JAKAFI (ruxolitinib phosphate)
JAKAFI is indicated for the treatment of Myelofibrosis; Polycythemia Vera; Graft-Versus-Host Disease.
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.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2011-11-16
- Patent Cliff
- 2028
- 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
JAKAFI Target & Pathway
ProTarget
A pro-inflammatory cytokine that plays a central role in immune responses and inflammation. Excess TNF contributes to autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Blocking TNF reduces inflammation and prevents tissue damage.
JAKAFI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to JAKAFI
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
19 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02131584 | 2013-0044 NCI-2014-01465, 2013-0044 | Ph 2 | active not recruiting | Ruxolitinib Phosphate in Reducing Fatigue in Patients With Chronic Lymphocytic Leukemia |
| NCT01787487 | 2012-0737 NCI-2013-00704, 2012-0737 | Ph 2 | completed | Ruxolitinib Phosphate and Azacytidine in Treating Patients With Myelofibrosis or Myelodysplastic Syndrome/Myeloproliferative Neoplasm |
| NCT07317700 | FMF-03 | Ph 3 | recruiting | A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosis |
| NCT03120624 results posted | MC1562 NCI-2017-00615, MC1562 | Ph 1 | active not recruiting | VSV-hIFNbeta-NIS With or Without Ruxolitinib Phosphate in Treating Stage IV or Recurrent Endometrial Cancer |
| NCT07278856 | 25404 NCI-2025-08060, 25404 | Ph 1 | not yet recruiting | Ruxolitinib in Combination With CHOP Chemotherapy for the Treatment of Untreated Nodal T-Follicular Helper Cell Lymphomas |
| NCT06128070 | 23010 NCI-2023-07401, 23010 | Ph 2 | recruiting | Ruxolitinib With Tacrolimus and Methotrexate for the Prevention of Graft Versus Host Disease in Pediatric and Young Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome |
| NCT02257138 results posted | 2014-0344 NCI-2014-02299, 2014-0344 | Ph 1, Ph 2 | completed | Ruxolitinib Phosphate and Decitabine in Treating Patients With Relapsed or Refractory or Post Myeloproliferative Acute Myeloid Leukemia |
| NCT02420717 results posted | 2014-0521 NCI-2015-00779, 2014-0521 | Ph 2 | terminated | Ruxolitinib Phosphate or Dasatinib With Chemotherapy in Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Like Acute Lymphoblastic Leukemia |
| NCT02713386 results posted | NRG-GY007 NCI-2016-00203, NRG-GY007 | Ph 1, Ph 2 | completed | Ruxolitinib Phosphate, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer |
| NCT03012230 | MC1534 NCI-2016-02057, 15-006282 | Ph 1 | completed | Pembrolizumab and Ruxolitinib Phosphate in Treating Patients With Metastatic Stage IV Triple Negative Breast Cancer |
| NCT02917096 | 16337 NCI-2016-01400, 16337 | Ph 1 | completed | Ruxolitinib Phosphate and Chemotherapy Given Before and After Reduced Intensity Donor Stem Cell Transplant in Treating Patients With Myelofibrosis |
| NCT01431209 results posted | 0283-11-FB NCI-2011-02733, P30CA036727 | Ph 2 | completed | Ruxolitinib Phosphate to Treat Diffuse Large B-Cell or Peripheral T-Cell Non-Hodgkin Lymphoma After Stem Cell Transplant |
| NCT00778700 results posted | INCB 18424-203 | Ph 2 | completed | A Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Participants With Plaque Psoriasis |
| NCT03041636 results posted | 2015-0570 NCI-2017-00478, 2015-0570 | Ph 2 | completed | Ruxolitinib Phosphate in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
| NCT02092324 results posted | IRB00010262 NCI-2014-00633, IRB00010262 | Ph 2 | completed | Ruxolitinib Phosphate in Treating Patients With Chronic Neutrophilic Leukemia or Atypical Chronic Myeloid Leukemia |
| NCT02779283 | IRB00011766 NCI-2016-00083, IRB00011766 | Ph 1 | completed | Personalized Kinase Inhibitor Therapy Combined With Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia |
| NCT01732445 results posted | MC1283 NCI-2012-02201, MC1283 | Ph 2 | completed | Ruxolitinib Phosphate and Danazol in Treating Anemia in Patients With Myelofibrosis |
| NCT02528877 | 14129 NCI-2015-01333, 14129 | Ph 1 | withdrawn | Ruxolitinib Phosphate, Tacrolimus and Sirolimus in Preventing Acute Graft-versus-Host Disease During Reduced Intensity Donor Hematopoietic Cell Transplant in Patients With Myelofibrosis |
| NCT01164163 | ADVL1011 COG-ADVL1011 | Ph 1 | completed | INCB18424 in Treating Young Patients With Relapsed or Refractory Solid Tumor, Leukemia, or Myeloproliferative Disease |
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
Indications & Usage
FDA Label (PDF)JAKAFI is indicated for the treatment of Myelofibrosis; Polycythemia Vera; Graft-Versus-Host Disease.
JAKAFI Patents & Exclusivity
Patents (16 active)
Exclusivity
Pro Intelligence Preview
Deep insights for JAKAFI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2028
- • 725 active patents
Trial Analysis
- • 19 total trials
- • Stage: Stable
Competitive Landscape
- • 5 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment