Research Use Only. Bremelanotide is FDA-approved for a specific indication (HSDD in premenopausal women). Off-label use is not established in clinical trials. The approved product is a prefilled autoinjector — not a research vial.
PT-141 Protocol Reference
FDA-approved Vyleesi label framework, dosing limits, and off-label research context.
Sourced Protocol Frameworks
Source: FDA Vyleesi Label (bremelanotide)Protocol philosophy: The FDA label is the evidence-supported framework. Off-label use for other populations or indications has no validated clinical protocol.
FDA LABEL1.75 mg SC as needed, at least 45 minutes before anticipated sexual activity. Approved dose for HSDD in premenopausal women.
LIMITSMaximum 1 dose per 24 hours. Maximum 8 doses per month. Per FDA label.
OFF-LABELMale use and other populations are off-label. No established validated protocol exists — physician practice only without trial support.
FDA-Approved Product: Prefilled Autoinjector
Vyleesi — FDA-Approved Format
APPROVED FORM
Prefilled autoinjector — 1.75 mg
FORMULATION
Ready-to-use — no reconstitution
SITE
SC — abdomen or thigh
TIMING
At least 45 min before activity
MAX FREQUENCY
1/24h; 8/month per label
STORAGE
Room temperature per FDA label
⚠ Research vial use is off-label. The above applies to the FDA-approved Vyleesi autoinjector only.
Cycle & Reassessment
| Parameter | Framework | Source |
|---|---|---|
| As-needed | Not a continuous cycle — as-needed per event | FDA label |
| Maximum | Max 1/24h; 8/month | FDA label |
| Off-label | No established cycle | Off-label note |
Evidence Status
| Category | Status |
|---|---|
| Overall | FDA-approved for specific indication/population |
| Phase III RECONNECT | Improved desire and reduced distress vs placebo |
| FDA status | Approved — HSDD in premenopausal women only |
| Off-label status | Male use and other populations not FDA-approved |
Source PT-141 at Forge Scientific
Third-party tested, HPLC + Mass Spec verified, lot-specific COA. Ships same day — Fort Worth, TX.