TheraRadar
Data updated: May 26, 2026

DASATINIB

Genetically Validated
Oncology Approved 2016-06-10

DASATINIB is indicated for the treatment of Chronic Myeloid Leukemia; Acute Lymphoblastic Leukemia.

Source: FDA Label • BIOCON PHARMA
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How DASATINIB Works

Dasatinib is a potent inhibitor of multiple kinases, including BCR-ABL, the SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ. Unlike earlier inhibitors, dasatinib is predicted to bind to multiple conformations of the ABL kinase, allowing it to maintain activity against many imatinib-resistant variants of BCR-ABL. It effectively overcomes resistance mediated by BCR-ABL kinase domain mutations, multi-drug resistance gene overexpression, and the activation of alternative

Source: FDA Label
7
Indications
--
Phase 3 Trials
9
Years on Market

Details

Status
Prescription
First Approved
2016-06-10
Routes
ORAL
Dosage Forms
TABLET

Companies

BIOCON PHARMA Apotex EUGIA PHARMA ZYDUS PHARMS Lupin Teva ALEMBIC Dr. Reddy's
Active Ingredient: DASATINIB

DASATINIB Approval History

2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
96 FDA actions from 2016 to 2025
Nov 2025 ORIGINAL
Update
Sep 2025 SUPPL
Label · Labeling
Aug 2025 SUPPL
Label · Labeling

What DASATINIB Treats

2 indications

DASATINIB is approved for 2 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Chronic Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
Source: FDA Label

DASATINIB Target & Pathway

Pro

Target

BCR-ABL (Breakpoint Cluster Region-Abelson) Fusion Protein

An abnormal fusion protein created by a chromosomal translocation, found in chronic myeloid leukemia (CML). BCR-ABL has constitutive kinase activity that drives leukemic cell proliferation. Targeting BCR-ABL transformed CML from a fatal disease to a manageable condition.

DASATINIB Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

5

Same target(s) AND same indication — head-to-head.

IMKELDI
SHORLA ONCOLOGY
2024 7 indic.
DANZITEN
AZURITY
2024 1 indic.

MoA expansion candidates

7

Same target(s), different indications — where else is this mechanism being explored?

PAZOPANIB HYDROCHLORIDE
Teva
2023 2 indic.
SUNITINIB MALATE
Dr. Reddy's
2021 3 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

KOMZIFTI
KURA
2025 1 indic.
GRAFAPEX
MEDEXUS
2025 2 indic.
Unlock 16 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in DASATINIB's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DASATINIB treats. First-in-class if their pivotal trials read out positive.

Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca
ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials

Drugs Similar to DASATINIB

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

IMKELDI
IMATINIB MESYLATE
2 shared
SHORLA ONCOLOGY
Shared indications:
Chronic Myeloid LeukemiaAcute Lymphoblastic Leukemia
PHYRAGO
DASATINIB
2 shared
HANDA THERAP
Shared indications:
Chronic Myeloid LeukemiaAcute Lymphoblastic Leukemia
SPRYCEL
DASATINIB
2 shared
Bristol-Myers Squibb
Shared indications:
Chronic Myeloid LeukemiaAcute Lymphoblastic Leukemia
View all 20 similar drugs Pro
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Clinical Trial Registry

