Ozmosi | Dasatinib Drug Profile
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Dasatinib

Alternative Names: dasatinib, sprycel, bms-354825, DAZATINIB
Clinical Status: Inactive
Latest Update: 2026-03-02
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: Eastern America
Company Founding Year: 1989
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, Ireland, Israel, Italy, Jordan, Korea, Lebanon, Malaysia, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Tunisia, United Kingdom, United States, Vietnam

Active Clinical Trial Count: 23

Recent & Upcoming Milestones

Highest Development Phases

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

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

Phase 1: Blast Crisis|Burkitt Lymphoma|Healthy Volunteers|Leukemia, Plasma Cell|Lymphoma, Non-Hodgkin|Multiple Myeloma

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

NCT03595917

NCT03595917

P1

Recruiting

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

2026-11-01

12%

2025-11-05

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

NCT04603872

DASA001

P1

Recruiting

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

2023-11-01

59%

2020-10-28

Primary Endpoints|Treatments

NCT05751044

HEM-iSMART B

P2

Recruiting

T-Cell Leukemia|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|B-Cell Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia|Lymphoma, B-Cell

2032-02-01

2%

2025-09-17

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

NCT06390319

SJALL23T

P2

Recruiting

T-Cell Peripheral Lymphoma|Precursor Cell Lymphoblastic Leukemia-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

NCT05007873

NCI-2021-08486

P2

Recruiting

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

2026-10-30

12%

2024-08-28

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

NCT06018467

SENIOR

P2

Active, not recruiting

Bone Diseases, Metabolic|Osteoporosis

2026-04-30

50%

2026-01-29

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

2021-001288-26

2021-001288-26

P2

Active, not recruiting

HIV Infections

2024-07-29

NCT01471106

NCI-2012-00037

P2

Completed

Breast Cancer

2024-01-31

61%

2024-07-11

Primary Completion Date|Primary Endpoints|Study Completion Date

NCT01254864

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

NCT03117751

TOT17

P3

Active, not recruiting

Acute Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma

2026-09-30

10%

2024-11-27

Primary Endpoints|Treatments

jRCT2021210060

jRCT2021210060

P3

Active, not recruiting

Chronic Myeloid Leukemia

2029-03-31

NCT03020030

NCT03020030

P3

Active, not recruiting

Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia

2026-11-30

40%

2025-01-04

NCT06257394

VHR ALL

P2

Recruiting

Acute Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma

2034-12-31

2025-06-10

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

2010-019119-39

GIMEMA Study LAL1509

P2

Completed

Acute Lymphoid Leukemia

2024-12-31

2025-05-06

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

2024-510784-36-00

CA180-226

P2

Completed

Chronic Myeloid Leukemia

2024-10-25

2025-05-02

Treatments

NCT04872790

STUDY00022691

P1

Recruiting

Precursor Cell Lymphoblastic Leukemia-Lymphoma|Acute Lymphoid Leukemia

2026-12-02

50%

2026-02-12

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

NCT06145217

XS004-17

P1

Completed

Healthy Volunteers

2023-08-22

2023-11-27

Primary Endpoints|Treatments

NCT03625388

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

2016-004106-34

2016-004106-34

P2

Completed

Chronic Myeloid Leukemia

2023-02-01

2025-07-05

Treatments

CTR20132365

CTR20132365

P2

Recruiting

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

None

2025-04-29

Patient Enrollment|Treatments

CTR20131053

CTR20131053

P2

Active, not recruiting

Leukemia

None

2025-04-29

Treatments

2015-003502-16

DasaHIT

P3

Completed

Chronic Myeloid Leukemia

2023-03-31

2025-07-04

Treatments

NCT06533748

SJALL23H

P2

Recruiting

Acute Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma

2028-05-01

12%

2025-01-11