PT-141 is bremelanotide. FDA approval belongs to Vyleesi.
The active molecular identity connects PT-141 and bremelanotide, but product claims still split sharply. Vyleesi is an FDA-approved prescription medicine for a defined premenopausal HSDD population. Seller-labelled 10 mg research vials are not Vyleesi, and the early male studies do not create an approved treatment for men.
The molecule is real, the approval is narrow, and the research vial is a different product record.
FDA approved Vyleesi under NDA 210557 for premenopausal women with acquired, generalized hypoactive sexual desire disorder that meets the label's defined conditions. The label says it is not indicated for men, postmenopausal women, children, or sexual-performance enhancement.
The two Phase 3 trials found statistically significant improvements in sexual desire and distress related to low desire. The label also says satisfying sexual events did not differ significantly. Early small studies in men measured erectile responses, but they did not create an approved male indication or validate current research-market vials.
Go straight to the PT-141 answer you need.
Keep the molecular identity, exact Vyleesi approval, human trial evidence, destination status, and research-market records in their correct lanes.
Compare PT-141 / Bremelanotide with VYLEESI, without losing the country context.
Put evidence status, ClinicalTrials.gov coverage, official United States records, and qualified US research prices in one view. Blank fields stay blank when the underlying dataset does not support a number.
US research-market identity with a separate FDA-approved medicine record
Official product and seller records attached
Product-specific FDA-approved US medicine record
Read the PT-141 and bremelanotide record in four fields.
This is a sourced status snapshot, not a safety score, treatment recommendation, or seller certification. Each field links back to the detailed record below.
Phase 2 plus two Phase 3 trials
The strongest patient-outcome evidence concerns a narrowly defined premenopausal HSDD population, not a universal libido or erectile-function claim.
Inspect the human evidenceDesire and distress improved
The co-primary outcomes favored treatment, while satisfying sexual events did not differ significantly in the current label.
Audit the popular claimsExact Vyleesi product approved
NDA 210557 does not transfer approval to 10 mg research vials, compounded preparations, blends, sprays, or imported products.
Check status and destination routesDated US price boards
Ingredient, approved medicine, clinical population, and research market must stay separate.
A reliable answer preserves the exact product, presentation, country, indication, population, endpoint, manufacturer, supplier, and source date.
PT-141 is the development name for bremelanotide
PubChem records bremelanotide as a cyclic seven-amino-acid peptide and includes PT-141 among its names. A shared ingredient name does not make every seller vial the FDA-approved Vyleesi finished product.
Approval belongs to exact Vyleesi
FDA approved Vyleesi under NDA 210557 for a defined population of premenopausal women with acquired, generalized HSDD. The label excludes use in men, postmenopausal women, and sexual-performance enhancement.
Strongest evidence is narrow, not universal
Two Phase 3 trials found statistically significant improvements in sexual desire and distress for the approved population. They did not find a significant difference in satisfying sexual events, and they do not establish a general libido, erectile-dysfunction, or performance claim.
A 10 mg research vial is not Vyleesi
The research listings monitored by Peptide Local differ from Vyleesi in presentation, manufacturing review, labeling, supply chain, intended use, and regulatory record. Price or a certificate does not bridge that gap.
Popular PT-141 claims beside the exact record that limits them.
An approved ingredient, a finished prescription product, a small male study, and an online vial do not carry the same claim.
PT-141 is FDA approved
FDA approved the exact Vyleesi bremelanotide prescription product under NDA 210557 in 2019 for a narrowly defined HSDD population.
Approval belongs to that application, finished product, autoinjector presentation, label, manufacturer record, and regulated supply chain. It does not transfer to a seller-labelled PT-141 vial, blend, spray, or compounded preparation.
PT-141 is approved for men
Small early studies reported RigiScan erectile-response signals in selected men, including men reporting inadequate sildenafil response and a 19-person sildenafil combination study.
The current Vyleesi label explicitly says the medicine is not indicated for men. Early pharmacodynamic signals are not evidence of FDA approval, a proven male treatment, long-term effectiveness, or equivalence to an online research vial.
PT-141 works like Viagra
Bremelanotide is a melanocortin receptor agonist, while sildenafil is a phosphodiesterase-5 inhibitor. One small study evaluated the two together in a controlled crossover design.
Different mechanisms, populations, endpoints, products, and approval records prevent a simple equivalence claim. There is no cited head-to-head trial proving that one is better for the same approved use.
