PT-141 (Bremelanotide): Sexual Health Research

Walk into a pharmacy and ask about sexual dysfunction treatments, and you'll get a predictable answer: Viagra, Cialis, or their generic equivalents. They work by increasing blood flow to the genitals. If your plumbing is fine but your brain isn't interested, you're out of luck.

PT-141 (bremelanotide) takes a different approach. Instead of targeting blood vessels, it targets the brain — specifically, the melanocortin receptors in the hypothalamus that regulate sexual desire. This isn't experimental research confined to mouse studies. Bremelanotide is FDA-approved, marketed under the brand name Vyleesi®, and prescribed to premenopausal women with hypoactive sexual desire disorder (HSDD). It's one of the few peptides to cross the regulatory finish line, which makes it worth examining in detail.

This article covers the science: how PT-141 works, what the clinical trial data shows, who uses it, and where the research stands today.

Quick Facts
What Is PT-141?
Mechanism of Action
- Melanocortin Receptors and Sexual Function
- Central vs. Peripheral Mechanisms
Clinical Research
Pharmacokinetics
Administration and Dosing
PT-141 vs. PDE5 Inhibitors
Off-Label Use in Men
Side Effects and Safety
Legal Status and Availability
Frequently Asked Questions
The Bottom Line
References

Quick Facts

Property	Details
Full Name	Bremelanotide
Brand Name	Vyleesi®
Common Name	PT-141
Peptide Type	Synthetic cyclic heptapeptide, melanocortin receptor agonist
Amino Acid Sequence	Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH
Molecular Mass	1,025.16 Da
Primary Targets	MC3R, MC4R (melanocortin receptors)
Mechanism	Central nervous system activation of sexual desire pathways
Developer	Palatin Technologies
FDA Approval	June 21, 2019
Approved Indication	Hypoactive sexual desire disorder (HSDD) in premenopausal women
Administration	Subcutaneous injection via autoinjector pen
Typical Dose	1.75 mg
Timing	At least 45 minutes before sexual activity
Bioavailability	~100% (subcutaneous)
Half-Life	2.7 hours (range: 1.9–4.0 hours)
Protein Binding	21%

What Is PT-141?

PT-141, formally known as bremelanotide, is a synthetic peptide derived from Melanotan II, an analog of alpha-melanocyte stimulating hormone (α-MSH). While Melanotan II was originally developed for its tanning effects, researchers discovered it also triggered sexual arousal as a side effect. PT-141 is a metabolite of Melanotan II — structurally, it's identical except for the replacement of the C-terminal amide group with a carboxylic acid (hydroxyl group).

The result is a peptide that retains the sexual arousal effects while shedding some of the cardiovascular complications that plagued earlier formulations. PT-141 acts as a non-selective agonist of melanocortin receptors, primarily MC3R and MC4R, which are concentrated in the central nervous system.

Unlike Viagra or Cialis, which work peripherally by increasing blood flow to the genitals, PT-141 works centrally — it activates neural pathways in the hypothalamus and limbic system that regulate sexual desire and arousal. This makes it a fundamentally different class of treatment, one that addresses the psychological component of sexual dysfunction rather than just the mechanical one.

In 2019, the FDA approved bremelanotide under the brand name Vyleesi® for the treatment of acquired, generalized HSDD in premenopausal women. It's the second drug ever approved for this indication (the first was flibanserin, marketed as Addyi). The approval was based on data from two Phase 3 clinical trials known as the RECONNECT studies, which demonstrated statistically significant improvements in sexual desire and reduction in distress related to low libido.

Mechanism of Action

Melanocortin Receptors and Sexual Function

The melanocortin system is a family of five G protein-coupled receptors (MC1R through MC5R) that regulate a range of physiological functions, including pigmentation, appetite, energy balance, inflammation, and sexual behavior. PT-141 is an agonist of most melanocortin receptors (except MC2R), but its therapeutic effects are primarily mediated by MC3R and MC4R.

MC4R is the key player. It's heavily expressed in the hypothalamus, particularly in the paraventricular nucleus (PVH) and medial preoptic area (mPOA), regions that govern sexual motivation and arousal. When bremelanotide binds to MC4R, it activates adenylyl cyclase and increases cyclic AMP (cAMP) production, triggering downstream signaling cascades. One critical effect is increased dopamine release in the mPOA — dopamine is a neurotransmitter strongly associated with sexual desire and reward.

Research in rodent models has shown that activation of MC4R enhances copulatory behavior, increases erectile activity, and stimulates sexual solicitations. In female rats, administration of α-MSH (the endogenous melanocortin ligand) into the ventromedial hypothalamus or mPOA triggers lordosis behavior, a stereotyped posture indicating sexual receptivity. Genetic studies using MC4R knockout mice confirm that loss of this receptor impairs sexual function, while pharmacological activation with melanocortin agonists restores it.

MC3R also plays a role, though it's less well-characterized. MC3R is distributed throughout the hypothalamus and limbic structures with connections to areas controlling sexual behavior. Studies suggest it modulates sexual solicitations and arousal in both male and female animals, though its precise contribution relative to MC4R is still being mapped out.

Human evidence: Functional MRI studies in women with HSDD show that bremelanotide increases activation in brain regions associated with sexual arousal, including the hypothalamus and amygdala, when subjects are exposed to sexual stimuli. This confirms that the peptide's effects are neurogenic — it's changing how the brain processes sexual cues, not just how the body responds to them.

Central vs. Peripheral Mechanisms

This is where PT-141 diverges sharply from traditional erectile dysfunction treatments.

PDE5 inhibitors (sildenafil, tadalafil, vardenafil) work peripherally. They block phosphodiesterase type 5, an enzyme that breaks down cyclic GMP in smooth muscle cells lining the blood vessels of the penis. By preserving cGMP, these drugs cause vasodilation, increasing blood flow to the corpus cavernosum and enabling an erection. But they don't touch the brain. If you're not aroused, they won't make you want sex — they just make the plumbing work better if you do.

PT-141 works centrally. It doesn't directly affect blood flow or vascular function. Instead, it acts on melanocortin receptors in the hypothalamus to increase sexual desire, motivation, and arousal. The erectile response (in men) or genital arousal (in women) follows as a downstream consequence of that central activation. The pathway runs from brain to body, not the other way around.

This has practical implications. PDE5 inhibitors are effective for men with erectile dysfunction caused by vascular insufficiency — poor blood flow due to diabetes, cardiovascular disease, or aging. But they're less effective for men with psychogenic ED (where anxiety or depression suppresses arousal) or for women, who generally don't benefit from increased genital blood flow alone. PT-141, by contrast, targets the desire and arousal circuitry directly, which makes it potentially useful for sexual dysfunction with a psychological or neurological component.

The two mechanisms are complementary, not mutually exclusive. Research has shown that co-administration of PT-141 and a PDE5 inhibitor produces significantly enhanced erectile responses compared to either drug alone — the PDE5 inhibitor handles the vascular side, while PT-141 boosts the central drive. For men who don't respond well to PDE5 inhibitors alone, this combination strategy is under investigation.

Clinical Research

The RECONNECT Studies

Bremelanotide's FDA approval was based on two identical Phase 3, randomized, double-blind, placebo-controlled trials known as RECONNECT Study 301 and RECONNECT Study 302. These were multicenter trials conducted in the United States and Canada between January 2015 and August 2016. They enrolled 1,247 premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).

HSDD is characterized by persistently low sexual desire that causes marked distress or interpersonal difficulty. "Acquired" means it developed after a period of normal sexual function. "Generalized" means it's not limited to a specific partner or situation. The diagnosis requires that the low desire isn't better explained by a relationship problem, medical condition, or medication side effect.

Study Design and Endpoints

Both trials followed the same protocol:

Screening period (4 weeks): Patients were assessed for eligibility and baseline characteristics.
Single-blind placebo run-in (4 weeks): All participants received placebo injections to establish a stable baseline.
Randomized treatment period (24 weeks): Patients were randomized 1:1 to receive either bremelanotide 1.75 mg or placebo, administered subcutaneously as needed before sexual activity (maximum one dose per 24 hours, no more than eight doses per month).
Open-label extension (52 weeks): Patients who completed the randomized phase could enter an uncontrolled extension where all received bremelanotide.

