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Peptide Spencer
Partner

Reproductive & melanocortin

PT-141 (bremelanotide)

Also known as bremelanotide, PT-141, Vyleesi (brand, FDA-approved autoinjector)

FDA-approved productTier A applies only to the FDA approval of Vyleesi (bremelanotide) for premenopausal women with acquired, generalized hypoactive sexual desire disorder at 1.75 mg subcutaneously. All other uses, including in men, are off-label.

Melanocortin receptor agonist (MC3R/MC4R), alpha-MSH analogue

FDA-approved as Vyleesi (bremelanotide). Compounded PT-141 is not FDA-approved. Source, Nov 13, 2025

Identity. PT-141 is bremelanotide, a cyclic heptapeptide melanocortin analogue (alpha-MSH analogue). It is the active ingredient of the FDA-approved product Vyleesi (1.75 mg subcutaneous autoinjector, premenopausal women with HSDD). It is not melanotan II, which is a different peptide. The formulary 10 mg vial is a compounded presentation, and the sources found give no concentration or reconstitution data for it. The label dose of 1.75 mg is bremelanotide free base (equivalent to 1.89 mg bremelanotide acetate). Ask the partner pharmacy whether its 10 mg vial is labeled as base or acetate, a difference of about 8%. Gray-market 'melanotan' products are a different molecule family. Do not apply melanotan I/II dosing or safety data to PT-141. In the formulary's oxytocin/PT-141 blend, calculate the PT-141 dose from the PT-141 component's mg/mL only.

At a glance

These dosages are a helpful guide, not a prescription. Every clinician is expected to do their own due diligence before prescribing.

  1. Start

    1.75 mg subcutaneously per dose, abdomen or thigh, as needed1

    Approved label

  2. Ceiling

    1.75 mg SC per dose, no titration; over 8 doses per month not recommended1

    Approved label
Frequency
As needed, at least 45 min before activity; no more than one dose in 24 hours1
Route
Subcutaneous, abdomen or thigh (autoinjector)1
Course
Discontinue after 8 weeks if no improvement in symptoms1
Contraindicated in uncontrolled hypertension or known cardiovascular disease; approved only for premenopausal women, and male trials used intranasal doses that do not convert to subcutaneous.
Calculate this dose

Dosing detail

Approved label

Approved label

  • Vyleesi label, premenopausal women with acquired, generalized HSDD

    1.75 mg1

    Route
    subcutaneous, abdomen or thigh (autoinjector)
    Frequency
    as needed, at least 45 minutes before anticipated sexual activity; do not administer more than one dose within 24 hours; more than 8 doses per month is not recommended
    Duration
    Discontinue after 8 weeks if the patient does not report an improvement in her symptoms
    n
    not applicable (label)
    Design
    FDA-approved labeling (DailyMed; openFDA record last_updated 2026-10-14, label text Revised 3/2024)
    Source quote
    The recommended dosage of VYLEESI is 1.75 mg administered subcutaneously in the abdomen or thigh, as needed, at least 45 minutes before anticipated sexual activity.

    Finding. Fixed 1.75 mg flat dose, as needed. Maximum one dose per 24 hours and eight doses per month.

Human studies

Human study

  • Premenopausal women with HSDD, two identical phase 3 trials (RECONNECT 301 and 302)

    1.75 mg2

    Route
    subcutaneous
    Frequency
    as needed
    Duration
    24 weeks
    n
    1,267 randomized; 1,202 in modified intent-to-treat
    Design
    Randomized 1:1, double-blind, placebo-controlled, multicenter
    Source quote
    evaluated the safety and efficacy of bremelanotide 1.75 mg administered subcutaneously as needed in premenopausal women with hypoactive sexual desire disorder. Patients were randomized 1:1 to 24 weeks of treatment with bremelanotide or placebo.

    Finding. Significant increase in desire (integrated 0.35, P<.001) and reduced distress (integrated -0.33, P<.001) versus placebo.

  • Premenopausal women with female sexual dysfunctions (phase 2b dose-finding)

    0.75, 1.25 or 1.75 mg3

    Route
    subcutaneous, self-administered
    Frequency
    as desired
    Duration
    12 weeks
    n
    327 (efficacy data)
    Design
    Randomized, placebo-controlled dose-finding trial
    Source quote
    Patients randomized to receive placebo or BMT 0.75, 1.25 or 1.75 mg self-administered subcutaneously, as desired, over 12 weeks.

