PT-141
Bremelanotide · Vyleesi
Bremelanotide (PT-141). Vyleesi is FDA-approved 1.75 mg SC for premenopausal HSDD, max one dose per 24 h and eight per month. Research cakes are not Vyleesi. Central MC4R arousal, not a PDE5. Male ED is off-label. Nausea and transient BP rise are on the label.
Use-case scores
0–10 against the evidence we have, not a gym ranking. Hidden domains do not apply here.
- Sexual / hormonal7.5/10
Vyleesi is FDA-approved for premenopausal HSDD. Ceiling 9; haircut because a research cake is not Vyleesi, male ED is off-label, and nausea/BP limits real-world use.
Compound card
- Sequence
- Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH
- Class
- Cyclic melanocortin agonist (bremelanotide; Vyleesi is the labeled product)
- Formula
- C50H68N14O10
- Status
- FDA-approved
How it works
PT-141 (bremelanotide) is an MC4R agonist. PDE5 inhibitors work on blood flow. Vyleesi is labeled for acquired, generalized HSDD in premenopausal women. Gray-market cakes are not that product. Male ED use is off-label. Derived from Melanotan II with less MC1R tanning activity; nausea and transient BP rise still sit on the file.
Source: FDA Label (Vyleesi)
Goal context
Desire vs erection plumbing
MC4R is central arousal. Sildenafil is nitric-oxide plumbing. Non-responders to PDE5 are a hypothesis, not a guarantee this vial will work.
Background & History
PT-141 (Bremelanotide) is a cyclic heptapeptide derived from alpha-MSH (alpha-melanocyte-stimulating hormone) developed by Palatin Technologies. Unlike sildenafil and other PDE5 inhibitors that act peripherally, PT-141 acts centrally in the hypothalamus via MC4R (melanocortin-4 receptor) to initiate sexual arousal - making it effective for both men and women. FDA approved in 2019 as Vyleesi for hypoactive sexual desire disorder (HSDD) in premenopausal women - the first centrally acting sexual dysfunction treatment approved for women.
Research Use Cases
- ✓Identity: Vyleesi labeled HSDD vs a research cake
- ✓Why this is not a PDE5 and not a general ED NDA
- ✓Nausea, BP, and the 8-doses-per-month cap
Dosing
| Phase | Dose | Frequency | Notes |
|---|---|---|---|
| Low / Sensitivity Test | 500 - 750 mcg | As needed (max 1x/24h) | Start here to assess nausea tolerance. Inject 45-60 min before anticipated need. |
| FDA-Approved Dose | 1.75 mg | As needed (max 8x/month) | Approved dose (Vyleesi) for women. Used off-label for both sexes in research. |
Administration
Timeline
Who it is for
Sexual Dysfunction (Female HSDD)
HighFDA-approved (Vyleesi) - the first central-acting sexual dysfunction treatment for women.
Sexual Dysfunction (Male, off-label)
LowNot a male-ED NDA. Central MC4R is a different mechanism than PDE5. That is a hypothesis, not a guarantee.
Reconstitution
| Vial | Water | Concentration | Example dose |
|---|---|---|---|
| 10 mg lyophilized | 2 mL BAC | 5 mg/mL | 1.75 mg labeled Vyleesi is a device. On a 10 mg / 2 mL cake (5 mg/mL), 500 mcg = 0.10 mL = 10 units on a U-100. |
Change vial size or water volume? Open the reconstitution calculator.
Safety & Considerations
FDA-approved as Vyleesi. May cause nausea, flushing, and headache. Maximum 1 dose per 24 hours, 8 doses per month. Transient blood pressure elevation possible. Not for uncontrolled hypertension.
Regulatory & Legal Status
FDA-approved as Vyleesi® for hypoactive sexual desire disorder (HSDD) in premenopausal women
Not currently on the WADA 2026 Prohibited List. Policies may change - verify before competition.
Prescription Drug
US Compounding: Available via licensed pharmacy Rx
⚠️ This information is for educational purposes only and may not reflect the most current regulatory updates. Always verify with official FDA, WADA, and jurisdiction-specific sources before use.
Limits of current evidence
- Vyleesi label is not a male-ED NDA. Off-label male use is a different evidence body.
- Do not combine with PDE5 inhibitors without a clinician. Transient BP rise is on the label.
- Nausea is common. Starting at 1.75 mg on a first research-chem shot is how people drop out.
Verdict
PT-141 is bremelanotide. The labeled job is Vyleesi 1.75 mg SC for premenopausal HSDD, max one dose per 24 h and eight per month. Research vials are not that product. It is not a PDE5 and not a general ED cure.
Interactions & Contraindications
Common side effect: transient nausea and flushing (MC1R-mediated). Causes transient blood pressure increase - contraindicated with cardiovascular disease, high blood pressure, or concurrent use of antihypertensives. Do not combine with PDE5 inhibitors (sildenafil, tadalafil) without medical clearance - additive blood pressure reduction risk. Maximum dosing frequency: once per 24 hours.
Synergies & Common Stacks
Different axis: kisspeptin is GnRH/LH, PT-141 is central MC4R. Clinics pair them. That is not a combination trial and not a male-ED NDA.
Pitocin is labor. Intranasal oxytocin is not Vyleesi. Pairing them is a catalog habit, not a sexual-wellness protocol.
PT-141 vs. Melanotan-2
Canonical comparison: PT-141 vs Melanotan-2
| Attribute | PT-141 | Melanotan-2 |
|---|---|---|
| FDA Status | Approved as Vyleesi® (HSDD) | Research chemical - not FDA approved |
| Mechanism | MC4R agonist (sexual circuits) | MC1R + MC4R agonist (tanning + sexual) |
| Primary Effect | Sexual arousal / desire | Skin tanning + sexual arousal |
| Tanning Effect | Minimal (MC1R activity much lower) | Strong melanin-stimulated tanning |
| Side Effects | Nausea, flushing (self-limiting) | Nausea, erections, pigmentation, moles |
| Dose | 0.5–1.75 mg per dose (SC) | 0.5–1 mg per dose (SC) |
Verdict: PT-141 is the safer, FDA-approved option for sexual health with a well-defined safety profile. Melanotan-2 adds tanning effects but carries greater risk (uncontrolled pigmentation, mole growth). For pure sexual function, PT-141 is the preferred clinical choice.
Appears in goal guides
Goal guides are maps, not clinic protocols. A mention here is not a treatment plan.
Sexual Health & Libido Restoration
PT-141 is Vyleesi for premenopausal HSDD. Kisspeptin is upstream GnRH biology. This page maps the SKUs. It is not a PDE5 and not a general ED or libido NDA.
Perimenopause & Menopause Optimization
Kisspeptin, Epitalon, MOTS-c, and PT-141 as they show up next to menopause folklore. Not HRT and not a vasomotor-symptom indication.
Frequently Asked Questions
How quickly does PT-141 work?▼
What is the PT-141 dose?▼
Can men use PT-141?▼
References
- Diamond LE et al. “"Bremelanotide: a melanocortin agonist for the treatment of female sexual dysfunction".” Expert Opinion on Investigational Drugs (2006). PMID: 16466772
- Kingsberg SA, et al. “Bremelanotide for treatment of hypoactive sexual desire disorder (RECONNECT).” Obstet Gynecol (2019). PMID: 31135742
- Rosen RC, et al. “Melanocortin receptor agonists for the treatment of sexual dysfunction.” J Sex Med (2004). PMID: 15497047
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