Drugs / flecainide
flecainide
also known as
Tambocor · Flecainide Acetate · Apocard R · Flecainida · FLECAINIDE COMPONENT OF THN-102 · Flecainide EG · Flecainide monoacetate · FlecIH-103 · +1 more
Small molecule targets SCN5A via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | TAMBOCOR | — | 1985-10-31 | fda.gov ↗ |
Trials 25
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial · 1 met primary | ||||||
| Phase 1 | NCT03182413 | Sep → Dec 2015 | — | Theranexus | Completed | Met primary |
| Phase 26 trials · 1 missed | ||||||
| Phase 2 | NCT06205550 | Mar → Oct 2025 overdue | Andersen-Tawil syndrome, cardiogenetic disease | Academic Medical Center - University of Amsterdam | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT03624920 | Jul 2018 → Dec 2019 | Parkinson disease | Theranexus | Completed | No outcome recorded |
| Phase 2 | NCT03539302 | May 2018 → Jan 2022 | paroxysmal atrial fibrillation | InCarda Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02821715 | Sep 2016 → Dec 2018 | narcolepsy | Theranexus | Completed | Missed primary |
| Phase 2 | NCT00002996 | May 1998 → Apr 2006 | — | Eastern Cooperative Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT00000504 | Sep 1982 → Sep 1985 | cardiac rhythm disease | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 34 trials · 1 missed | ||||||
| Phase 3 | NCT05631730 | Jan 2023 → Jun 2026 overdue | cardiac rhythm disease, mitral valve prolapse | Oslo University Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05213104 | Mar 2022 → Feb 2024 overdue | cardiac rhythm disease, patent foramen ovale, stroke disorder | Assistance Publique - Hôpitaux de Paris | Active not recruiting | Missed primary |
| Phase 3 | NCT00000556 | Mar 1995 → Sep 2002 | atrial fibrillation | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 3 | NCT00000526 | Aug 1986 → Mar 1998 | cardiac arrest, coronary artery disorder, myocardial infarction, myocardial ischemia +1 | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 47 trials · 1 met primary | ||||||
| Phase 4 | NCT07405671 | Sep 2026 → Dec 2029 expected | atrial fibrillation, coronary artery disorder | Universitaire Ziekenhuizen KU Leuven | Recruiting | No outcome recorded |
| Phase 4 | NCT06142604 | Jul 2024 → Jun 2025 | atrial fibrillation | Population Health Research Institute | Withdrawn | No outcome recorded |
| Phase 4 | NCT02347111 | Dec 2020 → Jun 2026 overdue | atrial fibrillation | University of Illinois at Chicago | Recruiting | No outcome recorded |
| Phase 4 | NCT01505296 | Dec 2011 → Jan 2014 | atrial fibrillation | Valley Health System | Withdrawn | No outcome recorded |
| Phase 4 | NCT00340314 | Jan 2005 → May 2006 | atrial fibrillation | IRCCS San Raffaele | Completed | Met primary |
| Phase 4 | NCT00189319 | Sep 2003 → ? | paroxysmal atrial fibrillation | MEDA Pharma GmbH & Co. KG | Completed | No outcome recorded |
| Phase 4 | NCT00408473 | — | atrial fibrillation | MEDA Pharma GmbH & Co. KG | Terminated | No outcome recorded |
| Phase not applicable7 trials · 4 met primary · 1 missed | ||||||
| — | NCT07447297 | Jan 2024 → Dec 2027 expected | atrial fibrillation, atrial flutter | Samsung Medical Center | Recruiting | No outcome recorded |
| — | NCT02825979 | Jan 2017 → Sep 2022 | atrial fibrillation | Jason Andrade | Unknown | Met primary |
| — | NCT01117454 | Dec 2011 → Dec 2015 | catecholaminergic polymorphic ventricular tachycardia | Vanderbilt University Medical Center | Completed | Met primary |
| — | NCT02051621 | Aug 2010 → Aug 2015 | atrial fibrillation, atrial flutter | University of Rostock | Unknown | Met primary |
| — | NCT00408200 | Nov 2006 → Apr 2008 | paroxysmal atrial fibrillation | University of Pennsylvania | Completed | Met primary |
| — | NCT00578617 | Sep 2006 → Feb 2009 | atrial fibrillation | Mayo Clinic | Completed | No outcome recorded |
| — | NCT00215774 | Mar 2005 → Oct 2009 | atrial fibrillation | Atrial Fibrillation Network | Completed | Missed primary |
| Comparator or background therapy35 trials | ||||||