The study population was predominantly White (86%) and Black (12%), with a mean age of 39 years (range: 19–56 years).

Primary Endpoints:

The studies used two coprimary efficacy endpoints, measured as change from baseline to end-of-study (week 24):

Female Sexual Function Index – Desire Domain (FSFI-D): A validated 6-item questionnaire measuring sexual desire. Higher scores indicate greater desire.
Female Sexual Distress Scale – Desire/Arousal/Orgasm, Item 13 (FSDS-DAO Item 13): A single-item measure of distress related to low sexual desire. Lower scores indicate less distress.

To claim success, bremelanotide had to demonstrate statistically significant improvement on both endpoints compared to placebo. The inference threshold was set at p < 0.025 (adjusted for two primary endpoints).

Secondary Endpoints:

Satisfying sexual events (SSEs)
Other domains of the FSFI (arousal, lubrication, orgasm, satisfaction, pain)
Patient Global Impression of Change (PGIC)

Results

Both trials met their primary endpoints. PT-141 significantly outperformed placebo on both measures of sexual desire and distress.

FSFI-D (Sexual Desire):

Study	Bremelanotide	Placebo	Difference	p-value
Study 301	+0.63	+0.33	+0.30	<0.001
Study 302	+0.73	+0.31	+0.42	<0.001
Integrated	+0.68	+0.33	+0.35	<0.001

FSDS-DAO Item 13 (Distress):

Study	Bremelanotide	Placebo	Difference	p-value
Study 301	-1.05	-0.68	-0.37	<0.001
Study 302	-0.95	-0.66	-0.29	0.005
Integrated	-1.00	-0.67	-0.33	<0.001

Both sexual desire and distress improved significantly in the bremelanotide group compared to placebo. The effect sizes were modest but clinically meaningful. The integrated analysis (both studies combined) showed an improvement in FSFI-D of 0.35 points and a reduction in distress of 0.33 points.

Secondary Endpoints:

Bremelanotide also demonstrated significant improvements in arousal and orgasm domains of the FSFI. Analysis of satisfying sexual events showed a statistically significant increase in the number of SSEs in the bremelanotide group compared to placebo, though the magnitude of the effect was small.

Long-Term Safety:

In the 52-week open-label extension, 684 patients received bremelanotide. The safety profile remained consistent with the randomized phase. Most adverse events were mild to moderate and related to tolerability (nausea, flushing, headache). Discontinuation rates due to adverse events were low.

Notable Findings:

The incidence of nausea was highest with the first dose and declined with subsequent doses, suggesting tolerance develops.
Blood pressure increases were transient, peaking 4–8 hours post-dose and returning to baseline within 12 hours.
There were no serious cardiovascular events attributed to bremelanotide.
Patient Global Impression of Change (PGIC) scores indicated that a significantly higher proportion of women in the bremelanotide group felt their condition had improved compared to placebo.

Pharmacokinetics

Understanding how PT-141 moves through the body helps explain its dosing requirements and safety profile.

Absorption:

Following subcutaneous injection, bremelanotide has a bioavailability of approximately 100%. Peak plasma concentrations (Cmax) are reached in about 1 hour (range: 0.5–1.0 hours). The mean Cmax after a 1.75 mg dose is 72.8 ng/mL, and the area under the curve (AUC) is 276 hr·ng/mL.

Distribution:

Bremelanotide has relatively low plasma protein binding (21%), meaning most of the circulating drug is free and pharmacologically active. This contributes to its rapid onset of action.

Metabolism:

Bremelanotide is metabolized primarily via hydrolysis of its peptide bonds. It undergoes minimal hepatic metabolism, which reduces the risk of drug-drug interactions and makes it relatively safe in patients with mild to moderate liver impairment. In patients with moderate hepatic impairment (Child-Pugh B), systemic exposure increases 1.7-fold.

Elimination:

The elimination half-life is 2.7 hours (range: 1.9–4.0 hours). Bremelanotide is excreted 64.8% in urine and 22.8% in feces. In patients with severe renal impairment, systemic exposure increases twofold, which may require dose adjustments.

