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digoxin

Trade name: lanoxin

Small moleculeapproved

Approved

Nov 16, 1954

Digoxin, a cardiac glycoside similar to digitoxin, is used to treat congestive heart failure and supraventricular arrhythmias due to reentry mechanisms, and to control ventricular rate in the treatment of chronic atrial fibrillation. Digoxin inhibits the Na-K-ATPase membrane pump, resulting in an increase in intracellular sodium. The sodium calcium exchanger (NCX) in turn tries to extrude the sodium and in so doing, pumps in more calcium. Increased intracellular concentrations of calcium may promote activation of contractile proteins (e.g., actin, myosin). Digoxin also acts on the electrical activity of the heart, increasing the slope of phase 4 depolarization, shortening the action potential duration, and decreasing the maximal diastolic potential. — NCATS

Clinical trial activity

213 trials · 201 clinical orgs · 20 marketing orgs

Phase 1
155
Phase 2
34
Phase 3
10
Phase 4
13

Earliest trial started Mar 1, 1995 (NCT00000556)

Timeline

1930s

  1. Jun 1, 1930

    Evidence of US Marketing

1950s

  1. Nov 16, 1954

    Covis — Earliest FDA Approval

  2. Nov 16, 1954

    Covis — Marketing Organization

  3. Nov 16, 1954

    Covis — NDA Secondary Org

  4. Nov 16, 1954

    Covis — NDA Organization

1970s

  1. Oct 24, 1975

    West-Ward Pharmaceutical — Marketing Organization

  2. Jul 12, 1976

    American Home Products — Marketing Organization

1980s

  1. Jul 26, 1982

    GlaxoSmithKline — NDA Secondary Org

1990s

  1. Jan 1, 1995

    Earliest Phase 3 Sponsor(trial)

  2. Apr 25, 1996

    Hospira — Marketing Organization

  3. Sep 30, 1997

    Advanz Pharma — Marketing Organization

  4. Sep 30, 1997

    Advanz Pharma — NDA Secondary Org

  5. Dec 23, 1999

    Mylan — Marketing Organization

  6. Dec 23, 1999

    Rising Pharmaceuticals — Marketing Organization

2000s

  1. Jan 1, 2002

    Earliest Phase 1 Sponsor(trial)

  2. Jul 26, 2002

    Jerome Stevens Pharmaceuticals — Marketing Organization

  3. Jan 31, 2003

    Sun Pharmaceuticals — Marketing Organization

  4. Aug 21, 2003

    Sandoz — Marketing Organization

  5. Aug 21, 2003

    Novartis — Marketing Organization

  6. Aug 26, 2004

    Hikma — NDA Secondary Org

  7. Jan 1, 2006

    Earliest Phase 2 Sponsor(trial)

  8. Oct 30, 2007

    Hikma — Marketing Organization

  9. Jul 20, 2009

    Impax Laboratories — Marketing Organization

2010s

  1. Oct 4, 2019

    Novitium Pharma — Marketing Organization

  2. Oct 4, 2019

    VistaPharm, Inc. — Marketing Organization

2020s

  1. Nov 22, 2021

    Ani Pharmaceuticals — Marketing Organization

  2. Feb 8, 2022

    Aurobindo Pharma — Marketing Organization

  3. Mar 11, 2022

    Amici — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewNov 16, 1954
  • approvedJun 1, 1930

Chemistry & pharmacology

Loading structure…

SMILES

C[C@H]1O[C@H](C[C@H](O)[C@@H]1O)O[C@H]2[C@@H](O)C[C@H](O[C@H]3[C@@H](O)C[C@H](O[C@H]4CC[C@@]5(C)[C@H](CC[C@@H]6[C@@H]5C[C@@H](O)[C@]7(C)[C@H](CC[C@]67O)C8=CC(=O)OC8)C4)O[C@@H]3C)O[C@@H]2C
Mol. weight
780.9385 g/mol
Lipinski Ro5
3 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Sources

