flecainide
Trade name: tambocor
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
Earliest trial started Sep 1, 1982 (NCT00000504)
Timeline
1980s
- Jan 1, 1982
Earliest Phase 2 Sponsor(trial)
- Oct 31, 1985
County Line — Earliest FDA Approval
- Oct 31, 1985
County Line — NDA Organization
- Oct 31, 1985
County Line — NDA Secondary Org
- Oct 31, 1985
Alvogen — Marketing Organization
- Oct 31, 1985
Alvogen — NDA Secondary Org
- Jan 1, 1986
Earliest Phase 3 Sponsor(trial)
2000s
- Jul 31, 2001
Amneal Pharmaceuticals — Marketing Organization
- Oct 28, 2002
Ani Pharmaceuticals — Marketing Organization
- Jan 14, 2003
West-Ward Pharmaceutical — Marketing Organization
- Jan 14, 2003
Hikma — Marketing Organization
- Mar 28, 2003
Sun Pharmaceuticals — Marketing Organization
- Jul 9, 2009
Chartwell Pharmaceuticals — Marketing Organization
- Jul 9, 2009
Apotex — Marketing Organization
2010s
- Jan 1, 2010
Earliest Phase 1 Sponsor(trial)
- Nov 3, 2017
Aurobindo Pharma — Marketing Organization
2020s
- Sep 16, 2020
Beximco — Marketing Organization
- Sep 8, 2022
Yichang Humanwell Pharmaceutical Co.,Ltd — Marketing Organization
Indications
Approved for
Studied for
- Ablation Techniques · Phase 2
- Andersen Syndrome · Phase 2
- Arrhythmias, Cardiac · Phase 3
- Arrhythmogenic Right Ventricular Dysplasia · Phase 2
- Atrial Fibrillation · Phase 4
- Brugada Syndrome · Phase 4
- Cardiac Complexes, Premature · Phase 2
- Cardiomyopathies · Phase 4
- Cardiovascular Diseases · Phase 3
- Carvedilol · Phase 4
- Coronary Artery Disease · Phase 3
- Coronary Disease · Phase 3
- Death, Sudden, Cardiac · Phase 3
- Fetal Development · Phase 3
- Foramen Ovale, Patent · Phase 3
- General Surgery · Phase 4
- Heart Arrest · Phase 3
- Heart Diseases · Phase 4
- Heart Failure · Phase 3
- Ischemic Stroke · Phase 3
- Lung Neoplasms · Phase 1/Phase 2
- Mitral Valve Prolapse · Phase 3
- Myocardial Infarction · Phase 3
- Myocardial Ischemia · Phase 3
- Pain · Phase 2
- Recurrence · Phase 2/Phase 3
- Tachycardia · Phase 3
- Tachycardia, Ventricular · Phase 4
- Ventricular Outflow Obstruction · Phase 4
- Ventricular Premature Complexes · Phase 4
Mechanism of action
Approval history
- approvedOct 31, 1985
Chemistry & pharmacology
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
Sources
- ChEMBLCHEMBL652 ↗
- WikipediaFlecainide ↗
- NCATSK94FTS1806 ↗
- ChEMBLCHEMBL1200822 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07270848 | Phase 4 | Dec 1, 2025 | Inha University |
| NCT06205550 | Phase 2 | Apr 30, 2024 | University of Amsterdam |
| NCT06322017 | N/A | Apr 9, 2024 | University of Nantes |
| NCT06142604 | Phase 4 | Jan 1, 2024 | McMaster University |
| NCT06096337 | N/A | Dec 15, 2023 | Boston Scientific Corporation, The Cleveland Clinic |
| NCT05939076 | Phase 3 | Aug 21, 2023 | Orebro University, Swedish Heart Lung Foundation, The Swedish Research Council, Uppsala University |
| NCT05631730 | Phase 3 | Dec 31, 2022 | Government of Norway, University of Oslo |
| NCT05549752 | Phase 3 | Oct 1, 2022 | Aristotle University of Thessaloniki, Pharmassist Ltd, Win Medica |
| NCT05039359 | Phase 3 | Apr 26, 2022 | InCarda Therapeutics |
| NCT05213104 | Phase 3 | Mar 23, 2022 | Assistance Publique - Hôpitaux de Paris, Fonds de Dotation ACTION |
