Is enicepatide FDA-approved?

No. Enicepatide is investigational: it's being studied in clinical trials and isn't FDA-approved for any use.

Checked 1 Nov 2026. The sources are below.

Enicepatide

Also: CT-388, RO7795068, RG6640

Status label in the Peptimes Library
Phase 3 Trials
Routes in Peptimes
Subcutaneous
Updated
1 Nov 2026

US regulatory status

  • FDA status

    Not FDA-approved for any use. Drugs@FDA lists no application with enicepatide as an active ingredient.

    Source: Drugs@FDA, checked 1 Nov 2026

  • Investigational

    Yes.

    Source: ClinicalTrials.gov, checked 1 Nov 2026

What studies have looked at

Each point says who or what was studied and what the study reported, with its source and the date we checked it. These are findings from the sources cited, not advice or a promise of any result.

  • In humans

    ENITH-1, a double-blind, placebo-controlled Phase 3 trial in about 2,000 adults with obesity, or overweight without type 2 diabetes, measures the change in body weight at week 72. It began in March 2026 and is recruiting; no results yet.

    Source: NCT07351045, checked 1 Nov 2026

How to track it in Peptimes

Add enicepatide 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 “Phase 3 Trials”, which describes its investigational status. It isn’t an approval.

  • 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 enicepatide or any other compound.

More sources

  • NIH, ClinicalTrials.gov, ENITH-1 (NCT07351045), checked 1 Nov 2026: a Phase 3 study of enicepatide (RO7795068) sponsored by Hoffmann-La Roche, recruiting.
  • NIH, ClinicalTrials.gov, studies of enicepatide, checked 1 Nov 2026: registered studies, including Phase 3 studies sponsored by Hoffmann-La Roche.
  • FDA, Drugs@FDA, searched 1 Nov 2026: no application lists enicepatide as an active ingredient.
  • FDA, Global Substance Registration System, Enicepatide, checked 1 Nov 2026: its sequence of 38 amino acids and the codes CT-388 and RO7795068.

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