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entecavir

Trade name: baraclude

Small moleculeapproved

Approved

Mar 29, 2005

BARACLUDE® is the tradename for entecavir, a guanosine nucleoside analogue with selective activity against hepatitis B virus (HBV). It inhibits all three steps in the viral replication process. By competing with the natural substrate deoxyguanosine triphosphate, entecavir functionally inhibits all three activities of the HBV polymerase (reverse transcriptase, rt): (1) base priming, (2) reverse transcription of the negative strand from the pregenomic messenger RNA, and (3) synthesis of the positive strand of HBV DNA. Upon activation by kinases, the drug can be incorporated into the DNA which has the ultimate effect of inhibiting the HBV polymerase activity. Entecavir is used for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. — NCATS

Clinical trial activity

232 trials · 179 clinical orgs · 23 marketing orgs

Phase 1
30
Phase 2
88
Phase 3
34
Phase 4
87

Earliest trial started Jan 1, 2001 (NCT01438424)

Timeline

2000s

  1. Jan 1, 2001

    Bristol-Myers Squibb — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2001

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

  3. Mar 29, 2005

    Bristol-Myers Squibb — Earliest FDA Approval

  4. Mar 29, 2005

    Bristol-Myers Squibb — NDA Organization

  5. Jan 1, 2007

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

2010s

  1. Aug 26, 2014

    Teva — Marketing Organization

  2. Aug 21, 2015

    Hetero Labs Ltd — Marketing Organization

  3. Aug 26, 2015

    Aurobindo Pharma — Marketing Organization

  4. Nov 12, 2015

    Amneal Pharmaceuticals — Marketing Organization

  5. Nov 23, 2016

    Strides Pharma Science — Marketing Organization

  6. Nov 23, 2016

    Par Pharmaceuticals — Marketing Organization

  7. Nov 23, 2016

    Chartwell Pharmaceuticals — Marketing Organization

  8. Dec 6, 2016

    Cipla — Marketing Organization

  9. May 11, 2017

    CASI Pharmaceuticals, Inc. — Marketing Organization

  10. Jun 23, 2017

    Zydus Discovery DMCC — Marketing Organization

  11. Aug 25, 2017

    Accord Research — Marketing Organization

  12. Oct 10, 2017

    Prinston Inc — Marketing Organization

  13. Mar 15, 2018

    Esteve Labs — Marketing Organization

  14. Mar 26, 2019

    Rising Pharmaceuticals — Marketing Organization

  15. Mar 26, 2019

    Mylan — Marketing Organization

  16. Sep 25, 2019

    BrightGene — Marketing Organization

  17. Nov 4, 2019

    Fosun — Marketing Organization

2020s

  1. May 20, 2020

    Sunshine Lake Pharma Co., Ltd. — Marketing Organization

  2. Aug 10, 2020

    Swiss Pharmaceuticals — Marketing Organization

  3. Aug 10, 2020

    Pharmadax Inc — Marketing Organization

  4. Nov 10, 2021

    Yung Shin Pharm. Ind. Co., Ltd. — Marketing Organization

  5. Dec 23, 2024

    CONBA USA — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewMar 29, 2005

Chemistry & pharmacology

Loading structure…

SMILES

NC1=NC2=C(N=CN2[C@H]3C[C@H](O)[C@@H](CO)C3=C)C(=O)N1
Mol. weight
277.2792 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warningProdrug

Sources

Also known as

  • anhydrous entecavir
  • anhydrous entecavir
  • anhydrous entecavir
  • anti-hbv placenta transfer factor
  • baraclude
  • baraclude
  • baraclude
  • baraclude
  • baraclude
  • baraclude
  • bms-200475-01
  • bms-200475-01
  • bms-200475-01
  • enecavir
  • entacavir
  • entecabell
  • entecavir
  • entecavir
  • entecavir
  • entecavir
  • entecavir
  • entecavir
  • entecavir
  • entecavir
  • entecavir
  • entecavir
  • entecavir
  • entecavir anhydrous
  • entecavir anhydrous
  • entecavir (anhydrous)
  • entecavir (anhydrous)
  • entecavir hydrate
  • entecavir maleate
  • entecavir maleate
  • entecavir monohydrate
  • entecavir monohydrate
  • entecavir monohydrate
  • entecavir monohydrate
  • entecavir monohydrate
  • entecavir monohydrate
  • entecavirum
  • entecavirum
  • sq-34676
  • sq-34676

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07295873Phase 1Dec 30, 2025GNI Group
NCT07253220N/ADec 1, 2025Sun Yat-Sen University
NCT07189377Phase 4Sep 24, 2025University of Toronto
NCT07145268Phase 2Sep 1, 2025Tanta University
NCT07095855Phase 3Aug 31, 2025Shanghai Zhimeng Biopharma, Inc.
NCT06990776Phase 2Jul 9, 2025Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
NCT06966232Phase 3May 15, 2025Sun Yat-Sen University
NCT06150014Phase 1/Phase 2 (Phase 2)Dec 7, 2023Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
NCT06000657Phase 4Jul 28, 2023Daewoong Pharmaceutical Co. LTD.
NCT05721300N/AFeb 10, 2023Fudan University
NCT05793268N/ADec 20, 2022I-Shou University
NCT05484466Phase 2Nov 15, 2022Jinlin University, Shanghai Zhimeng Biopharma, Inc., Tigermed Consulting Co., Ltd
NCT05550519Early Phase 1 (Phase 1)Oct 31, 2022Janssen Pharmaceutica NV
NCT05404919Phase 2Sep 6, 2022University of Pennsylvania
NCT05453435Phase 2Jul 15, 2022Sun Yat-Sen University
NCT05423106Phase 1Jul 4, 2022Johnson and Johnson
NCT05275023Phase 2Jun 30, 2022—
NCT05382351Phase 2May 10, 2022Sun Yat-Sen University
NCT05453448N/AMay 1, 2022Central South University
NCT05107778Phase 2Dec 17, 2021Ascletis Pharmaceuticals Co., Ltd.
Showing 20 of 232 trials
Page 1 / 12

Organizations

Research & Development (179)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Bristol-Myers SquibbFor profit322652001
Sun Yat-Sen UniversityAcademic/Hospital252542007
Jiao Tong UniversityAcademic/Hospital16542008
Huazhong University of Science and TechnologyAcademic/Hospital12632008
Fudan UniversityAcademic/Hospital11332008
People's Liberation Army of ChinaGovernment11442008
Catholic University of KoreaAcademic/Hospital10342007
Peking UniversityAcademic/Hospital10322008
Yonsei UniversityAcademic/Hospital10622007
Capital Medical UniversityAcademic/Hospital9612008
National Taiwan UniversityAcademic/Hospital9722007
RocheFor profit9632007
Southern Medical UniversityAcademic/Hospital9342010
Janssen Pharmaceutica NVFor profit8822019
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,LtdFor profit8632008
Korea UniversityAcademic/Hospital8322007
University of UlsanAcademic/Hospital7622009
Zhejiang UniversityAcademic/Hospital7222008
Assembly BiosciencesFor profit6622016
Pusan National UniversityAcademic/Hospital6212008
179 organizations
Page 1 / 9

Marketing (29)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGAug 25, 2017
Amneal PharmaceuticalsFor profitMKTGNov 12, 2015
Aurobindo PharmaFor profitSYNAug 26, 2015
Aurobindo PharmaFor profitMKTGAug 26, 2015
BrightGeneFor profitMKTGSep 25, 2019
Bristol-Myers SquibbFor profitNDAMar 29, 2005
Bristol-Myers SquibbFor profitSYNMar 29, 2005
CASI Pharmaceuticals, Inc.For profitMKTGMay 11, 2017
CONBA USAFor profitMKTGDec 23, 2024
Chartwell PharmaceuticalsFor profitMKTGNov 23, 2016
CiplaFor profitMKTGDec 6, 2016
Esteve LabsFor profitSYNMar 15, 2018
Esteve LabsFor profitMKTGMar 15, 2018
FosunFor profitMKTGNov 4, 2019
Hetero Labs LtdFor profitMKTGAug 21, 2015
MylanFor profitMKTGMar 26, 2019
MylanFor profitSYNMar 26, 2019
Par PharmaceuticalsFor profitMKTGNov 23, 2016
Pharmadax IncFor profitMKTGAug 10, 2020
Prinston IncFor profitMKTGOct 10, 2017
Rising PharmaceuticalsFor profitMKTGMar 26, 2019
Rising PharmaceuticalsFor profitSYNMar 26, 2019
Strides Pharma ScienceFor profitMKTGNov 23, 2016
Sunshine Lake Pharma Co., Ltd.For profitSYNMay 20, 2020
Sunshine Lake Pharma Co., Ltd.For profitMKTGMay 20, 2020
Swiss PharmaceuticalsFor profitMKTGAug 10, 2020
TevaFor profitMKTGAug 26, 2014
Yung Shin Pharm. Ind. Co., Ltd.For profitMKTGNov 10, 2021
Zydus Discovery DMCCFor profitMKTGJun 23, 2017