Is tirzepatide FDA-approved?

Yes, as specific products: Mounjaro and Zepbound (tirzepatide) injections are FDA-approved, by prescription, for the uses in their labels.

Checked 23 Oct 2026. The sources are below.

Tirzepatide

Also: LY3298176

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

US regulatory status

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

  • Mounjaro (tirzepatide) 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 at high risk for them.

    Source: DailyMed label, checked 23 Oct 2026

  • Zepbound (tirzepatide) injection

    Subcutaneous

    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, and "to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity".

    Source: DailyMed label, checked 23 Oct 2026

  • Prescription

    Prescription only. Drugs@FDA lists both products as "Prescription".

    Source: Drugs@FDA, checked 23 Oct 2026

  • Investigational

    No, for the products and uses above.

    Source: Drugs@FDA, checked 23 Oct 2026

How to track it in Peptimes

Add tirzepatide 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 detail by product.

  • 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 tirzepatide or any other compound.

More sources

  • FDA, Drugs@FDA: NDA 215866 (Mounjaro) and NDA 217806 (Zepbound), checked 23 Oct 2026: product, route and marketing status.
  • FDA, Global Substance Registration System, Tirzepatide, checked 23 Oct 2026: the code name LY3298176.

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