172 trials
Trial Sponsor ID Phase Status Title
NCT02465060 NCI-2015-00054 NCI-2015-00054, EAY131 Ph 2 active not recruiting Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
NCT04530565 NCI-2020-06381 NCI-2020-06381, EA9181 Ph 3 active not recruiting Testing the Use of Steroids and Tyrosine Kinase Inhibitors With Blinatumomab or Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia in Adults
NCT06124157 NCI-2023-09214 NCI-2023-09214, AALL2131 Ph 2 recruiting A Study Testing the Combination of Dasatinib or Imatinib to Chemotherapy Treatment With Blinatumomab for Children, Adolescents, and Young Adults With Philadelphia Chromosome Positive (Ph+) or ABL-Class Philadelphia Chromosome-Like (Ph-Like) B-cell Acute Lymphoblastic Leukemia (B-ALL)
NCT04877522 CABL001A2001B 2021-000602-17, 2023-507557-16-00 Ph 4 recruiting Asciminib Roll-over Study
NCT04872790 STUDY00022691 NCI-2021-01791, STUDY00022691 Ph 1 active not recruiting Venetoclax, Dasatinib, Prednisone, Rituximab and Blinatumomab for the Treatment of Newly Diagnosed or Relapsed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia
NCT07000734 FOES 202503023 Ph 2 completed Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study
NCT07269470 2025-1526 NCI-2025-08780 Ph 2 not yet recruiting Phase II Study Assessing the Safety and Efficacy of Dasatinib in Combination With Ropeginterferon in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase
NCT02883049 results posted NCI-2011-03797 NCI-2011-03797, S12-01254 Ph 3 active not recruiting Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations
NCT06390319 SJALL23T NCI-2024-03015 Ph 2 recruiting 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)
NCT06533748 SJALL23H NCI-2024-06013 Ph 2 recruiting Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma
NCT01445509 090019 09-C-0019 Ph 1 completed Dasatinib in Combination With Bevacizumab to Treat Advanced Solid Tumors
NCT02559778 PEDS-PLAN NMTRC012 Ph 2 recruiting Pediatric Precision Laboratory Advanced Neuroblastoma Therapy
NCT04925648 PICASSO PICASSO Ph 2 completed Psma Intensity Can be Altered by Androgen and Phospho-SrC Obstruction
NCT05838560 202302203 Ph 2 active not recruiting Dasatinib Plus Quercetin for Accelerated Aging in Mental Disorders
NCT02143414 results posted NCI-2014-01047 NCI-2014-01047, SWOG-S1318 Ph 2 active not recruiting Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia
NCT01660971 NCI-2012-01290 NCI-2012-01290, VICCGI1173 Ph 1 active not recruiting Gemcitabine Hydrochloride, Dasatinib, and Erlotinib Hydrochloride in Treating Patients With Pancreatic Cancer That Is Metastatic or Cannot Be Removed by Surgery
NCT00792948 results posted NCI-2009-00800 NCI-2009-00800, S0805 Ph 2 active not recruiting Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia
NCT04329325 19-343 Ph 2 active not recruiting Blinatumomab and Tyrosine Kinase Inhibitor Therapy in People With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
NCT04971226 results posted CABL001J12301 2023-508838-33-00 Ph 3 active not recruiting A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
NCT03516279 EA9171 NCI-2017-02161, EA9171 Ph 2 active not recruiting Pembrolizumab and Dasatinib, Imatinib Mesylate, or Nilotinib in Treating Patients With Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease
NCT07342491 A5413 Ph 1 not yet recruiting Dasatinib for HIV-1 Reservoir Reduction
NCT04747912 IRB20-1749 Ph 2 suspended Study of Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia With Inotuzumab Ozogamicin (InO)
NCT03297606 CAPTUR PM1 ESR-17-12831, CA209-9DL Ph 2 recruiting Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)
NCT06645886 KQB198-102 Ph 1 active not recruiting A Study to Investigate the Safety and Efficacy of KQB198 as Monotherapy and in Combination in Participants With Advanced Hematologic Malignancies
NCT07493408 ASIM-POST Ph+ ASCPT-01 Ph 2 not yet recruiting Asciminib & Standard-of-Care Integration in Maintenance Therapy for POST Allogeneic Stem Cell Transplant (Allo-HSCT) of Patient With Ph+ B-ALL or Blastic Transformed CML
NCT07144293 IPACE-HIV A5426 Ph 2 active not recruiting Improving Physical Ability and Cellular Senescence Elimination in HIV
NCT06055621 VEN-R DASA VEN-R DASA-IPC 2022-067 Ph 2 recruiting Evaluation of DASATINIB Monotherapy Efficacy in Acute Myeloid Leukemia Patients Refractory to VENETOCLAX-AZACITIDINE
