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
Additional 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:
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|Mantle-Cell Lymphoma|Other
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| jRCT2031210296 | P3 |
Completed |
Follicular Lymphoma|Marginal Zone Lymphoma |
2032-08-25 |
|
| INCB050465 | P2 |
Active, not recruiting |
Lymphoma, Non-Hodgkin|Lymphoma, B-Cell|Acute Respiratory Distress Syndrome |
2027-09-30 |
12% |
| jRCT2031200424 | P3 |
Active, not recruiting |
Myelofibrosis|Polycythemia Vera|Thrombocythemia, Essential |
2025-06-01 |
|
| topMIND | P2 |
Completed |
Chronic Lymphoid Leukemia|Lymphoma, Non-Hodgkin |
2024-12-30 |
|
| LIMBER-313 | P3 |
Completed |
Myelofibrosis |
2024-11-25 |
|
| topMIND | P2 |
Completed |
Lymphocytic Chronic B-Cell Leukemia|Lymphoma, Non-Hodgkin|Lymphoma, B-Cell|Chronic Lymphoid Leukemia |
2024-10-22 |
36% |
| INCB 50465-801 | P2 |
Recruiting |
Other |
2024-09-30 |
|
| CITADEL-205 | P2 |
Completed |
Lymphoma |
2024-04-30 |
72% |
| (CITADEL-205) | P2 |
Completed |
Mantle-Cell Lymphoma |
2024-04-30 |
72% |
| PATHWAY | P3 |
Completed |
Anemia, Hemolytic, Autoimmune |
2024-04-25 |
|
| 2017-003652-22 | P2 |
Completed |
Anemia, Hemolytic, Autoimmune |
2024-04-02 |
|
| LIMBER-304 | P3 |
Not yet recruiting |
Myelofibrosis|Polycythemia Vera|Thrombocythemia, Essential|Thrombocytosis |
2023-11-28 |
28% |
| CTR20192392 | P2 |
Completed |
Follicular Lymphoma |
2023-11-21 |
|
| jRCT2080225276 | P2 |
Completed |
Follicular Lymphoma |
2023-10-31 |
|
| LIMBER-313 | P3 |
Recruiting |
Myelofibrosis|Polycythemia Vera|Thrombocytosis|Thrombocythemia, Essential |
2023-09-26 |
28% |
| jRCT2080224158 | P1 |
Completed |
Lymphoma |
2023-06-30 |
|
| jRCT2021220038 | P2 |
Not yet recruiting |
Unknown |
2023-07-10 |
|
| CITADEL-213 | P2 |
Completed |
Follicular Lymphoma |
2023-02-16 |
39% |
| jRCT2071200114 | P3 |
Active, not recruiting |
Myelofibrosis|Polycythemia Vera|Thrombocythemia, Essential |
1970-01-01 |
|
| jRCT2051210140 | P3 |
Active, not recruiting |
Anemia, Hemolytic, Autoimmune |
1970-01-01 |