Is dulaglutide FDA-approved?

Yes, as specific products: Trulicity injection is FDA-approved for the uses in its label, and it's prescription only.

Checked 23 Oct 2026. The sources are below.

Dulaglutide

Also: LY2189265

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
Subcutaneous
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.

  • Trulicity (dulaglutide) injection

    Subcutaneous

    Type 2 diabetes mellitus: glycemic control with diet and exercise in adults and children aged 10 and older, and reducing the risk of major adverse cardiovascular events in adults with established cardiovascular disease or multiple cardiovascular risk factors.

    Source: DailyMed label, checked 23 Oct 2026

  • Prescription

    Prescription only. Drugs@FDA lists each Trulicity strength as "Prescription".

    Source: Drugs@FDA, checked 23 Oct 2026

  • Investigational

    No, for the product and uses above.

    Source: Drugs@FDA, checked 23 Oct 2026

How to track it in Peptimes

Add dulaglutide 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 entry above gives the product it applies to.

  • Logging: the amount you took and how you feel.
  • Injection sites: each dose records the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the GLP-1 tracker app page.

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

More sources

  • FDA, Drugs@FDA, BLA 125469 (Trulicity), checked 23 Oct 2026: product, route and marketing status.
  • FDA, Global Substance Registration System, Dulaglutide, checked 23 Oct 2026: the code name LY2189265.

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