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dasatinib

Generic: DASATINIB·Brand: DASATINIB, PHYRAGO, Phyrago, SPRYCEL, Sprycel

dasatinib: developed by 1 company · 22 clinical trials tracked · 2 FDA decisions.

dasatinib evidence translation

What we can confirm

2 FDA records · 22 tracked trials

What it means

Source-backed records connect dasatinib to BMY; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could dasatinib → BMY affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence8 indications · 8 study sponsors
Development Pipeline (2)
CompanyPhase
BRISTOL MYERS SQUIBB CO (BMY)Approved
BRISTOL MYERS SQUIBB CO (BMY)Approved
Clinical Trials (22)showing 10 most recent

Efficacy and Safety of Adding Asciminib to the Standard-of-care for Post Allogenic Hematopoietic Stem-cell Transplant (HSCT) Maintenance in Philadelphia Chromosome-positive B-cell Acute Lymphoblastic Leukemia (Ph+ B-ALL) or Blastic Transformed CML (Myeloid or Lymphoid) (CML-BP)

NCT07493408·Phase 2
Not yet recruiting

Primary endpoint: Morphological relapse-free survival (M-RFS)

InterventionalRandomizedopen45 targetStarted 2026-03Completion 2037-121 site · Hong KongThe University of Hong Kong

An International Pilot Study of Chemotherapy and Tyrosine Kinase Inhibitors With Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or ABL-Class Philadelphia Chromosome-Like B-Cell Acute Lymphoblastic Leukemia

NCT06124157·Phase 3·COSM
Recruiting

Primary endpoint: Philadelphia chromosome-positive (Ph+) (BCR::ABL1-rearranged) 3-year event free survival (EFS)

Interventionalopen222 targetStarted 2025-05Completion 2030-1250 sites · United StatesNational Cancer Institute (NCI)

SJALL23H: Combination Antigen-Directed Induction Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma

NCT06533748·Phase 2
Recruiting

Primary endpoint: End of induction minimal residual disease negative remission

Interventionalopen128 targetStarted 2025-01Completion 2034-053 sites · United StatesSt. Jude Children's Research Hospital

SJALL23T: 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)

NCT06390319·Phase 2
Recruiting

Primary endpoint: Minimal residual disease (MRD)-negativity rate in patients with T cell acute lymphoblastic leukemia

Interventionalopen100 targetStarted 2024-12Completion 2033-124 sites · United StatesSt. Jude Children's Research Hospital

Phase 1b Study of Brexucabtagene Autoleucel Plus Dasatinib in Adults With Acute Lymphoblastic Leukemia

NCT05993949·Phase 1

Primary endpoint: Feasibility of dasatinib pulses

Interventionalopen8 targetStarted 2023-10Completion 2027-061 site · United StatesStanford University

A Dose-Finding Phase Ib Study of the Oral BCL-2 Inhibitor Venetoclax (ABT-199) in Combination With Standard Induction Therapy, Dasatinib and Prednisone (and Rituximab in CD20+ Patients), in Adult Patients With Newly Diagnosed and Relapsed Philadelphia Chromosome Positive (Ph+) ALL and Ph+ MPAL

NCT04872790·Phase 1·ABBV
Recruiting

Primary endpoint: Incidence of dose-limiting toxicities

Interventionalopen20 targetStarted 2022-09Completion 2026-121 site · United StatesOHSU Knight Cancer Institute

An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment

NCT04877522·Phase 4·NVS
Recruiting

Primary endpoint: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

Interventionalopen347 targetStarted 2022-08Completion 2030-0850 sites · Argentina, Austria, Brazil, Bulgaria…Novartis Pharmaceuticals

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

NCT04838041·Phase 2
Recruiting

Primary endpoint: One-year "second" treatment-free remission.

Interventionalopen51 targetStarted 2021-11Completion 2029-075 sites · United StatesMedical College of Wisconsin

A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

NCT04971226·Phase 3·NVS
Active, not recruiting

Primary endpoint: Percentage of Participants With Major Molecular Response (MMR) at Week 48 - Ascimimib vs. Investigator Selected TKI

InterventionalRandomizedopen405 enrolledStarted 2021-10Completion 2031-0150 sites · Australia, Austria, Belgium, Bulgaria…Novartis Pharmaceuticals

A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor (TKI) Induction With Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL) in Adults

NCT04530565·Phase 3·AXIM
Recruiting

Primary endpoint: Overall survival (OS)

InterventionalRandomizedopen348 targetStarted 2021-01Completion 2028-0750 sites · United StatesNational Cancer Institute (NCI)
FDA Decisions2 records
Approval1 INDICATIONS AND USAGE Dasatinib tablets are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treat(BMY)FDA ↗
NDA021986Type 1 - New Molecular EntityOrphan DrugPriorityOralTablet
Approval1 INDICATIONS AND USAGE SPRYCEL (dasatinib) is indicated for the treatment of adult patients with • newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. • chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. • Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. SPRYCEL (dasatinib) is indicated for t(BMY)FDA ↗
NDA022072Type 6 - New Indication (no longer used)PriorityOralTablet

Frequently asked questions

Who is developing dasatinib?

dasatinib is being developed by BRISTOL MYERS SQUIBB CO.

How many clinical trials involve dasatinib?

BioSniper tracks 22 clinical trials involving dasatinib.

What is dasatinib's latest FDA decision?

The most recent tracked FDA decision for dasatinib is Approval for 1 INDICATIONS AND USAGE Dasatinib tablets are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treat, dated June 28, 2006.