PT-141 increases libido for everyone
The Phase 3 program found statistically significant desire and distress changes in selected premenopausal women with acquired, generalized HSDD.
The label excludes low desire due to medical or psychiatric conditions, relationship problems, or medication effects. It is not indicated for men, postmenopausal women, children, or sexual-performance enhancement.
Side effects are minor
In pooled Phase 3 data, nausea occurred in 40.0%, flushing in 20.3%, injection-site reactions in 13.2%, headache in 11.3%, and vomiting in 4.8% of Vyleesi-treated participants.
The label also carries blood-pressure, heart-rate, hyperpigmentation, pregnancy, drug-interaction, and cardiovascular warnings. Trial-product rates do not establish the safety of a different vial, concentration, formulation, or supplier.
More satisfying sexual events were proven
The two Phase 3 studies met their co-primary patient-reported desire and low-desire distress endpoints.
The current label states there was no significant treatment-group difference in change in satisfying sexual events, a secondary endpoint. That distinction should remain visible when describing benefit.
A COA proves a PT-141 vial is Vyleesi
A matched laboratory report may support a limited identity, purity, quantity, or contaminant result for the exact sample tested.
It does not establish the Vyleesi application, finished-product formulation, sterile manufacturing review, autoinjector presentation, lawful prescription supply chain, clinical benefit, or delivered-vial chain of custody.
The female Phase 3 program and the early male studies answer different questions.
Patient-reported desire, distress, satisfying events, RigiScan response, adverse events, and long-term extension findings are distinct outcomes.
Phase 2 dose-ranging study
- Identity
- Subcutaneous bremelanotide versus placebo
- Design
- Randomized, triple-masked, parallel-group Phase 2 dose-ranging trial
- Participants
- 612 premenopausal women enrolled
The registry reports multiple patient-reported sexual-function outcomes and dose-group adverse events. This development study informed later registration work, but its selected female population and controlled product do not establish benefit for men, general wellness, or seller-labelled research vials.
Two RECONNECT Phase 3 trials
- Identity
- Vyleesi development product versus placebo
- Design
- Two identical 24-week randomized, double-blind, placebo-controlled trials
- Participants
- 1,267 randomized; 1,202 in the efficacy population
Integrated treatment differences favored bremelanotide for sexual desire and distress related to low desire. The current label separately reports no significant difference in satisfying sexual events. Most participants were White and US-based, and the evidence applies to the defined HSDD population.
Pooled Phase 3 safety population
- Identity
- Exact Vyleesi clinical-development product
- Design
- Integrated safety analysis from two randomized controlled trials
- Participants
- 1,247 participants in the pooled safety population
Nausea was reported by 40.0% versus 1.3% on placebo, flushing by 20.3% versus 0.3%, injection-site reactions by 13.2% versus 8.4%, headache by 11.3% versus 1.9%, and vomiting by 4.8% versus 0.2%. Label warnings add transient blood-pressure elevation and focal hyperpigmentation.
RECONNECT long-term extension
- Identity
- Open-label Vyleesi development product
- Design
- Uncontrolled 52-week extension after the randomized core trials
- Participants
- 684 entered; 272 completed the extension
The publication reported sustained descriptive improvements and no new safety signal, with nausea, flushing, and headache most common. Entry required completion of the core phase without serious adverse events, there was no placebo control, and attrition limits causal interpretation.
Early subcutaneous study in men
- Identity
- PT-141 development product
- Design
- Small Phase 2 dose-ranging and crossover pharmacodynamic studies
- Participants
- Healthy men and selected men reporting inadequate sildenafil response
RigiScan measurements showed statistically significant erectile-response signals in selected groups. This early short-term study did not establish an approved male indication, patient-important long-term outcomes, comparative effectiveness, or equivalence to a current research-market product.
PT-141 plus sildenafil study in men
- Identity
- Intranasal PT-141 development product plus sildenafil
- Design
- Randomized crossover pharmacodynamic study
- Participants
- 19 men with erectile dysfunction who reported response to sildenafil or vardenafil
The combination produced a greater RigiScan response than the lower sildenafil dose alone during a six-hour observation window. The tiny selected cohort, intranasal development product, surrogate endpoint, and combination design cannot support a general male-use or seller-vial claim.
Two positive co-primary outcomes. One non-significant secondary outcome.
The result is meaningful only when the outcome and population remain attached.
Statistically significant
Both studies reported a greater increase in the FSFI desire-domain score versus placebo for the defined premenopausal HSDD population.