    Finding. 1.25/1.75 mg pooled beat placebo on satisfying sexual events (+0.7 vs +0.2 per month, p = 0.0180).

  • Men with erectile dysfunction who did not respond to sildenafil

    10 mg4

    Route
    intranasal spray
    Frequency
    45 minutes to 2 hours prior to sexual stimulation; at least 16 doses/attempts at home
    Duration
    not stated in abstract
    n
    342 (172 bremelanotide, 170 placebo)
    Design
    Randomized, double-blind, placebo-controlled
    Source quote
    A total of 342 married men (28 to 59 years old) with erectile dysfunction who did not respond to sildenafil were randomly assigned to receive 10 mg bremelanotide as an intranasal spray (group 1, 172) 45 minutes to 2 hours prior to sexual stimulation, or a similar regimen of placebo (group 2, 170).

    Finding. Positive clinical results in 33.5% of the bremelanotide group versus 8.5% on placebo (p = 0.03); more drug-related adverse effects.

  • Viagra- or Levitra-responsive men with erectile dysfunction, co-administration with sildenafil

    7.5 mg5

    Route
    intranasal
    Frequency
    single dose per crossover period
    Duration
    6-hour postdose observation per period
    n
    19
    Design
    Randomized cross-over, RigiScan response to visual sexual stimulation
    Source quote
    Nineteen patients with erectile dysfunction who were responders to either Viagra or Levitra by self-report were given 25 mg sildenafil and 7.5 mg intranasal PT-141, 25 mg sildenafil and an intranasal placebo spray, and a placebo tablet and an intranasal placebo spray in a randomized cross-over design.

    Finding. PT-141 plus 25 mg sildenafil produced a greater erectile response than sildenafil alone; no new or worse adverse events.

  • Healthy males and Viagra-responsive men with mild-to-moderate erectile dysfunction (phase 1 and pharmacodynamic study)

    greater than 7 mg6

    Route
    intranasal
    Frequency
    not stated in abstract
    Duration
    not stated in abstract
    n
    not stated in abstract
    Design
    Double-blind, placebo-controlled; RigiScan erectile response
    Source quote
    In both studies, an erectile response induced by PT-141 administration was statistically significant, compared to placebo, at doses greater than 7 mg, with the onset of the first erection occurring in approximately 30 min.

    Finding. Erectile response significantly above placebo at doses greater than 7 mg, onset about 30 minutes; maximum-tolerated dose not identified.

What clinics and vendors publish

These ranges come from clinic and vendor publications, not studies.

Clinic-reported

All practice numbers come from one clinic education page (published July 24, 2026, updated September 11, 2026). The page states that a clinical team reviewed it but names no physician reviewer. The numbers are not derived from trials and do not appear in a peer-reviewed review. The page describes use in men as entirely off-label. No controlled trial of subcutaneous dosing in men exists. The male trials used intranasal doses of 7.5 to 10 mg. The mg per dose depends on the pharmacy's vial concentration, which no source specifies for the 10 mg formulary vial. The only label-based evidence is for premenopausal women at 1.75 mg. Everything else in this section is clinic-reported.

StartClinic-reported
0.5 mg subcutaneously as a test dose (clinic page range: 0.5 to 1.0 mg test dose). 0.5 mg is below any subcutaneous dose studied (0.75, 1.25, 1.75 mg in the phase 2b trial). Efficacy was shown for pooled 1.25/1.75 mg.
TitrationClinic-reported
Clinic page: start at a 0.5 to 1.0 mg test dose and titrate to a 1.0 to 1.75 mg working dose, guided by tolerability. This is clinic-reported only. The label has no titration: one fixed 1.75 mg dose.
TypicalClinic-reported
Men, off-label: 1.0 to 1.75 mg subcutaneously as the working dose; the page's reported 'sweet spot' for many men is about 1.5 to 1.75 mg
CeilingClinic-reported
Clinic-reported: approximately 2 mg per dose. This is above the label dose and above the highest dose tested for efficacy in any subcutaneous trial (1.75 mg), and trials do not support it. The label has no weight-based dosing. Label: nausea, focal hyperpigmentation and more pronounced blood pressure increases are more likely with higher doses.
FrequencyClinic-reported
Label: do not give more than one dose in 24 h (additive BP risk); more than 8 doses per month is not recommended (few phase 3 patients exceeded it; more frequent dosing raises hyperpigmentation risk and time with raised BP). Clinic page, men off-label: frequency kept to no more than a couple of times per week.
RouteClinic-reported
Subcutaneous
TimingClinic-reported
45 minutes or more before anticipated activity
CycleClinic-reported
Not specified by the practice source; the label advises stopping after 8 weeks without improvement
  • Clinic-reportedPharmacy or clinic protocol7
    Physician-directed compounded protocols often begin with a 0.5 mg test dose
  • Clinic-reportedPharmacy or clinic protocol7
    Clinicians who use PT-141 off-label for men with low libido or PDE5-non-responsive erectile dysfunction typically describe starting at a 0.5–1.0 mg test dose and titrating to a 1.0–1.75 mg working dose
  • Clinic-reportedPharmacy or clinic protocol7
    The reported “sweet spot” for many men is around 1.5–1.75 mg — enough for effect while limiting nausea.
  • Clinic-reportedPharmacy or clinic protocol7
    The ceiling remains roughly 2 mg, and frequency is kept to no more than a couple of times per week.
  • Clinic-reportedPharmacy or clinic protocol7
    injected subcutaneously 45 minutes or more before activity

