Peptimes

Track semaglutide in Peptimes

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. It is the active ingredient in several FDA-approved prescription medicines, some injected under the skin and some taken as tablets. (Source: DailyMed label.)

Is semaglutide FDA-approved?

Yes, as specific products: Ozempic and Wegovy injections and Rybelsus, Ozempic and Wegovy tablets are FDA-approved, by prescription, for the uses in their labels.

Checked 23 Oct 2026. The sources are below.

Semaglutide

Also: NN9535, NNC 0113-0217

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

  • Ozempic (semaglutide) injection

    Subcutaneous

    Adults with type 2 diabetes mellitus: glycemic control with diet and exercise, and reducing the risk of cardiovascular and kidney events in the groups the label defines.

    Source: DailyMed label, checked 23 Oct 2026

  • Wegovy (semaglutide) injection

    Subcutaneous

    With a reduced-calorie diet and increased physical activity: "to reduce excess body weight and maintain weight reduction long term", reducing the risk of major adverse cardiovascular events, and noncirrhotic MASH with moderate to advanced liver fibrosis (accelerated approval), each in the patients the label defines.

    Source: DailyMed label, checked 23 Oct 2026

  • Wegovy (semaglutide) tablets

    Oral

    The injection's weight-reduction and cardiovascular uses, in adults only (no MASH use).

    Source: DailyMed label, checked 23 Oct 2026

  • Rybelsus and Ozempic (semaglutide) tablets

    Oral

    Adults with type 2 diabetes mellitus: glycemic control with diet and exercise, and reducing the risk of major adverse cardiovascular events in those at high risk.

    Source: DailyMed label, checked 23 Oct 2026

  • Prescription

    Prescription only. Drugs@FDA lists each product above 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 semaglutide 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.

  • Routes: subcutaneous or oral. Choose the one that matches each dose.
  • 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. Oral 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 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 semaglutide or any other compound.

More sources

  • FDA, Drugs@FDA: NDA 209637 (Ozempic injection), NDA 215256 (Wegovy injection), NDA 218316 (Wegovy tablets), NDA 213051 (Ozempic and Rybelsus tablets) and NDA 213182 (Rybelsus tablets), checked 23 Oct 2026: product, route and marketing status.
  • FDA, Global Substance Registration System, Semaglutide, checked 23 Oct 2026: the code names NN9535 and NNC 0113-0217.

GLP-1 tracker appOzempic trackerWegovy trackerInjection-site history in PeptimesWhat FDA status terms mean

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