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edoxaban

Trade name: savaysa

Small moleculeapproved

Approved

Jan 8, 2015

Edoxaban (DU-176b, trade names Savaysa, Lixiana) is a selective factor Xa inhibitor reduces thrombin generation and thrombus formation and is an orally bioavailable anticoagulant drug. It was developed by Daiichi Sankyo to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF) and for the treatment of deep vein thrombosis and pulmonary embolism following 5-10 days of initial therapy with a parenteral anticoagulant. — NCATS

Clinical trial activity

96 trials · 116 clinical orgs · 2 marketing orgs

Phase 1
11
Phase 2
47
Phase 3
34
Phase 4
21

Earliest trial started Jan 1, 2005 (NCT00107900)

Timeline

2000s

  1. Jan 1, 2005

    Daiichi Sankyo — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2008

    Daiichi Sankyo — Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2013

    Daiichi Sankyo — Earliest Phase 1 Sponsor(trial)

  2. Jan 8, 2015

    Daiichi Sankyo — Earliest FDA Approval

  3. Jan 8, 2015

    Daiichi Sankyo — NDA Organization

2020s

  1. Nov 16, 2022

    Zydus Discovery DMCC — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJan 8, 2015

Chemistry & pharmacology

Loading structure…

SMILES

CN1CCc2nc(C(=O)N[C@@H]3C[C@@H](C(=O)N(C)C)CC[C@@H]3NC(=O)C(=O)Nc3ccc(Cl)cn3)sc2C1
Mol. weight
548.07 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • du-176
  • du-176
  • du-176
  • du176b
  • du-176b
  • du-176b
  • du-176b
  • du-176b
  • du-176b
  • edoxaban
  • edoxaban
  • edoxaban
  • edoxaban
  • edoxaban
  • edoxaban
  • edoxaban
  • edoxaban
  • edoxaban
  • edoxaban tosilate
  • edoxaban tosilate hydrate
  • edoxaban tosylate
  • edoxaban tosylate
  • edoxaban tosylate
  • edoxaban tosylate
  • edoxaban tosylate
  • edoxaban tosylate
  • edoxaban tosylate
  • edoxaban tosylate monohydrate
  • ethanediamide, n1-(5-chloro-2-pyridinyl)-n2-((1s,2r,4s)-4- ((dimethylamino)carbonyl)- 2-(((4,5,6,7-tetrahydro-5-methylthiazolo(5,4-c)pyridin-2-yl)carbonyl)amino)cyclohexyl)-
  • lixiana
  • lixiana
  • lixiana
  • lixiana
  • n-(5-chloropyridin-2-yl)-n'-((1s,2r,4s)-4-(n,n-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7- tetrahydro(1,3)thiazolo(5,4-c)pyridine-2-carboxamido)cyclohexyl)oxamide
  • n-(5-chloropyridin-2-yl)-n'-((1s,2r,4s)-4-(n,n-dimethylcarbamoyl)-2-(5-methyl-4,5,6,7-tetrahydrothiazolo(5,4-c)pyridine-2-carboxamido)cyclohexyl)ethanediamide p-toluenesulfonate monohydrate
  • savaysa
  • savaysa
  • savaysa

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07116239N/ASep 30, 2025Chinese Academy of Medical Sciences, Peking University
NCT07113054Phase 1Sep 2, 2025Korea University
NCT06900725Phase 2/Phase 3 (Phase 3)Apr 1, 2025National Taiwan University
NCT06864052N/AMar 1, 2025Ewha Womans University
NCT06650501Phase 4Jan 7, 2025McGill University, University of Melbourne
NCT06326138Phase 1Mar 11, 2024Laval University
NCT06372483Phase 1Feb 21, 2024VarmX B.V.
NCT06285942N/AFeb 1, 2024University of Eastern Piedmont
NCT06212674N/AJan 31, 2024Medical University of Lodz, Pomeranian Medical University, Silesian University of Medicine
NCT05976685N/AJan 1, 2024University of Bern
NCT06149533Phase 3Nov 30, 2023Chinese Academy of Medical Sciences
NCT05869591Phase 2Oct 31, 2023University of Lausanne
NCT05955365Phase 3Sep 1, 2023University of Bern
NCT05723510Phase 1Mar 6, 2023Inno.N, Jeonbuk National University
NCT05419583N/ASep 1, 2022Government of Scotland, University of Edinburgh
NCT05491460Phase 1Jul 1, 2022Doasense GmbH, University of Heidelberg
NCT05540587Phase 2May 20, 2022Catholic University of Korea, Daiichi Sankyo
NCT05320627Phase 4Mar 30, 2022Chinese Academy of Medical Sciences
NCT05152420Phase 1Oct 29, 2021VarmX B.V.
NCT05035277Phase 3Sep 30, 2021University of Oslo
Showing 20 of 96 trials
Page 1 / 5

Organizations

Research & Development (116)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Daiichi SankyoFor profit362752005
Osaka Koseinenkin HospitalAcademic/Hospital6022006
University of BernAcademic/Hospital4422017
Chinese Academy of Medical SciencesAcademic/Hospital3232022
Laval UniversityAcademic/Hospital3332018
McMaster UniversityAcademic/Hospital3322019
University of UlsanAcademic/Hospital3322018
Aalborg UniversityAcademic/Hospital2022018
Aarhus UniversityAcademic/Hospital2112018
CardioVascular Research Foundation, KoreaAcademic/Hospital2012018
Chiltern InternationalFor profit2012017
Chong Kun Dang PharmaceuticalFor profit2212020
Danish Heart FoundationAcademic/Hospital2212017
Hamilton Health Sciences CorporationAcademic/Hospital2012019
H Plus Yangji HospitalAcademic/Hospital2012020
IQVIAFor profit2022014
Portola PharmaceuticalsFor profit2212012
Spanish Society of CardiologyAcademic/Hospital2012017
Sungkyunkwan UniversityAcademic/Hospital2222017
University of BirminghamAcademic/Hospital2012016
116 organizations
Page 1 / 6

Marketing (2)

OrganizationOrg typeRelationshipDate
Daiichi SankyoFor profitNDAJan 8, 2015
Zydus Discovery DMCCFor profitMKTGNov 16, 2022