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
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: Eastern America
Company Founding Year: 1991
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: 133
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 Reported - 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|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|Adult T-Cell Leukemia-Lymphoma|Anemia, Aplastic|Anemia, Refractory, with Excess of Blasts|Anemia, Sickle Cell|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|Hematopoietic Stem Cell Transplant|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|Lymphoma, Non-Hodgkin|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|Prolymphocytic Leukemia|Prolymphocytic T-Cell Leukemia|Prostate Cancer|Renal Cell Carcinoma|Stem Cell Transplant|T-Cell Cutaneous Lymphoma|T-Cell Leukemia|T-Cell Peripheral Lymphoma
Phase 1: Cachexia|Cytokine Release Syndrome|Healthy Volunteers|Multiple Myeloma|Neurodermatitis|Oncology Unspecified|Pancreatic Ductal Carcinoma|Wasting Syndrome
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05088356 |
IRB-60439 | P1 |
Recruiting |
Myelogenous, Chronic, BCR-ABL Positive Leukemia|Acute Myeloid Leukemia|Chronic Myeloid Leukemia|Myeloproliferative Disorders|Myelodysplastic Syndrome |
2027-11-01 |
50% |
2025-12-20 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05714072 |
NCT05714072 | P1 |
Recruiting |
Myelofibrosis|Polycythemia Vera |
2027-01-01 |
2% |
2025-11-19 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06008808 |
NCT06008808 | P1 |
Recruiting |
Graft vs Host Disease|Cytokine Release Syndrome |
2026-09-09 |
50% |
2025-07-03 |
Patient Enrollment|Primary Endpoints|Treatments |
NCT03571321 |
IRB17-1110 | P1 |
Recruiting |
Acute Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma |
2026-09-01 |
50% |
2024-11-27 |
Primary Endpoints|Treatments |
NCT06209606 |
I-RUX-20-52 | P1 |
Recruiting |
Multiple Myeloma |
2026-05-01 |
12% |
2024-12-19 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT05745714 |
HEM-iSMART C | P2 |
Recruiting |
Lymphoma, B-Cell|T-Cell Leukemia|B-Cell Leukemia|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
2032-02-01 |
2% |
2025-09-17 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
NCT06991101 |
2023-AHL-001 | P2 |
Recruiting |
Glioblastoma|Brain Cancer |
2030-12-01 |
12% |
2025-12-27 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT07228624 |
RG1125655 | P2 |
Recruiting |
Myelofibrosis|Myelodysplastic-Myeloproliferative Diseases |
2030-09-01 |
50% |
2026-01-23 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT07085039 |
NCT07085039 | P2 |
Recruiting |
Castleman Disease |
2028-12-31 |
12% |
2025-10-11 |
|
NCT03801434 |
IRB-47457 | P2 |
Recruiting |
Hypereosinophilic Syndrome|Hepatomegaly|Eosinophilia |
2028-12-30 |
50% |
2025-12-24 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT07252050 |
RUX-HAPLO | P2 |
Not yet recruiting |
Anemia, Sickle Cell|Hematopoietic Stem Cell Transplant |
2028-11-19 |
2025-11-27 |
Primary Endpoints|Treatments |
|
NCT06616155 |
UMCC 2023.109 | P2 |
Recruiting |
Prostate Cancer|Adenocarcinoma |
2028-01-30 |
12% |
2025-12-11 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
NCT07283822 |
AAAV7563 | P2 |
Recruiting |
T-Cell Peripheral Lymphoma|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|T-Cell Cutaneous Lymphoma |
2028-01-01 |
12% |
2025-12-17 |
Primary Endpoints|Treatments |
NCT07219576 |
PRISM | P2 |
Recruiting |
Non-Small-Cell Lung Cancer|Renal Cell Carcinoma |
2027-12-01 |
12% |
2026-01-14 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT02955940 |
INCB 18424-270 | P2 |
Active, not recruiting |
Pancreatic Cancer|Breast Cancer|Colorectal Cancer|Lung Cancer |
2027-09-30 |
12% |
2025-02-05 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT04644211 |
NCT04644211 | P2 |
Recruiting |
Thrombocythemia, Essential|Thrombocytosis|Polycythemia Vera |
2027-07-01 |
50% |
2025-07-04 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT07249346 |
OSU-24102 | P2 |
Recruiting |
Myelodysplastic Syndrome|Chronic Myelomonocytic Leukemia|Anemia, Refractory, with Excess of Blasts |
2027-06-01 |
50% |
2025-12-25 |
|
NCT06936566 |
MAGIC V | P2 |
Recruiting |
Graft vs Host Disease|Bone Marrow Transplantation|Stem Cell Transplant |
2027-06-01 |
12% |
2025-05-15 |
Primary Endpoints|Start Date|Treatments |
NCT06752694 |
RG1124040 | P2 |
Recruiting |
Anemia, Aplastic |
2027-06-01 |
12% |
2025-04-18 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT03954236 |
NCT03954236 | P2 |
Active, not recruiting |
Graft vs Host Disease|Bronchiolitis Obliterans |
2027-02-06 |
12% |
2026-02-12 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT07356245 |
OSU-24353 | P2 |
Recruiting |
Precursor Cell Lymphoblastic Leukemia-Lymphoma|Graft vs Host Disease|Adult T-Cell Leukemia-Lymphoma|T-Cell Cutaneous Lymphoma|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|T-Cell Peripheral Lymphoma|Lymphoid Leukemia|Prolymphocytic T-Cell Leukemia|Prolymphocytic Leukemia|Lymphoma, Non-Hodgkin |
2026-12-31 |
12% |
2026-01-22 |
Primary Endpoints|Treatments |
NCT04414514 |
NCT04414514 | P2 |
Recruiting |
Hidradenitis Suppurativa |
2026-10-01 |
50% |
2024-11-30 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2023-506139-13-00 |
XPORT-MF-034 | P3 |
Recruiting |
Anemia|Myelofibrosis |
2028-08-31 |
18% |
2025-05-02 |
Treatments |
NCT06548360 |
INCB18424-312 | P3 |
Recruiting |
Vitiligo |
2026-08-10 |
78% |
2024-12-03 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT06832618 |
TRuE-AD5 | P3 |
Recruiting |
Dermatitis, Atopic |
2026-07-13 |
78% |
2025-06-03 |
Primary Endpoints|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
03/05/2026 |
News Article |
Atavistik Bio Closes $40 Million Series B Extension for Advancement of its Pipeline Bringing Total Round Proceeds to $160 Million |
|
02/10/2026 |
News Article |
Incyte Reports Fourth Quarter and Full Year 2025 Financial Results |
|
01/21/2026 |
News Article |
Opna Bio Announces Orphan Drug Designation Granted to OPN-2853 (Zavabresib) for the Treatment of Myelofibrosis |
|
01/12/2026 |
News Article |
Syndax Reports Preliminary 2025 Financial Highlights and Provides Business Updates at the 44th Annual J.P. Morgan Healthcare Conference |