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dasatinib

Trade name: sprycel

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

Jun 28, 2006

Dasatinib [BMS 354825] is an orally active, small molecule, dual inhibitor of both SRC and ABL kinases that is under development with Bristol-Myers Squibb for the treatment of patients with chronic myelogenous leukaemia (CML) and imatinib-acquired resistance/intolerance. It’s used for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia with resistance or intolerance to prior therapy. Also indicated for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy. While imatinib remains a frontline therapy for CML, patients with advanced disease frequently develop resistance to imatinib therapy through multiple mechanisms. Dasatinib is also undergoing preclinical evaluation for its potential as a therapy against multiple myeloma. Bristol-Myers Squibb has a composition-of-matter patent covering this research approach that will expire in 2020. Dasatinib, at nanomolar concentrations, inhibits the following kinases: BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ. Based on modeling studies, dasatinib is predicted to bind to multiple conformations of the ABL kinase. — NCATS

Clinical trial activity

330 trials · 236 clinical orgs · 6 marketing orgs

Phase 1
120
Phase 2
219
Phase 3
21
Phase 4
10

Earliest trial started Jul 1, 2001 (NCT00036738)

Timeline

2000s

  1. Jan 1, 2001

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2003

    Bristol-Myers Squibb — Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2005

    Bristol-Myers Squibb — Earliest Phase 3 Sponsor(trial)

  4. Nov 18, 2005

    Orphan Drug Designation

  5. Jun 28, 2006

    Bristol-Myers Squibb — Earliest FDA Approval

  6. Jun 28, 2006

    Bristol-Myers Squibb — NDA Organization

2010s

  1. Jun 10, 2016

    Apotex — Marketing Organization

2020s

  1. Jun 9, 2022

    Alembic — Marketing Organization

  2. Jul 1, 2022

    Teva — Marketing Organization

  3. Aug 22, 2022

    Lupin — Marketing Organization

  4. Dec 5, 2023

    NANOCOPOEIA LLC — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedFast trackJun 28, 2006

Chemistry & pharmacology

Loading structure…

SMILES

CC1=NC(NC2=NC=C(S2)C(=O)NC3=C(C)C=CC=C3Cl)=CC(=N1)N4CCN(CCO)CC4
Mol. weight
488.006 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

First in class

Sources

Also known as

  • anh. dasatinib
  • anh. dasatinib
  • anhydrous dasatinib
  • anhydrous dasatinib
  • bms-354825
  • bms-354825
  • bms-354825
  • bms-354825-03
  • bms-354825-03
  • bms dasatinib
  • bms dasatinib
  • dasatinib
  • dasatinib
  • dasatinib
  • dasatinib
  • dasatinib
  • dasatinib
  • dasatinib
  • dasatinib
  • dasatinib
  • dasatinib
  • dasatinib
  • dasatinib
  • dasatinib (anh.)
  • dasatinib (anh.)
  • dasatinib (anhydrous)
  • dasatinib (anhydrous)
  • dasatinib hydrate
  • dasatinibum
  • dasatinibum
  • n-(2-chloro-6-methylphenyl)-2-({6-[4-(2-hydroxyethyl)piperazin-1-yl]-2-methylpyrimidin-4-yl}amino)-1,3-thiazole-5-carboxamide
  • n-(2-chloro-6-methylphenyl)-2-({6-[4-(2-hydroxyethyl)piperazin-1-yl]-2-methylpyrimidin-4-yl}amino)-1,3-thiazole-5-carboxamide
  • sprycel
  • sprycel
  • sprycel
  • sprycel
  • spyrcel

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07269470Phase 2May 1, 2026University of Texas at Houston
NCT07270120Phase 1Jan 15, 2026Ohio State University
NCT07144293Phase 2Oct 15, 2025National Institute of Allergy and Infectious Diseases (NIAID), National Institute on Aging (NIA)
NCT07025226Early Phase 1 (Phase 1)Aug 12, 2025Mayo Clinic
NCT07000734Phase 2Jul 31, 2025Washington University in St. Louis
NCT06940297Phase 2Jun 23, 2025Mayo Clinic, National Cancer Institute (NCI)
NCT06855810Phase 2/Phase 3 (Phase 3)Mar 31, 2025China Academy of Chinese Medical Sciences, Chinese Academy of Medical Sciences
NCT06533748Phase 2Dec 31, 2024Amgen, Pfizer, St. Jude Children's Hospital
NCT06390319Phase 2Dec 31, 2024AbbVie, St. Jude Children's Hospital
NCT05638763Phase 2Nov 30, 2024Universidad Autonoma de Nuevo Leon
NCT06645886Phase 1Oct 31, 2024Kumquat Biosciences Inc.
NCT06355037Phase 2May 20, 2024Fudan University
NCT06124157Phase 3Jan 22, 2024National Cancer Institute (NCI)
NCT06055621Phase 2Dec 31, 2023Institut Paoli-Calmettes
NCT05944783Phase 4Nov 1, 2023—
NCT07046182Phase 4Oct 21, 2023Zhengzhou University
NCT05780073Phase 2Oct 16, 2023Badalona Hospital Germans Trias i Pujol, FUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA, IrsiCaixa, Spanish Clinical Research Network, Universidad Carlos III Madrid, University of Turin
NCT05993949Phase 1Oct 2, 2023Kite Pharma, Inc., Stanford University
NCT05751044Phase 1/Phase 2 (Phase 2)Oct 1, 2023Fight Kids Cancer, Humboldt University, Innovative Therapies For Children with Cancer Consortium, Princess Maxima Center for Pediatric Oncology, Utrecht University
NCT06018467Phase 2Sep 6, 2023Novo Nordisk, University of Southern Denmark
Showing 20 of 330 trials
Page 1 / 17

Organizations

Research & Development (236)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Bristol-Myers SquibbFor profit1105252003
National Cancer Institute (NCI)Government683742001
University of Texas at HoustonAcademic/Hospital332642005
Mayo ClinicAcademic/Hospital12732008
Harvard UniversityAcademic/Hospital10832006
Duke UniversityAcademic/Hospital9822007
Cornell UniversityAcademic/Hospital8622006
St. Jude Children's HospitalAcademic/Hospital8832007
University of South FloridaAcademic/Hospital7632007
Chinese Academy of Medical SciencesAcademic/Hospital6352015
PfizerFor profit6022011
Southwest Oncology GroupAcademic/Hospital6222004
AstraZenecaFor profit5022009
City of Hope National Medical CenterAcademic/Hospital5422007
NovartisFor profit5232014
Oregon Health and Science UniversityAcademic/Hospital5322011
University of California, Los AngelesAcademic/Hospital5422003
ECOG-ACRIN Cancer Research GroupAcademic/Hospital4122015
Jiao Tong UniversityAcademic/Hospital4432021
University of AmsterdamAcademic/Hospital4422008
236 organizations
Page 1 / 12

Marketing (7)

OrganizationOrg typeRelationshipDate
AlembicFor profitMKTGJun 9, 2022
ApotexFor profitMKTGJun 10, 2016
ApotexFor profitSYNNov 23, 2021
Bristol-Myers SquibbFor profitNDAJun 28, 2006
LupinFor profitMKTGAug 22, 2022
NANOCOPOEIA LLCFor profitMKTGDec 5, 2023
TevaFor profitMKTGJul 1, 2022