequency as each study reported them, with the denominator where the abstract gives one.
-
The most common adverse events (AEs) were nausea (40.0% vs. 1.3%), flushing (20.3% vs. 1.3%), headache (11.3% vs. 1.9%), and injection site reactions (5.4 vs. 0.5), bremelanotide versus placebo groups, respectively, in the integrated double-blind portion of the phase 3 studies ( N = 1247).
Sourcepmid-35147466· quoted verbatim from the abstract -
Bremelanotide was safe and well tolerated and demonstrated significant improvement in efficacy vs placebo in the phase 2b trial.
Sourcepmid-31277966· quoted verbatim from the abstract -
Co-administration of PT-141 and sildenafil was safe and well-tolerated and did not result in new adverse events or adverse events that were increased in frequency or severity compared with monotherapy.
Sourcepmid-15833522· quoted verbatim from the abstract -
PT-141 was safe and well tolerated in both studies.
Sourcepmid-14999221· quoted verbatim from the abstract -
PT-141 was safely administered and well tolerated in both studies.
Sourcepmid-14963471· quoted verbatim from the abstract -
Women who completed the 24-week double-blind core phase of RECONNECT, composed of two parallel phase 3 trials (301 and 302) examining the safety and efficacy of bremelanotide compared with placebo in premenopausal women with hypoactive sexual desire disorder, could enroll in the 52-week open-label extension, provided they had not experienced serious adverse events during the core phase.
Sourcepmid-31599847· quoted verbatim from the abstract
Study durations
Treatment and follow-up periods as stated in each abstract.
- Durations stated: 52 week; 24 weeks
Food and Drug Administration for treatment of acquired generalized HSDD in premenopausal women, were established in the phase 3 RECONNECT studies, two identically designed double-blind randomized placebo-controlled studies with an optional 52-week open-label extension.
Sourcepmid-35230162· quoted verbatim from the abstract - Durations stated: 24 weeks
Patients were randomized 1:1 to 24 weeks of treatment with bremelanotide or placebo.
Sourcepmid-31599840· quoted verbatim from the abstract, emphasis added - Durations stated: 12 weeks
Patients randomized to receive placebo or BMT 0.75, 1.25 or 1.75 mg self-administered subcutaneously, as desired, over 12 weeks.
Sourcepmid-27181790· quoted verbatim from the abstract, emphasis added - Durations stated: 52 week
During the 52-week open-label extension of RECONNECT, no new safety signals were observed, and premenopausal women treated with bremelanotide exhibited sustained improvements in hypoactive sexual desire disorder symptoms.
Sourcepmid-31599847· quoted verbatim from the abstract - Durations stated: 4 day
Study B was a crossover trial with six distinct treatment sequences consisting of three 4-day treatment periods, investigating once-a-day and twice-a-day exposure to bremelanotide versus placebo.
Sourcepmid-35170192· quoted verbatim from the abstract
Routes studied
Routes of administration named in each study.
- administration by subcutaneous route reported
Patients self-administered bremelanotide 1.75 mg or placebo subcutaneously using an autoinjector, as needed, before sexual activity for 24 weeks.
Sourcepmid-35230162· quoted verbatim from the abstract - administration by subcutaneous route reported
Two identical phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trials (RECONNECT) evaluated the safety and efficacy of bremelanotide 1.75 mg administered subcutaneously as needed in premenopausal women with hypoactive sexual desire disorder.
Sourcepmid-31599840· quoted verbatim from the abstract - administration by subcutaneous route reported
Clinical implications These responder definitions were subsequently used in the bremelanotide phase 3 registration studies (RECONNECT) that evaluated the safety and efficacy of the bremelanotide 1.75 mg subcutaneous dose in premenopausal women with HSDD.
Sourcepmid-31277966· quoted verbatim from the abstract - administration by subcutaneous route reported
Bremelanotide is an on-demand, subcutaneous melanocortin-receptor agonist that binds to the melanocortin receptor 4 and is being developed for the treatment of female sexual dysfunction.
Sourcepmid-27977473· quoted verbatim from the abstract - administration by intranasal route reported
Nineteen patients with erectile dysfunction who were responders to either Viagra or Levitra by self-report were given 25 mg sildenafil and 7.5 mg intranasal PT-141, 25 mg sildenafil and an intranasal placebo spray, and a placebo tablet and an intranasal placebo spray in a randomized cross-over design.
Sourcepmid-15833522· quoted verbatim from the abstract - administration by subcutaneous route reported
PT-141, a cyclic heptapeptide melanocortin analog, was evaluated following subcutaneous administration to healthy male subjects and to patients with erectile dysfunction (ED) who report an inadequate response to Viagra.
Sourcepmid-14999221· quoted verbatim from the abstract
Reported interactions
Sentences in which the compound is studied alongside another agent. Read the quotation: the word interaction can also be statistical.
-
This was a Phase I study to evaluate the safety, tolerability, and hemodynamic and pharmacokinetic effects of bremelanotide (BMT) coadministered with ethanol to healthy male and female participants.
