Is baricitinib FDA-approved?

Yes, as a specific product: Olumiant (baricitinib) tablets are FDA-approved, by prescription, for the uses in their label.

Checked 1 Nov 2026. The sources are below.

Baricitinib

Also: Olumiant, LY3009104, INCB028050

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
Oral
Updated
1 Nov 2026

US regulatory status

FDA approval belongs to the product below, for its route and the uses in its label. Label uses are shortened unless quoted.

  • Olumiant (baricitinib) tablets

    Oral

    Severe alopecia areata in adults and children aged 12 and older; moderately to severely active rheumatoid arthritis in the adults the label defines; and COVID-19 in the hospitalized adults the label defines.

    Source: DailyMed label, checked 1 Nov 2026

  • Investigational

    No, for the product and uses above.

    Source: Drugs@FDA, checked 1 Nov 2026

How to track it in Peptimes

Add baricitinib 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 “FDA Approved”; the entry above gives the product it applies to.

  • 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 baricitinib or any other compound.

More sources

  • FDA, Drugs@FDA, NDA 207924 (Olumiant), checked 1 Nov 2026: product, route and marketing status.
  • FDA, Global Substance Registration System, Baricitinib, checked 1 Nov 2026: the code names LY3009104 and INCB028050.

Brand names on this page are trademarks of their owners. Peptimes isn't affiliated with or endorsed by them.

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