PT-141, also called bremelanotide or Vyleesi, is a melanocortin-receptor agonist peptide studied mainly for hypoactive sexual desire disorder in premenopausal women. It appears to act through central nervous-system pathways rather than by directly increasing genital blood flow. Evidence includes multiple randomized trials, but safety, dosing, and fit require clinician review.
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See if you qualify →What it is
PT-141 is a peptide drug also called bremelanotide, and Vyleesi is a brand name tied to the same active ingredient in clinical research. It belongs to a class called melanocortin-receptor agonists, which means it activates melanocortin pathways involved in sexual response and other nervous-system signaling 4.
In plain terms, PT-141 is not a blood-flow drug in the same way sildenafil is. The published trials mainly studied bremelanotide in premenopausal women with hypoactive sexual desire disorder, female sexual dysfunction, or female sexual arousal disorder 4 10.
Names: PT-141, bremelanotide, and Vyleesi
- PT-141: common peptide name used in patient searches and earlier research.
- Bremelanotide: the generic active-ingredient name used in most clinical trial papers 4.
- Vyleesi: a brand name people may see when searching bremelanotide information.
- Melanocortin-receptor agonist: the drug class named in human studies of bremelanotide 7.
Mechanism of action
PT-141 works through melanocortin receptor pathways, which are signaling routes in the brain and nervous system. The human studies describe bremelanotide as a melanocortin-receptor agonist, but a clinical trial title alone does not prove every downstream step in humans 7.
Melanocortin-receptor agonism
A receptor agonist is a molecule that turns on a receptor. Bremelanotide has been studied as a melanocortin-receptor agonist in sexual arousal and desire conditions, which supports a central nervous-system mechanism rather than a purely vascular one 7 10.
How PT-141 differs from blood-flow medications
Sildenafil, known by the brand name Viagra, is commonly discussed as a blood-flow medication for erectile dysfunction. In contrast, PT-141 has been studied for subjective sexual response and desire-related outcomes, including in premenopausal women and in one randomized trial of men who had not responded to sildenafil 2 7.
| Question | PT-141 / bremelanotide | Sildenafil / Viagra |
|---|---|---|
| Main pathway discussed in these sources | Melanocortin receptor pathway in the nervous system 7 | Blood-flow medication comparison is relevant because one bremelanotide trial studied sildenafil nonresponders 2 |
| Main populations in the retrieved PT-141 evidence | Premenopausal women with hypoactive sexual desire disorder or related female sexual dysfunction 4 10 | Men with erectile dysfunction were represented in a sildenafil-nonresponder bremelanotide trial 2 |
| What this means for expectations | Studied outcomes focus on desire, arousal, patient experience, and safety 4 8 | Not directly interchangeable with PT-141; mechanism and studied populations differ |
Evidence
Evidence grade: A — two or more human randomised controlled trials. The main evidence base includes randomized phase 3 trials in premenopausal women with hypoactive sexual desire disorder, a randomized dose-finding trial in female sexual dysfunction, an earlier randomized study in female sexual arousal disorder, and a randomized study in men who had not responded to sildenafil 4 10 7 2.
A — two or more human randomised controlled trials. B — one human randomised trial, or two or more human clinical trials. C — human research exists, none of it randomised. D — animal or in-vitro research only; no human studies indexed. E — no trial evidence indexed in PubMed. The grade describes the quantity and design of published evidence, not whether the substance works, and not whether it is safe.
What the human research studied
The RECONNECT phase 3 program evaluated bremelanotide in premenopausal women with hypoactive sexual desire disorder, and later subgroup analyses examined prespecified and integrated findings from those studies 4 3. A separate phase 2b program evaluated dose-ranging approaches, and responder analyses looked at how participants responded within that program 10 5.
What the evidence does not prove
The retrieved evidence does not show that PT-141 is a universal libido medication for every adult. It also does not prove that compounded PT-141 nasal spray has the same outcomes as the bremelanotide products and routes studied in trials; compounded formulations do not have FDA-evaluated outcomes data.
