Dasatinib

Overview

Dasatinib is an orally available multikinase inhibitor indicated for the treatment of Philadelphia chromosome (Ph)-positive leukemias. Ph is a chromosomal abnormality found in patients with chronic myelogenous leukemia (CML) and acute lymphocytic leukemia (ALL), where the ABL tyrosine kinase and the breakpoint cluster region (BCR) gene transcribe the chimeric protein BCR-ABL. BCR-ABL is associated with the uncontrolled activity of the ABL tyrosine kinase and is involved in the pathogenesis of CML and 15-30% of ALL cases. Dasatinib also inhibits a spectrum of kinases involved in cancer, including several SRC-family kinases. Unlike imatinib, another tyrosine kinase used for the treatment of CML and Ph-positive ALL, dasatinib inhibits the active and inactive conformations of the ABL kinase domain. Also, mutations in the kinase domain of BCR-ABL may lead to relapse during imatinib treatment. Since dasatinib does not interact with some of the residues involved in those mutations, the use of this drug represents a therapeutic alternative for patients with cancers that have developed imatinib-resistance. The use of dasatinib was first approved by the FDA in 2006.

Indication

Dasatinib is indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, as well as adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib, and adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib is also indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase or newly diagnosed Ph+ ALL in combination with chemotherapy.

Associated Conditions

Accelerated Phase Chronic Myelogenous Leukemia (CML)
Acute Lymphoblastic Leukaemias (ALL)
Chronic Phase Chronic Myeloid Leukemia
Blast phase Chronic myeloid leukemia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Improving Physical Ability and Cellular Senescence Elimination in HIV	2025/08/27	NCT07144293	Not Applicable	Not yet recruiting	National Institute of Allergy and Infectious Diseases (NIAID)
Sequential Treatments or Combinations Including Dasatinib, Quercetin, Fisetin and/or Temozolomide for the Treatment of Previously Treated Glioma With Residual Disease	2025/06/17	NCT07025226	Early Phase 1	Recruiting	Mayo Clinic
Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study	2025/06/03	NCT07000734	Phase 2	Recruiting	Washington University School of Medicine
Dasatinib and Quercetin With CAR-T Therapy for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma	2025/04/23	NCT06940297	Phase 2	Recruiting	Mayo Clinic
Newly-diagnosed Pediatric T-cell ALL Protocol	2025/03/04	NCT06855810	Phase 2	Recruiting	Institute of Hematology & Blood Diseases Hospital, China
A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies	2024/10/17	NCT06645886	Phase 1	Recruiting	Kumquat Biosciences Inc.
Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma	2024/08/01	NCT06533748	Phase 2	Recruiting	St. Jude Children's Research Hospital
Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)	2024/04/30	NCT06390319	Phase 2	Recruiting	St. Jude Children's Research Hospital
Dasatinib Combined With Quercetin to Reverse Chemo Resistance in Triple Negative Breast Cancer	2024/04/09	NCT06355037	Phase 2	Recruiting	Fudan University
Ma-Spore ALL 2020 Study	2024/03/28	NCT06336395	Phase 2	Recruiting	National University Hospital, Singapore

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Dasatinib	Teva Pharmaceuticals, Inc.	0480-5101	ORAL	20 mg in 1 1	8/31/2024
Dasatinib	Teva Pharmaceuticals, Inc.	0480-5102	ORAL	50 mg in 1 1	8/31/2024
DASATINIB	Aurobindo Pharma Limited	59651-545	ORAL	80 mg in 1 1	8/3/2024
Dasatinib	Teva Pharmaceuticals, Inc.	0480-3523	ORAL	80 mg in 1 1	8/31/2024
DASATINIB	Aurobindo Pharma Limited	59651-542	ORAL	20 mg in 1 1	8/3/2024
SPRYCEL	E.R. Squibb & Sons, L.L.C.	0003-0528	ORAL	50 mg in 1 1	11/15/2018
DASATINIB	Aurobindo Pharma Limited	59651-543	ORAL	50 mg in 1 1	8/3/2024
DASATINIB	Aurobindo Pharma Limited	59651-546	ORAL	100 mg in 1 1	8/3/2024
DASATINIB	Aurobindo Pharma Limited	59651-547	ORAL	140 mg in 1 1	8/3/2024
SPRYCEL	E.R. Squibb & Sons, L.L.C.	0003-0852	ORAL	100 mg in 1 1	11/15/2018

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Sprycel	Bristol-Myers Squibb Pharma EEIG,Plaza 254,Blanchardstown Corporate Park 2,Dublin 15,D15 T867,Ireland	Authorised	11/20/2006
Sprycel	Bristol-Myers Squibb Pharma EEIG,Plaza 254,Blanchardstown Corporate Park 2,Dublin 15,D15 T867,Ireland	Authorised	11/20/2006

