Which JAK inhibitors are approved in the U.S?
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 |
|
Oral tablets
Once daily |
January 14, 2022 | Pfizer Inc. |
|
Inrebic (fedratinib)
JAK2 inhibitor |
|
Oral capsules
Once daily |
August 16, 2019 | Bristol-Myers Squibb Company |
|
Jakafi (ruxolitinib)
JAK 1 / 2 inhibitor |
|
Oral tablets
Twice daily |
November 16, 2011 | Incyte Corporation |
|
Litfulo (ritlecitinib) AK3 and TEC (tyrosine kinase expressed in hepatocellular carcinoma) inhibitor |
|
Oral capsules
Once daily |
June 23, 2023 | Pfizer Inc. |
|
Ojjaara (momelotinib)
JAK1 / JAK2 and activin A receptor type 1 (ACVR1) inhibitor |
|
Oral tablets
Once daily |
September 15, 2023 | GSK |
|
Olumiant (baricitinib)
JAK inhibitor (greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3) |
|
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 |
|
Topical cream
Apply twice daily |
September 21, 2021 | Incyte Pharmaceuticals |
|
Rinvoq (upadacitinib) JAK inhibitor |
|
Oral tablets, extended-release
Once daily |
August 16, 2019 | AbbVie Inc. |
|
Vonjo (pacritinib)
JAK2 / FLT3 / IRAK1 inhibitor
|
|
Oral capsules
Twice daily |
February 28, 2022 | CTI BioPharma Corp. |
|
Xeljanz, Xeljanz XR (tofacitinib)
JAK inhibitor |
|
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. |
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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
- Fact Sheet for Healthcare Providers - Emergency Use Authorization (EUA) of baricitinib. Eli Lilly & Co. Indianapolis, IN. Revised May 2022. Accessed Dec. 6, 2023 at https://pi.lilly.com/eua/baricitinib-eua-factsheet-hcp.pdf
- Opzelura (ruxolitinib) cream. Prescribing information. Incyte. Wilmington, DE. Revised Jan 2023. Accessed Dec. 6, 2023 at https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215309s004lbl.pdf
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