Product Description
Ruxolitinib is in a class of medications called kinase inhibitors. It works to treat myelofibrosis and PV by blocking the signals that cause cancer cells to multiply. This helps to stop the spread of cancer cells. It works to treat GVHD by blocking the signals of the cells that cause GVHD.
Mechanisms of Action: JAK1 Inhibitor, JAK2 Inhibitor, STAT Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral, Topical
FDA Designation: *
Approval Status: Approved
Approved Countries: Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Incyte
Company Location: WILMINGTON DE 19803
Company CEO: Hervé Hoppenot
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 122
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Incyte presented P3 Prurigo results on 2025-09-17 for Ruxolitinib
- Clinical Outcomes Reported - Incyte presented P3 Prurigo results on 2025-03-08 for Ruxolitinib
- Clinical Outcomes Expected - Incyte announced they will present P3 Prurigo results in YE25 for Ruxolitinib
Highest Development Phases
Phase 3: Acute Lymphoid Leukemia|Anemia|Dermatitis|Dermatitis, Atopic|Graft vs Host Disease|Hidradenitis Suppurativa|Myelofibrosis|Myeloproliferative Disorders|Neurodermatitis|Polycythemia Vera|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Prurigo|Pruritus|Thrombocythemia, Essential|Thrombocytosis|Vitiligo
Phase 2: Acute Monocytic Leukemia|Acute Myeloid Leukemia|Acute Myelomonocytic Leukemia|Adenocarcinoma|Anemia, Aplastic|B-Cell Leukemia|Blast Crisis|Bone Cancer|Bone Marrow Diseases|Bone Marrow Transplantation|Brain Cancer|Breast Cancer|Breast Diseases|Bronchiolitis Obliterans|Castleman Disease|Chronic Myeloid Leukemia|Chronic Myelomonocytic Leukemia|Colorectal Cancer|Dermatitis, Seborrheic|Ductal Breast Carcinoma|Ductal Carcinoma|Eosinophilia|Exanthema|Glioblastoma|Hepatitis B, Chronic|Hepatomegaly|Hodgkin Lymphoma|Hypereosinophilic Syndrome|Inflammatory Breast Cancer|Intraductal Noninfiltrating Carcinoma|Juvenile Myelomonocytic Leukemia,|Lichen Planus|Lichen Sclerosus et Atrophicus|Lobular Carcinoma|Lung Cancer|Lupus Erythematosus, Discoid|Lupus Erythematosus, Systemic|Lymphohistiocytosis, Hemophagocytic|Lymphoid Leukemia|Lymphoma, B-Cell|Myelodysplastic Syndrome|Myelodysplastic-Myeloproliferative Diseases|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Non-Small-Cell Lung Cancer|Pancreatic Cancer|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|Preleukemia|Prostate Cancer|Renal Cell Carcinoma|Stem Cell Transplant|T-Cell Leukemia
Phase 1: Cachexia|Cytokine Release Syndrome|Healthy Volunteers|Multiple Myeloma|Oncology Unspecified|Pancreatic Ductal Carcinoma|Wasting Syndrome
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| NCT06008808 | P1 |
Recruiting |
Graft vs Host Disease|Cytokine Release Syndrome |
2026-09-09 |
12% |
2025-07-03 |
Patient Enrollment|Primary Endpoints|Treatments |
| IRB17-1110 | P1 |
Recruiting |
Acute Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma |
2026-09-01 |
50% |
2024-11-27 |
Primary Endpoints|Treatments |
| I-RUX-20-52 | P1 |
Recruiting |
Multiple Myeloma |
2026-05-01 |
12% |
2024-12-19 |
Primary Endpoints|Start Date|Treatments|Trial Status |
| NCT05714072 | P1 |
Recruiting |
Polycythemia Vera|Myelofibrosis |
2026-01-01 |
2% |
2025-02-06 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| IRB-60439 | P1 |
Recruiting |