| Phase 2 | NCT03685149 Comparator | Jul 2019 → Jul 2022 | arrhythmogenic right ventricular cardiomyopathy | University of Rochester | Completed | No outcome recorded |
| Phase 2 | NCT01833455 Comparator | Feb 2013 → Jun 2016 | cardiac rhythm disease, hypertensive disorder | University of Wisconsin, Madison | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01709682 Comparator | Nov 2007 → Jan 2012 | paroxysmal atrial fibrillation | Meshalkin Research Institute of Pathology of Circulation | Completed | No outcome recorded |
| Phase 2/3 | NCT03162120 Comparator | Sep → Dec 2018 | atrial fibrillation | Elpen Pharmaceutical Co. Inc. | Withdrawn | No outcome recorded |
| Phase 3 | NCT05939076 Comparator | Aug 2023 → Dec 2027 expected | persistent atrial fibrillation | Region Örebro County | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05549752 Comparator | Mar 2023 → Dec 2025 overdue | nonobstructive coronary artery disease, paroxysmal atrial fibrillation | Hippocration General Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05039359 Comparator | Apr 2022 → May 2023 | paroxysmal atrial fibrillation | InCarda Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT02624765 Comparator | Feb 2016 → Mar 2024 | atrial flutter, hydrops fetalis | Edgar Jaeggi | Completed | No outcome recorded |
| Phase 3 | NCT00589303 Comparator | Dec 2007 → Jul 2011 | atrial fibrillation, heart failure | Mayo Clinic | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT00523978 Comparator | Oct 2006 → Aug 2010 | paroxysmal atrial fibrillation | Medtronic Cardiac Rhythm and Heart Failure | Completed | No outcome recorded |
| Phase 3 | NCT00392106 Comparator | Apr 2006 → Dec 2010 | atrial fibrillation | ProRhythm, Inc. | Suspended | No outcome recorded |
| Phase 4 | NCT07270848 Comparator | Jan 2026 → Jun 2028 expected | atrial fibrillation | Inha University Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT03587558 Comparator | Sep 2017 → Dec 2019 | cardiac rhythm disease | Keimyung University Dongsan Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT03005366 Comparator | Jan 2017 → Jun 2023 | paroxysmal atrial fibrillation | David Filgueiras-Rama | Completed | No outcome recorded |
| Phase 4 | NCT02389218 Comparator | Mar 2015 → May 2020 | atrial fibrillation | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 4 | NCT01780311 Comparator | Jan 2013 → Jan 2014 | ventricular tachycardia | Ospedale San Donato | Unknown | No outcome recorded |
| Phase 4 | NCT01646281 Comparator | Aug 2012 → Aug 2013 | atrial fibrillation | Maastricht University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT01477983 Comparator | Nov 2011 → Jul 2017 | atrial fibrillation | Kyoto University, Graduate School of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT00863213 Comparator | Mar 2009 → Mar 2011 | atrial fibrillation | Hospital Clinic of Barcelona | Completed | No outcome recorded |
| Phase 4 | NCT00702117 Comparator | Jun 2008 → Jan 2010 | Brugada syndrome, atrial fibrillation, ventricular tachycardia | Hospital Clinic of Barcelona | Completed | No outcome recorded |
| Phase 4 | NCT00540787 Comparator | Aug 2003 → Jun 2006 | paroxysmal atrial fibrillation | Biosense Webster, Inc. | Completed | No outcome recorded |
| — | NCT07445334 Comparator | Mar 2026 → Sep 2027 expected | ventricular tachycardia | Western Sydney Local Health District | Recruiting | No outcome recorded |
| — | NCT06699342 Comparator | Jan 2025 → Dec 2027 expected | atrial fibrillation | Seoul National University Hospital | Recruiting | No outcome recorded |
| — | NCT06322017 Comparator | Apr 2024 → Apr 2030 expected | atrial fibrillation | Nantes University Hospital | Recruiting | No outcome recorded |
| — | NCT06096337 Comparator | Dec 2023 → Feb 2026 overdue | persistent atrial fibrillation | Boston Scientific Corporation | Active not recruiting | No outcome recorded |
