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: Eastern America
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:
Recent & Upcoming Milestones
- PDUFA summary: Priority review for parsaclisib in relapsed or refractory MCL and MZL, with a target action date of April 30, 2022.
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 ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
jRCT2031210296 |
jRCT2031210296 | P3 |
Completed |
Marginal Zone Lymphoma|Follicular Lymphoma |
2032-08-25 |
|||
2021-002844-66 |
PATHWAY | P3 |
Completed |
Anemia, Hemolytic, Autoimmune |
2024-04-25 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Trial Status |
|
NCT04816565 |
LIMBER-304 | P3 |
Not yet recruiting |
Polycythemia Vera|Myelofibrosis|Thrombocythemia, Essential|Thrombocytosis |
2023-11-28 |
28% |
2021-03-26 |
|
NCT04809467 |
topMIND | P2 |
Completed |
Lymphocytic Chronic B-Cell Leukemia|Chronic Lymphoid Leukemia|Lymphoma, Non-Hodgkin|Lymphoma, B-Cell |
2024-10-22 |
36% |
2024-11-19 |
|
2022-501687-18-00 |
INCB 50465-801 | P2 |
Recruiting |
Other |
2024-09-30 |
2025-05-02 |
Treatments |
|
2017-003148-19 |
CITADEL-205 | P2 |
Completed |
Lymphoma |
2024-04-30 |
72% |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
NCT03235544 |
(CITADEL-205) | P2 |
Completed |
Mantle-Cell Lymphoma |
2024-04-30 |
72% |
2025-03-19 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT04509700 |
INCB050465 | P2 |
Active, not recruiting |
Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Acute Respiratory Distress Syndrome |
2027-09-30 |
12% |
2024-11-02 |
Patient Enrollment|Primary Endpoints|Treatments|Trial Status |
2020-003130-21 |
LIMBER-313 | P3 |
Completed |
Myelofibrosis |
2024-11-25 |
2025-05-27 |
Treatments |
|
NCT04816578 |
LIMBER-313 | P3 |
Recruiting |
Polycythemia Vera|Thrombocythemia, Essential|Thrombocytosis|Myelofibrosis |
2023-09-26 |
28% |
2021-03-26 |
|
jRCT2071200114 |
jRCT2071200114 | P3 |
Active, not recruiting |
Polycythemia Vera|Myelofibrosis|Thrombocythemia, Essential |
1970-01-01 |
|||
jRCT2080224158 |
jRCT2080224158 | P1 |
Completed |
Lymphoma |
2023-06-30 |
|||
jRCT2051210140 |
jRCT2051210140 | P3 |
Active, not recruiting |
Anemia, Hemolytic, Autoimmune |
1970-01-01 |
|||
2020-005591-35 |
topMIND | P2 |
Completed |
Chronic Lymphoid Leukemia|Lymphoma, Non-Hodgkin |
2024-12-30 |
2025-05-06 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
2017-003652-22 |
2017-003652-22 | P2 |
Completed |
Anemia, Hemolytic, Autoimmune |
2024-04-02 |
2025-06-29 |
Treatments |
|
CTR20192392 |
CTR20192392 | P2 |
Completed |
Follicular Lymphoma|Marginal Zone Lymphoma |
2023-11-21 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
jRCT2080225276 |
jRCT2080225276 | P2 |
Completed |
Follicular Lymphoma |
2023-10-31 |
|||
jRCT2021220038 |
jRCT2021220038 | P2 |
Not yet recruiting |
Unknown |
2023-07-10 |
|||
NCT04434937 |
CITADEL-213 | P2 |
Completed |
Follicular Lymphoma |
2023-02-16 |
39% |
2023-11-19 |
Primary Endpoints|Study Completion Date|Treatments|Trial Status |
jRCT2031200424 |
jRCT2031200424 | P3 |
Active, not recruiting |
Thrombocythemia, Essential|Polycythemia Vera|Myelofibrosis |
2025-06-01 |