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Amdizalisib

Alternative Names: Amdizalisib, hmpl-689, hmpl689, hmpl 689
Latest Update: 2024-05-16
Latest Update Note: News Article

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

Map of Global Clinical Trials for Amdizalisib

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

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