flecainide

Trade name: tambocor

Small moleculeapproved

Approved

Oct 31, 1985

Flecainide is a potent anti-arrhythmia agent, effective in a wide range of ventricular and atrial arrhythmias and tachycardias. Flecainide has local anesthetic activity and belongs to the membrane stabilizing (Class 1) group of antiarrhythmic agents; it has electrophysiologic effects characteristic of the IC class of antiarrhythmics. Flecainide acts on sodium channels on the neuronal cell membrane, limiting the spread of seizure activity and reducing seizure propagation. The antiarrhythmic actions are mediated through effects on sodium channels in Purkinje fibers. Flecainide is a sodium channel blocker, binding to voltage gated sodium channels. It stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses. Ventricular excitability is depressed and the stimulation threshold of the ventricle is increased during diastole. Flecainide is sold under the trade name Tambocor (manufactured by 3M pharmaceuticals). Flecainide went off-patent on February 10, 2004. In addition to being marketed as Tambocor, it is also available in generic version and under the trade names Almarytm, Apocard, Ecrinal, and Flécaine. — NCATS

Clinical trial activity

47 trials · 80 clinical orgs · 12 marketing orgs

Phase 1
2
Phase 2
19
Phase 3
12
Phase 4
14

Earliest trial started Sep 1, 1982 (NCT00000504)

Timeline

1980s

  1. Jan 1, 1982

    Earliest Phase 2 Sponsor(trial)

  2. Oct 31, 1985

    County Line — Earliest FDA Approval

  3. Oct 31, 1985

    County Line — NDA Organization

  4. Oct 31, 1985

    County Line — NDA Secondary Org

  5. Oct 31, 1985

    Alvogen — Marketing Organization

  6. Oct 31, 1985

    Alvogen — NDA Secondary Org

  7. Jan 1, 1986

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jul 31, 2001

    Amneal Pharmaceuticals — Marketing Organization

  2. Oct 28, 2002

    Ani Pharmaceuticals — Marketing Organization

  3. Jan 14, 2003

    West-Ward Pharmaceutical — Marketing Organization

  4. Jan 14, 2003

    Hikma — Marketing Organization

  5. Mar 28, 2003

    Sun Pharmaceuticals — Marketing Organization

  6. Jul 9, 2009

    Chartwell Pharmaceuticals — Marketing Organization

  7. Jul 9, 2009

    Apotex — Marketing Organization

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

  2. Nov 3, 2017

    Aurobindo Pharma — Marketing Organization

2020s

  1. Sep 16, 2020

    Beximco — Marketing Organization

  2. Sep 8, 2022

    Yichang Humanwell Pharmaceutical Co.,Ltd — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedOct 31, 1985

Chemistry & pharmacology

Loading structure…

SMILES

O=C(NCC1CCCCN1)c1cc(OCC(F)(F)F)ccc1OCC(F)(F)F
Mol. weight
414.35 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • ccris 313
  • ccris 313
  • flecaine
  • flecaine
  • flecaine
  • flecainida
  • flecainida
  • flecainide
  • flecainide
  • flecainide
  • flecainide
  • flecainide
  • flecainide
  • flecainide
  • flecainide
  • flecainide
  • (+-)-flecainide
  • (+-)-flecainide
  • flecainide acetate
  • flecainide acetate
  • flecainide acetate
  • flecainide acetate
  • flecainidum
  • flecainidum
  • n-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide
  • n-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide
  • tambocor
  • tambocor
  • tambocor
  • tambocor
  • tambocor
  • tambocor
  • tambocor