Also known as

  • 12beta-hydroxydigitoxin
  • 12beta-hydroxydigitoxin
  • 12β-hydroxydigitoxin
  • 12β-hydroxydigitoxin
  • 4-[(3s,5r,8r,9s,10s,12r,13s,14s)-3-[(2s,4s,5r,6r)-5-[(2s,4s,5r,6r)-5-[(2s,4s,5r,6r)-4,5-dihydroxy-6-methyl-oxan-2-yl]oxy-4-hydroxy-6-methyl-oxan-2-yl]oxy-4-hydroxy-6-methyl-oxan-2-yl]oxy-12,14-dihydroxy-10,13-dimethyl-1,2,3,4,5,6,7,8,9,11,12,15,16,17-tetradecahydrocyclopenta[a]phenanthren-17-yl]-5h-furan-2-one
  • 4-[(3s,5r,8r,9s,10s,12r,13s,14s)-3-[(2s,4s,5r,6r)-5-[(2s,4s,5r,6r)-5-[(2s,4s,5r,6r)-4,5-dihydroxy-6-methyl-oxan-2-yl]oxy-4-hydroxy-6-methyl-oxan-2-yl]oxy-4-hydroxy-6-methyl-oxan-2-yl]oxy-12,14-dihydroxy-10,13-dimethyl-1,2,3,4,5,6,7,8,9,11,12,15,16,17-tetradecahydrocyclopenta[a]phenanthren-17-yl]-5h-furan-2-one
  • 6-dig
  • acetyldigoxin
  • acetyldigoxin
  • acetyldigoxin
  • acetyldigoxin
  • acetyldigoxin
  • beta acetyldigoxin
  • beta-acetyldigoxin
  • beta-acetyldigoxin
  • beta-acetyldigoxin
  • cardiogoxin
  • digamex
  • digazolan
  • digazolan
  • digossina
  • digossina
  • digoxin
  • digoxin
  • digoxin
  • digoxin
  • digoxin
  • digoxin
  • digoxin
  • digoxin
  • digoxin
  • digoxin
  • digoxin
  • digoxina
  • digoxina
  • digoxine
  • digoxine
  • digoxine
  • digoxin pediatric
  • digoxin pediatric
  • digoxinum
  • digoxinum
  • lanadicor
  • lanadicor
  • lanoxicaps
  • lanoxicaps
  • lanoxin
  • lanoxin
  • lanoxin
  • lanoxin-125
  • lanoxin pediatric
  • lanoxin pediatric
  • lanoxin-pg
  • lanoxin-pg
  • novodigal
  • vanoxin
  • vanoxin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07269756Phase 1Dec 31, 2025Suzhou Suncadia Biopharmaceuticals Co., Ltd.
NCT07272902N/ADec 31, 2025Government of Canada, Heart and Stroke Foundation of Canada
NCT07128888Phase 1Nov 17, 2025Gan and Lee Pharmaceuticals, USA
NCT07223671Phase 1Nov 12, 2025Bristol-Myers Squibb
NCT07215260Phase 1Nov 5, 2025Boehringer Ingelheim
NCT07118215Phase 1Sep 29, 2025Bristol-Myers Squibb, Karuna Pharmaceuticals
NCT07025850Phase 1/Phase 2 (Phase 2)Aug 1, 2025Anyang Regional Hospital, Fudan University
NCT07066722Phase 1Jul 7, 2025ViiV Healthcare
NCT07065058Phase 1Jul 1, 2025Government of China
NCT06981299Phase 1May 29, 2025Protego Biopharma Pty Ltd
NCT07047209Phase 2May 27, 2025Harvard University
NCT06921941Phase 1Apr 8, 2025Atea Pharmaceuticals, Inc.
NCT06899061Phase 1Mar 25, 2025AstraZeneca, Parexel
NCT06813924Phase 1Feb 6, 2025Novo Nordisk
NCT06793943Phase 1Jan 23, 2025Takeda
NCT06723691Phase 1Dec 31, 2024Jiangsu ShengDiYa Medicine Co., Ltd.
NCT06701812Phase 2Nov 30, 2024National Pediatric Cancer Foundation, University of South Florida
NCT06677957Phase 1Nov 6, 2024Genentech
NCT06588699Phase 2Oct 31, 2024National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Yale University
NCT06601517Phase 1Oct 31, 2024Hangzhou Zhongmei
Showing 20 of 213 trials
Page 1 / 11

Organizations

Research & Development (201)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Boehringer IngelheimFor profit161622006
Bristol-Myers SquibbFor profit11712006
Eli LillyFor profit101012010
AstraZenecaFor profit8812008
AstellasFor profit5512006
CelgeneFor profit4412017
Cutanea Life Sciences, Inc.For profit4412014
GlaxoSmithKlineFor profit4412008
Novo NordiskFor profit4412006
ParexelFor profit4012008
PfizerFor profit4112006
CovanceFor profit3012014
Hengrui Therapeutics, Inc.For profit3312020
Jiao Tong UniversityAcademic/Hospital3122011
MerckFor profit3312023
RocheFor profit3212012
University of TorontoAcademic/Hospital3112006
ViiV HealthcareFor profit3312010
Yale UniversityAcademic/Hospital3322019
Atea Pharmaceuticals, Inc.For profit2212021
201 organizations
Page 1 / 11

Marketing (28)

OrganizationOrg typeRelationshipDate
AbraxisFor profitMKTG—
Advanz PharmaFor profitMKTGSep 30, 1997
Advanz PharmaFor profitNDA2Sep 30, 1997
American Home ProductsFor profitMKTGJul 12, 1976
AmiciFor profitMKTGMar 11, 2022
Ani PharmaceuticalsFor profitMKTGNov 22, 2021
Aurobindo PharmaFor profitMKTGFeb 8, 2022
CovisFor profitMKTGNov 16, 1954
CovisFor profitNDA2Nov 16, 1954
CovisFor profitNDANov 16, 1954
GlaxoSmithKlineFor profitNDA2Jul 26, 1982
HikmaFor profitMKTGOct 30, 2007
HikmaFor profitSYNAug 26, 2004
HikmaFor profitNDA2Aug 26, 2004
HospiraFor profitMKTGApr 25, 1996
Impax LaboratoriesFor profitMKTGJul 20, 2009
Jerome Stevens PharmaceuticalsFor profitMKTGJul 26, 2002
MylanFor profitMKTGDec 23, 1999
NovartisFor profitMKTGAug 21, 2003
Novitium PharmaFor profitMKTGOct 4, 2019
Rising PharmaceuticalsFor profitSYNDec 23, 1999
Rising PharmaceuticalsFor profitMKTGDec 23, 1999
SandozFor profitMKTGAug 21, 2003
SandozFor profitSYNAug 21, 2003
Sun PharmaceuticalsFor profitMKTGJan 31, 2003
VistaPharm, Inc.For profitMKTGOct 4, 2019
West-Ward PharmaceuticalFor profitSYNOct 24, 1975
West-Ward PharmaceuticalFor profitMKTGOct 24, 1975