| — | NCT05790707 Comparator | Apr 2023 → Jan 2027 expected | cognitive impairment with or without cerebellar ataxia, persistent atrial fibrillation | Poitiers University Hospital | Recruiting | No outcome recorded |
| — | NCT03845010 Comparator | Feb 2019 → Jan 2023 | cardiac rhythm disease | Maatschap Cardiologie Zwolle | Completed | No outcome recorded |
| — | NCT03437356 Comparator | Feb 2018 → May 2022 | atrial fibrillation | AZ Sint-Jan AV | Completed | No outcome recorded |
| — | NCT05514860 Comparator | Jan 2017 → Sep 2022 | atrial fibrillation | University of British Columbia | Unknown | No outcome recorded |
| — | NCT02459574 Comparator | May 2015 → Sep 2018 | atrial fibrillation, heart failure | Imperial College London | Completed | No outcome recorded |
| — | NCT02248753 Comparator | Oct 2014 → Nov 2018 | atrial fibrillation | Maastricht University Medical Center | Completed | Met primary |
| — | NCT02110537 Background | Mar 2014 → Jul 2015 | persistent atrial fibrillation | Kyunghee University Medical Center | Unknown | No outcome recorded |
| — | NCT01775891 Comparator | Jul 2012 → Jul 2015 | paroxysmal atrial fibrillation | Korea University | Unknown | No outcome recorded |
| — | NCT00911508 Comparator | Nov 2009 → Dec 2017 | atrial fibrillation | Mayo Clinic | Completed | No outcome recorded |
| — | NCT02294955 Comparator | May 2008 → Sep 2018 | atrial fibrillation | Uppsala University Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2020-07-30 | Theranexus | Results THERANEXUS TO PRESENT THE RESULTS OF THN102 FOR PARKINSON'S DISEASE AT THE 2020 INTERNATIONAL CONGRESS OF PARKINSON'S DISEASE AND MOVEMENT DISORDERS actusnews.com ↗
The ESS score improved by 3.9 points in patients after treatment with THN102-200/2. |
| 2020-03-31 | Theranexus | Results THERANEXUS ANNOUNCES THE SUCCESS OF ITS PHASE II TRIAL FOR THN102 IN PARKINSON'S PATIENTS actusnews.com ↗ |
| 2019-09-03 | Theranexus | Results THERANEXUS ANNOUNCES THE PUBLICATION OF TWO SCIENTIFIC PAPERS AND A PRESENTATION AT THE EUROPEAN PAIN CONGRESS (EFIC) TO BE HELD ON 3-7 SEPTEMBER IN VALENCIA, SPAIN actusnews.com ↗ |
| 2019-02-27 | Theranexus | Results THERANEXUS ANNOUNCES PRELIMINARY RESULTS OF PHASE II TRIAL OF THN102 ON NARCOLEPSY PATIENTS actusnews.com ↗
However, the results do not indicate any difference in efficacy between THN102 (combination of modafinil and flecainide) and modafinil alone with respect to the trial’s primary endpoint (Epworth Sleepiness Scale). |
| 2018-07-05 | Theranexus | Results THERANEXUS PRESENTS NEW DATA ON THE STIMULATING EFFECT OF ITS DRUG CANDIDATE THN102 actusnews.com ↗
The research demonstrates that the histaminergic system is involved in the stimulating effect of THN102. |
| 2018-06-26 | Theranexus | Regulatory THERANEXUS ANNOUNCES GERMAN AUTHORITIES APPROVAL FOR ITS PHASE 2 CLINICAL TRIAL IN PARKINSON'S DISEASE actusnews.com ↗
We are pleased to announce this approval in Germany which will allow the opening of several centres for the phase 2 Parkinson's study. |
| 2018-05-22 | Theranexus | Results THERANEXUS ANNOUNCES THE PUBLICATION OF A SCIENTIFIC ARTICLE ON THE MECHANISM OF ACTION OF DRUG CANDIDATE THN102 IN THE INTERNATIONAL JOURNAL OF NEUROPSYCHOPHARMACOLOGY actusnews.com ↗
The study has established the effect of drug candidate THN102, a combination of modafinil and flecainide, on brain metabolic activity by means of an approved imaging technique called positron emission tomography, with radiolabelled glucose (fludeoxyglucose or FDG). |
| 2018-04-23 | Theranexus | Regulatory THN102 OBTAINS INVESTIGATIONAL NEW DRUG STATUS FROM THE FOOD AND DRUG ADMINISTRATION (FDA) actusnews.com ↗
It therefore authorises the phase 2 clinical trial to assess the clinical benefit of the THN102, a combination of modafinil and flecainide in 60 patients with Parkinson’s disease and suffering from EDS. |
| 2018-04-19 | Theranexus | Regulatory THERANEXUS ANNOUNCES THE FIRST EUROPEAN APPROVAL FOR ITS PHASE 2 CLINICAL TRIAL WITH THN 102 IN PARKINSON'S DISEASE PATIENTS actusnews.com ↗ |
