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adefovir dipivoxil

Trade name: hepsera

Small moleculeapproved

Approved

Sep 20, 2002

The potential antiviral effect of adefovir, an acyclic nucleoside phosphonate analog of 2′-deoxyadenosine monophosphate, was first studied by Holý and De Clercq in 1980s. Adefovir is an acyclic nucleotide analog of adenosine monophosphate which is phosphorylated to the active metabolite adefovir diphosphate by cellular kinases. Adefovir diphosphate inhibits HBV DNA polymerase (reverse transcriptase) by competing with the natural substrate deoxyadenosine triphosphate and by causing DNA chain termination after its incorporation into viral DNA. Oral adefovir dipivoxil is effective and generally well tolerated in HBeAg-positive and -negative patients chronically infected with wild-type or lamivudine-resistant HBV. — NCATS

Clinical trial activity

112 trials · 81 clinical orgs · 3 marketing orgs

Phase 1
14
Phase 2
50
Phase 3
26
Phase 4
43

Earliest trial started Dec 1, 1996 (NCT00001082)

Timeline

1990s

  1. Jan 1, 1996

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 1999

    Gilead Sciences — Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 1999

    Gilead Sciences — Earliest Phase 2 Sponsor(trial)

2000s

  1. Sep 20, 2002

    Gilead Sciences — Earliest FDA Approval

  2. Sep 20, 2002

    Gilead Sciences — NDA Organization

2010s

  1. Aug 29, 2013

    Sigmapharm Laboratories — Marketing Organization

  2. Jul 6, 2018

    Apotex — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewSep 20, 2002

Chemistry & pharmacology

Loading structure…

SMILES

NC1=NC=NC2=C1N=CN2CCOCP(O)(O)=O
Mol. weight
273.1857 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Prodrug

Sources

Also known as

  • 9-(2-((-bis((pivaloyloxy)methoxy)phosphinyl)methoxy)ethyl)adenine
  • 9-(2-phosphonomethoxyethyl)adenine
  • 9-(2-phosphonylmethoxyethyl)adenine
  • 9-pmea
  • adefovir
  • adefovir
  • adefovir
  • adefovir
  • adefovir
  • adefovir depivoxil
  • adefovir di(pivaloyloxymethyl) ester
  • adefovir di(pivaloyloxymethyl) ester
  • adefovir dipivoxil
  • adefovir dipivoxil
  • adefovir dipivoxil
  • adefovir dipivoxil
  • adefovir dipivoxil
  • adefovir dipivoxil
  • adefovir dipivoxil
  • adefovir dipivoxil
  • adefovir dipivoxil
  • adefovir dipivoxil
  • adefovir pivoxil
  • adefovir pivoxil
  • bis-pom pmea
  • bis-pom pmea
  • gs-0393
  • gs-0393
  • gs-0840
  • gs-0840
  • gs-0840
  • gs 840
  • hepsera
  • hepsera
  • hepsera
  • hepsera
  • hepsera
  • hepsera
  • preveon
  • preveon

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT03801759Phase 1Jul 20, 2018Akebia Therapeutics, Sponsor GmbH
NCT03253250Phase 4Sep 1, 2017Fudan University
NCT03084250Phase 4Mar 10, 2017Nanhua Hospital, Shanghai Medical University
NCT02743260Phase 4Apr 1, 2016Umm Al-Qura University, University of Cologne
NCT03236584Phase 3Sep 1, 2015Catholic University of Korea
NCT02560649Phase 4May 1, 2015Jiao Tong University
NCT02482272Phase 4May 1, 2015University of Ulsan
NCT02826070Phase 4Apr 1, 2015Major Science and Technology Special Project of China Twelfth-Five-Year Project, Novartis, Southern Medical University
NCT02327416Phase 3Oct 1, 2014Huazhong University of Science and Technology, Xiamen Amoytop Biotech Co., Ltd.
NCT01943799Phase 2Sep 1, 2013Gilead Sciences
NCT02366247Phase 3Aug 1, 2013Jiangsu Hansoh Pharmaceutical Co., Ltd., Nanjing Medical University
NCT01844063Phase 1/Phase 2 (Phase 2)Jul 1, 2013Sun Yat-Sen University
NCT01829685Phase 4Mar 1, 2013Government of China, Southern Medical University
NCT01834508Phase 4Mar 1, 2013Major Science and Technology Special Project of China Twelfth-Five-Year Project, Southern Medical University
NCT01799486Phase 4Feb 1, 2013Novartis, Sun Yat-Sen University
NCT02965859Phase 2Dec 1, 2012Guangzhou Yipinhong Pharmaceutical CO.,LTD, Nanjing Medical University, People's Liberation Army of China, Wannan Medical College
NCT01718587Phase 1/Phase 2 (Phase 2)Nov 1, 2012Chinese People's Armed Police Forces, General Hospital of Chinese Armed Police Forces, Hebei University
NCT01732367Phase 4Nov 1, 2012Daegu Catholic University, Dongguk University, Keimyung University, Kyungpook University, Pusan National University, Yeungnam University
NCT01491295Phase 4Sep 1, 2012Chiayi Christian Hospital, Chimei Medical Center, China Medical University, Kaohsiung Medical University, Taipei Veteran General hospital
NCT01693679Phase 4Sep 1, 2012Sun Yat-Sen University
Showing 20 of 112 trials
Page 1 / 6

Organizations

Research & Development (81)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Gilead SciencesFor profit242251999
GlaxoSmithKlineFor profit13932002
National Institute of Allergy and Infectious Diseases (NIAID)Government101041996
Bristol-Myers SquibbFor profit8632001
Bukwang PharmaceuticalFor profit7632007
NovartisFor profit7522004
Southern Medical UniversityAcademic/Hospital5512010
Sun Yat-Sen UniversityAcademic/Hospital5522007
Catholic University of KoreaAcademic/Hospital4132007
RocheFor profit4422005
Government of ChinaGovernment3012010
Korea UniversityAcademic/Hospital3312007
Nanjing Medical UniversityAcademic/Hospital3022011
Yonsei UniversityAcademic/Hospital3212007
Bausch Health CompaniesFor profit2212004
DuPontFor profit2011999
Glaxo WellcomeFor profit2011999
Hallym UniversityAcademic/Hospital2012007
Huazhong University of Science and TechnologyAcademic/Hospital2222009
Jiangsu Hansoh Pharmaceutical Co., Ltd.For profit2222011
81 organizations
Page 1 / 5

Marketing (4)

OrganizationOrg typeRelationshipDate
ApotexFor profitMKTGJul 6, 2018
ApotexFor profitSYNJul 6, 2018
Gilead SciencesFor profitNDASep 20, 2002
Sigmapharm LaboratoriesFor profitMKTGAug 29, 2013