Is ecnoglutide FDA-approved?

Not in the US. Drugs@FDA lists no application with ecnoglutide as an active ingredient. It has been approved in China, but that doesn't apply in the US.

Checked 1 Nov 2026. The sources are below.

Ecnoglutide

Also: XW003, XW-003

Status label in the Peptimes Library
Approved outside the US
Routes in Peptimes
Subcutaneous
Updated
1 Nov 2026

US regulatory status

  • FDA status

    Not FDA-approved in the US. Drugs@FDA lists no application with ecnoglutide as an active ingredient.

    Source: Drugs@FDA, checked 1 Nov 2026

How to track it in Peptimes

Add ecnoglutide 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 “Approved outside the US”. In the US it is not FDA-approved. A 2026 review in the journal Drugs reports that ecnoglutide injection, from Sciwind Biosciences, received its first approvals in China in January and March 2026; Sciwind names the regulator as China’s National Medical Products Administration (NMPA). That approval doesn’t apply in the US, and other ecnoglutide products don’t share it.

  • 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 ecnoglutide or any other compound.

More sources

  • Shirley M, “Ecnoglutide: First Approvals”, Drugs, 2026, PMID 42412371, checked 1 Nov 2026: subcutaneous ecnoglutide first approved in China in January 2026, with a second approval in March 2026.
  • Sciwind Biosciences, press release on the NMPA approval (copy on BioSpace, March 2026), checked 1 Nov 2026: approval of ecnoglutide injection by China’s NMPA (company-reported).
  • FDA, Drugs@FDA, searched 1 Nov 2026: no application lists ecnoglutide as an active ingredient.
  • FDA, Global Substance Registration System, Ecnoglutide, checked 1 Nov 2026: its sequence of 31 amino acids, the attached fatty-acid chain and the codes XW003 and XW-003.

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