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
SPRYCEL TABLETS 50MG	AstraZeneca Pharmaceuticals LP, Patheon Inc.	SIN13354P	TABLET, FILM COATED	50mg per tab	9/14/2007
SPRYCEL TABLETS 20MG	AstraZeneca Pharmaceuticals LP, Patheon Inc.	SIN13353P	TABLET, FILM COATED	20 mg	9/14/2007
SPRYCEL TABLETS 70MG	AstraZeneca Pharmaceuticals LP, Patheon Inc.	SIN13352P	TABLET, FILM COATED	70mg/tab	9/14/2007
DASATINIB-TEVA FC TABLET 50MG	PLIVA Croatia Ltd	SIN16730P	TABLET, FILM COATED	50 mg	3/2/2023
DASATINIB-TEVA FC TABLET 70MG	PLIVA Croatia Ltd	SIN16729P	TABLET, FILM COATED	70 mg	3/2/2023
DASATINIB-TEVA FC TABLET 20MG	PLIVA Croatia Ltd	SIN16731P	TABLET, FILM COATED	20 mg	3/2/2023
MYOPHIL FILM COATED TABLETS 20MG	Biocon Pharma Limited	SIN17176P	TABLET, FILM COATED	20mg	2/10/2025
MYOPHIL FILM COATED TABLETS 70MG	Biocon Pharma Limited	SIN17175P	TABLET, FILM COATED	70mg	2/10/2025
MYOPHIL FILM COATED TABLETS 50MG	Biocon Pharma Limited	SIN17177P	TABLET, FILM COATED	50mg	2/10/2025

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
DASATINIB STADA TABLETS 20MG	N/A	STADA PHARMACEUTICALS (ASIA) LIMITED	N/A	N/A	12/23/2024
DASATINIB STADA TABLETS 50MG	N/A	STADA PHARMACEUTICALS (ASIA) LIMITED	N/A	N/A	12/23/2024
DASATINIB SANDOZ TABLETS 50MG	N/A	Sandoz Hong Kong Limited	N/A	N/A	4/27/2020
DASATINIB TEVA TABLETS 20MG	N/A	TEVA PHARMACEUTICAL HONG KONG LIMITED	N/A	N/A	7/14/2022
SPRYCEL TAB 70MG	N/A	Bristol-Myers Squibb Pharma Company	N/A	N/A	8/9/2007
DASATINIB STADA TABLETS 70MG	N/A	STADA PHARMACEUTICALS (ASIA) LIMITED	N/A	N/A	12/23/2024

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
SPRYCEL dasatinib 100 mg tablet bottle	157352	Bristol-Myers Squibb Australia Pty Ltd	Medicine	A	2/16/2010
DASATINIB APOTEX dasatinib 100 mg film coated tablet bottle	290134	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	7/31/2018
DASATINIB RBX dasatinib 20 mg tablet blister pack	375025	Sun Pharma ANZ Pty Ltd	Medicine	A	7/20/2022
SPRYCEL dasatinib 20 mg tablet bottle	125557	Bristol-Myers Squibb Australia Pty Ltd	Medicine	A	1/15/2007
DASATINIB VIATRIS dasatinib 70 mg film coated tablet bottle	290141	Helix Pharmaceuticals Pty Ltd	Medicine	A	7/31/2018
DASATINIB RBX dasatinib 50 mg tablet blister pack	375033	Sun Pharma ANZ Pty Ltd	Medicine	A	7/20/2022
DASATINIB APOTEX dasatinib 20 mg film coated tablet bottle	422638	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	12/6/2023
DASATINIB-RJIC dasatinib 50 mg film coated tablet bottle	422635	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	12/6/2023
DASATINIB RAN dasatinib 50 mg tablet bottle pack	375032	Sun Pharma ANZ Pty Ltd	Medicine	A	7/20/2022
DASATINIB SANDOZ dasatinib 70 mg film-coated tablet bottle	335110	Sandoz Pty Ltd	Medicine	A	3/25/2021

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
APO-DASATINIB	Apotex Inc	02481502	Tablet - Oral	80 MG	1/6/2020
TARO-DASATINIB	Taro Pharmaceuticals Inc	02499312	Tablet - Oral	70 MG	3/4/2021
APO-DASATINIB	Apotex Inc	02470713	Tablet - Oral	50 MG	1/6/2020
APO-DASATINIB	Apotex Inc	02470705	Tablet - Oral	20 MG	1/6/2020
TARO-DASATINIB	Taro Pharmaceuticals Inc	02499282	Tablet - Oral	20 MG	3/4/2021
TARO-DASATINIB	Taro Pharmaceuticals Inc	02499347	Tablet - Oral	140 MG	3/4/2021
TARO-DASATINIB	Taro Pharmaceuticals Inc	02499304	Tablet - Oral	50 MG	3/4/2021
APO-DASATINIB	Apotex Inc	02470721	Tablet - Oral	100 MG	1/6/2020
APO-DASATINIB	Apotex Inc	02481499	Tablet - Oral	70 MG	1/6/2020
TARO-DASATINIB	Taro Pharmaceuticals Inc	02499320	Tablet - Oral	80 MG	3/4/2021

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
DASATINIB STADA 50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorio Stada S.L.	85288	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized
DASATINIB NEWLINE PHARMA 20 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Newline Pharma S.L.	86017	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Not Commercialized
DASATINIB ACCORD 70 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Accord Healthcare S.L.U.	1211540011	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Not Commercialized
DASATINIB ZYDUS 50 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG	Laboratorios Combix S.L.U.	90421	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Not Commercialized
DASATINIB ACCORD 20 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Accord Healthcare S.L.U.	1211540003	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Not Commercialized
DASATINIB VIATRIS 70 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Viatris Limited	85231	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized
DASATINIB ACCORD 50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Accord Healthcare S.L.U.	1211540007	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Not Commercialized
DARUPH 79 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Zentiva K.S.	89525	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Not Commercialized
DARUPH 55 MG COMPRIMIDOS RECUBIERTOS CON PELICULA	Zentiva K.S.	89524	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Not Commercialized
DASATINIB VIATRIS 50 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Viatris Limited	85230	COMPRIMIDO RECUBIERTO CON PELÍCULA	Diagnóstico Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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