Evidence in men and sildenafil nonresponders
One randomized, double-blind, placebo-controlled study evaluated bremelanotide as a salvage approach in men who had not responded to sildenafil 2. That is useful evidence, but it is much narrower than the larger female sexual dysfunction and hypoactive sexual desire disorder research base 4 10.
What studies exist
| Year | Design | Study | Journal | Record |
|---|---|---|---|---|
| 2022 | Randomised controlled trial | Safety Profile of Bremelanotide Across the Clinical Development Program | Journal of women's health (2002) | PMID 35147466 |
| 2008 | Randomised controlled trial | Salvage of sildenafil failures with bremelanotide: a randomized, double-blind, placebo controlled study | The Journal of urology | PMID 18206919 |
| 2022 | Randomised controlled trial | Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide | Journal of women's health (2002) | PMID 35230162 |
| 2019 | Randomised controlled trial | Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials | Obstetrics and gynecology | PMID 31599840 |
| 2019 | Randomised controlled trial | Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide | The journal of sexual medicine | PMID 31277966 |
| 2008 | Randomised controlled trial | RETRACTED: Evaluation of the safety and efficacy of bremelanotide, a melanocortin receptor agonist, in female subjects with arousal disorder: a double-blind placebo-controlled, fix | The journal of sexual medicine | PMID 18179455 |
| 2006 | Randomised controlled trial | An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT-141), a melanocortin receptor agonist | The journal of sexual medicine | PMID 16839319 |
| 2021 | Randomised controlled trial | The Patient Experience of Premenopausal Women Treated with Bremelanotide for Hypoactive Sexual Desire Disorder: RECONNECT Exit Study Results | Journal of women's health (2002) | PMID 33538638 |
| 2004 | Clinical trial | Gateways to clinical trials | Methods and findings in experimental and clinical pharmacology | PMID 15672123 |
| 2016 | Randomised controlled trial | Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial | Women's health (London, England) | PMID 27181790 |
| 2017 | Randomised controlled trial | Usefulness of ambulatory blood pressure monitoring to assess the melanocortin receptor agonist bremelanotide | Journal of hypertension | PMID 27977473 |
| 2017 | Randomised controlled trial | Phase I Randomized Placebo-controlled, Double-blind Study of the Safety and Tolerability of Bremelanotide Coadministered With Ethanol in Healthy Male and Female Participants | Clinical therapeutics | PMID 28189361 |
| Registration | Phase | Status | Enrolment | Title |
|---|---|---|---|---|
| NCT02338960 | PHASE3 | COMPLETED | 714 | 2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder |
| NCT01382719 | PHASE2 | COMPLETED | 612 | Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder |
| NCT02333071 | PHASE3 | COMPLETED | 723 | 1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder |
This table is retrieved from PubMed and ClinicalTrials.gov rather than assembled by hand, so it shows what is indexed — including the absences. Last retrieved 2026-09-02.
Reported dosing ranges
Published PT-141 dosing should not be copied as self-treatment. The retrieved studies include dose-finding and phase 3 research, but the source records provided here do not give full patient-level dosing instructions that can be safely applied to an individual reader 10 5 4.
| Source | Population | What was studied or labelled | How to interpret it |
|---|---|---|---|
| Clayton et al., 2016 10 | Premenopausal women with female sexual dysfunction | A randomized, placebo-controlled dose-finding trial of bremelanotide | This supports that dosing was studied in a controlled trial, not that readers should copy a protocol. |
| Althof et al., 2019 5 | Participants from a phase 2b dose-ranging program | Responder analyses from a phase 2b dose-ranging study | Responder data help interpret trial results, but do not replace clinician-guided dosing. |
| Kingsberg et al., 2019 4 | Premenopausal women with hypoactive sexual desire disorder | Two randomized phase 3 trials of bremelanotide | Phase 3 dosing details belong in the trial protocol or label, not as self-directed instructions. |
| Clayton et al., 2017 12 | Healthy male and female participants | A phase 1 randomized study of bremelanotide coadministered with ethanol | Safety-context studies are not dosing guides for sexual health use. |
Why dosing should not be copied from studies
Study dosing is chosen for research rules, not for your personal health history. A clinician needs to consider blood pressure, cardiovascular risk, current medications, side-effect risk, and whether the symptom pattern matches the studied populations 1 11.