Sourcepmid-28189361· quoted verbatim from the abstract -
To evaluate the safety and pharmacodynamic effect of co-administration of subtherapeutic doses of PT-141, a cyclic heptapeptide melanocortin analogue, and sildenafil to patients with erectile dysfunction.
Sourcepmid-15833522· quoted verbatim from the abstract -
The results of this study are discussed in conjunction with similar studies in rats, with the conclusion that bremelanotide does not act on the VTA-NAc reward circuit and does not enhance the rewarding effects of sexual interactions.
Sourcepmid-39793696· quoted verbatim from the abstract
Biomarkers measured in studies
Laboratory and clinical measures the studies report tracking, including which hormones did and did not change.
-
This report investigates efficacy of bremelanotide versus placebo according to prespecified subgroups (age, weight, body mass index [BMI], and bioavailable testosterone) in the RECONNECT studies.
Sourcepmid-35230162· quoted verbatim from the abstract -
Although not deemed clinically important, bremelanotide should be used with caution in patients at risk of cardiovascular disease, and blood pressure should be well controlled during treatment.
Sourcepmid-35147466· quoted verbatim from the abstract -
Althof S, Derogatis LR, Greenberg S, et al. Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide.
Sourcepmid-31277966· quoted verbatim from the abstract -
We studied the effects of bremelanotide administration on ambulatory BP and heart rate (HR), in a randomized, double-blind, placebo-controlled, and parallel-arm trial of three doses of bremelanotide (0.75, 1.25, and 1.75 mg) in 397 premenopausal women with female sexual dysfunction with normotension or controlled hypertension.
Sourcepmid-27977473· quoted verbatim from the abstract -
This was a Phase I study to evaluate the safety, tolerability, and hemodynamic and pharmacokinetic effects of bremelanotide (BMT) coadministered with ethanol to healthy male and female participants.
Sourcepmid-28189361· quoted verbatim from the abstract -
Co-administration of intranasal PT-141 and a phosphodiesterase type 5 inhibitor may constitute a treatment alternative for patients in whom higher doses of a single therapy are not effective or well tolerated.
Sourcepmid-15833522· quoted verbatim from the abstract
Reported timelines
Onset, peak and duration figures as each study reported them.
-
In both studies, an erectile response induced by PT-141 administration was statistically significant, compared to placebo, at doses greater than 7 mg, with the onset of the first erection occurring in approximately 30 min.
Sourcepmid-14963471· quoted verbatim from the abstract
Storage and stability
Stability and storage conditions as reported.
-
The recent clinical success of macrocyclic peptides, such as bremelanotide and setmelanotide, highlights the potential of this modality as a "Goldilocks" chemical class, effectively balancing the properties of small molecules and biologics while optimizing their affinity, stability, and pharmacokinetics.
Sourcepmid-42340853· quoted verbatim from the abstract -
Bremelanotide (BRM) is a cyclic peptide therapeutic whose intrinsic stability and degradation behavior have not been extensively investigated.
Sourcepmid-42485063· quoted verbatim from the abstract
Method note · shared across compounds
Reconstitution mathematics
Lyophilised peptide is supplied as a mass in a vial and dissolved in a stated volume of diluent. Two figures follow from that and nothing else:
- Concentration = mass in vial ÷ diluent volume. A 5 mg vial in 2 mL is 2.5 mg/mL, or 2,500 mcg/mL.
- Volume for a given mass = that mass ÷ concentration. 250 mcg at 2,500 mcg/mL is 0.1 mL. On a U-100 insulin syringe, where 1 mL is 100 units, that is 10 units.
Study doses on this page are quoted as published, in the units the authors used. Converting between mcg, mg and IU, or between a mass and a syringe volume, is arithmetic; deciding a mass is not, and this page does not do it. The reconstitution calculator performs the conversion with the formula shown.
Method note · shared across compounds
Reading a certificate of analysis
A certificate of analysis is a laboratory report on one batch. Reading it means checking four things in order.
- Identity. Mass spectrometry should report an observed molecular mass matching the peptide's theoretical mass within the instrument's stated tolerance. A certificate with no mass spectrometry, or one that lists only the expected value, has not confirmed identity.
- Purity. HPLC purity is the area of the main peak as a share of all peaks, at a stated wavelength. It says nothing about what the other peaks are, and it is not a measure of quantity.
- Quantity. Net peptide content, by amino acid analysis or UV, is the fraction of the vial's mass that is peptide rather than counter-ions and water. A 5 mg vial at 80% net content holds 4 mg of peptide, and every concentration figure above changes accordingly.
- Provenance. The batch number on the certificate should match the vial, the laboratory should be named and independent of the seller, and the test date should be recent.
This page rates no supplier and links to none. It describes how to read the document.
Method note · shared across compounds
Equipment described in studies
Published human studies of injectable peptides report the same small set of materials: single-use insulin syringes with fixed needles, most often U-100 with 29 to 31 gauge needles; bacteriostatic water or sterile water for injection as diluent, with the choice stated in the methods; alcohol swabs; and refrigerated storage of reconstituted solution. Animal studies more often report intraperitoneal or intragastric administration and state the vehicle used. Where a study in this record's ledger names its materials or vehicle, that sentence appears under storage or routes above; where it does not, nothing is assumed here.
