Is tesamorelin FDA-approved?

Yes, as specific products: Egrifta SV and Egrifta WR (tesamorelin) for injection are FDA-approved, by prescription, for the use in their labels.

Checked 23 Oct 2026. The sources are below.

Tesamorelin

Also: TH9507, tesamorelin acetate

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.

  • Egrifta SV (tesamorelin) for injection

    Subcutaneous

    "for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy".

    Source: DailyMed label, checked 23 Oct 2026

  • Egrifta WR (tesamorelin) for injection

    Subcutaneous

    "for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy".

    Source: DailyMed label, checked 23 Oct 2026

  • Prescription

    Prescription only. Drugs@FDA lists the application's products as "Prescription", and both labels are marked "Rx only".

    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 tesamorelin 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 peptide tracker app page.

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

More sources

  • FDA, Drugs@FDA, BLA 022505 (Egrifta), checked 23 Oct 2026: product, route and marketing status. Both current labels on DailyMed give this application.
  • FDA, Global Substance Registration System, Tesamorelin, checked 23 Oct 2026: the code name TH9507, and tesamorelin acetate as a separate record.

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