Data updated: May 26, 2026
JAKAFI XR (ruxolitinib phosphate)
Trial Activity: Stable 100 active trials
Approved 2026-05-01
Development Insights
Incyte Corporation conducting 35 trials (15%)
335 indications explored (Broad Platform)
→ myelofibrosis (39 trials)
→ primary myelofibrosis (22 trials)
→ polycythemia vera (11 trials)
1
Indication
--
Phase 3 Trials
0
Years on Market
Details
- Status
- Prescription
- First Approved
- 2026-05-01
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
JAKAFI XR Approval History
Original
New Indication
New Form
Label Update
5 FDA actions from 2026 to 2026
What JAKAFI XR Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
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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 |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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 XR FDA Label Details
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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