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Dasatinib

Alternative Names: dasatinib, sprycel, bms-354825, DAZATINIB
Clinical Status: Inactive
Latest Update: 2025-06-08
Latest Update Note: Clinical Trial Update

Product Description

Dasatinib is used to treat a certain type of chronic myeloid leukemia (CML; a type of cancer of the white blood cells) as a first treatment and in people who can no longer benefit from other leukemia medications including imatinib (Gleevec) or in those who cannot take these medications because of side effects. Dasatinib is also used to treat a certain type of chronic CML in children. Dasatinib is also used to treat a certain type of acute lymphoblastic leukemia (ALL; a type of cancer of the white blood cells) in people who can no longer benefit from other leukemia medications or who cannot take these medications because of side effects. Dasatinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. (Sourced from: https://medlineplus.gov/druginfo/meds/a607063.html)

Mechanisms of Action: TK Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: *

Approval Status: Approved

Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malta | Mexico | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela

Approved Indications: None

Known Adverse Events: None

Company: Bristol-Myers Squibb
Company Location: NEW YORK NY 10016
Company CEO: Giovanni Caforio
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Dasatinib

Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, India, Israel, Italy, Jordan, Korea, Lebanon, Malaysia, Netherlands, New Zealand, Norway, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Tunisia, United Kingdom, United States, Vietnam

Active Clinical Trial Count: 25

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Acute Lymphoid Leukemia|Chronic Myeloid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma

Phase 2: Acute Myeloid Leukemia|Bone Diseases, Metabolic|Breast Cancer|Chronic Lymphoid Leukemia|HIV Infections|Leukemia|Lymphoma, Non-Hodgkin|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Osteoporosis|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|Prostate Cancer|T-Cell Leukemia|T-Cell Peripheral Lymphoma

Phase 1: B-Cell Leukemia|Blast Crisis|Healthy Volunteers|Leukemia, Plasma Cell|Lymphoid Leukemia|Lymphoma, B-Cell|Multiple Myeloma|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

HEM-iSMART B

P2

Not yet recruiting

Acute Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Lymphoma, Non-Hodgkin

2031-10-01

2024-06-28

SJALL23T

P2

Recruiting

Precursor Cell Lymphoblastic Leukemia-Lymphoma|T-Cell Peripheral Lymphoma|T-Cell Leukemia|Acute Lymphoid Leukemia|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

2027-12-01

12%

2025-02-04

Patient Enrollment|Primary Endpoints|Treatments

SENIOR

P2

Recruiting

Osteoporosis|Bone Diseases, Metabolic

2025-12-31

50%

2023-10-03

Primary Endpoints|Start Date|Treatments

NCT03595917

P1

Recruiting

Acute Myeloid Leukemia|Acute Lymphoid Leukemia|Lymphoma, B-Cell|Blast Crisis|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Chronic Lymphoid Leukemia|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|B-Cell Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Chronic Myeloid Leukemia

2025-11-01

23%

2023-11-29

Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments

IRB-68603

P1

Recruiting

Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma

2025-08-01

23%

2023-10-11

Primary Endpoints|Start Date|Treatments|Trial Status

2021-001288-26

P2

Active, not recruiting

HIV Infections

2024-07-29

NCI-2012-00037

P2

Completed

Breast Cancer

2024-01-31

61%

2024-07-11

Primary Completion Date|Primary Endpoints|Study Completion Date

NCI-2011-00267

P2

Completed

Prostate Cancer

2023-12-07

47%

2023-12-16

Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status

DASA001

P1

Recruiting

Leukemia, Plasma Cell|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Multiple Myeloma|Acute Lymphoid Leukemia|Lymphoma, Non-Hodgkin

2023-11-01

59%

2020-10-28

Primary Endpoints|Treatments

VHR ALL

P2

Recruiting

Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia

2034-12-31

2025-06-10

Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status

jRCT2021210060

P3

Active, not recruiting

Chronic Myeloid Leukemia

2029-03-31

SJALL23H

P2

Recruiting

Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia

2028-05-01

12%

2025-01-11

STUDY00022691

P1

Recruiting

Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia

2026-12-31

23%

2025-03-07

Primary Completion Date|Primary Endpoints|Treatments

NCT03020030

P3

Active, not recruiting

Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia

2026-11-30

38%

2025-01-04

NCI-2021-08486

P2

Recruiting

Myelogenous, Chronic, BCR-ABL Positive Leukemia|Chronic Myeloid Leukemia

2026-10-30

12%

2024-08-28

Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments

TOT17

P3

Active, not recruiting

Acute Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma

2026-09-30

27%

2024-11-27

Primary Endpoints|Treatments

KISS

P2

Active, not recruiting

Myelogenous, Chronic, BCR-ABL Positive Leukemia|Chronic Myeloid Leukemia

2025-12-31

2022-11-08

Patient Enrollment|Primary Endpoints|Treatments|Trial Status

GIMEMA Study LAL1509

P2

Completed

Acute Lymphoid Leukemia

2024-12-31

2025-05-06

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

CA180-226

P2

Completed

Chronic Myeloid Leukemia

2024-10-25

2025-05-02

Treatments

XS004-17

P1

Completed

Healthy Volunteers

2023-08-22

2023-11-27

Primary Endpoints|Treatments

LPI-JOR-LEB-KSA-TUN-2017-01

P2

Completed

Chronic Myeloid Leukemia|Myelogenous, Chronic, BCR-ABL Positive Leukemia

2023-07-22

55%

2023-09-23

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

DasaHIT

P3

Completed

Chronic Myeloid Leukemia

2023-03-31

2025-06-14

Treatments

2016-004106-34

P2

Completed

Chronic Myeloid Leukemia

2023-02-01

2025-06-06

Treatments

CTR20132365

P2

Recruiting

Acute Lymphoid Leukemia|Acute Myeloid Leukemia|Chronic Lymphoid Leukemia|Chronic Myeloid Leukemia

None

2025-04-29

Patient Enrollment|Treatments

CTR20131053

P2

Active, not recruiting

Leukemia

None

2025-04-29

Treatments