Sexual health
PT-141 (Bremelanotide)
Vyleesi
The 'desire shot'; strong telehealth + gray-market pull across both sexes. FDA-approved for premenopausal women's HSDD.
Evidence
AFDA-approved RCTs
Status
Category 2 — restrictedas of 2026-06
Approval
FDA-approved
Category
Sexual health
Route
Subcutaneous · Intranasal
Demand rank
#8 most-searched
01Dosing & Protocol
Typical · reference only
Label: 1.75 mg SC on-demand (women), >=45 min pre-activity, max 1/24h & <=8/month. Off-label community: 0.5-2 mg, start 0.5 mg
Titration
Label dose is fixed; community 'start at 0.5 mg, never 2 mg'
Reconstitution — illustrative, not a recommendation
10 mg vial + 2 mL BAC = 5 mg/mL; 1.75 mg = 35 U, 0.5 mg = 10 U on U-100. Autoinjector is 1.75 mg/0.3 mL (~5.83 mg/mL) - do NOT back-calculate from it.
Reconstitution calculatorlive tool
35units
on a U-100 syringedraw to the 35 mark
Concentration5 mg/mL
Draw volume0.35 mL
Illustrative, not a recommendation. mg vs mcg confusion drives 5–1000× overdoses — always recompute for your own vial and syringe.
Units are not milligrams. mg-vs-mcg confusion drives documented 5–1000× overdoses — always recompute for your own vial.
02Regulatory Status
Removal from Category 2 ≠ legal to compound ≠ FDA-approved. Compounded PT-141's legality is contested; telehealth 'legally compounded' claims are marketing, not settled law.
Status
Category 2 — restricted
503A bulks
Not on the bulks list
Category 2
NOT freed in Apr 2026; still Category 2 AND a copy of an approved drug
PCAC review
none scheduled
WADA
Not listed
03Evidence — the honest read
What the evidence actually shows
RECONNECT (n=1,267) met co-primaries with MODEST effect; did NOT increase satisfying sexual events. Men's use is Phase 2 at best / off-label.
04Safety
Contraindications
- Uncontrolled hypertensionhard stop
- Known cardiovascular diseasehard stop
- Pregnancyhard stop
- Daily/chronic use (hyperpigmentation)
Key interactions
- Oral naltrexone (HARD_STOP/avoid; ~60% Cmax / 40% AUC drop -> addiction-treatment failure)
- PDE5 inhibitors in men (additive hypotension/priapism; off-label)
- Reduces absorption of other oral drugs
Serious signals
- Transient BP rise (+6/+3 mmHg)
- Focal hyperpigmentation (~38% with daily use vs ~1% PRN)
- Nausea ~40%
- Rare acute hepatitis case
Monitoring
Baseline BP + CV history before first use; respect <=8 doses/month.
05Sources
The primary sources behind this monograph — each opens the registry so you can verify the claim yourself. Last verified 2026-06-13.
FDA labelFDA label — Vyleesi (application 210557)FDA-approved label — dosing & safety · NDA 210557 · DailyMedHow we source & verify — the full method →Beyond these primaries, every monograph is distilled from TrackurStack’s research dossier — 584 de-duplicated sources across 4 research iterations, adversarially verified against primary sources.
Not medical or legal advice. Educational / harm-reduction reference. Regulatory and dosing claims in this field move monthly — re-verify against primary sources (FDA docket FDA-2025-N-6895, DailyMed, ClinicalTrials.gov) before acting.
Last reviewed — 2026-06-13 · confidence: med-high