Ozmosi | Birelentinib Drug Profile
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Birelentinib

Pronounced as: bih-rel-eh-tin-ib

Alternative Names: Birelentinib, dzd-8586, dzd 8586, dzd8586
Clinical Status: Active
Latest Update: 2026-01-22
Latest Update Note: Clinical Trial Update

Product Description

For Hematological Malignancy (Sourced from: http://www.dizalpharma.com/innovation/P&S)

Mechanisms of Action: BCR Inhibitor

Novel Mechanism: Yes

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: Fast Track - Chronic Lymphoid Leukemia *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Dizal Pharmaceuticals
Company Location: Asia Pacific
Company CEO:
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Birelentinib

Countries in Clinic: Australia, China, Italy, United States

Active Clinical Trial Count: 12

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Chronic Lymphoid Leukemia|Lymphocytic Chronic B-Cell Leukemia|Lymphoma|Lymphoma, B-Cell

Phase 2: Diffuse Large B-Cell Lymphoma|Lymphoma, Non-Hodgkin|Purpura, Thrombocytopenic, Idiopathic|Thrombocytopenia

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

NCT07294365

TAI-SHAN11

P2

Recruiting

Thrombocytopenia|Purpura, Thrombocytopenic, Idiopathic

2027-07-01

50%

2026-01-23

Primary Endpoints|Start Date|Treatments|Trial Status

NCT06539195

TAI-SHAN9

P2

Active, not recruiting

Diffuse Large B-Cell Lymphoma

2026-01-01

12%

2025-12-13

NCT06539182

TAI-SHAN8

P2

Recruiting

Lymphoma, B-Cell|Lymphocytic Chronic B-Cell Leukemia|Chronic Lymphoid Leukemia

2027-09-01

12%

2024-08-07

Primary Endpoints|Treatments

2025-522669-32-00

DZ2024B0002

P3

Not yet recruiting

Lymphoma|Chronic Lymphoid Leukemia

2028-11-30

NCT05824585

DZ2022B0002

P1

Recruiting

Lymphoma, B-Cell|Lymphoma, Non-Hodgkin

2027-04-30

50%

2024-07-24

Patient Enrollment|Primary Endpoints|Start Date|Treatments|Trial Status

CTR20240120

CTR20240120

P2

Recruiting

Lymphoma|Chronic Lymphoid Leukemia

None

2025-05-11

Patient Enrollment|Treatments

CTR20240121

CTR20240121

P2

Active, not recruiting

Diffuse Large B-Cell Lymphoma

None

2025-12-21

Patient Enrollment|Start Date|Treatments|Trial Status

NCT07139873

TAI-SHAN6

P3

Recruiting

Lymphocytic Chronic B-Cell Leukemia|Chronic Lymphoid Leukemia|Lymphoma, B-Cell

2029-01-01

21%

2025-11-19

Primary Endpoints|Start Date|Treatments|Trial Status

CTR20250291

CTR20250291

P1

Completed

Lymphoma, B-Cell|Lymphoma, Non-Hodgkin

2025-04-03

2025-08-05

Patient Enrollment|Primary Completion Date|Study Completion Date|Treatments|Trial Status

NCT07059650

TAI-SHAN12

P2

Recruiting

Diffuse Large B-Cell Lymphoma

2030-10-01

12%

2025-08-29

Primary Endpoints|Start Date|Treatments|Trial Status

NCT07154264

TAI-SHAN10

P2

Recruiting

Chronic Lymphoid Leukemia|Lymphocytic Chronic B-Cell Leukemia|Lymphoma, B-Cell

2029-12-01

12%

2025-11-18

Primary Endpoints|Start Date|Treatments|Trial Status

NCT05844956

TAI-SHAN1

P2

Completed

Lymphoma, B-Cell|Lymphoma, Non-Hodgkin

2024-02-29

70%

2025-02-22

Primary Endpoints