Product Description
Parsaclisib is a potent, highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kd). It is currently under evaluation as a monotherapy in several ongoing Phase 2 trials as a treatment for non-Hodgkin lymphomas (follicular, marginal zone and mantle cell); and in a Phase 3 study for autoimmune hemolytic anemia (AIHA). (Sourced from: https://investor.incyte.com/press-releases/press-releases/2022/Incyte-Provides-Update-on-Parsaclisib-and-MCLA-145/default.aspx)
Mechanisms of Action: PI3K Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Breakthrough Therapy - Follicular Lymphoma|Lymphoma *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Incyte
Company Location: WILMINGTON DE 19803
Company CEO: Hervé Hoppenot
Additonal Commercial Interests: Innovent Biologics
Clinical Description
Countries in Clinic: Austria, Belgium, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Japan, Korea, Netherlands, Norway, Poland, Romania, Russia, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 25
Highest Development Phases
Phase 3: Anemia, Hemolytic, Autoimmune|Follicular Lymphoma|Marginal Zone Lymphoma|Myelofibrosis|Polycythemia Vera|Thrombocythemia, Essential|Thrombocytosis
Phase 2: Acute Respiratory Distress Syndrome|Chronic Lymphoid Leukemia|Lymphocytic Chronic B-Cell Leukemia|Lymphoma|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Other|Pemphigus Vulgaris
Phase 1: Kidney Diseases|Oncology Unspecified
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| jRCT2031210296 | P3 |
Completed |
Marginal Zone Lymphoma|Follicular Lymphoma |
2032-08-25 |
|
| PATHWAY | P3 |
Active, not recruiting |
Anemia, Hemolytic, Autoimmune |
2028-01-30 |
|
| LIMBER-313 | P3 |
Active, not recruiting |
Myelofibrosis |
2026-03-10 |
|
| LIMBER-304 | P3 |
Active, not recruiting |
Myelofibrosis |
2025-07-13 |