Is Orexin-A FDA-approved?

No. Orexin-A isn't FDA-approved, and Drugs@FDA lists no application with it as an active ingredient.

Checked 1 Nov 2026. The sources are below.

Orexin-A

Also: hypocretin-1, orexin A

Status label in the Peptimes Library
Not FDA-Approved
Routes in Peptimes
Nasal
Updated
1 Nov 2026

US regulatory status

  • FDA status

    Not FDA-Approved. Drugs@FDA lists no application with orexin-A (hypocretin-1) as an active ingredient.

    Source: Drugs@FDA, 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

    A placebo-controlled crossover pilot in 8 people with narcolepsy with cataplexy: orexin-A reduced REM sleep and direct wake-to-REM transitions, with no significant effect on night-time wakefulness.

    Source: PMID 22036605, checked 1 Nov 2026

  • In humans

    A placebo-controlled crossover study in 7 people with narcolepsy with cataplexy: their odour-detection threshold scores improved after orexin-A compared with placebo.

    Source: PMID 18718966, checked 1 Nov 2026

  • In humans

    A double-blind crossover pilot in 10 healthy men: orexin-A raised resting muscle sympathetic nerve activity compared with placebo, while blood pressure, heart rate and baroreflex sensitivity did not change.

    Source: PMID 35044844, checked 1 Nov 2026

How to track it in Peptimes

Add orexin-A 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 “Not FDA-Approved”.

  • Logging: the amount you took and how you feel. It’s logged as nasal, 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 orexin-A or any other compound.

More sources

  • FDA, Global Substance Registration System, Orexin A, checked 1 Nov 2026: its sequence of 33 amino acids and the names hypocretin-1 and orexin-A.
  • FDA, Drugs@FDA, checked 1 Nov 2026: no application lists orexin-A or hypocretin-1 as an active ingredient.

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