Bremelanotyd, often referred to by the research name PT-141, is a cyclic heptapeptide related to alpha-melanotropic hormone (α-MSH). Its structure is usually represented as Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH. It is also described as cyclo-Ac-[Nle4, Asp5, D-Phe7, Lys10] α-MSH-(4–10).
Unlike drugs whose main effect is peripheral vasoconstriction, bremelanotide acts on melanocortin signaling in the central nervous system.
Its best documented clinical application is the treatment of acquired generalized hypoactive sexual desire disorder (HSDD) in a specific group of premenopausal women. In 2019, the U.S. Food and Drug Administration (FDA) approved the prescription-only drug bremelanotide for this indication [1,2].
The studies also included the effects of bremelanotide on sexual arousal, erectile responses, dopamine-related neural circuits, and subjectively assessed sexual functioning.
However, not all of these lines of research should be treated as equivalent evidence. Controlled clinical trials in the population covered by the approved indication, early studies in men, animal experiments, and observations from individual clinics address different questions.
This review presents the results described in the available literature and explains where the conclusions remain limited.
What is bremelanotide (PT-141)?
PT-141 is a synthetic melanocortin receptor agonist developed based on a modified peptide sequence related to α-MSH.
Its cyclic lactam structure and amino acid substitutions distinguish it from the natural hormone.
The researchers focused primarily on the signaling of the melanocortin type 4 receptor (MC4R) as a possible explanation for the effect of bremelanotide on motivation and sexual responses.
The pharmacology of melanocortins, however, encompasses many subtypes of receptors and related biological pathways [1,24,25].
In clinical trials involving premenopausal women meeting the criteria for the approved indication, improvements in sexual desire assessment scores and a reduction in associated psychological discomfort were documented.
However, this does not mean that bremelanotide is a fixed method of treatment for all forms of sexual difficulties, nor that the results obtained in women can be automatically transferred to men.
Studies of erectile dysfunction and other populations remain separate from the indication approved by the FDA [1,2].
Bremelanotyd and a reduced sexual desire in women
HSDD is characterized by a persistent decrease in sexual desire accompanied by clinically significant psychological discomfort.
Studies of bremelanotide evaluated both the desire itself and the discomfort associated with its reduction.
These are endpoints other than the frequency of sexual intercourse or the ability to achieve orgasm. Moreover, statistically detectable change does not always mean a significant benefit for a specific individual.
Long-term clinical results
Simon and colleagues (2019) observed 684 participants during a 52-week extension of the study after an initial phase lasting 24 weeks.
The study used a subcutaneous formulation of bremelanotide at a dose of 1.75 mg and evaluated, among other things, the Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale.
The researchers described the continued improvement in parameters related to sexual desire and the absence of unexpected safety signals during the prolonged phase.
The frequently reported adverse reactions included nausea, skin redness and headache. Nausea was particularly important for the tolerability of the treatment.
Since this was a prolonged study, its results should be interpreted taking into account the selection of participants and factors influencing continued participation [3].
Randomized study of different doses
Clayton and colleagues (2016) studied premenopausal women in a randomized, double-blind, placebo-controlled trial aimed at evaluating different doses.
The study included groups receiving 0.75 mg, 1.25 mg and 1.75 mg of bremelanotide.
In a pooled analysis of groups receiving higher doses, the number of satisfying sexual events increased by 0.7 per month, compared with an increase of 0.2 in the placebo group (p = 0.0180).
The results of the FSFI changed by +3.6 compared to +1.9 (p = 0.0017), while the results of the sexual discomfort scale changed by −11.1 compared to −6.8 (p = 0.0014).
Nausea, skin redness and headache were again among the significant observations regarding tolerance.
The magnitude of the difference in the frequency of sexual events constitutes an important interpretative context, even if the results achieved statistical significance [4].
Kingsberg and colleagues (2014) analyzed psychological discomfort in 327 participants during a 12-week treatment period, preceded by a placebo-controlled baseline phase.
In the 1.75 mg group, the change in the discomfort score was −13.1.
In the combined groups of 1.25 mg and 1.75 mg, the change was −11.1, compared with −6.8 in the placebo group.
The results support the possibility of influencing the measured discomfort in the studied population. However, the source is presented as a conference abstract rather than a full, independent report of the clinical trial [9].
The manuscript provided also assigns the same numerical results — +0.7 versus +0.2 events, +3.6 versus +1.9 in the FSFI, and −11.1 versus −6.8 in the discomfort scale — to Seftel’s 2016 publication [11].
Since [11] is a commentary on the Clayton study and not an independent randomized clinical trial, these values should not be taken as confirmation of the results in a separate study.
The original citation notation has been retained for clarity.
Results of subgroup analyses of the RECONNECT Phase III studies
The integrated analysis by Simon and colleagues (2022) included 1202 participants in the RECONNECT study.
In the analyzed categories of age, body mass, body mass index (BMI), initial level of available testosterone, use of hormonal contraception, and duration of HSDD, bremelanotide was associated with an improvement in the domain of desire in FSFI and a reduction in discomfort assessed using the position 13 of the FSDS-DAO scale.
The results suggest that the observed effects were not limited to one measured demographic subgroup.
However, they do not show identical responses in every person [10].
A separate analysis of the subgroup of RECONNECT participants using hormonal contraception showed a numerical improvement in desire in FSFI and a significant reduction in the FSDS-DAO Item 13 score.
Since the results are presented in the form of a conference abstract, they require more careful interpretation than a full review report [13].
Experiences reported by the participants
Koochaki and colleagues (2021) collected the reports of 242 RECONNECT participants after they had completed the study.
Women receiving bremelanotide described changes in sexual interest, subjective physical arousal, and perceived quality of sexual experiences and partner relationships.
The participants receiving the placebo also described the benefits associated with participating in care, seeking help, or talking with partners about sexual difficulties.
Qualitative results provide valuable information about patients' experiences, but they do not replace blinded efficacy measurements [5].
A previous survey by Koochaki and colleagues (2017) included 61 premenopausal women aged 22–53 years, with an average age of 39 years.
The participants described sexual difficulties that lasted from several months to over ten years.
In 42% previous attempts at other treatments, they were unsuccessful.
The relationships were characterized by anxiety, concerns about one’s own body image, a change in self-confidence in the sexual sphere, and difficulties in relationships.
Some participants described an improvement in sensitivity, initiating sexual contact, satisfaction, and self-confidence after using bremelanotide.
Interviews allow for a better understanding of the experiences of patients, but without a controlled design they do not confirm the comparative effectiveness [23].
Studies on the reported use of bremelanotide in women
Diamond and colleagues (2006) evaluated 18 premenopausal women with sexual arousal disorders in a double-blind cross-over experiment.
The experimental reporting formulation was used at a dose of 20 mg.
More participants reported moderate or high desire for bremelanotide than for placebo (p = 0.0114).
The assessments of genital arousal showed a tendency towards improvement (p = 0.0833), whereas the satisfaction with arousal among women attempting sexual intercourse within 24 hours differed significantly (p = 0.0256).
The small sample size and the older experimental route of administration limit the possibility of a direct comparison with the approved subcutaneous preparation [7].
A 2006 commentary summarized the early results of observational studies in women aged 22–44 years.
67% participants receiving bremelanotide reported an increase in desire compared to 22% in the placebo group, and 72% reported an increase in genital arousal compared to 39%.
These values are presented in accordance with the manuscript provided. However, the cited publication is a brief review, not a full report of the original clinical study [12].
How large are the clinical benefits?
Mayer and Lynch (2020) analyzed the evidence from Phase II and III studies.
They emphasized that statistically significant changes in desire and discomfort can translate into a relatively small improvement in clinical symptoms in some people.
The review reported nausea in 39.9% participants, facial flushing in 20.4%, and headache in 11%.
The authors also discussed the relatively limited data on interactions and the still evolving role of bremelanotide in clinical practice [8].
A balanced interpretation therefore takes into account both the improvement in the results of validated scales and the frequency of adverse events.
Studies of the actual practice of prescribing bremelanotide to women
In a single-site analysis, Goldstein and colleagues (2023) described the prescriptions implemented from the end of 2019 to November 2022.
64 cases of recurrence were recorded in women before menopause, with a recurrence rate of 25%, and 97 in women after menopause, with a recurrence rate of 54%.
Among women before menopause, the cumulative recurrence rates were 10% for the period 2019–2020, 17% for 2019–2021, 25% for 2019–2022, and 37% for 2021–2022.
The corresponding values in women after menopause were 43%, 52%, 54% and 65% [19].
