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← All drugs Report issue

ensartinib

Trade name: Ensacove

Small moleculeapproved

Approved

Dec 18, 2024

Clinical trial activity

33 trials · 28 clinical orgs · 1 marketing orgs

Phase 1
9
Phase 2
24
Phase 3
2
Phase 4
1

Earliest trial started Jun 1, 2012 (NCT01625234)

Timeline

2010s

  1. Jan 1, 2012

    Xcovery — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2016

    Xcovery — Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2017

    Earliest Phase 2 Sponsor(trial)

2020s

  1. Dec 18, 2024

    Xcovery — Earliest FDA Approval

  2. Dec 18, 2024

    Xcovery — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 18, 2024

Chemistry & pharmacology

Loading structure…

SMILES

C[C@@H]1CN(C(=O)c2ccc(NC(=O)c3cc(O[C@H](C)c4c(Cl)ccc(F)c4Cl)c(N)nn3)cc2)C[C@H](C)N1
Mol. weight
561.45 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • ensartinib
  • ensartinib
  • x-396
  • x-396
  • x-396
  • x-396

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07235306Phase 2Dec 1, 2025Huazhong University of Science and Technology
NCT06772610Phase 2Mar 15, 2025Huazhong University of Science and Technology
NCT06762327Phase 2Feb 28, 2025Nanjing Medical University
NCT06785584Phase 4Feb 1, 2025Fujian Medical University
NCT06779539Phase 2Jan 15, 2025Sichuan University
NCT06780839Phase 2Jan 15, 2025Betta Pharmaceuticals Co.,Ltd., Peking University
NCT06563999Phase 2Dec 1, 2024Sun Yat-Sen University
NCT06492525Phase 1Jul 31, 2024Betta Pharmaceuticals Co.,Ltd.
NCT05665283Phase 1Jan 1, 2023Xcovery
NCT05491811Phase 2Aug 31, 2022Dalian Medical University, Handan Central Hospital, Harbin Medical University, Hebei University, Huai'an First People's Hospital, Huazhong University of Science and Technology, Jiangsu Cancer Institute & Hospital, Nanjing Medical University, Shenyang Chest Hospital, Soochow University, Sun Yat-Sen University, Wenzhou Medical University, Zhejiang University
NCT05380024Phase 2Aug 17, 2022Peking University
NCT05341583Phase 3May 24, 2022Betta Pharmaceuticals Co.,Ltd.
NCT05241028Phase 2Feb 28, 2022Hebei University
NCT05186506Phase 2Jan 1, 2022Betta Pharmaceuticals Co.,Ltd., Sichuan University
NCT05178511Phase 2Dec 1, 2021Sun Yat-Sen University
NCT04837716Phase 1Mar 18, 2021University of Texas at Houston
NCT03737994Phase 2Apr 1, 2019National Cancer Institute (NCI), NRG Oncology
NCT04415320Phase 2Mar 21, 2019Betta Pharmaceuticals Co.,Ltd., Fudan University
NCT03753685Phase 2Dec 31, 2018Betta Pharmaceuticals Co.,Ltd., Fudan University
NCT03804541Phase 1Dec 28, 2018Betta Pharmaceuticals Co.,Ltd., Nanjing Medical University
Showing 20 of 33 trials
Page 1 / 2

Organizations

Research & Development (28)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Betta Pharmaceuticals Co.,Ltd.For profit12932016
XcoveryFor profit6442012
Sun Yat-Sen UniversityAcademic/Hospital5322016
Fudan UniversityAcademic/Hospital3122018
Huazhong University of Science and TechnologyAcademic/Hospital3212022
Nanjing Medical UniversityAcademic/Hospital3122018
National Cancer Institute (NCI)Government3312017
Hebei UniversityAcademic/Hospital2112022
Peking UniversityAcademic/Hospital2212022
Sichuan UniversityAcademic/Hospital2212022
Zhejiang UniversityAcademic/Hospital2022018
Cancer Research InstituteAcademic/Hospital1012017
Dalian Medical UniversityAcademic/Hospital1012022
Fujian Medical UniversityAcademic/Hospital1112025
Guangdong Association of Clinical TrialsAcademic/Hospital1112018
Handan Central HospitalAcademic/Hospital1012022
Harbin Medical UniversityAcademic/Hospital1012022
Huai'an First People's HospitalAcademic/Hospital1012022
Jiangsu Cancer Institute & HospitalAcademic/Hospital1012022
Laura & Isaac Perlmutter Cancer CenterAcademic/Hospital1012017
28 organizations
Page 1 / 2

Marketing (1)

OrganizationOrg typeRelationshipDate
XcoveryFor profitNDADec 18, 2024