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07270848Phase 4Dec 1, 2025Inha University
NCT06205550Phase 2Apr 30, 2024University of Amsterdam
NCT06322017N/AApr 9, 2024University of Nantes
NCT06142604Phase 4Jan 1, 2024McMaster University
NCT06096337N/ADec 15, 2023Boston Scientific Corporation, The Cleveland Clinic
NCT05939076Phase 3Aug 21, 2023Orebro University, Swedish Heart Lung Foundation, The Swedish Research Council, Uppsala University
NCT05631730Phase 3Dec 31, 2022Government of Norway, University of Oslo
NCT05549752Phase 3Oct 1, 2022Aristotle University of Thessaloniki, Pharmassist Ltd, Win Medica
NCT05039359Phase 3Apr 26, 2022InCarda Therapeutics
NCT05213104Phase 3Mar 23, 2022Assistance Publique - Hôpitaux de Paris, Fonds de Dotation ACTION
NCT04496674Phase 1/Phase 2 (Phase 2)Sep 1, 2020German Cancer Research Center, University of Tuebingen
NCT04037397Phase 3Jul 22, 2019Biosense Webster, Inc., Texas Cardiac Arrhythmia Institute, University of Pennsylvania
NCT03845010N/AFeb 12, 2019Isala Clinics, Zwolle, The Netherlands, Maatschap Cardiologie Zwolle
NCT03685149Phase 2Jan 31, 2019University of Rochester
NCT03539302Phase 2May 29, 2018InCarda Therapeutics
NCT03587558Phase 4Sep 5, 2017Chong Kun Dang Pharmaceutical, Keimyung University
NCT03162120Phase 2/Phase 3 (Phase 3)May 20, 2017Aristotle University of Thessaloniki, Elpen Pharmaceutical Co. Inc.
NCT02825979N/AJan 1, 2017University of British Columbia, University of Ottawa
NCT03005366Phase 4Jan 1, 2017Hospital San Carlos, Madrid, Universidad Carlos III Madrid, Universidad Complutense de Madrid
NCT02924285Phase 4Oct 1, 2016University of Leipzig
Showing 20 of 47 trials
Page 1 / 3

Organizations

Research & Development (80)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MedaFor profit3222003
National Heart, Lung, and Blood Institute (NHLBI)Government3321982
Vanderbilt UniversityAcademic/Hospital3231982
Aristotle University of ThessalonikiAcademic/Hospital2112017
Biosense Webster, Inc.For profit2122003
InCarda TherapeuticsFor profit2222018
Johns Hopkins UniversityAcademic/Hospital2021982
Maastricht UniversityAcademic/Hospital2222012
MedtronicFor profit2122006
Swedish Heart Lung FoundationAcademic/Hospital2022008
University of LondonAcademic/Hospital2122015
University of PennsylvaniaAcademic/Hospital2222006
University of RochesterAcademic/Hospital2111982
Uppsala UniversityAcademic/Hospital2122008
3MFor profit1012006
Assistance Publique - Hôpitaux de ParisAcademic/Hospital1112022
Baylor UniversityAcademic/Hospital1011982
Boston Scientific CorporationFor profit1112023
Canadian Institutes of Health Research (CIHR)Academic/Hospital1012015
Chong Kun Dang PharmaceuticalFor profit1012017
80 organizations
Page 1 / 4

Marketing (16)

OrganizationOrg typeRelationshipDate
AlvogenFor profitMKTGOct 31, 1985
AlvogenFor profitNDA2Oct 31, 1985
Amneal PharmaceuticalsFor profitMKTGJul 31, 2001
Ani PharmaceuticalsFor profitMKTGOct 28, 2002
Ani PharmaceuticalsFor profitSYNOct 28, 2002
ApotexFor profitMKTGJul 9, 2009
Aurobindo PharmaFor profitMKTGNov 3, 2017
BeximcoFor profitMKTGSep 16, 2020
Chartwell PharmaceuticalsFor profitMKTGJul 9, 2009
County LineFor profitNDAOct 31, 1985
County LineFor profitNDA2Oct 31, 1985
HikmaFor profitMKTGJan 14, 2003
HikmaFor profitSYNJan 14, 2003
Sun PharmaceuticalsFor profitMKTGMar 28, 2003
West-Ward PharmaceuticalFor profitMKTGJan 14, 2003
Yichang Humanwell Pharmaceutical Co.,LtdFor profitMKTGSep 8, 2022