OPZELURA

Peak

ruxolitinib

NDATOPICALCREAMPriority Review
Approved
Sep 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

Ruxolitinib, a Janus kinase (JAK) inhibitor, inhibits JAK1 and JAK2 which mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. JAK signaling involves recruitment of STATs (signal transducers and activators of transcription) to…

Indications (1)

Clinical Trials (5)

NCT07249346Phase 2Recruiting

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
NCT07340138Phase 1Not Yet Recruiting

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)
NCT07424222Phase 1Not Yet Recruiting

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)
NCT07357727Phase 3Not Yet Recruiting

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)
NCT07228624Phase 2Recruiting

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
May 5, 2041
184 months away
Patent Expiry
May 5, 2041
Exclusivity Expiry
Sep 18, 2028

Patent Records (5)

Patent #ExpiryTypeUse Code
9079912
Dec 12, 2026
U-3229
10639310
Dec 12, 2026
U-3229
9974790
Dec 12, 2026
U-3229
9974790*PED
Jun 12, 2027
10639310*PED
Jun 12, 2027