An additional clinical report from 2024 described 76 prescriptions for women before menopause (29% re-fillings), 104 for women after menopause (52%), and 444 for men (65%) as of June 30, 2023.
In the last 18 months of this period, the rates of re-execution were 47%, 52% and 73% respectively [20].
The re-implementation of prescriptions may reflect perceived usefulness, tolerability, availability, cost, and prescribing practices.
However, it does not constitute independent evidence of safety or clinical effectiveness.
Its use in postmenopausal women and in men also goes beyond the FDA-approved indication discussed in the article.
PT-141 in men: studies of erectile dysfunction and sexual function
Although bremelanotide has been studied in men with erectile dysfunction (ED) and other sexual difficulties, the FDA has not approved it for the treatment of sexual dysfunction in men.
Available evidence includes controlled early-phase studies, sildenafil experiments, and observations from a single clinical setting.
Its central melanocortin activity differs from the main peripheral vascular mechanism of phosphodiesterase type 5 inhibitors.
Men with insufficient response to sildenafil
Safarinejad and Hosseini (2008) conducted a randomized study involving 342 married men aged 28–59 who did not achieve sufficient response to sildenafil.
The participants were assigned to a group receiving the experimental bremelanotide formulation at a dose of 10 mg or placebo.
The results were evaluated using the International Index of Erectile Function.
Beneficial results were observed in 33.5% men in the bremelanotide group compared to 8.5% in the control group (p = 0.03).
Satisfaction with the sexual relationship was also higher (p = 0.03), although adverse drug reactions occurred more frequently (p = 0.01).
The results refer to a specific population and formulation, and not to a fixed therapeutic recommendation [15].
Studies on the connection with sildenafil
Diamond and colleagues (2005) conducted a randomized cross-over design in 19 men with erectile dysfunction.
The experimental conditions included 25 mg of sildenafil in combination with 7.5 mg of the reported PT-141, sildenafil with the reported placebo, and double-blind placebo.
The registrations of RigiScan indicated a stronger erectile response when both substances were used than when sildenafil was used alone.
The experiment was small and focused on short-term physiological measurements.
It does not allow determining long-term safety or justifying the independent combination of these substances [16].
Early pharmacodynamic studies
Rosen and colleagues (2004) studied subcutaneous PT-141 in healthy men and men with an inadequate response to sildenafil.
The submitted manuscript describes significant erectile responses at doses exceeding 1.0 mg in healthy volunteers and responses at 4 and 6 mg in men with erectile dysfunction during visual sexual stimulation.
These were experimental dose levels used to characterize the pharmacodynamic effects [17].
In a separate double-blind study, Diamond and colleagues (2004) evaluated the reported effects of PT-141 in healthy men and men with mild or moderate erectile dysfunction.
Statistically significant erectile responses were observed at doses exceeding 7 mg.
The first erections occurred about 30 minutes after administration.
The most commonly reported adverse reactions were skin redness and nausea.
No clinically relevant changes in the evaluated vital parameters, electrocardiograms, laboratory tests, or physical examinations were described.
The results refer to the specific conditions of the short-term study [18].
Observational reports in men
Goldstein and colleagues (2024) described 444 prescriptions issued to men between September 2019 and June 2023.
The overall rate of repeat executions was 65%, and in the last 18 months it was 73%.
In a small group of respondents, 25 men agreed to participate, and 20 completed the assessment.
The reported changes included:
- greater satisfaction with the quality of life and its duration — 75%;
- easier penetration of the vagina — 88%;
- easier achieving orgasm — 67%;
- greater comfort in initiating sexual activity — 80%;
- Greater expectation of pleasant experiences — 73%.
On the Patient Global Impression of Improvement (PGI-I) scale, 72% reported an improvement in sexual functioning.
The reported adverse reactions included nausea (30%), skin redness (22%), headache (13%), and spontaneous erections (13%) [21].
In another report from 2024, 21 men were recruited. Of these, 19 completed online questionnaires and 12 participated in follow-up interviews.
Among the respondents to the questionnaire:
- 80% reported greater satisfaction with their relationships;
- 93% easier vaginal penetration;
- 71% easier achieving orgasm;
- 86% greater freedom to initiate sexual activity;
- 79% greater expectation of pleasure;
- 69% more satisfying orgasm;
- 73% greater pleasure from sexual activity;
- 79% perceived improvement in the partner's experience.
53% reported an improvement in PGI-I.
