Data updated: Jul 17, 2026
Ruxolitinib · Apotex
Trial Activity: Stable 100 active trials
Oncology
Development Insights
Incyte Corporation conducting 35 trials (15%)
335 indications explored (Broad Platform)
→ myelofibrosis (39 trials)
→ primary myelofibrosis (22 trials)
→ polycythemia vera (11 trials)
Details
- Status
- None (Tentative Approval)
- First Approved
- N/A
- Routes
- ORAL
- Dosage Forms
- TABLET
Ruxolitinib Approval History
No approval records found
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Clinical Trial Registry
232 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04455841 results posted | INCB 00928-104 2023-503625-19-00, 2020-004029-21 | Ph 1, Ph 2 | active not recruiting | INCB000928 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Anemia Due to Myeloproliferative Disorders |
| NCT06150157 | 88549968MPN1001 2023-505584-36-00 | Ph 1 | recruiting | A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms |
| NCT05088356 | IRB-60439 NCI-2021-12228 | Ph 1 | active not recruiting | Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft |
| NCT07357727 MANIFEST-3 | CDAK539A12303 2025-523555-66-00 | Ph 3 | recruiting | A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF) |
| NCT06079879 | 3543-006 2023-504865-21-00, IMG-7289-CTP-301 | Ph 3 | active not recruiting | A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006) |
| NCT04817007 | CA011-023 2023-509635-89 | Ph 1, Ph 2 | active not recruiting | A Study to Assess the Safety and Tolerability of BMS-986158 Alone and in Combination With Either Ruxolitinib or Fedratinib in Participants With Blood Cancer (Myelofibrosis) |
| NCT07566897 | PH-L19IL2CORK-01/25 2025-522243-17-00 | Ph 1 | not yet recruiting | A Phase I Study to Evaluate the Safety and Efficacy of L19IL2 in Combination With Ruxolitinib in Patients With Advanced Solid Tumors |
| NCT06616155 | UMCC 2023.109 NCI-2024-06533, HUM00249478 | Ph 1, Ph 2 | recruiting | Ruxolitinib and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer |
| NCT07252050 RUX-HAPLO | 24-0735 | Ph 1, Ph 2 | recruiting | Ruxolitinib-Enhanced Haplo HCT for Children and Young Adults With Sickle Cell Disease |
| NCT07424222 RISE | J2632 IRB00544306 | Ph 1 | recruiting | Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE) |
| NCT04176198 | BBI-TP-3654-102 | Ph 1, Ph 2 | recruiting | A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis |
| NCT07340138 | CDAK539A11101 | Ph 1 | recruiting | Study of Pelabresib add-on to Ruxolitinib in Japanese Adult Patients With Myelofibrosis |
| NCT04116502 MITHRIDATE | RG_16-148 | Ph 3 | recruiting | MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polycythemia Vera |
| NCT05998408 results posted | 10001667 001667-H | Ph 1, Ph 2 | active not recruiting | JAK1/2 Inhibitor Ruxolitinib for Relapsed/Refractory Immune Bone Marrow Failure |
| NCT03878199 results posted | OSU-20393 NCI-2019-03712 | Ph 1, Ph 2 | terminated | Testing the Effect of Taking Ruxolitinib and CPX-351 in Combination for the Treatment of Advanced Phase Myeloproliferative Neoplasms |
| NCT04551131 | HLHRUXO NCI-2020-08320 | Ph 1, Ph 2 | active not recruiting | Use Of A Response-Adapted Ruxolitinib-Containing Regimen For The Treatment Of Hemophagocytic Lymphohistiocytosis |
| NCT07548983 | STUDY00028015 NCI-2025-09157, STUDY00028015 | Ph 1 | recruiting | Ruxolitinib With Azacitidine Maintenance for the Treatment of Patients With Acute Myeloid Leukemia Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation |
| NCT05762640 R-HLH | APHP200023 2021-006878-23 | Ph 2 | recruiting | Ruxolitinib as First Line Treatment in Primary Haemophagocytic Lymphohistiocytosis (R-HLH) |
| NCT06973668 | 2024-1940 NCI-2025-03239 | Ph 2 | recruiting | A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophosphamide, Sirolimus, Mycophenolate Mofetil to Prevent Graft Versus Host Disease |
| NCT02974647 | 16-1542 | Ph 2 | recruiting | Study of Ruxolitinib in Relapsed or Refractory T or NK Cell Lymphoma |
| NCT07085039 | 858269 | Ph 2 | recruiting | Ruxolitinib in Previously Treated Idiopathic Multicentric Castleman Disease |
| NCT06008808 | 202401211 | Ph 1 | recruiting | Ruxolitinib With and Without CTLA-4 Ig Abatacept for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation |
| NCT04061421 ABNL-MARRO | VICC HEMP 1977 | Ph 1, Ph 2 | recruiting | Active Myeloid Target Compound Combinations in MDS/MPN Overlap Syndromes Overlap Syndromes (ABNL-MARRO) |
| NCT07025538 | 24752 NCI-2025-03045, 24752 | Ph 1 | recruiting | Biomarker-Guided Ruxolitinib for the Prevention of Chronic Graft Versus Host Disease After Allogeneic Hematopoietic Cell Transplantation |
| NCT06034002 | INCA33989-102 | Ph 1 | recruiting | A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms |
| NCT07521046 | HCI171996 | Ph 1 | not yet recruiting | Tolerability of Ropeginterferon Alfa-2b Add-on to Ongoing Ruxolitinib Therapy in Myelofibrosis (RopeRux in Myelofibrosis) |
| NCT07032727 | 2025-0520 NCI-2025-04331 | Ph 2 | recruiting | Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations |
| NCT07356245 | OSU-24353 NCI-2026-00140 | Ph 2 | recruiting | Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma |
| NCT04384692 | RG1006507 NCI-2020-01626, 10093 | Ph 2 | active not recruiting | Peritransplant Ruxolitinib for Patients With Primary and Secondary Myelofibrosis |
| NCT03017820 | MC1684 R01CA262613, P50CA186781 | Ph 1 | recruiting | A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma |
| NCT06508463 | MC1684 Arm E R01CA262613, P50CA186781 | Ph 1 | recruiting | Intravenous Vesicular Stomatitis Virus in Patients With Peripheral T-cell Lymphoma |
| NCT06160791 | 232513 NCI-2023-09578 | Ph 2 | active not recruiting | Ruxolitinib With De-Intensified HLH-94 for the Treatment of Hemophagocytic Lymphohistiocytosis (HLH) |
| NCT03069326 | 16-1498 | Ph 2 | active not recruiting | A Clinical Study to Test the Effects of Ruxolitinib And Thalidomide Combination for Patients With Myelofibrosis |
| NCT02928978 TBCRC042 | H-38855 | Ph 2 | completed | Ruxolitinib for Premalignant Breast Disease |
| NCT07498205 APEX-MF | 26CTP.LEUK02 | Ph 4 | not yet recruiting | Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts |
| NCT04562389 SENTRY | XPORT-MF-034 2020-003883-19, 2023-506139-13-00 | Ph 3 | active not recruiting | Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis |
| NCT05010005 | 21-176 | Ph 1 | recruiting | A Study of Ruxolitinib and Duvelisib in People With Lymphoma |
| NCT06660355 | MCC-23051 | Ph 2 | recruiting | Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy |
| NCT04908735 HSCT | 2020-0719 | Ph 2 | terminated | Ruxolitinib for Early Lung Dysfunction After Hematopoietic Stem Cell Transplant |
| NCT06773195 | 24-157 | Ph 1, Ph 2 | recruiting | A Study of Ruxolitinib in Combination With Ulixertinib in People With Myelofibrosis |
| NCT03722407 results posted | MCC-19727 | Ph 2 | active not recruiting | Ruxolitinib for the Treatment of Chronic Myelomonocytic Leukemia (CMML): A Phase 2 Expansion |
| NCT03610971 | MCC-19660 HJKC3-0002 | Ph 2 | active not recruiting | Treatment Free Remission After Combination Therapy With Ruxolitinib Plus Tyrosine Kinase Inhibitors |
| NCT04279847 LIMBER | INCB 57643-103 2023-506145-38-00, 2020-003532-25 | Ph 1 | active not recruiting | Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms |
| NCT04328844 | IOA-244-101 2019-000686-20 | Ph 1 | active not recruiting | A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers |
| NCT02251821 results posted | 9033 NCI-2014-01882, 9033 | Ph 2 | completed | JAK Inhibitor Before Donor Stem Cell Transplant in Treating Patients With Primary or Secondary Myelofibrosis |
| NCT03286530 | 17-273 | Ph 2 | active not recruiting | Ruxolitinib + Allogeneic Stem Cell Transplantation in AML |
| NCT05936359 | INCA 33989-101 2022-502514-86-00 | Ph 1 | recruiting | A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms |
| NCT03874052 | STUDY00018238 NCI-2019-03272, STUDY00018238 | Ph 1 | recruiting | Ruxolitinib in Combination With Venetoclax With and Without Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia |
| NCT04472598 TRANSFORM-1 results posted | M16-191 2020-000097-15 | Ph 3 | completed | Study of Oral Navitoclax Tablet In Combination With Oral Ruxolitinib Tablet When Compared With Oral Ruxolitinib Tablet To Assess Change In Spleen Volume In Adult Participants With Myelofibrosis |
| NCT06936566 MAGIC V | STUDY-24-01656 P01CA039542 | Ph 2 | recruiting | MAGIC Ruxolitinib for aGVHD |
Showing 50 of 232 trials
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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.
Ruxolitinib 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