Bremelanotide dosage in published studies and labels
These are the doses used for Bremelanotide in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.
Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.
Last checked against primary sources:
Studied regimens and sources
Bremelanotide has an FDA-approved human dosage: 1.75 mg by subcutaneous autoinjector into the abdomen or thigh, taken as needed at least 45 minutes before anticipated sexual activity, with no more than one dose in 24 hours and no more than 8 doses per month. It is approved only for acquired, generalised hypoactive sexual desire disorder in premenopausal women.
| Human dosing established | Yes |
|---|---|
| Studied dose range | 1.75 mg per dose, as needed |
| Route | Subcutaneous |
| Frequency | As needed, at least 45 minutes before anticipated sexual activity; maximum one dose per 24 hours and 8 doses per month |
| Duration studied | The label directs discontinuation if there is no improvement after 8 weeks |
| Titration | None. The approved dose is fixed at 1.75 mg with no escalation. |
| Evidence level | FDA Approved |
| Last reviewed | 2026-09-05 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| FDA label — VyleesiFDA-approved label · FDA prescribing information | Premenopausal women with acquired, generalised hypoactive sexual desire disorder | 1.75 mg | Subcutaneous autoinjector, abdomen or thigh | As needed; maximum 1 dose per 24 hours, 8 doses per month | Ongoing as needed | Hypoactive sexual desire disorder | VYLEESI (bremelanotide) injection — FDA prescribing information, DailyMed |
| RECONNECT 301 — phase 3, results postedClinical trial · Phase 3 randomised placebo-controlled trial with posted results | Premenopausal women with hypoactive sexual desire disorder (n=723) | 1.75 mg | Subcutaneous | As needed | 24 weeks | Sexual desire and related distress | NCT02333071 — Study to Evaluate the Efficacy and Safety of Bremelanotide in Premenopausal Women With HSDD |
| RECONNECT 302 — phase 3, results postedClinical trial · Phase 3 randomised placebo-controlled trial with posted results | Premenopausal women with hypoactive sexual desire disorder (n=714) | 1.75 mg | Subcutaneous | As needed | 24 weeks | Sexual desire and related distress | NCT02338960 — Study to Evaluate the Efficacy and Safety of Bremelanotide in Premenopausal Women With HSDD |
Where sources disagree
- The approved product is an autoinjector delivering a fixed 1.75 mg dose. Research-grade PT-141 is supplied as a lyophilised powder for reconstitution, and doses quoted for it commonly range from 0.5 mg to 2 mg. Only 1.75 mg by autoinjector has been evaluated in the phase 3 programme and approved.
- The approval is specific to premenopausal women with HSDD. Use in men, and use for erectile function, has no approved indication and no phase 3 evidence in those populations behind the labelled dose.