Is upadacitinib FDA-approved?

Yes, as specific products: Rinvoq, Rinvoq LQ and a generic upadacitinib tablet are FDA-approved, by prescription, for the uses in their labels. Those uses don't include alopecia areata.

Checked 1 Nov 2026. The sources are below.

Upadacitinib

Also: Rinvoq, Rinvoq LQ, ABT-494

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

US regulatory status

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

  • Rinvoq (upadacitinib) extended-release tablets

    Oral

    In the patients the label defines: rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, non-radiographic axial spondyloarthritis, polyarticular juvenile idiopathic arthritis and giant cell arteritis. Alopecia areata isn't among its uses.

    Source: DailyMed label, checked 1 Nov 2026

  • Rinvoq LQ (upadacitinib) oral solution

    Oral

    Psoriatic arthritis and polyarticular juvenile idiopathic arthritis, in the patients aged 2 and older the label defines.

    Source: DailyMed label, checked 1 Nov 2026

  • Generic upadacitinib extended-release tablets (Aurobindo), with Rinvoq as the reference product

    Oral

    As stated on its label, which may not list every use on Rinvoq's (approved through an abbreviated new drug application, ANDA).

    Source: Drugs@FDA, checked 1 Nov 2026

  • Investigational

    No, for the products and uses above.

    Source: Drugs@FDA, checked 1 Nov 2026

How to track it in Peptimes

Add upadacitinib 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 list above gives the detail by product.

  • 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 upadacitinib or any other compound.

More sources

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

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