In the screening survey, 69% participants indicated erectile dysfunction as the reason for receiving a prescription, while 64% described additional difficulties related to sexual health.
Among these difficulties, sex-related anxiety (54%) and decreased desire (45%) were mentioned.
Participants in the interviews described an improvement in sexual function (91%) and a reduction in sex-related anxiety (64%).
The reported adverse reactions included skin redness and nausea (after 36%), headache and spontaneous erections (after 27%), and urinary incontinence, abdominal cramps or burning (after 9%) [22].
Descriptive results should not be considered evidence of an effect obtained in a placebo-controlled study.
Small, self-selected samples, a single clinic, subjective endpoints, and overlapping observation periods limit the possibility of generalization.
Both reports may partially include the same clinical populations and should not be summed up as independent groups of participants.
How does bremelanotide affect desire and sexual arousal?
Preclinical studies place melanocortin signaling within a broader network of neuronal circuits involved in motivation, attention directed towards sexual stimuli, and behavioral responses.
MC4R activation is associated with the hypothalamus and connections involving the mid-preoptic area (mPOA), the ventral tegmental area (VTA), and the amygdala.
One of the proposed elements of further signaling is the dopamine system, including processes related to D1 receptors [24,25].
In animal experiments, markers of activation were observed in regions of the brain associated with sexual behaviors.
Studies of female rats after removal of the ovaries showed more frequent behaviors initiating sexual contact, such as jumping, rapid movements, and other behaviors of approaching.
However, no equivalent changes in the pace of contact or lordosis were observed.
The distinction suggests that some measured behaviors related to sexual motivation were more susceptible to influence than other elements of the copulatory behavior [24,25].
Experiments blocking the melanocortin or dopamine receptors further support the involvement of these pathways.
However, neuronal signaling is not limited to a single behavioral function, and rodent studies do not confirm the same mechanism or the same degree of receptor selectivity in humans.
The source also describes the neuroimaging results regarding the amygdala, the brainstem, the cerebellum, the additional motor field, and the secondary somatosensory cortex [20].
Before these descriptions are considered conclusive neuroimaging evidence, the cited conference abstract should be examined.
The formulations and routes of administration studied
The approved bremelanotide product in the United States is an under-the-skin auto-injector that is dispensed on prescription.
The original manuscript describes a dosage with a product characteristic of 1.75 mg, administration around the abdomen or thigh, a minimum 24-hour interval between doses and a maximum of eight doses per month.
This information describes the labeling of an approved product, not an individual recommendation. Decisions regarding the prescribing of the drug require consideration of the current official documentation and evaluation by a qualified physician [1,2,8].
The research publications also describe older reporting formulations, including experimental doses of 20 mg in women and various doses in studies in men [7,15–18].
It should not be assumed that these formulations are equivalent to the approved injection product.
In particular, the claim in the submitted manuscript that the 10 mg aerosol dose is a „standard dose” is not supported by the cited clinical evidence.
The original instructions for preparing a reportable aerosol should not be presented as validated instructions for an unapproved formulation.
Similarly, the reported starting time of 30–60 minutes and the duration of the effect of 6–12 hours should be treated as generalized statements.
These are not reliably established pharmacokinetic or clinical ranges for each individual.
Sexual response and exposure to the drug are not the same measurements.
Regulatory status and clinical application scope
The FDA approved bremelanotide, sold under the name Vyleesi, in 2019 for the strictly defined indication of HSDD in women before menopause.
Approval does not include men, postmenopausal women, or all cases of reduced sexual interest.
Regulatory permits can also vary between countries.
Just being approved in the United States does not mean that it will be allowed to be sold or that it will have a legal status in Poland or other countries [1,2].
The source discusses both approved clinical use and experimental or off-label use.
Distinguishing these categories is essential when presenting the results of studies, prescribing practices, and safety.
Safety and adverse reactions in bremelanotide studies
A safety analysis including the clinical development program revealed frequent adverse reactions in phase III studies.
The following was noted:
- nausea in about 40.0% participants receiving bremelanotide compared to 1.3% in the placebo group;
- redness of the skin in 20.3% cases compared to 1.3%;
- headache in 11.3% cases compared to 1.9%;
- reactions at the injection site were 5.4% vs. 0.5%.
The original manuscript describes 1247 participants over an 18-month period of the clinical development program.
Nausea was an important factor contributing to discontinuation of treatment [6].
