Approved Vyleesi vs gray-market PT-141 vials
Every row cites its source. Where a cell reflects our own reading of the evidence rather than an external source, the row says so.
| Aspect | Vyleesi (approved) | Gray-market 'PT-141' vials | Source |
|---|---|---|---|
| Regulatory status | Approved NDA 210557; the only bremelanotide product in Drugs@FDA | Not FDA-approved; FDA does not verify safety, effectiveness or quality of compounded drugs | source |
| Format and dose control | Prefilled single-dose autoinjector, exactly 1.75 mg/0.3 mL | Lyophilized powder; buyer reconstitutes and self-selects dose | source |
| Marketed audience | Premenopausal women with diagnosed acquired, generalized HSDD | Predominantly men, ED and 'performance', populations the label excludes | source |
| Evidence at the marketed use | Two phase 3 RCTs on the labeled endpoints | Male ED evidence stops at small 2004-2008 studies; FDA: programs did not lead to approved products; largest trial integrity-flagged, one related trial retracted | source |
| Dose logic | Max 1/24 h and 8/month; caps exist for BP and pigmentation reasons | No enforced cap; exposure plateaus at 7.5 mg so megadoses extend side effects, not effect | source |
| Known frequent-use harm | 1% focal hyperpigmentation at labeled frequency | 38% hyperpigmentation with daily dosing for 8 days in a controlled study; possibly permanent | source |
The same molecule under two product realities: a sealed, fixed-dose, FDA-verified autoinjector with one narrow indication, versus unverified powder marketed for men, ED and libido at doses and frequencies no label supports. This is a comparison of verification, not of chemistry.
This site publishes no reconstitution calculator for PT-141 vials: with no approved vial format, any mixing protocol would be an invented regimen for an unverified product. That absence is an editorial decision, not an oversight.