CDEK
← All drugs Report issue

tucatinib

Trade name: Tukysa

Small moleculeapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA

Approved

Apr 17, 2020

Tucatinib, sold under the brand name Tukysa, is an anticancer medication used for the treatment of HER2-positive breast cancer. It is a small molecule inhibitor of HER2. It was developed by Array BioPharma and licensed to Cascadian Therapeutics. — Wikipedia

Clinical trial activity

54 trials · 58 clinical orgs · 1 marketing orgs

Phase 1
22
Phase 2
37
Phase 3
5
Phase 4
0

Earliest trial started Dec 1, 2013 (NCT02025192)

Timeline

2010s

  1. Jan 1, 2013

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2015

    Earliest Phase 2 Sponsor(trial)

  3. Jun 5, 2017

    Orphan Drug Designation

  4. Jan 1, 2019

    Seattle Genetics — Earliest Phase 3 Sponsor(trial)

2020s

  1. Apr 17, 2020

    Seattle Genetics — Earliest FDA Approval

  2. Apr 17, 2020

    Seattle Genetics — Marketing Organization

  3. Apr 17, 2020

    Seattle Genetics — NDA Secondary Org

  4. Apr 17, 2020

    Seattle Genetics — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackBreakthroughApr 17, 2020

Chemistry & pharmacology

Loading structure…

SMILES

Cc1cc(Nc2ncnc3ccc(NC4=NC(C)(C)CO4)cc23)ccc1Oc1ccn2ncnc2c1
Mol. weight
480.53 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • tucatinib
  • tucatinib
  • tucatinib

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07193394Phase 2Dec 5, 2025Curie Institute, Eurofins, Pfizer, UNICANCER
NCT06686394Phase 1/Phase 2 (Phase 2)Dec 19, 2024Daiichi Sankyo, Merck
NCT06439693Phase 2Nov 30, 2024Harvard University, Johns Hopkins University, Translational Breast Cancer Research Consortium
NCT06157892Phase 1/Phase 2 (Phase 2)Feb 29, 2024RemeGen, Seattle Genetics
NCT06067776Phase 1Jan 1, 2024National Cancer Institute (NCI), University of California, Davis
NCT06162559Phase 1Dec 18, 2023Netherlands Cancer Institute, Seattle Genetics
NCT05800275Phase 2Nov 30, 2023Centre Leon Berard, Seattle Genetics, UNICANCER
NCT05955170Phase 2Nov 30, 2023Curie Institute, Seattle Genetics
NCT06016387Phase 2Oct 5, 2023Pfizer, Seattle Genetics, University of Toronto
NCT05748834Phase 2Jul 24, 2023SCRI Development Innovations, Seattle Genetics
NCT05673928Phase 2May 16, 2023Genentech, Seattle Genetics, University of Texas at Houston
NCT05892068Phase 2May 9, 2023Memorial Sloan-Kettering Cancer Center, Seattle Genetics
NCT05583110Phase 2Feb 1, 2023Hospital General Universitario Gregorio Marañon, Osakidetza, Seattle Genetics, Spanish Breast Cancer Research Group, Universidad de Cordoba
NCT05553522Phase 1Dec 31, 2022Baptist Health, Seattle Genetics, University of Miami
NCT05672524Phase 2Dec 30, 2022Memorial Sloan-Kettering Cancer Center
NCT05868226Phase 1Dec 22, 2022QuantumLeap Healthcare Collaborative, University of Texas at Houston
NCT05356897Phase 2Nov 30, 2022Academic and Community Cancer Research United, National Cancer Institute (NCI)
NCT05458674Phase 2Nov 15, 2022Criterium, Inc.
NCT05253651Phase 3Oct 24, 2022Merck, Seattle Genetics
NCT05323955Phase 2Sep 1, 2022Duke University, Seattle Genetics
Showing 20 of 54 trials
Page 1 / 3

Organizations

Research & Development (58)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Seattle GeneticsFor profit321442018
MerckFor profit6332021
Cascadian Therapeutics Inc.For profit5432013
National Cancer Institute (NCI)Government4132017
UNICANCERAcademic/Hospital3212021
University of Texas at HoustonAcademic/Hospital3122018
Academic and Community Cancer Research UnitedAcademic/Hospital2212017
Centre Leon BerardAcademic/Hospital2012021
Criterium, Inc.For profit2212022
Curie InstituteAcademic/Hospital2212023
Duke UniversityAcademic/Hospital2112017
GenentechFor profit2112020
Harvard UniversityAcademic/Hospital2222019
Johns Hopkins UniversityAcademic/Hospital2012018
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital2212022
NovartisFor profit2012022
PfizerFor profit2012023
Translational Breast Cancer Research ConsortiumAcademic/Hospital2012018
University of Colorado, DenverAcademic/Hospital2112017
ARCAGY-GINECOFor profit1012021
58 organizations
Page 1 / 3

Marketing (4)

OrganizationOrg typeRelationshipDate
Seattle GeneticsFor profitMKTGApr 17, 2020
Seattle GeneticsFor profitSYNApr 17, 2020
Seattle GeneticsFor profitNDA2Apr 17, 2020
Seattle GeneticsFor profitNDAApr 17, 2020