NDAORALTABLETPriority Review
Approved
Nov 2011
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Mechanism of Action
Janus Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Clinical Trials (5)
Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis in Myeloablative Allogeneic Peripheral Blood Stem Cell Transplantation
Started Jun 2026
124 enrolled
LeukemiaMyelodysplasiaChronic Myelomonocytic Leukemia
Study of Pelabresib add-on to Ruxolitinib in Japanese Adult Patients With Myelofibrosis
Started May 2026
6 enrolled
Primary Myelofibrosis (PMF)Post-polycythemia Vera Myelofibrosis (Post-PV MF)Post-essential Thrombocythemia Myelofibrosis (Post-ET MF)
Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE)
Started May 2026
16 enrolled
Immune Effector Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (IEC-HS)
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Started Apr 2026
460 enrolled
Primary Myelofibrosis (PMF)Post-polycythemia Vera Myelofibrosis (PPV-MF)Post-essential Thrombocythemia Myelofibrosis (PET-MF)
Ruxolitinib Before, During and After Hematopoietic Cell Transplant in Older Patients With Myelofibrosis and Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes
Started Feb 2026
50 enrolled
Myelodysplastic/Myeloproliferative NeoplasmPrimary MyelofibrosisSecondary Myelofibrosis
Loss of Exclusivity
LOE Date
Dec 12, 2028
33 months away
Patent Expiry
Dec 12, 2028
Exclusivity Expiry
Mar 22, 2029
Patent Records (5)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 9079912 | Dec 12, 2026 | U-3230 | |
| 9814722 | Dec 12, 2026 | U-3230 | |
| 9814722*PED | Jun 12, 2027 | — | |
| 9079912*PED | Jun 12, 2027 | — | |
| 7598257 | Dec 24, 2027 | SubstanceProduct | U-3228 |
Company
Incyte
DE - Wilmington