Protocol Reference — PT-141 (Bremelanotide)

FDA-approved dose (female HSDD)

1.75 mg SC at least 45 minutes before anticipated sexual activity

This is the only FDA-approved dosing regimen. No more than 1 dose per 24 hours.

Cautious start (clinical practice)

0.5-1.0 mg SC to assess individual nausea and blood pressure sensitivity

Many clinicians begin below the FDA dose to gauge tolerance before escalating.

Advanced male ED dose

1.0-2.0 mg SC, titrated from low starting dose

Off-label. Based on smaller clinical trial data. Not FDA-approved for this population.

Frequency limit

Maximum 8 doses per month

Exceeding this limit significantly increases hyperpigmentation risk. Phase 3 trials tested up to 12/month but the FDA set the threshold at 8.

Timing

Administer at least 45 minutes before anticipated activity

Tmax is 30-60 minutes. Neural stimulation persists for 4-8 hours after dosing.