Is ARA-290 FDA-approved?

No. ARA-290 (cibinetide) is investigational: it has been studied in clinical trials and isn't FDA-approved for any use.

Checked 1 Nov 2026. The sources are below.

ARA-290

Also: cibinetide, ARA 290, pHBSP, pyroglutamate helix B surface peptide

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

US regulatory status

  • FDA status

    Not FDA-approved for any use. Drugs@FDA lists no application with cibinetide (ARA 290) 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

    In a blinded, placebo-controlled trial in people with sarcoidosis and small nerve fibre loss, ARA-290 improved neuropathic symptoms and was associated with higher corneal small nerve fibre density and a longer 6-minute walk. Its authors include the developer's staff.

    Source: PMID 24136731, checked 1 Nov 2026

How to track it in Peptimes

Add ARA-290 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.

  • Routes: subcutaneous or Other (intravenous doses are logged as Other). 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. Doses logged as Other skip this step.
  • 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 ARA-290 or any other compound.

More sources

  • NIH, ClinicalTrials.gov, studies of cibinetide (ARA 290), checked 1 Nov 2026: Phase 2 and Phase 1/2 studies, none currently active.
  • FDA, Drugs@FDA, checked 1 Nov 2026: no application lists cibinetide (ARA 290) as an active ingredient.
  • FDA, Global Substance Registration System, Cibinetide, checked 1 Nov 2026: its 11-amino-acid sequence and the names ARA 290 and pHBSP.

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