Is NSI-189 FDA-approved?

No. NSI-189 is investigational: it has been studied in registered clinical trials and isn't FDA-approved for any use.

Checked 1 Nov 2026. The sources are below.

NSI-189

Also: amdiglurax, NSI-189 phosphate

Status label in the Peptimes Library
Phase 2 Trials
Routes in Peptimes
Oral
Updated
1 Nov 2026

US regulatory status

  • FDA status

    Not FDA-approved for any use. Drugs@FDA lists no application with NSI-189 (amdiglurax) as an active ingredient.

    Source: Drugs@FDA, checked 1 Nov 2026

  • Investigational

    Yes.

    Source: ClinicalTrials.gov, checked 1 Nov 2026

How to track it in Peptimes

Add NSI-189 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 2 Trials”, which describes its investigational status. It isn’t an approval.

  • Logging: the amount you took and how you feel. It’s logged as oral, so there’s no injection site to record.
  • 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 NSI-189 or any other compound.

More sources

  • NIH, ClinicalTrials.gov, NCT02695472, checked 1 Nov 2026: a Phase 2 study of NSI-189 in major depressive disorder. ClinicalTrials.gov also lists other studies of NSI-189, including two completed Phase 1 studies.
  • FDA, Drugs@FDA, checked 1 Nov 2026: no application lists NSI-189 or amdiglurax as an active ingredient.
  • FDA, Global Substance Registration System, Amdiglurax, checked 1 Nov 2026: its chemical name and formula, and the names NSI-189 and amdiglurax.

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