Baricitinib: clinical trials recruiting now

FDA drug label

FDA-approved

Yes. Baricitinib appears in the FDA drug-label database. Marketed as Olumiant.

Drug class

Janus Kinase Inhibitor (FDA established pharmacologic class)

Mechanism of action

Janus Kinase Inhibitors (as stated on the FDA label)

Boxed warning

The FDA label for Baricitinib carries a boxed warning (the FDA's most serious warning). See the full label for details.

FDA-approved use

OLUMIANT ® is a Janus kinase (JAK) inhibitor indicated for: the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF blockers. ( 1.1 ) Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. ( 1.1 ) the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. ( 1.2 ) the treatment of adult patients with severe alopecia areata. ( 1.3 ) Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. ( 1.3 ) 1.1 Rheumatoid Arthritis OLUMIANT ® (baricitinib) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers. Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immun…

FDA label via openFDA