Special Populations:

Renal impairment: Mild or moderate renal impairment increases exposure by 1.2- to 1.5-fold. Severe impairment doubles exposure. Use with caution.
Hepatic impairment: Mild impairment increases exposure by 1.2-fold; moderate impairment by 1.7-fold. No dose adjustment recommended for mild impairment, but caution is advised for moderate impairment.
Age, race, and body weight: No clinically significant effects on pharmacokinetics.

Administration and Dosing

Vyleesi® (the FDA-approved formulation of PT-141) is supplied as a prefilled autoinjector pen containing 1.75 mg of bremelanotide in a single-dose injection.

Administration:

Inject subcutaneously into the abdomen or thigh at least 45 minutes before anticipated sexual activity.
Do not use more than one dose within 24 hours.
Do not use more than eight doses per month.

The 45-minute lead time corresponds to the pharmacokinetic profile — peak plasma concentrations occur around 1 hour post-injection, so effects are typically felt within 30–60 minutes.

Why subcutaneous?

Early development of PT-141 explored intranasal administration. Patients received the drug as a nasal spray, and initial studies in men showed dose-dependent improvements in erectile function at doses starting around 7 mg intranasally. However, intranasal bremelanotide was associated with dose-related increases in blood pressure, which led to safety concerns. By 2008, the manufacturer (Palatin Technologies) halted nasal formulation trials and pivoted to subcutaneous injection, which showed fewer cardiovascular side effects.

Subcutaneous administration also offers higher bioavailability. Intranasal absorption is less efficient and more variable (affected by nasal congestion, mucosal health, and delivery technique), requiring significantly higher doses to achieve equivalent plasma levels. The subcutaneous route delivers consistent, reliable exposure with lower doses.

Compounded formulations:

Some patients obtain PT-141 from compounding pharmacies, which may offer different dosing options (e.g., 1.25 mg, 2.0 mg) or alternative formulations (nasal spray, troches). These are not FDA-approved and lack the quality assurance and clinical validation of Vyleesi®. Efficacy and safety profiles may differ.

PT-141 vs. PDE5 Inhibitors

The comparison between PT-141 and drugs like Viagra (sildenafil) or Cialis (tadalafil) highlights two fundamentally different approaches to treating sexual dysfunction.

Feature	PT-141 (Bremelanotide)	PDE5 Inhibitors (Viagra, Cialis)
Mechanism	Central (brain) – activates melanocortin receptors in hypothalamus	Peripheral (vascular) – blocks PDE5 enzyme, increases blood flow
Target	Sexual desire and arousal	Erectile function / genital blood flow
Effect on libido	Increases sexual desire	No direct effect on desire
FDA approval	HSDD in premenopausal women	Erectile dysfunction in men; pulmonary hypertension
Administration	Subcutaneous injection	Oral tablet
Timing	45 minutes before sex	30–60 minutes before sex (sildenafil); can be taken daily (tadalafil)
Duration	~2–4 hours	4–6 hours (sildenafil); up to 36 hours (tadalafil)
Effective for women?	Yes (FDA-approved for women)	No
Effective for psychogenic ED?	Potentially yes	Limited effectiveness
Common side effects	Nausea, flushing, headache, blood pressure increase	Headache, flushing, nasal congestion, visual disturbances
Contraindications	Uncontrolled hypertension, cardiovascular disease	Nitrate use, severe cardiovascular disease

When PT-141 might be preferred:

Sexual dysfunction driven primarily by low desire rather than mechanical erectile issues
Patients who don't respond to PDE5 inhibitors
Women with HSDD (PDE5 inhibitors are not effective for women)
Psychogenic sexual dysfunction where the problem is motivation or arousal, not blood flow

When PDE5 inhibitors might be preferred:

Erectile dysfunction with a clear vascular cause (diabetes, cardiovascular disease, post-prostatectomy)
Patients who prefer oral administration over injection
Patients with normal libido but impaired erectile response
Situations where a longer duration of action is desired (tadalafil can last up to 36 hours)

Combination therapy:

Research has explored combining PT-141 with PDE5 inhibitors. A study published in Urology showed that co-administration of low-dose intranasal PT-141 (1–2 mg) with sildenafil significantly enhanced erectile responses compared to sildenafil alone, increasing the duration of erectile activity by a factor of 5.3 on average. The two drugs act on complementary pathways — PT-141 boosts central arousal, while sildenafil improves vascular function — which can produce synergistic effects, particularly in men who respond poorly to PDE5 inhibitors alone.

