Is orforglipron FDA-approved?

Yes, as a specific product: Foundayo (orforglipron) tablets are FDA-approved, by prescription, for the use in their label.

Checked 25 Oct 2026. The sources are below.

Orforglipron

Also: Foundayo, LY3502970, orforglipron calcium

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

  • Foundayo (orforglipron) tablets

    Oral

    With a reduced-calorie diet and increased physical activity: "to reduce excess body weight and maintain weight reduction long term" in the adults the label defines.

    Source: DailyMed label, checked 25 Oct 2026

  • Prescription

    Prescription only. Drugs@FDA lists each Foundayo strength 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 orforglipron 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.
  • 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 orforglipron or any other compound.

More sources

  • FDA, Drugs@FDA, NDA 220934 (Foundayo), checked 25 Oct 2026: product, route and marketing status.
  • FDA, Global Substance Registration System, Orforglipron, checked 25 Oct 2026: the code name LY3502970.

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

Coming soon to the App Store

See planned pricing