Dose form, timing, and supervision considerations
The retrieved evidence pool includes bremelanotide trials, safety analyses, ambulatory blood-pressure monitoring, and ethanol coadministration research 1 11 12. Those sources support a careful, supervised approach rather than self-directed use from a research-chemical supplier.
Legal status
| Date | Action | What it means | Source | Evidence |
|---|---|---|---|---|
| 2026-09-02 | FDA-approved labelling containing PT-141 is on file with DailyMed (verified 2026-09-02) | An FDA-approved product with this active ingredient is available by prescription. | DailyMed (NLM) | FDA / Federal Register |
This section is generated from a dated log of federal actions rather than written by hand, and it is re-checked daily against the Federal Register and FDA sources. Last checked 2026-09-02. See the full legal-status tracker for every compound we follow.
Safety
PT-141 safety has been evaluated across a clinical development program, but that does not mean it is safe for everyone. Safety papers and randomized studies specifically examined adverse events, blood-pressure effects, and tolerability with ethanol coadministration 1 11 12.
Nausea, flushing, headache, and other reported adverse events
The safety profile paper for bremelanotide across the clinical development program is the best retrieved source for overall adverse-event reporting 1. Commonly discussed patient-facing side effects include nausea, flushing, and headache; a clinician should also review less common risks and reasons treatment may not fit.
Blood pressure and heart-rate findings
Blood pressure matters with PT-141 because a randomized study used ambulatory blood-pressure monitoring to assess the melanocortin-receptor agonist bremelanotide 11. If a person has hypertension, cardiovascular disease, fainting episodes, or uses blood-pressure medication, that history should be reviewed before any treatment decision.
Alcohol coadministration study findings
A phase 1 randomized, placebo-controlled, double-blind study assessed the safety and tolerability of bremelanotide when coadministered with ethanol in healthy male and female participants 12. That type of study helps frame alcohol-related safety questions, but it does not make alcohol use risk-free for every patient.
Risks of unregulated supply
A major safety issue is where the substance comes from. “Research use only” material is not medical care; it may raise identity, sterility, impurity, and dosing-accuracy concerns because it is not dispensed through a clinician-reviewed patient process.
Who should ask a clinician before considering PT-141?
- Anyone with high or unstable blood pressure, because blood-pressure monitoring has been studied with bremelanotide 11.
- Anyone with heart disease, chest pain, fainting, or complex cardiovascular history.
- Anyone taking medications that affect blood pressure, sexual function, nausea, or mood.
- Anyone who is pregnant, trying to become pregnant, or breastfeeding.
- Anyone using alcohol around the time of sexual activity, because ethanol coadministration has been specifically studied 12.
Interactions
Medication review is part of PT-141 safety, especially when blood pressure, alcohol, or sexual-function medications are involved. The retrieved evidence includes specific studies on ambulatory blood-pressure monitoring and ethanol coadministration, but it does not provide a complete interaction map for every drug or supplement 11 12.
Why medication review matters before use
Sexual-function symptoms can be affected by antidepressants, blood-pressure drugs, hormone changes, sleep, stress, alcohol, and relationship factors. The patient-experience study from the RECONNECT program can help describe how participants experienced treatment, but it should not replace a full medical review 8.
Cardiovascular risk and blood-pressure medication considerations
Because ambulatory blood-pressure monitoring was important enough to study in randomized bremelanotide research, people with blood-pressure conditions should treat this as a clinician-review issue, not a supplement-style purchase 11. This is especially important if multiple medications affect blood pressure or heart rate.