Palatin Technologies is currently conducting Phase 2 trials evaluating bremelanotide co-formulated with a PDE5 inhibitor specifically for men who do not respond to PDE5 inhibitor monotherapy.

Off-Label Use in Men

Vyleesi® is FDA-approved only for premenopausal women with HSDD. Its use in men is off-label — meaning it's not officially approved for male sexual dysfunction, though some clinicians prescribe it and some men obtain it through compounding pharmacies or research peptide suppliers.

Clinical Evidence in Men:

Early-phase clinical trials of PT-141 included men with erectile dysfunction. A dose-ranging study found that intranasal administration of PT-141 at doses exceeding 7 mg resulted in statistically significant improvements in erectile activity compared to placebo, with the first erection occurring roughly 30 minutes after administration. In another trial involving men with ED, 34% of those receiving bremelanotide reported significantly better results compared to 9% receiving placebo, including the ability to attain and maintain an erection sufficient for intercourse.

These studies suggested that PT-141 could be effective for ED in men, particularly those with psychogenic ED or men who don't respond well to PDE5 inhibitors. However, cardiovascular side effects (notably blood pressure increases with intranasal administration) led the FDA to redirect development toward the subcutaneous formulation for women with HSDD.

Current Use:

Despite the lack of FDA approval for men, PT-141 is used off-label, often obtained through:

Compounding pharmacies: Prescribers can write off-label prescriptions for compounded bremelanotide.
Research peptide suppliers: Some men purchase PT-141 from online vendors marketing it as a "research chemical." These products are not regulated, may be of variable quality, and are not intended for human use.
Clinical trials: Palatin Technologies continues to investigate bremelanotide for male sexual dysfunction, including studies combining it with PDE5 inhibitors.

Mechanism in Men:

The central mechanism of PT-141 is the same in men as in women. Activation of MC4R in the hypothalamus increases dopamine release and stimulates neural pathways governing sexual desire and arousal. In male animal models, MC4R activation enhances copulatory behavior and increases erectile responses. The peptide acts independently of androgen (testosterone) levels, which differentiates it from testosterone replacement therapy.

Considerations:

Off-label use lacks the robust safety and efficacy data available for the approved indication in women.
Men using PT-141 off-label should be aware of the same side effects observed in women (nausea, blood pressure increases, flushing) and should avoid use if they have uncontrolled hypertension or cardiovascular disease.
Combination with PDE5 inhibitors may offer better results than PT-141 alone for men with vascular ED.

Side Effects and Safety

Bremelanotide's safety profile is well-characterized from the RECONNECT trials and their open-label extensions, which included more than 1,200 women and nearly 700 person-years of exposure.

Most Common Adverse Events:

Adverse Event	Bremelanotide	Placebo
Nausea	40%	1%
Flushing	20%	1%
Headache	11%	8%
Injection site reactions	13%	4%
Vomiting	6%	<1%

Nausea:

Nausea is the most frequently reported side effect, affecting 40% of patients in clinical trials. The median onset is 1 hour post-injection, with a median duration of 2 hours. Importantly, tolerance develops — the incidence was highest with the first dose and declined with subsequent doses. Pre-treatment with antiemetics (e.g., ondansetron) can help manage nausea, particularly during initial doses.

Cardiovascular Effects:

Bremelanotide causes transient increases in blood pressure. Ambulatory blood pressure monitoring showed mean increases of 1.9 mmHg in systolic BP and 1.7 mmHg in diastolic BP during daytime hours after 8 days of dosing. Peak increases (2.8 mmHg systolic, 2.7 mmHg diastolic) occurred 4–8 hours post-injection, returning to baseline within 12 hours.

These increases are generally mild and transient, but they raise concerns in patients with pre-existing cardiovascular disease or uncontrolled hypertension. The FDA label includes a warning:

"Bremelanotide causes increases in blood pressure that can last for at least 12 hours after administration. Because of the increase in blood pressure, use is not recommended in women with uncontrolled high blood pressure or known cardiovascular disease."

