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Muscle & PerformanceBeginnerFDA-Approved

PT-141

Bremelanotide (Vyleesi)

Low Dose
1 mg PRN
Medium Dose
1.75 mg PRN
Route
SubQ (FDA-approved autoinjector); intranasal used in earlier trials
Cycle Length
Ongoing / PRN

Mechanism of Action

Melanocortin 3/4 receptor (MC3R/MC4R) agonist. Acts centrally on hypothalamic and mesolimbic circuits involved in sexual arousal, rather than on penile/vascular smooth muscle like PDE5 inhibitors — explaining its efficacy independent of vascular blood flow.

Key Benefits

  • FDA-approved efficacy for HSDD in premenopausal women (RECONNECT phase 3 trials)
  • On-demand dosing rather than daily use
  • Effective independent of vascular mechanism — an option when PDE5 inhibitors underperform
  • Off-label male use for libido/arousal support is common in research/TRT-adjacent practice, though not FDA-studied in men

Dosing Protocol

Low / Starting Dose
1 mg PRN
Medium / Maintenance Dose
1.75 mg PRN
Administration Route
SubQ (FDA-approved autoinjector); intranasal used in earlier trials
Half-Life
~2.7 hours
Frequency
As needed, ≥45 min before activity; max 8 doses/month per FDA labeling
Cycle Length
Ongoing / PRN
Protocol Notes

Nausea is the dose-limiting side effect; many protocols start at 1 mg before moving to the FDA-labeled 1.75 mg dose. FDA data covers only premenopausal women — male dosing is extrapolated off-label.

Ideal Candidates

FDA-approved population: premenopausal women with acquired generalized HSDD. Off-label: men seeking libido/arousal support alongside other hormone protocols.

Side Effects & Safety

Nausea (~40%, most common), flushing, headache, transient blood pressure increase. Not studied in men in FDA trials — off-label male dosing is extrapolated from the approved female regimen.

Regulatory Status

FDA-Approved

FDA-approved (Vyleesi, 2019) for acquired generalized hypoactive sexual desire disorder in premenopausal women. Use in men or other indications is off-label/research.

Evidence & Citations

Frequently asked

What is PT-141?+

PT-141 (Bremelanotide (Vyleesi)) is a peptide studied for melanocortin agonist and on-demand libido support. Melanocortin 3/4 receptor (MC3R/MC4R) agonist. Acts centrally on hypothalamic and mesolimbic circuits involved in sexual arousal, rather than on penile/vascular smooth muscle like PDE5 inhibitors — explaining its efficacy independent of vascular blood flow.

What is the dosing protocol for PT-141?+

Literature commonly references 1 mg PRN (low) to 1.75 mg PRN (maintenance) via SubQ (FDA-approved autoinjector); intranasal used in earlier trials, on a ongoing / prn cycle. Educational reference only — a licensed Stackhaus Health provider sets any personalized protocol.

What is the regulatory status of PT-141?+

FDA-approved (Vyleesi, 2019) for acquired generalized hypoactive sexual desire disorder in premenopausal women. Use in men or other indications is off-label/research.

Where can I access PT-141?+

Research-grade PT-141 is available through Stackhaus Research. For a personalized, provider-reviewed protocol, consult a licensed clinician through Stackhaus Health.

More in Muscle & Performance

Used in these stacks

PT-141 appears in 1 research protocol in the Stackhaus Academy library.

Written and reviewed by Stackhaus Academy Editorial Team · Last reviewed July 2026

Educational Only. This page is educational reference material, not medical advice. It does not establish a doctor-patient relationship and is not a substitute for individualized clinical guidance. Personalized protocols and clinical decisions are made through a licensed provider via Stackhaus Health.