Open the result tables →Statistically significant
Both studies reported a greater reduction in the FSDS-DAO item measuring bother from low sexual desire versus placebo.
Read the trial publication →No significant difference
The current label reports no significant treatment-group difference for change in satisfying sexual events, a secondary endpoint.
Check the label language →PT-141, Vyleesi, and Melanotan II are not interchangeable products.
Related melanocortin history creates search overlap, but approval and safety evidence remain product-specific.
PT-141 / bremelanotide
A cyclic heptapeptide identity. A current seller listing must still prove its own form, strength, lot, testing, sterility, supplier, and lawful status.
Open the 10 mg research board →Vyleesi
The exact bremelanotide prescription product under NDA 210557, with a defined autoinjector presentation, indication, label, and regulated supply chain.
Open the Vyleesi record →Melanotan II
A separate cyclic melanocortin analogue with distinct sequence, evidence, risk reports, country status, and seller-market records.
Open the Melanotan II guide →The current label makes the tradeoffs unusually concrete.
These rates apply to the exact clinical product and study population, not to an unverified research formulation.
40.0% nausea
Flushing occurred in 20.3%, injection-site reactions in 13.2%, headache in 11.3%, and vomiting in 4.8% of Vyleesi-treated Phase 3 participants.
Read the adverse-reaction table →Blood pressure rises transiently
The label reports temporary blood-pressure increases and heart-rate reductions, contraindicates uncontrolled hypertension or known cardiovascular disease, and advises cardiovascular risk assessment.
Open FDA's risk review →Focal hyperpigmentation
The label records a 1% signal under the studied intermittent regimen, higher risk with more frequent exposure, greater risk in darker skin, and incomplete resolution in some cases.
Read the development safety review →A public 10 mg PT-141 listing is not the approved Vyleesi product.
These are dated research-market observations, not a prescription pathway or medical validation. Price and availability do not establish identity, sterility, approval, seller authority, legal access, or suitability.
03
The board compares public US 10 mg research listings under one evidence policy. It does not combine those prices with the prescription medicine.
Inspect every source row →02
Only explicit current availability language enters the count. A row without a usable stock signal cannot set the available-market low.
Check source freshness →$45.00-47.29
The research-vial range excludes shipping, taxes, coupons, checkout-only discounts, and ambiguous stock rows. It is not the cost of Vyleesi.
Compare landed cost →US Vyleesi approval is not a global PT-141 authorization.
Country status depends on the exact finished product, presentation, marketing authorization, prescription route, pharmacy, seller, import path, and intended claim. Health Canada and SAHPRA have published specific unauthorized-product records involving PT-141, while other destinations require their own current product and seller searches.
Fourteen PT-141 questions, answered from the exact record.
This is educational reporting, not medical advice, a prescription, emergency guidance, or a use protocol.
What is PT-141?
PT-141 is a development and research name associated with bremelanotide, a cyclic seven-amino-acid melanocortin receptor agonist. Bremelanotide is the active ingredient in the FDA-approved Vyleesi prescription product. A molecular name connects identity records, but it does not make a 10 mg research vial, compounded preparation, nasal product, or online listing the same finished product as Vyleesi.
Is PT-141 the same as bremelanotide or Vyleesi?
PT-141 and bremelanotide can refer to the same active molecular identity, while Vyleesi is an exact FDA-approved finished bremelanotide product under NDA 210557. That distinction matters. Vyleesi has a specific autoinjector presentation, label, approved population, manufacturing review, and regulated supply chain. A seller-labelled research vial does not inherit those product attributes merely because it uses PT-141 or bremelanotide in its name.
What are the proven benefits of PT-141?
The strongest evidence supports the exact Vyleesi product for a defined group of premenopausal women with acquired, generalized hypoactive sexual desire disorder. Two Phase 3 trials found statistically significant improvements in reported sexual desire and distress related to low desire versus placebo. The label also states that satisfying sexual events did not differ significantly, so the benefit should not be described as universal libido or performance enhancement.
Is PT-141 FDA approved?
FDA approval belongs to Vyleesi, the exact bremelanotide prescription product reviewed under NDA 210557 and approved in 2019. It does not apply broadly to every item marketed as PT-141. The seller-labelled 10 mg research vials monitored by Peptide Local are not Vyleesi and do not inherit its approval, formulation, manufacturing review, indication, instructions, or prescription supply chain.
What is Vyleesi FDA approved for?