Skin Hyperpigmentation:

Bremelanotide is a melanocortin receptor agonist, and MC1R (one of its targets) regulates skin pigmentation. Focal hyperpigmentation (darkening of the skin, particularly in sun-exposed areas or at injection sites) has been reported with chronic use of melanocortin agonists like Melanotan II. This was not a prominent finding in the RECONNECT trials, but long-term use may carry this risk.

Other Adverse Events:

Injection site reactions: Redness, pain, or bruising at the injection site (13% vs. 4% placebo).
Flushing: Warmth and redness of the face and chest (20% vs. 1% placebo).
Headache: 11% vs. 8% placebo.

Serious Adverse Events:

Serious adverse events were rare and did not differ significantly between bremelanotide and placebo groups. There were no deaths attributed to bremelanotide in the clinical trials.

Contraindications:

Bremelanotide is contraindicated in patients with:

Uncontrolled hypertension
Known cardiovascular disease (due to transient blood pressure increases)
History of hypersensitivity to bremelanotide or any component of the formulation

Drug Interactions:

Bremelanotide has minimal hepatic metabolism and low plasma protein binding, which reduces the risk of drug-drug interactions. However, caution is advised when co-administered with other drugs that affect blood pressure.

Pregnancy and Lactation:

Bremelanotide is classified as Pregnancy Category C. There are no adequate studies in pregnant women. It's unknown whether bremelanotide is excreted in breast milk. Use during pregnancy or lactation is not recommended unless the potential benefit justifies the risk.

Legal Status and Availability

FDA-Approved Formulation:

Bremelanotide is FDA-approved under the brand name Vyleesi® for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It's available by prescription in the United States and is supplied as a single-dose prefilled autoinjector pen (1.75 mg).

Vyleesi® is not approved for use in men, postmenopausal women, or for any indication other than HSDD.

Off-Label Prescribing:

Physicians can prescribe bremelanotide off-label for other purposes (e.g., male sexual dysfunction), though this lacks FDA-endorsed efficacy and safety data.

Compounding Pharmacies:

Some compounding pharmacies produce bremelanotide formulations for patients with a prescription. These may include:

Different doses (e.g., 1.25 mg, 2.0 mg)
Alternative routes (nasal spray, sublingual troches)

Compounded formulations are not FDA-approved. Quality, purity, and consistency can vary. The FDA has issued warnings about compounded drugs, particularly peptides, due to concerns about contamination and mislabeling.

Research Chemical Suppliers:

PT-141 is available from online vendors that market it as a "research chemical" not intended for human consumption. These products are unregulated, may be of unknown purity, and carry significant legal and health risks. Purchasing, possessing, or using such products may violate federal or state laws.

International Availability:

Regulatory status varies by country. In some jurisdictions, bremelanotide may be available through specialty pharmacies or clinical trials. Always consult local regulations and healthcare providers.

Insurance Coverage:

In the United States, insurance coverage for Vyleesi® varies. Some plans may not cover it, or may require prior authorization and documentation of HSDD diagnosis. Out-of-pocket costs can be substantial (often several hundred dollars per dose).

Frequently Asked Questions

1. What's the difference between PT-141 and Viagra?

Viagra (sildenafil) increases blood flow to the penis by blocking the PDE5 enzyme, which helps achieve and maintain an erection. It doesn't affect desire. PT-141 works in the brain, activating melanocortin receptors in the hypothalamus to increase sexual desire and arousal. PT-141 addresses the "wanting" part of sex; Viagra addresses the mechanical function. They target different problems and can be used together.

2. Is PT-141 approved for men?

No. PT-141 (bremelanotide) is FDA-approved only for premenopausal women with hypoactive sexual desire disorder (HSDD). Its use in men is off-label. Some clinicians prescribe it off-label, and some men obtain it through compounding pharmacies or research suppliers, but this lacks FDA endorsement and robust clinical data.

3. How quickly does PT-141 work?

Bremelanotide reaches peak plasma levels about 1 hour after subcutaneous injection. Effects are typically felt within 30–60 minutes, which is why the recommended timing is at least 45 minutes before sexual activity.

4. Can PT-141 be used daily?

No. The FDA-approved dosing is a maximum of one dose per 24 hours and no more than eight doses per month. PT-141 is intended for on-demand use before sexual activity, not as a daily medication. Daily use has not been studied and may increase the risk of side effects, particularly nausea and blood pressure changes.

5. Does PT-141 cause nausea in everyone?

No, but nausea is common (40% of patients in clinical trials). The good news: tolerance develops. Nausea is most frequent with the first dose and declines with repeated use. Pre-treating with an antiemetic like ondansetron can reduce nausea, especially during initial doses.

6. Is PT-141 safe for people with high blood pressure?

Bremelanotide causes transient increases in blood pressure (average 1.9 mmHg systolic, 1.7 mmHg diastolic), peaking 4–8 hours post-injection and returning to baseline within 12 hours. It is contraindicated in people with uncontrolled hypertension or known cardiovascular disease. If you have well-controlled blood pressure, discuss the risks with your doctor before using PT-141.

7. Can women use PT-141 after menopause?

Vyleesi® is FDA-approved only for premenopausal women with HSDD. It has not been studied in postmenopausal women, and efficacy and safety in this population are unknown. Off-label use is possible, but should be discussed with a healthcare provider.

8. How does PT-141 compare to semaglutide or BPC-157?

They're entirely different peptides with different mechanisms. Semaglutide is a GLP-1 receptor agonist used for type 2 diabetes and weight loss. BPC-157 is a gastric peptide studied for tissue repair and wound healing (though it lacks FDA approval). PT-141 is a melanocortin receptor agonist for sexual dysfunction. They don't overlap in function or clinical use.

The Bottom Line

PT-141 (bremelanotide) is one of the few peptides to achieve FDA approval, which makes it a genuine pharmaceutical rather than an experimental compound confined to research labs or underground markets. It works by a mechanism that's fundamentally different from the standard treatments for sexual dysfunction — instead of increasing blood flow to the genitals, it activates neural pathways in the brain that regulate sexual desire and arousal.

The clinical trial data is solid. Two well-designed Phase 3 studies (the RECONNECT trials) demonstrated that subcutaneous bremelanotide significantly improves sexual desire and reduces distress in premenopausal women with hypoactive sexual desire disorder. The effect sizes are modest, but statistically and clinically meaningful. The safety profile is acceptable, with nausea being the most common side effect, and tolerance developing with repeated use.

For men, the evidence is thinner. Early trials showed promise for erectile dysfunction, particularly in combination with PDE5 inhibitors, but the drug was never brought through FDA approval for male indications. Off-label use happens, but it lacks the regulatory validation and robust data available for women.

PT-141 is not a universal solution. It won't help someone whose sexual dysfunction is purely mechanical (vascular ED with normal libido, for instance), and it carries contraindications for people with cardiovascular disease or uncontrolled hypertension. But for individuals whose problem is a lack of desire — the brain not being interested, even when the opportunity is there — PT-141 offers a pharmacological intervention that targets the root of the issue rather than working around it.

The broader significance is this: PT-141 proves that central-acting peptides can be developed, tested, and approved for clinical use. The melanocortin system is implicated in a range of other conditions (appetite regulation, inflammation, pain), and bremelanotide's success opens the door for more targeted therapies in those areas. Palatin Technologies is already exploring bremelanotide in combination with GLP-1 agonists for obesity, leveraging the MC4R pathway's role in appetite control.

If you're considering PT-141, work with a healthcare provider who understands both the approved indication and the off-label landscape. Don't rely on compounded formulations or research chemical vendors without understanding the risks. And if you're expecting it to work like Viagra, recalibrate. This is a desire drug, not an erection drug. It changes the conversation about what sexual dysfunction treatment can target.

Disclaimer

This article is for educational purposes only. It is not medical advice and should not be used to diagnose, treat, or prevent any disease. PT-141 (bremelanotide) is an FDA-approved prescription medication for hypoactive sexual desire disorder in premenopausal women. Off-label use, compounded formulations, and products marketed as research chemicals carry significant risks and lack regulatory oversight. Always consult a qualified healthcare provider before using any peptide or pharmaceutical.

Table of Contents