JAKAFI
Jakafi is a kinase inhibitor indicated for the treatment of adults with intermediate or high-risk myelofibrosis, including primary and post-disease forms. It is also used to treat adults with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. Additionally, the medication is approved for adult and pediatric patients aged 12 years and older for the treatment of steroid-refractory acute graft-versus-host disease and chronic graft-versus-host disease after the failure of prior systemic therapies.
How JAKAFI Works
Ruxolitinib inhibits Janus Associated Kinases (JAK1 and JAK2), which are enzymes that mediate the signaling of cytokines and growth factors essential for hematopoiesis and immune function. By blocking these kinases, the drug prevents the activation and localization of signal transducers and activators of transcription (STATs) to the cell nucleus, thereby modulating gene expression. This process reduces the dysregulated JAK signaling associated with myeloproliferative neoplasms and decreases the inflammatory cytokine activity and immune-cell activation involved in graft-versus-host disease.
Details
- Status
- Prescription
- First Approved
- 2011-11-16
- Routes
- ORAL
- Dosage Forms
- TABLET
JAKAFI Approval History
What JAKAFI Treats
3 indicationsJAKAFI is approved for 3 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Myelofibrosis
- Polycythemia Vera
- Graft-Versus-Host Disease
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
JAKAFI FDA Label Details
ProIndications & Usage
FDA Label (PDF)Jakafi is a kinase inhibitor indicated for treatment of: intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in adults. polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. 1.1 Myelofibrosis Jakafi is i...
JAKAFI Patents & Exclusivity
Patents (725 active)
Exclusivity
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.