Another recognized risk is skin discoloration.
The source indicates local skin darkening in more than one-third of the participants receiving 16 consecutive daily doses under specific study conditions.
This is not an estimate of risk during normal use in accordance with the approved product characteristics.
The drug can also cause a temporary increase in blood pressure, which is particularly important when assessing safety in people with cardiovascular diseases [6,8].
The review presented indicates uncontrolled hypertension and recognized cardiovascular disease as important issues related to contraindications.
He also mentions pharmacokinetic interactions related to oral indomethacin and naltrexone.
Therefore, it is not appropriate to generalize these findings into the claim that bremelanotide does not have clinically relevant interactions.
In a separate randomized study, the simultaneous administration of ethanol to healthy volunteers was evaluated, but the results do not resolve all possible interactions or issues regarding long-term safety [14].
A continuation of participation in the open-label phase was observed in 70% participants receiving bremelanotide and 87% participants receiving placebo.
The difference should be considered in conjunction with the frequency of adverse reactions.
Just continuing participation is not a direct measure of satisfaction or benefits [6].
Limitations of evidence and their interpretation
The literature includes various clinical indications, formulations, study periods, endpoints, and populations.
The most relevant evidence for the approved indication comes from controlled studies of premenopausal women with HSDD.
Early observational studies and small studies in men provide scientific information, but do not confirm equivalent efficacy or safety in other groups.
Animal experiments provide mechanistic hypotheses, whereas repeat-dose response statistics and small-scale observational studies describe real experiences, rather than causal effects of treatment.
Part of the citations in the submitted manuscript refer to conference abstracts, commentaries, or overlapping reports from the same studies.
Therefore, the numbers from the sources should not be equated with the number of independent studies that confirm the results.
The bibliography cited in the source material has not been independently verified for accuracy.
Frequently asked questions about PT-141
What is PT-141?
PT-141 is the trade name for bromeletanotide, a cyclic synthetic peptide that activates melanocortin receptors. It has been studied for its effects on sexual desire and arousal. It has an FDA-approved indication for use by prescription in certain women with HSDD before menopause [1,2].
Is bremelanotide approved for men with erectile dysfunction?
No. Studies in men have shown changes in erectile responses and subjectively assessed sexual function, but they do not constitute a basis for FDA approval for the treatment of erectile dysfunction in men [15–18,21,22].
Does bremelanotide work the same way as sildenafil?
No. Bremelanotyd is primarily studied as a centrally acting agonist of melanocortin receptors, whereas sildenafil acts by inhibiting type 5 phosphodiesterase. In small studies, both compounds were analyzed together, but this does not establish a routine combination therapy regimen [16,24].
What have clinical studies shown in women with HSDD?
Controlled studies have shown improvements in validated measures of sexual desire and associated discomfort. Some differences, including a change in the monthly number of satisfying sexual events, were relatively small, and adverse effects such as nausea occurred frequently [3,4,8,10].
What side effects were most frequently reported?
Nausea, skin redness, headache and injection site reactions were among the most frequently reported events in clinical trials. Additional safety issues include transient increases in blood pressure and skin discoloration [6,8].
Is the reporting PT-141 an approved alternative to injection?
The source describes the experimental reporting formulations used in previous studies. However, these results should not be interpreted as allowing the standardized reporting formulation to replace the approved prescription auto-injector [7,15–18].
Do high rates of repeat prescriptions indicate the effectiveness of PT-141?
No. There are many factors influencing the re-implementation of prescriptions; these data do not include a controlled comparison necessary to determine the effect of the drug. The cited reports from real-world practice provide useful descriptive information, but they do not replace randomized clinical trials [19–22].
Is bremelanotide approved in Poland?
The sources provided document the approval by the American FDA, rather than the Polish or European marketing authorization. The legal status of a specific product or formulation should be checked in the current local regulatory registries [1,2].
Summary
Bremelanotyd is a peptide associated with the melanocortin system, acting centrally and having evidence from controlled clinical trials indicating an improvement in sexual desire and a reduction in the associated discomfort in certain premenopausal women with HSDD.
Studies in men, reporting formulations, and neural mechanisms provide additional scientific context, but the strength of these findings varies significantly.
A responsible interpretation requires a quantification of the measurable benefits of adverse effects, a distinction between approved use and experimental or off-label practices, and the avoidance of treating observational reports as conclusive evidence of efficacy.
References
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