| NCT04496674 | Phase 1/Phase 2 (Phase 2) | Sep 1, 2020 | German Cancer Research Center, University of Tuebingen |
| NCT04037397 | Phase 3 | Jul 22, 2019 | Biosense Webster, Inc., Texas Cardiac Arrhythmia Institute, University of Pennsylvania |
| NCT03845010 | N/A | Feb 12, 2019 | Isala Clinics, Zwolle, The Netherlands, Maatschap Cardiologie Zwolle |
| NCT03685149 | Phase 2 | Jan 31, 2019 | University of Rochester |
| NCT03539302 | Phase 2 | May 29, 2018 | InCarda Therapeutics |
| NCT03587558 | Phase 4 | Sep 5, 2017 | Chong Kun Dang Pharmaceutical, Keimyung University |
| NCT03162120 | Phase 2/Phase 3 (Phase 3) | May 20, 2017 | Aristotle University of Thessaloniki, Elpen Pharmaceutical Co. Inc. |
| NCT02825979 | N/A | Jan 1, 2017 | University of British Columbia, University of Ottawa |
| NCT03005366 | Phase 4 | Jan 1, 2017 | Hospital San Carlos, Madrid, Universidad Carlos III Madrid, Universidad Complutense de Madrid |
| NCT02924285 | Phase 4 | Oct 1, 2016 | University of Leipzig |
Organizations
Research & Development (80)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Meda | For profit | 3 | 2 | 2 | 2003 |
| National Heart, Lung, and Blood Institute (NHLBI) | Government | 3 | 3 | 2 | 1982 |
| Vanderbilt University | Academic/Hospital | 3 | 2 | 3 | 1982 |
| Aristotle University of Thessaloniki | Academic/Hospital | 2 | 1 | 1 | 2017 |
| Biosense Webster, Inc. | For profit | 2 | 1 | 2 | 2003 |
| InCarda Therapeutics | For profit | 2 | 2 | 2 | 2018 |
| Johns Hopkins University | Academic/Hospital | 2 | 0 | 2 | 1982 |
| Maastricht University | Academic/Hospital | 2 | 2 | 2 | 2012 |
| Medtronic | For profit | 2 | 1 | 2 | 2006 |
| Swedish Heart Lung Foundation | Academic/Hospital | 2 | 0 | 2 | 2008 |
| University of London | Academic/Hospital | 2 | 1 | 2 | 2015 |
| University of Pennsylvania | Academic/Hospital | 2 | 2 | 2 | 2006 |
| University of Rochester | Academic/Hospital | 2 | 1 | 1 | 1982 |
| Uppsala University | Academic/Hospital | 2 | 1 | 2 | 2008 |
| 3M | For profit | 1 | 0 | 1 | 2006 |
| Assistance Publique - Hôpitaux de Paris | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Baylor University | Academic/Hospital | 1 | 0 | 1 | 1982 |
| Boston Scientific Corporation | For profit | 1 | 1 | 1 | 2023 |
| Canadian Institutes of Health Research (CIHR) | Academic/Hospital | 1 | 0 | 1 | 2015 |
| Chong Kun Dang Pharmaceutical | For profit | 1 | 0 | 1 | 2017 |
Marketing (16)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Alvogen | For profit | MKTG | Oct 31, 1985 |
| Alvogen | For profit | NDA2 | Oct 31, 1985 |
| Amneal Pharmaceuticals | For profit | MKTG | Jul 31, 2001 |
| Ani Pharmaceuticals | For profit | MKTG | Oct 28, 2002 |
| Ani Pharmaceuticals | For profit | SYN | Oct 28, 2002 |
| Apotex | For profit | MKTG | Jul 9, 2009 |
| Aurobindo Pharma | For profit | MKTG | Nov 3, 2017 |
| Beximco | For profit | MKTG | Sep 16, 2020 |
| Chartwell Pharmaceuticals | For profit | MKTG | Jul 9, 2009 |
| County Line | For profit | NDA | Oct 31, 1985 |
| County Line | For profit | NDA2 | Oct 31, 1985 |
| Hikma | For profit | MKTG | Jan 14, 2003 |
| Hikma | For profit | SYN | Jan 14, 2003 |
| Sun Pharmaceuticals | For profit | MKTG | Mar 28, 2003 |
| West-Ward Pharmaceutical | For profit | MKTG | Jan 14, 2003 |
| Yichang Humanwell Pharmaceutical Co.,Ltd | For profit | MKTG | Sep 8, 2022 |