The current US label covers premenopausal women with acquired, generalized HSDD that causes marked distress or interpersonal difficulty and is not due to a coexisting medical or psychiatric condition, relationship problems, or a medication or drug substance. The label says Vyleesi is not indicated for postmenopausal women, men, children, or sexual-performance enhancement. That boundary is narrower than common online PT-141 claims.
Does PT-141 work for men?
Small early studies reported short-term erectile-response signals in selected men, including men reporting an inadequate sildenafil response and a 19-person crossover study combining intranasal PT-141 with sildenafil. Those findings are preliminary and pharmacodynamic. Vyleesi is not indicated for men, and the cited evidence does not establish approved use, long-term effectiveness, a general erectile-dysfunction treatment, or safety of an online research vial.
Does PT-141 treat erectile dysfunction?
Early development studies used RigiScan measurements and observed erectile responses in small, selected male groups. That is not the same as an FDA-approved erectile-dysfunction indication or proof of patient-important benefit in broad clinical practice. The approved Vyleesi record concerns HSDD in a defined premenopausal female population. Men seeking evaluation for erectile dysfunction should not treat a research-market listing as an approved substitute for medical assessment.
What are the side effects of PT-141 or Vyleesi?
For the exact Vyleesi product, pooled Phase 3 rates included nausea in 40.0%, flushing in 20.3%, injection-site reactions in 13.2%, headache in 11.3%, and vomiting in 4.8% of treated participants. The label also warns about temporary blood-pressure increases, reduced heart rate, focal hyperpigmentation, pregnancy risk, and some oral-drug interactions. These rates cannot define the safety of another formulation or seller lot.
Does PT-141 raise blood pressure?
The current Vyleesi label says bremelanotide transiently increased blood pressure and reduced heart rate after each dose in clinical studies, with peak mean increases of 6 mmHg systolic and 3 mmHg diastolic. Vyleesi is contraindicated in uncontrolled hypertension or known cardiovascular disease and is not recommended for people at high cardiovascular risk. This product-specific warning cannot be made safer by calling a vial research use only.
Can PT-141 cause skin darkening?
Yes, focal hyperpigmentation is a labeled Vyleesi risk. In the Phase 3 trials it was reported in 1% of participants using the approved intermittent regimen, and more frequent consecutive dosing produced a much higher signal in another study. The label notes that changes may not fully resolve and that darker skin was associated with higher risk. A different concentration or unverified formulation has no established safer profile.
Is PT-141 like Viagra?
No simple equivalence is supported. Bremelanotide acts as a melanocortin receptor agonist, while sildenafil is a phosphodiesterase-5 inhibitor. The drugs have different mechanisms, approved uses, contraindications, and evidence populations. A 19-person crossover study tested low-dose intranasal PT-141 with sildenafil, but that combination signal does not prove that PT-141 is a Viagra substitute, that it is better, or that research-vial combinations are safe.
What is the correct PT-141 dosage?
The only authoritative US dosage record belongs to the exact prescription Vyleesi autoinjector and its FDA-approved label, not to seller-labelled 10 mg research vials, compounded products, sprays, blends, or imported presentations. Peptide Local does not convert the Vyleesi label into research-vial dosing, reconstitution, injection, cycling, or stacking instructions. Product identity, medical eligibility, contraindications, and prescriber oversight must remain attached to the approved medicine.
How long does PT-141 last?
The current Vyleesi label states that the duration of efficacy after a dose is unknown and that the optimal administration window has not been fully characterized. Online claims promising an exact number of hours often overstate what the label establishes. Pharmacokinetic half-life, measured desire outcomes, erectile-response monitoring, and an individual's perceived duration are different endpoints and should not be collapsed into one guaranteed timeline.
Can I buy PT-141 online?
Online listings exist, but a listing, price, local-currency display, shipping claim, or certificate does not establish an approved medicine, authorized seller, lawful import, identity, sterility, or suitability. In the United States, use the Vyleesi medicine record for the approved prescription product and keep research-market price rows separate. In other countries, check the exact product and seller through the destination regulator and pharmacy routes before drawing any status conclusion.
Do not convert the Vyleesi label into a research-vial protocol.
The approved label concerns a defined finished product, population, indication, presentation, manufacturing record, prescription relationship, and supply chain. A 10 mg research vial, compounded preparation, blend, spray, or imported package can differ in form, concentration, excipients, impurities, sterility, endotoxin control, storage, exposure, and intended use.
This page does not provide dosing, reconstitution, injection, cycling, stacking, titration, or combination instructions. Product approval, country access, seller availability, laboratory testing, medical eligibility, and individual care remain separate records.