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: WILMINGTON DE 19803
Company CEO: Hervé Hoppenot
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 115
Recent & Upcoming Milestones
- 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
- Clinical Outcomes Reported - Incyte presented P2 Hidradenitis Suppurativa results on 2024-09-26 for Ruxolitinib
Highest Development Phases
Phase 3: Acute Lymphoid Leukemia|Anemia|Dermatitis, Atopic|Graft vs Host Disease|Hidradenitis Suppurativa|Myelofibrosis|Neurodermatitis|Polycythemia Vera|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Prurigo|Thrombocythemia, Essential|Thrombocytosis|Vitiligo
Phase 2: Acute Monocytic Leukemia|Acute Myeloid Leukemia|Acute Myelomonocytic Leukemia|Adenocarcinoma|Anemia, Aplastic|Blast Crisis|Bone Cancer|Bone Marrow Diseases|Bone Marrow Transplantation|Brain Cancer|Breast Cancer|Breast Diseases|Bronchiolitis Obliterans|Chronic Myeloid Leukemia|Chronic Myelomonocytic Leukemia|Colorectal Cancer|Dermatitis|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, Non-Hodgkin|Myelodysplastic Syndrome|Myelodysplastic-Myeloproliferative Diseases|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Myeloproliferative Disorders|Pancreatic Cancer|Preleukemia|Prostate Cancer|Stem Cell Transplant
Phase 1: Cachexia|Cytokine Release Syndrome|Healthy Volunteers|Multiple Myeloma|Non-Small-Cell Lung Cancer|Oncology Unspecified|Pancreatic Ductal Carcinoma|Wasting Syndrome
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| HEM-iSMART C | P2 |
Not yet recruiting |
Lymphoma, Non-Hodgkin|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia |
2031-10-01 |
2024-06-28 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
|
| 2023-AHL-001 | P2 |
Not yet recruiting |
Glioblastoma|Brain Cancer |
2031-07-01 |
12% |
2025-05-28 |
Primary Endpoints |
| INCB 18424-270 | P2 |
Active, not recruiting |
Breast Cancer|Colorectal Cancer|Lung Cancer|Pancreatic Cancer |
2027-09-30 |
12% |
2025-02-05 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| UMCC 2023.109 | P2 |
Recruiting |
Prostate Cancer|Adenocarcinoma |
2027-07-30 |
12% |
2025-06-06 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
| RG1124040 | P2 |
Recruiting |
Anemia, Aplastic |
2027-06-01 |
50% |
2025-04-18 |
Primary Endpoints|Start Date|Treatments|Trial Status |
| 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 |
12% |
2024-09-24 |
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 |
| NCT06008808 | P1 |
Recruiting |
Cytokine Release Syndrome|Graft vs Host Disease |
2026-09-09 |
23% |
2024-05-10 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
| IRB17-1110 | P1 |
Recruiting |
Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia |
2026-09-01 |
23% |
2024-11-27 |
Primary Endpoints|Treatments |
| I-RUX-20-52 | P1 |
Recruiting |
Multiple Myeloma |
2026-05-01 |
23% |
2024-12-19 |
Primary Endpoints|Start Date|Treatments|Trial Status |
| INCB 18424-269 | P2 |
Active, not recruiting |
Precursor Cell Lymphoblastic Leukemia-Lymphoma|Lymphoid Leukemia |
2026-02-01 |
12% |
2024-11-27 |
Primary Endpoints|Treatments |
| TBCRC042 | P2 |
Active, not recruiting |
Ductal Carcinoma|Ductal Breast Carcinoma|Breast Diseases|Lobular Carcinoma|Breast Cancer|Intraductal Noninfiltrating Carcinoma |
2026-01-01 |
12% |
2025-05-16 |
Primary Endpoints|Treatments |
| IRB-47457 | P2 |
Recruiting |
Eosinophilia|Hypereosinophilic Syndrome|Hepatomegaly |
2025-11-30 |
12% |
2023-11-03 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| TRUX-LST | P2 |
Not yet recruiting |
Exanthema |
2025-11-01 |
12% |
2024-05-04 |
Primary Endpoints|Treatments |
| JapicCTI-205336 | P2 |
Active |
Graft vs Host Disease |
2025-10-31 |
|||
| TRuE-AD4 | P3 |
Active, not recruiting |
Dermatitis, Atopic |
2025-08-30 |
57% |
2025-05-31 |
|
| INCB18424-110 | P1 |
Active, not recruiting |
Prurigo|Neurodermatitis |
2025-08-20 |
23% |
2025-05-24 |
|
| HLHRUXO | P2 |
Active, not recruiting |
Lymphohistiocytosis, Hemophagocytic |
2025-08-01 |
12% |
2025-02-19 |
Patient Enrollment|Primary Endpoints|Treatments |
| BTCRC-HEM15-027 | P2 |
Recruiting |
Hodgkin Lymphoma |
2025-07-01 |
53% |
2024-10-22 |
Primary Completion Date|Primary Endpoints|Study Completion Date |
| NCT04906746 | P1 |
Active, not recruiting |
Cachexia|Non-Small-Cell Lung Cancer|Wasting Syndrome |
2025-06-01 |
23% |
2025-05-01 |
Primary Endpoints|Treatments|Trial Status |
| NCT05440942 | P1 |
Completed |
Adenocarcinoma|Pancreatic Cancer|Pancreatic Ductal Carcinoma |
2025-05-30 |
23% |
2025-06-06 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| INCB 00928-104 | P2 |
Active, not recruiting |
Anemia|Myeloproliferative Disorders|Thrombocytosis|Polycythemia Vera|Myelofibrosis|Thrombocythemia, Essential |
2025-04-01 |
50% |
2025-05-06 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| INCB 18424-219 | P2 |
Completed |
Vitiligo |
2025-03-06 |
12% |
2025-04-12 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| OSU-20393 | P2 |
Active, not recruiting |
Myeloproliferative Disorders|Myelofibrosis|Thrombocytosis|Acute Myeloid Leukemia|Thrombocythemia, Essential|Polycythemia Vera |
2025-02-27 |
50% |
2025-04-03 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |