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:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China, Finland, France, Italy, Poland, Spain, United States
Active Clinical Trial Count: 8
Highest Development Phases
Phase 2: B-Cell Marginal Zone Lymphoma|Follicular Lymphoma|Lymphoma|Marginal Zone Lymphoma|Relapsed/Refractory Lymphoma
Phase 1: Healthy Volunteers|Lymphoma, B-Cell
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 2021-TAZ-00CH2 | P2 |
Recruiting |
Relapsed/Refractory Lymphoma |
2026-05-01 |
|
| 2018-689-00US1 | P1 |
Active, not recruiting |
Lymphoma |
2024-07-01 |
44% |
| 2020-689-00CH3 | P2 |
Recruiting |
Follicular Lymphoma|B-Cell Marginal Zone Lymphoma |
2024-04-01 |
34% |
| CTR20170429 | P1 |
Completed |
Lymphoma, B-Cell |
2023-08-02 |