Safety

Serious warnings

  • The Vyleesi label carries no boxed warning.8
  • Each dose transiently increases blood pressure and reduces heart rate. The label states: 'VYLEESI transiently increases blood pressure and reduces heart rate after each dose.' It is not recommended for patients at high risk for cardiovascular disease.8
  • Focal hyperpigmentation. In phase 3 trials, 1% of patients on up to 8 doses per month developed it (face, gingiva, breasts) versus none on placebo. In a separate daily-dosing study, 38% developed focal hyperpigmentation after daily dosing for 8 days, and a further 14% developed new changes among those who continued 8 more consecutive days. Patients with dark skin were more likely to develop it. Resolution was not confirmed in all patients after discontinuation. Consider discontinuing if it develops.1
  • Nausea was the most commonly reported adverse reaction (40%), requiring anti-emetic therapy in 13% and leading to premature discontinuation for 8%. Nausea improves for most patients with the second dose. Consider discontinuing for persistent or severe nausea, or starting an anti-emetic.1
  • Overdose and higher doses: no overdosage reports. Nausea, focal hyperpigmentation and more pronounced blood pressure increases are more likely with higher doses. Treatment is supportive.1

Contraindications

  • The label states: 'VYLEESI is contraindicated in patients who have uncontrolled hypertension or known cardiovascular disease'8

Adverse effects

  • Label Table 1 (Vyleesi n=627 vs placebo n=620): nausea 40.0% vs 1.3%, flushing 20.3% vs 0.3%, injection site reactions 13.2% vs 8.4%, headache 11.3% vs 1.9%. Also vomiting 4.8% vs 0.2%. Discontinuation due to adverse reactions 18% vs 2% (nausea 8%).8
  • 52-week open-label extension: 'The most common treatment-emergent adverse events considered related to study drug were nausea (40.4%), flushing (20.6%), and headache (12.0%)'; no new safety signals.9
  • Intranasal studies in men: 'Flushing and nausea were the most common adverse events reported in both studies'; a maximum-tolerated dose was not identified.6
  • Review of the phase 2 and 3 trials: 'The most common adverse effects include nausea (39.9%), facial flushing (20.4%), and headache (11%).'10

Monitoring

  • The label states: 'Blood pressure and heart rate returned to baseline usually within 12 hours post-dose.' It advises considering cardiovascular risk and ensuring blood pressure is well controlled before use.8
  • The label states: 'Discontinue VYLEESI after 8 weeks if the patient does not report an improvement in her symptoms.'1
  • Check baseline blood pressure and cardiovascular risk, and repeat periodically. Expect a transient rise of up to 6 mmHg systolic and 3 mmHg diastolic, peaking 2 to 4 h post-dose, with heart rate down up to 5 bpm, returning to baseline usually within 12 h.1
  • Examine skin and gums for focal hyperpigmentation at follow-up, especially in darker-skinned patients and anyone dosing frequently.1
  • Nausea plan: counsel that nausea improves for most patients with the second dose. In trials, 13% needed an anti-emetic and 8% discontinued.1

Interactions

  • The label states that Vyleesi may slow gastric emptying. Avoid use with concomitant oral drugs that depend on threshold concentrations for efficacy (for example antibiotics; indomethacin is a named example). Vyleesi may significantly decrease systemic exposure of orally administered naltrexone, so avoid it with oral naltrexone products for alcohol or opioid addiction.1
  • Co-administration of 7.5 mg intranasal PT-141 with 25 mg sildenafil 'did not result in new adverse events or adverse events that were increased in frequency or severity compared with monotherapy' (n=19 crossover).5

Handling

Reconstitution

No cited source covers reconstitution of the compounded 10 mg vial. Follow the dispensing pharmacy's labeling, and calculate volumes from the pharmacy's labeled mg/mL. For reference, the approved product is a single-dose autoinjector containing 1.75 mg (equivalent to 1.89 mg acetate) in 0.3 mL. That is not the concentration of the compounded vial.

Storage before mixing

The Vyleesi autoinjector label states: 'Store at or below 25°C (77°F). Do not freeze. Protect from light.' This applies to the approved product, not to the compounded vial.

Storage after mixing

No cited source found.18

Evidence

Vyleesi is FDA-approved for premenopausal women with acquired, generalized HSDD at 1.75 mg subcutaneously as needed. Two phase 3 RECONNECT trials showed statistically significant but modest gains in desire. Use in men is off-label. Human data in men come from small or single trials of intranasal doses (7.5 to 10 mg), not from the subcutaneous compounded route. Intranasal mg doses are not injectable doses and must not be converted to subcutaneous mg. Practice dosing for men comes from one clinic education page, not from a trial or a peer-reviewed review.

Mechanism

PT-141 is a synthetic analogue of alpha-MSH. It is an agonist at melanocortin receptors, including MC3R and MC4R, which are found mainly in the central nervous system. Its effect on sexual desire and arousal is central, not vascular. Per the label, each dose transiently raises blood pressure and lowers heart rate.811

Availability

Amounts offered

  • 10 mg

Custom strengths on request.

Blends that include PT-141 (bremelanotide)

References

According to PubMed

  1. 1openFDA drug label record for bremelanotide (Vyleesi)openFDA drug label API (record last_updated 2026-10-14; label text Revised 03/2024), 2024
  2. 2Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials.Obstet Gynecol 2019;134(5):899-908, 2019
  3. 3Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial.Womens Health (Lond) 2016;12(3):325-37, 2016
  4. 4Salvage of sildenafil failures with bremelanotide: a randomized, double-blind, placebo controlled study.J Urol 2008;179(3):1066-71, 2008
  5. 5Co-administration of low doses of intranasal PT-141, a melanocortin receptor agonist, and sildenafil to men with erectile dysfunction results in an enhanced erectile response.Urology 2005;65(4):755-9, 2005
  6. 6Double-blind, placebo-controlled evaluation of the safety, pharmacokinetic properties and pharmacodynamic effects of intranasal PT-141, a melanocortin receptor agonist, in healthy males and patients with mild-to-moderate erectile dysfunction.Int J Impot Res 2004;16(1):51-9, 2004
  7. 7PT-141 (Bremelanotide) Dosage Guide: Protocol, Reconstitution & Use for Men and WomenBeverly Hills Rejuvenation Center (clinic network); published July 24, 2026, updated September 11, 2026, 2026
  8. 8VYLEESI (bremelanotide acetate) injection, for subcutaneous use - prescribing informationDailyMed, National Library of Medicine (setid f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf; listed Updated November 13, 2025; label text Revised 3/2024), 2025
  9. 9Long-Term Safety and Efficacy of Bremelanotide for Hypoactive Sexual Desire Disorder.Obstet Gynecol 2019;134(5):909-917, 2019
  10. 10Bremelanotide: New Drug Approved for Treating Hypoactive Sexual Desire Disorder.Ann Pharmacother 2020;54(7):684-690, 2020
  11. 11PT-141: a melanocortin agonist for the treatment of sexual dysfunction.Ann N Y Acad Sci 2003;994:96-102, 2003
  12. 12Peptides in urology and sexual medicine: clinical effectiveness, dosing, indications, and safety: a narrative review.Sex Med Rev 2026;14(4) (full text paywalled; only abstract read), 2026
  13. 13Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C ActU.S. FDA (Content current as of 05/14/2026), 2026
  14. 14Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety RisksU.S. FDA (Content current as of 04/22/2026), 2026

Last reviewed 2026-10-14. 45 figures checked against their sources. How this works