Chronic Myeloid Leukemia|Myeloproliferative Disorders|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Acute Myeloid Leukemia|Myelodysplastic Syndrome |
2025-12-01 |
12% |
2025-06-27 |
Primary Endpoints |
| HEM-iSMART C | P2 |
Recruiting |
B-Cell Leukemia|Acute Lymphoid Leukemia|T-Cell Leukemia|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|Lymphoma, B-Cell|Precursor Cell Lymphoblastic Leukemia-Lymphoma |
2032-02-01 |
2% |
2025-09-17 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
| NCI-2025-05876 | P2 |
Not yet recruiting |
Acute Myelomonocytic Leukemia|Juvenile Myelomonocytic Leukemia,|Chronic Myelomonocytic Leukemia|Acute Monocytic Leukemia|Myelofibrosis |
2031-07-31 |
2025-08-20 |
Primary Endpoints|Treatments |
|
| 2023-AHL-001 | P2 |
Not yet recruiting |
Glioblastoma|Brain Cancer |
2031-07-01 |
12% |
2025-05-28 |
Primary Endpoints |
| NCT07085039 | P2 |
Recruiting |
Castleman Disease |
2028-12-31 |
12% |
2025-10-11 |
|
| PRISM | P2 |
Not yet recruiting |
Renal Cell Carcinoma|Non-Small-Cell Lung Cancer |
2027-12-01 |
12% |
2025-10-23 |
Primary Endpoints|Treatments |
| UMCC 2023.109 | P2 |
Recruiting |
Prostate Cancer|Adenocarcinoma |
2027-10-30 |
2% |
2025-09-09 |
Primary Endpoints |
| INCB 18424-270 | P2 |
Active, not recruiting |
Lung Cancer|Pancreatic Cancer|Colorectal Cancer|Breast Cancer |
2027-09-30 |
12% |
2025-02-05 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| NCT04644211 | P2 |
Recruiting |
Thrombocytosis|Polycythemia Vera|Thrombocythemia, Essential |
2027-07-01 |
50% |
2025-07-04 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| MAGIC V | P2 |
Recruiting |
Graft vs Host Disease|Stem Cell Transplant|Bone Marrow Transplantation |
2027-06-01 |
12% |
2025-05-15 |
Primary Endpoints|Start Date|Treatments |
| INCA34176-254 | P2 |
Recruiting |
Graft vs Host Disease|Bronchiolitis Obliterans |
2027-06-01 |
2% |
2024-09-24 |
Primary Endpoints|Start Date|Treatments|Trial Status |
| RG1124040 | P2 |
Recruiting |
Anemia, Aplastic |
2027-06-01 |
12% |
2025-04-18 |
Primary Endpoints|Start Date|Treatments|Trial Status |
| NCT04414514 | P2 |
Recruiting |
Hidradenitis Suppurativa |
2026-10-01 |
50% |
2024-11-30 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| INCB 18424-269 | P2 |
Active, not recruiting |
Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma |
2026-02-01 |
12% |
2024-11-27 |
Primary Endpoints|Treatments |
| TBCRC042 | P2 |
Active, not recruiting |
Intraductal Noninfiltrating Carcinoma|Ductal Carcinoma|Breast Cancer|Lobular Carcinoma|Ductal Breast Carcinoma|Breast Diseases |
2026-01-01 |
12% |
2025-05-16 |
Primary Endpoints|Treatments |
| BTCRC-HEM15-027 | P2 |
Recruiting |
Hodgkin Lymphoma |
2025-12-01 |
12% |
2025-08-29 |
Primary Completion Date|Primary Endpoints|Treatments |
| IRB-47457 | P2 |
Recruiting |
Eosinophilia|Hepatomegaly|Hypereosinophilic Syndrome |
2025-11-30 |
12% |
2023-11-03 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| HLHRUXO | P2 |
Active, not recruiting |
Lymphohistiocytosis, Hemophagocytic |
2025-11-01 |
50% |
2025-10-17 |
Primary Completion Date|Primary Endpoints|Treatments |
| TRUX-LST | P2 |
Not yet recruiting |
Exanthema |
2025-11-01 |
12% |
2024-05-04 |
Primary Endpoints|Treatments |
| XPORT-MF-034 | P3 |
Recruiting |
Myelofibrosis|Anemia |
2028-08-31 |
25% |
2025-05-02 |
Treatments |
| INCB18424-312 | P3 |
Recruiting |
Vitiligo |
2026-08-10 |
55% |
2024-12-03 |
Primary Endpoints|Start Date|Treatments|Trial Status |