How to obtain it legally
The legitimate care process for PT-141 starts with a health history, medication review, and clinician decision. At Chia, we offer PT-141 nasal spray and the Spark protocol through an online evaluation reviewed by a licensed US provider; a prescription requires a medical evaluation and is never guaranteed.
PT-141 at Chia: nasal spray with clinician review
Chia’s PT-141 offering is nasal spray, with plans currently starting at $159/month. If a provider determines treatment is clinically appropriate, medication is compounded in the US by a state-licensed 503A compounding pharmacy and shipped to the patient’s door; compounded medications are not FDA-approved.
| Chia option | Form | Current starting price | Care process |
|---|---|---|---|
| PT-141 | Nasal spray | From $159/mo | Online questionnaire, licensed-provider review, provider-guided dosing, 503A pharmacy dispensing when clinically appropriate |
| Spark | PT-141 nasal | From $159/mo | Protocol page for patients interested in the PT-141 nasal option and clinician-reviewed care |
How Chia’s online evaluation works
- 1You complete a short online health questionnaire about your goals, medical history, medications, and safety factors.
- 2A licensed US provider reviews whether treatment may be appropriate.
- 3If prescribed, dosing is provider-guided and adjusted through the patient portal when needed.
- 4If medication is dispensed, it is prepared by a state-licensed 503A compounding pharmacy and shipped to your door.
What Chia can and cannot promise
We can provide a structured medical review and a licensed care path when PT-141 fits. We cannot promise that a prescription will be written, that treatment will work for a specific person, or that side effects will not happen.
Why research-chemical vendors are not medical care
A research-chemical website is not a clinician evaluation, a prescription review, or a licensed pharmacy relationship. For any peptide used by people, the safer axis is licensed care versus unlicensed supply: identity, sterility, impurities, and follow-up all matter.
How does PT-141 compare with Viagra?
PT-141 and Viagra are different tools, and the retrieved PT-141 evidence should not be read as a head-to-head proof that one is better. One randomized trial studied bremelanotide in men who had not responded to sildenafil, while the larger PT-141 evidence base centers on premenopausal women with desire-related diagnoses 2 4.
| Feature | PT-141 / bremelanotide | Viagra / sildenafil |
|---|---|---|
| Mechanism focus | Melanocortin receptor pathway in the nervous system 7 | Often discussed as a blood-flow erectile dysfunction medication |
| Main PT-141 trial population in retrieved sources | Premenopausal women with hypoactive sexual desire disorder or related female sexual dysfunction 4 10 | Used as the comparator context in a sildenafil-nonresponder bremelanotide trial 2 |
| Best fit question | May be considered when the clinical issue is desire/arousal and safety factors are reviewed | Often considered when the clinical issue is erectile blood-flow response |
| Safety emphasis | Nausea, flushing, headache, blood-pressure review, and alcohol-related questions 1 11 12 | Requires its own medication and cardiovascular review |
Some patients who ask about PT-141 are also exploring broader longevity or energy protocols. Those are separate goals: Chia’s NAD+, sermorelin, and Foundation Longevity pages explain different treatment categories, forms, and care processes.
3-min quiz
See if PT-141 care through Chia may fit
Chia offers compounded PT-141 nasal spray and the Spark protocol with online licensed-provider review. A prescription requires a medical evaluation and is not guaranteed. Compounded drugs are not FDA-approved. You can also review the PT-141 page at PT-141 nasal spray before starting.
PT-141, also called bremelanotide, is a melanocortin-receptor agonist peptide studied mainly for sexual desire and arousal concerns. It appears to work through nervous-system signaling rather than mainly through direct genital blood-flow effects.
PT-141 is a common peptide name, bremelanotide is the generic active-ingredient name, and Vyleesi is a brand name people may see in searches. These names are related, but product form, route, and clinical review still matter.
Not necessarily. PT-141 and Viagra work through different pathways and were studied in different main populations. One randomized study looked at bremelanotide in men who had not responded to sildenafil, but that does not prove PT-141 is better for everyone.