NCT02389309 2014-0692 NCI-2015-00524, 2014-0692 Ph 1 active not recruiting Dasatinib, Temsirolimus, and Cyclophosphamide in Treating Patients With Advanced, Recurrent, or Refractory Solid Tumors
NCT02689440 2015-1040 NCI-2016-00362, 2015-1040 Ph 2 active not recruiting Dasatinib and Venetoclax in Treating Patients With Philadelphia Chromosome Positive or BCR-ABL1 Positive Early Chronic Phase Chronic Myelogenous Leukemia
NCT05007873 2021-0271 NCI-2021-08486, 2021-0271 Ph 2 recruiting ASTX727 and Dasatinib for the Treatment of Newly Diagnosed Philadelphia Chromosome or BCR-ABL Positive Chronic Myeloid Leukemia in Chronic Phase
NCT02523976 IIT2015001 Ph 2 completed Dasatinib Combined With Chemotherapy in Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
NCT06940297 MC240801 NCI-2025-02490, 24-002915 Ph 2 recruiting Dasatinib and Quercetin With CAR-T Therapy for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma
NCT03020030 16-001 Ph 3 active not recruiting Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents
NCT04785300 19-003394 Ph 1, Ph 2 active not recruiting ALSENLITE: Senolytics for Alzheimer's Disease
NCT03654768 results posted S1712 NCI-2017-02066, S1712 Ph 2 active not recruiting Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia
NCT03117751 TOT17 NCI-2017-00582 Ph 2, Ph 3 active not recruiting Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma
NCT03595917 18-170 Ph 1 recruiting ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML
NCT05198843 results posted NCI-2022-00004 NCI-2022-00004, 10480 Ph 1, Ph 2 terminated Testing an Omega-3 Fatty Acid-Based Anti-Cancer Therapy for Patients With Triple-Negative Inflammatory Breast Cancer That Has Spread to Other Parts of the Body
NCT05993949 IRB-68603 NCI-2023-05591 Ph 1 active not recruiting Study of Brexucabtagene Autoleucel Plus Dasatinib in Adults With Acute Lymphoblastic Leukemia
NCT05192889 results posted RAVEN NCI-2022-00304 Ph 1, Ph 2 active not recruiting Trial Treating Relapsed Acute Lymphoblastic Leukemia With Venetoclax and Navitoclax
NCT05751044 HEM-iSMART B 2022-501866-22-00 Ph 1, Ph 2 recruiting HEM-iSMART-B: Dasatinib + Venetoclax + Dexamethasone + Cyclophosphamide and Cytarabine in Pediatric Patients With Relapsed or Refractory Hematological Malignancies
NCT00777036 results posted CA180-226 2008-002260-33 Ph 2 completed A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib
NCT06855810 CCCG-TALL-2025 IIT2025014 Ph 2, Ph 3 recruiting Newly-diagnosed Pediatric T-cell ALL Protocol
NCT01990196 13-000714 NCI-2015-01448 Ph 2 active not recruiting Neoadjuvant Phase 2 Study Comparing the Effects of AR Inhibition With/Without SRC or MEK Inhibition in Prostate Cancer
NCT04838041 PRO00040685 Ph 2 recruiting Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation
NCT02494882 14-272 Ph 1 active not recruiting Adding Ruxolitinib to a Combination of Dasatinib Plus Dexamethasone in Remission Induction Therapy in Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients Aged 40 Years or Older
NCT02420717 results posted 2014-0521 NCI-2015-00779, 2014-0521 Ph 2 terminated Ruxolitinib Phosphate or Dasatinib With Chemotherapy in Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Like Acute Lymphoblastic Leukemia
NCT01751425 2012-0697 NCI-2018-01797, 2012-0697 Ph 1 terminated Ruxolitinib in Treating Participants With Chronic Myeloid Leukemia With Minimal Residual Disease While on Therapy With Tyrosine Kinase Inhibitors
NCT05527418 DASAHIVCURE 2021-001288-26 Ph 2 recruiting Safety, Tolerance and Antiretroviral Activity of Dasatinib: a Pilot Clinical Trial in Patients With Recent HIV-1 Infection
NCT03560908 IIT2018004 Ph 1 withdrawn Dasatinib Combined With Chemotherapy in Relapsed t(8;21) Acute Myeloid Leukemia With KIT D816 Mutation

Showing 50 of 172 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

DASATINIB FDA Label Details

Indications & Usage

DASATINIB is indicated for the treatment of Chronic Myeloid Leukemia; Acute Lymphoblastic Leukemia.

Looking for the branded version?

PHYRAGO

Full clinical data, patents, trials, and competitive landscape for dasatinib.

See PHYRAGO

Data Sources

FDA Approval: ANDA217217 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.