Other compounds in its class
Same class in the registry: Melanotan II. Each row shows what that compound's own record states; nothing is inferred across rows.
| Compound | Tier | Publications | RCTs | Record |
|---|---|---|---|---|
| Bremelanotide | Approved label | 127 | 14 | draft |
| Melanotan II | Human clinical trial | 646 | 1 | draft |
Regulatory status
Registry facts only. Jurisdiction-level status, compounding categories and sport prohibitions need their own cited documents before they appear here.
- Registry entry
Open questions and limitations
What is genuinely unknown, stated plainly. A missing field is not evidence that the outcome is safe, effective, or established.
- No study in this record's ledger reports weight-normalized doses for Bremelanotide.
- No study in this record's ledger reports exclusion criteria for Bremelanotide.
Questions people ask
Has Bremelanotide been tested in humans?
Yes. Europe PMC indexes 9 clinical trials and 14 randomized controlled trials naming Bremelanotide or a listed alias in the title or abstract. The evidence table above lists the ones in this record's ledger with their design and sample size; check the study name, since an alias can refer to a different formulation of the same molecule.
What kind of evidence exists for Bremelanotide?
The strongest tier is approved label: an approved medicine with a regulator-reviewed label. Every claim on this page carries its own tier, because a compound with one human trial and forty animal studies is described by both facts, not the better one.
Is Bremelanotide an approved medicine?
ChEMBL records CHEMBL4297533 at maximum clinical phase 4, first approved 2019. Approval status differs by jurisdiction and is pending human review on this record.
Which species has Bremelanotide been studied in?
Studies in this record's ledger report work in: Dogs, Humans, Swine. Findings in one species do not transfer to another, and weight-normalized doses in particular do not scale linearly between them.
Sources
Full citations. Every claim above links to one of these by its id.
- 1
- 2Goldilocks-Inspired Design of Mid-Size Macrocycles for Selective Targeting of Human Melanocortin Receptors.
pmid-42340853· · peer-reviewed - 3A biodegradable suction patch for sustainable transbuccal peptide delivery.
pmid-40513668· · peer-reviewed - 4FDA-approved drugs as potential covalent inhibitors of key SARS-CoV-2 proteins: an in silico approach.
pmid-40678415· · peer-reviewed - 5
- 6Targeting the central melanocortin system for the treatment of metabolic disorders.
pmid-37365323· · peer-reviewed - 7Effect of bremelanotide on body weight of obese women: Data from two phase 1 randomized controlled trials.
pmid-35170192· · peer-reviewed - 8Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide.
pmid-35230162· · peer-reviewed - 9Safety Profile of Bremelanotide Across the Clinical Development Program.
pmid-35147466· · peer-reviewed - 10Psychometric validation of the Female Sexual Distress Scale-Desire/Arousal/Orgasm.
pmid-34559353· · peer-reviewed - 11Structural insights into ligand recognition and activation of the melanocortin-4 receptor.
pmid-34433901· · peer-reviewed - 12
Show the remaining 15 sources
- 132019 FDA TIDES (Peptides and Oligonucleotides) Harvest.
pmid-32151051· · peer-reviewed - 14Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials.
pmid-31599840· · peer-reviewed - 15Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder.
pmid-31599847· · peer-reviewed - 16Bremelanotide: First Approval.
pmid-31429064· · peer-reviewed - 17Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide.
pmid-31277966· · peer-reviewed - 18Usefulness of ambulatory blood pressure monitoring to assess the melanocortin receptor agonist bremelanotide.
pmid-27977473· · peer-reviewed - 19
- 20Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial.
pmid-27181790· · peer-reviewed - 21
- 22Melanocortin receptors, melanotropic peptides and penile erection.
pmid-17584130· · peer-reviewed - 23Melanocortin peptide therapeutics: historical milestones, clinical studies and commercialization.
pmid-16412534· · peer-reviewed - 24
- 25
- 26
- 27PT-141: a melanocortin agonist for the treatment of sexual dysfunction.
pmid-12851303· · peer-reviewed
Reference card
Reference card · generated /compounds/bremelanotide-pt-141
- Compound
- Bremelanotide, melanocortin agonists
- Evidence tier
- Approved label
- Indexed publications
- 127 · 14 RCTs · 9 other clinical trials
- Approval
- approved (2019)
- Routes reported
- intranasal, subcutaneous
Study figures are as published in each source and are not recommendations. Print or save this card with its date.
Last reviewed and what changed
Newest first. These are the record's own revision dates, and the same dates feed the sitemap.
- · Claims drafted extractively from 27 ledger sources by scripts/draft_claims.py: 34 claims, 21 evidence-table rows. Status researched -> draft.
- · Claims drafted extractively from 27 ledger sources by scripts/draft_claims.py: 40 claims, 21 evidence-table rows. Status researched -> draft.
- · Claims drafted extractively from 27 ledger sources by scripts/draft_claims.py: 42 claims, 21 evidence-table rows. Status researched -> draft.
- · Evidence fetched from Europe PMC and ChEMBL by scripts/fetch_evidence.py; claims not yet written.