Timing depends on the product form, route, and the person using it. The safest answer is to follow the plan given by a licensed clinician rather than copying timing from online forums or research-chemical sellers.
Commonly discussed side effects include nausea, flushing, and headache. Blood-pressure effects and alcohol-related tolerability have also been studied, so a clinician should review cardiovascular history, medications, and alcohol use.
Chia offers PT-141 nasal spray with plans currently starting at $159/month. Pricing can change, so the product page is the best place to confirm current details.
Compounded drugs are not FDA-approved. Chia’s process uses licensed-provider review and state-licensed 503A pharmacy compounding when clinically appropriate, but treatment is not guaranteed.
Research-chemical vendors are not a substitute for medical care. They do not provide a clinician evaluation, medication review, prescription oversight, or the same patient-facing pharmacy process.
References
- 1.PMID 35147466 [randomised controlled trial] Clayton AH, Kingsberg SA, Portman D, et al. Safety Profile of Bremelanotide Across the Clinical Development Program. Journal of women's health (2002). 2022.
- 2.PMID 18206919 [randomised controlled trial] Safarinejad MR, Hosseini SY. Salvage of sildenafil failures with bremelanotide: a randomized, double-blind, placebo controlled study. The Journal of urology. 2008.
- 3.PMID 35230162 [randomised controlled trial] Simon JA, Kingsberg SA, Portman D, et al. Prespecified and Integrated Subgroup Analyses from the RECONNECT Phase 3 Studies of Bremelanotide. Journal of women's health (2002). 2022.
- 4.PMID 31599840 [randomised controlled trial] Kingsberg SA, Clayton AH, Portman D, et al. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstetrics and gynecology. 2019.
- 5.PMID 31277966 [randomised controlled trial] Althof S, Derogatis LR, Greenberg S, et al. Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide. The journal of sexual medicine. 2019.
- 6.PMID 18179455 [randomised controlled trial] Safarinejad MR. RETRACTED: Evaluation of the safety and efficacy of bremelanotide, a melanocortin receptor agonist, in female subjects with arousal disorder: a double-blind placebo-controlled, fixed dose, randomized study. The journal of sexual medicine. 2008.
- 7.PMID 16839319 [randomised controlled trial] Diamond LE, Earle DC, Heiman JR, et al. An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT-141), a melanocortin receptor agonist. The journal of sexual medicine. 2006.
- 8.PMID 33538638 [randomised controlled trial] Koochaki P, Revicki D, Wilson H, et al. The Patient Experience of Premenopausal Women Treated with Bremelanotide for Hypoactive Sexual Desire Disorder: RECONNECT Exit Study Results. Journal of women's health (2002). 2021.
- 9.PMID 15672123 [clinical trial] Bayés M, Rabasseda X, Prous JR. Gateways to clinical trials. Methods and findings in experimental and clinical pharmacology. 2004.
- 10.PMID 27181790 [randomised controlled trial] Clayton AH, Althof SE, Kingsberg S, et al. Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial. Women's health (London, England). 2016.
- 11.PMID 27977473 [randomised controlled trial] White WB, Myers MG, Jordan R, et al. Usefulness of ambulatory blood pressure monitoring to assess the melanocortin receptor agonist bremelanotide. Journal of hypertension. 2017.
- 12.PMID 28189361 [randomised controlled trial] Clayton AH, Lucas J, DeRogatis LR, et al. Phase I Randomized Placebo-controlled, Double-blind Study of the Safety and Tolerability of Bremelanotide Coadministered With Ethanol in Healthy Male and Female Participants. Clinical therapeutics. 2017.
About this article
Chia Health Editorial Team — Evidence-reviewed health education
This article is for educational purposes only and is not a substitute for individualized medical advice. Talk to a licensed clinician before starting, stopping, or changing any prescription.
AI tools may assist with research and drafting. Chia's editorial team reviews source use, clarity, treatment information, and safety framing before publication. A clinician is named only after explicit sign-off. Read our editorial standards.
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