Is PT-141 FDA-approved?

Yes, as a specific product: the Vyleesi (bremelanotide) autoinjector is FDA-approved, by prescription, for the uses in its label.

Checked 25 Oct 2026. The sources are below.

PT-141

Also: bremelanotide, bremelanotide acetate, Vyleesi

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
SubcutaneousNasal
Updated
25 Oct 2026

US regulatory status

FDA approval belongs to the product below, for its route and the uses in its label. Label uses are shortened unless quoted.

  • Vyleesi (bremelanotide) injection, autoinjector

    Subcutaneous

    The uses in its label.

    Source: Drugs@FDA, checked 25 Oct 2026

  • Prescription

    Prescription only. Drugs@FDA lists Vyleesi as "Prescription".

    Source: Drugs@FDA, checked 25 Oct 2026

  • Investigational

    No, for the product and uses above.

    Source: Drugs@FDA, checked 25 Oct 2026

How to track it in Peptimes

Add PT-141 in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “FDA Approved”; the list above gives the approved product and its route.

  • Routes: Vyleesi is an injection under the skin, and Drugs@FDA lists no nasal bremelanotide product. Peptimes offers subcutaneous and nasal routes: choose the one that matches each dose. A compounded or other unapproved product doesn’t share an approved product’s approval.
  • Logging: the amount you took, the route and how you feel.
  • Injection sites: subcutaneous doses record the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next. Nasal doses skip this step.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.

Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell PT-141 or any other compound.

More sources

  • FDA, Drugs@FDA, NDA 210557 (Vyleesi), checked 25 Oct 2026: product, route and marketing status, and the label (October 2020 version, section 11).
  • FDA, Global Substance Registration System, Bremelanotide acetate, checked 25 Oct 2026: the names PT-141 and Vyleesi.

Brand names on this page are trademarks of their owners. Peptimes isn't affiliated with or endorsed by them.

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