Product Description
The investigational drug candidate amdizalisib is a novel, selective small molecule inhibitor targeting the isoform phosphoinositide 3Õ-kinase delta (PI3K_), a key component in the B-cell receptor signaling pathway. We have designed amdizalisibÊ with increased PI3K_ isoform selectivity. Amdizalisib Õs pharmacokinetic properties have been found to be favorable with good oral absorption, moderate tissue distribution and low clearance in pre-clinical pharmacokinetic studies. (Sourced from: https://www.hutch-med.com/pipeline-and-products/our-pipeline/)
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: HUTCHMED
Company Location: HONG KONG K3 00000
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: China
Active Clinical Trial Count: 6
Recent & Upcoming Milestones
Highest Development Phases
Phase 2: B-Cell Marginal Zone Lymphoma|Follicular Lymphoma|Lymphoma|Marginal Zone Lymphoma|Relapsed/Refractory Lymphoma
Phase 1: Lymphoma, B-Cell
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| CTR20170429 | P1 |
Completed |
Lymphoma, B-Cell |
2023-08-02 |
2025-04-29 |
Patient Enrollment|Treatments |
|
| 2016-689-GLOB1 | P1 |
Completed |
Lymphoma |
2023-08-02 |
44% |
2023-08-24 |
|
| CTR20223063 | P2 |
Completed |
Lymphoma |
2024-12-31 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
| 2021-TAZ-00CH2 | P2 |
Completed |
Relapsed/Refractory Lymphoma |
2024-12-31 |
66% |
2025-01-23 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| 2020-689-00CH3 | P2 |
Completed |
B-Cell Marginal Zone Lymphoma|Follicular Lymphoma |
2024-02-29 |
57% |
2025-04-08 |
|
| CTR20210264 | P2 |
Completed |
Follicular Lymphoma|Marginal Zone Lymphoma |
2024-02-29 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |