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Which JAK inhibitors are approved in the U.S?

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Dec 6, 2023.

Official answer

by Drugs.com

There are currently 10 Janus kinase (JAK) inhibitors approved by the U.S. Food and Drug Administration (FDA). The most recent JAK approval was Ojjaara (momelotinib) on September 15, 2023. The first JAK inhibitor approved in the U.S. was Jakafi (ruxolitinib) on Nov. 16, 2011.

Related: Table of Approved U.S. JAK Inhibitors

What is a JAK Inhibitor?

Janus kinase (JAK) inhibitors are a group of medications that block immune system proteins in the body that often lead to inflammation and pain. JAKs help the immune system communicate with each other, but when JAK enzymes (such as JAK1, JAK2, JAK3, and TYK2) are blocked in the cell, this can help to lower overactivity of the immune system.

JAKs inhibitors are approved to treat of a variety medical conditions, including rheumatoid arthritis, atopic dermatitis (eczema), COVID-19, and certain rare blood cancers of the bone marrow (myelofibrosis).

When used for the treatment of rheumatoid arthritis or psoriatic arthritis, JAK inhibitors are part of a larger group of drugs called Disease-Modifying Anti-Rheumatic Drugs (DMARDs). DMARDs help to slow down ongoing, permanent joint or tissue damage in these conditions. They may be used when other more conventional treatments have not worked or were not tolerated.

Risks of JAK inhibitors include serious or even life-threatening side effects, like infections, cancer, heart attacks or blood clots, so they are not typically used as an initial treatment. Talk to your doctor about the side effects you can expect with the JAK inhibitor you are using.

JAK inhibitors come in oral and topical (skin) formulations and are typically administered once or twice daily.

Table of JAK Inhibitors Approved in the United States

Drug Indications Usual Administration FDA Approval Date Manufacturer
Cibinqo (abrocitinib)

JAK1 inhibitor
  • Atopic dermatitis (eczema) in adults and children 12 years of age and older.
 Oral tablets

Once daily

 January 14, 2022 Pfizer Inc.
Inrebic (fedratinib)

JAK2 inhibitor
  • Myelofibrosis (a rare type of blood cancer) in adults.
 Oral capsules

Once daily

 August 16, 2019 Bristol-Myers Squibb Company
Jakafi (ruxolitinib)

JAK 1 / 2 inhibitor
  • Myelofibrosis (a rare type of blood cancer) in adults.
  • Polycythemia vera (also a type of blood cancer) in adults.
  • Acute or chronic graft-versus-host disease in adults and children 12 years of age and older.
 Oral tablets

Twice daily

 November 16, 2011 Incyte Corporation

Litfulo (ritlecitinib)

AK3 and TEC (tyrosine kinase expressed in hepatocellular carcinoma) inhibitor
  • Alopecia areata (autoimmune disease leading to hair loss) in adults and children 12 years of age and older.
 Oral capsules

Once daily

 June 23, 2023 Pfizer Inc.
Ojjaara (momelotinib)

JAK1 / JAK2 and activin A receptor type 1 (ACVR1) inhibitor
  • Myelofibrosis (a rare type of blood cancer) in adults.
 Oral tablets

Once daily

 September 15, 2023 GSK
Olumiant (baricitinib)

JAK inhibitor (greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3)
  • Rheumatoid arthritis in adults.
  • Alopecia areata (autoimmune disease leading to hair loss) in adults.
  • Severe COVID-19 in hospitalized adults needing certain breathing support.
  • Use under FDA Emergency Use Authorization (EUA): COVID-19 in hospitalized children 2 to less than 18 years of age needing certain breathing support.
 Oral tablets

Once daily

In COVID-19, given for up to 14 days.		 May 31, 2018 Eli Lilly and Company
Opzelura (ruxolitinib)

JAK 1 / 2 inhibitor
  • Atopic dermatitis (eczema) in adults and children 12 years of age and older.
  • Nonsegmental vitiligo in adult and people 12 years of age and older.
 Topical cream

Apply twice daily

 September 21, 2021 Incyte Pharmaceuticals

Rinvoq (upadacitinib)

JAK inhibitor
  • Rheumatoid arthritis in adults
  • Psoriatic arthritis in adults.
  • Atopic dermatitis (eczema) in adults and children 12 years of age and older.
  • Ulcerative colitis in adults.
  • Crohn’s disease in adults.
  • Ankylosing spondylitis in adults.
  • Non-radiographic axial spondyloarthritis in adults.
 Oral tablets, extended-release

Once daily

 August 16, 2019 AbbVie Inc.
Vonjo (pacritinib)

JAK2 / FLT3 / IRAK1 inhibitor

  • FLT3 = FMS-like tyrosine kinase 3
  • IRAK1 = interleukin 1 receptor associated kinase-1
  • Myelofibrosis (a rare type of blood cancer) in adults.
 Oral capsules

Twice daily

 February 28, 2022 CTI BioPharma Corp.
Xeljanz, Xeljanz XR (tofacitinib)

JAK inhibitor
  • Rheumatoid arthritis in adults.
  • Psoriatic arthritis in adults.
  • Ulcerative colitis in adults.
  • Polyarticular course juvenile idiopathic arthritis in people 2 years of age and older.
  • Ankylosing spondylitis in adults.
 Oral tablets, immediate-release - usually given twice daily.

Oral tablets, extended-release - usually given once daily.

Oral solution - usually given twice daily.		 November 6, 2012 Pfizer Inc.

Related Questions

Related

This is not all the information you need to know about JAK inhibitors for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.

References

Read next

Rinvoq (upadacitinib) is an oral medicine that works by blocking intracellular Janus kinase (JAK) enzymes to help to reduce inflammation and pain in conditions such as rheumatoid arthritis. The half-life ranges from 8 to 14 hours and is the time it takes for half (50%) of the drug to be eliminated. Continue reading

Stopping treatment with Xeljanz may cause the symptoms of your condition to return. However, some patients are able to stop Xeljanz without their symptoms flaring up, according to the results of research conducted in patients with rheumatoid arthritis. You should not stop taking Xeljanz without consulting your doctor. Continue reading

Xeljanz can work in as little as three days for patients with ulcerative colitis. Some patients with rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis and ankylosing spondylitis will notice an improvement in their symptoms within two weeks, but others may have to wait up to three to four months for Xeljanz to work.

Xeljanz (tofacitinib citrate) is a Janus kinase (JAK) inhibitor and disease modifying anti-rheumatic drug (DMARD), which works by suppressing the immune system. Continue reading

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