Back to discover
Drug

Dasatinib

Established medicine
ClassBcr/Abl fusion protein inhibitorResearchActive indication expansion

Also known as Phyrago, Sprycel, BMS dasatinib, Dasatinibum.

6
Research papers
34
Active clinical trials
2
Protein targets
31
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Total Therapy XVII for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia and Lymphoma

Clinical trial2026-09-30Primary completion · ClinicalTrials.gov

Improving Physical Ability and Cellular Senescence Elimination in HIV

Clinical trial2026-09-10Status changed to Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Dasatinib
Aliases & brands
PhyragoSprycelBMS dasatinibDasatinibum
RxNorm CUI
475342
ChEMBL ID
CHEMBL5416410
UNII
RBZ1571X5H
Primary mechanism
Bcr/Abl fusion protein inhibitor
Regulatory jurisdictions
fdaema

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

INHIBITORBcr/Abl fusion protein inhibitor
INHIBITORBcr/Abl fusion protein inhibitor

Regulatory timeline

31 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2006-06-28 → 2008-05-30)
Earliest approval
2006-06-28
Latest approval
2026-09-11
Authorities
FDA · EMA
Total events
31
fdaU.S. Food and Drug Administration· 30 events
2026-10-16Label change
Label change: DASATINIB (NDA216099)
Evidence ↗
2026-10-16Label change
Label change: DASATINIB (NDA021986)
Evidence ↗
2026-09-11Generic approvalMarket
Generic approval: DASATINIB (ANDA219579)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2006-11-20Original application approvalMulti-authority
Marketing authorisation: Sprycel (EMA)
Indication: Sprycel is indicated for the treatment of paediatric patients with: newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia in chronic phase (Ph+ CML CP)… Show full indication

Sprycel is indicated for the treatment of paediatric patients with: newly diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia in chronic phase (Ph+ CML CP) or Ph+ CML CP resistant or intolerant to prior therapy including imatinib. newly diagnosed Ph+ acute lymphoblastic leukaemia (ALL) in combination with chemotherapy. Sprycel is indicated for the treatment of adult patients with: newly diagnosed Philadelphia-chromosome-positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase; chronic, accelerated or blast phase CML with resistance or intolerance to prior therapy including imatinib mesilate; Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy. Sprycel is indicated for the treatment of paediatric patients with: newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

190 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
190
registered trials across all phases
LATEST COMPLETION 2026
34
Active studies
12
Recruiting
22
Late-stage (III+)
92
Completed
64
Discontinued
PHASE DISTRIBUTIONn = 190
Early Phase 14Phase 146Phase 1 / 218Phase 2100Phase 2 / 35Phase 39Phase 45Phase N / A3

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

Research activity

6 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
2011–2024
Most influential
Recent papers
Major research themes6
Aniline Compounds1Cancer-Associated Fibroblasts1Drug Resistance, Neoplasm1Orchiectomy1Senotherapeutics1Sulfonamides1
Journals, researchers & institutions
Top journals
  • Anti-cancer drugs1
  • Cancer1
  • EBioMedicine1
  • International journal of molecular sciences1
  • Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer1
  • Leukemia1
Leading researchers
  • Apperley JF1
  • Azzoli CG1
  • Baccarani M1
  • Belotserkovskaya EV1
  • Beumer JH1
  • Bogdanova DA1
  • Borger DR1
  • Cervantes F1
Leading institutions
free-text, unnormalised
  • Almazov National Research Centre1
  • Amsterdam University Medical Center1
  • Barshop Institute for Longevity and Aging Studies1
  • Burnett School of Biomedical Sciences1
  • Case Western Reserve University1
  • Centre Hospitalier de Versailles1

Related drugs

5 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Acts on the same molecular target as Dasatinib, with an overlapping disease area.

2 shared targets1 shared disease1 shared paper

Acts on the same molecular target as Dasatinib, with an overlapping disease area.

Shared target1 shared disease1 shared paper

Studied across 3 of the same disease areas as Dasatinib in the shared literature.

3 shared diseases2 shared papers

Studied across 2 of the same disease areas as Dasatinib in the shared literature.

2 shared diseases1 shared paper

Studied across the same disease area as Dasatinib in the shared literature.

1 shared disease1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.