| 2015-02-19 | Eisai Inc. | Regulatory EISAI RECEIVES APPROVAL IN JAPAN FOR FINE GRANULE FORMULATION OF ANTI-ARRHYTHMIC AGENT TAMBOCOR® SUITABLE FOR PEDIATRIC PATIENTS eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has received marketing and manufacturing approval in Japan for Tambocor® Fine Granules 10%, a new formulation of anti-arrhythmic agent Tambocor (flecainide acetate). |
| 2010-05-13 | Eisai Inc. | Regulatory EISAI RECEIVES APPROVAL FOR ADDITIONAL INDICATION OF ANTI-ARRHYTHMIC AGENT TAMBOCOR® TABLETS FOR TACHYARRHYTHMIA IN PEDIATRIC PATIENTS IN JAPAN eisai.com ↗ |
| 2010-01-14 | Eisai Inc. | Regulatory Eisai Submits Application for Additional Indication of Anti-arrhythmic Agent Tambocor® Tablets for Tachyarrhythmia in Paediatric Patients in Japan eisai.com ↗
This submission for additional indication has been made in response to the conclusion reached by the committee. |
| 2007-06-26 | Eisai Inc. | Regulatory Tambocor® (Antiarrthymic Treatment) Received Approval for Paroxysmal Atrial Fibrillation/Flutter eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito) announced today that an additional indication for Tambocor ® Tablets 50 mg /100 mg (generic name: flecainide acetate) for the treatment of paroxysmal atrial fibrillation/flutter received approval in Japan. |
All press releases naming this drug 14 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 62 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | flecainide | “Pharmacologic therapy includes rate control with beta-blockers (e.g., bisoprolol), calcium channel blockers (e.g., diltiazem), or antiarrhythmic drugs (e.g., flecainide,...” NCT06699342 ↗57“Antiarrhythmic drug therapy (Class I - flecainide, propafenone; Class III - sotalol, dronedarone) will prescribed and monitored based on local clinical practice, and according...” NCT02825979 ↗ “Antiarrhythmic drug therapy (Class I - flecainide, propafenone; Class III - sotalol, dronedarone) will prescribed and monitored based on local clinical practice, and according...” NCT05514860 ↗ “In patients with structural heart disease, amiodarone is recommended, while flecainide plus diltiazem or beta-blockers are encouraged in patients without structural heart diseases.” NCT00863213 ↗ “The recommended drugs are flecainide, propafenone, sotalol and amiodarone, but the final choice of drug and dosage is left to the discretion of the attending physician.” NCT01477983 ↗ “Other class IC antiarrhythmic drug that they had been taking before catheter ablation will be administrated.(flecainide 100mg bid PO or propafenone 225mg tid)” NCT01775891 ↗ “THN102 Dosage B : 200 mg/2 mg THN102 is a combination of modafinil 100mg and flecainide 1 mg daily dosage is 200 mg of modafinil and 2 mg of flecainide” NCT03624920 ↗ “THN102 is a novel combination of modafinil and low-dose flecainide, targeting glial connexin activity to modulate modafinil effects.” PMID 31419329 ↗ Sep 2019 “If coronary artery disease and structural heart disease is ruled out, flecainide (class I anti-arrhythmic agent) may be used.” NCT07445334 ↗ “* procainamide * quinidine * disopyramide * propafenone * flecainide * sotalol * dofetilide * amiodarone” NCT00589303 ↗ “Amiodarone; Dronaderone; Sotalol Beta blockers; Calcium channel blockers; Flecainide; or Propafenone.” NCT02459574 ↗ |
| Known as | Apocard R | “Flecainide: Tambocor or Flecainide EG 100mg b.i.d., Apocard R 100 to 200mg overdose (OD)” NCT03437356 ↗ |
| Known as | Flecainida | ChEMBL registry synonym — accepted as the source's own label CHEMBL652 ↗ |
| Known as | Flecainide Acetate | “FlecIH-103 (flecainide acetate inhalation solution)” NCT05039359 ↗ |
| Known as | FLECAINIDE COMPONENT OF THN-102 | ChEMBL registry synonym — accepted as the source's own label CHEMBL652 ↗ |
| Known as | Flecainide EG | “Flecainide: Tambocor or Flecainide EG 100mg b.i.d., Apocard R 100 to 200mg overdose (OD)” NCT03437356 ↗ |
| Known as | Flecainide monoacetate | ChEMBL registry synonym — accepted as the source's own label CHEMBL652 ↗ |
| Known as | FlecIH-103 | “a 120 mg orally inhaled solution of flecainide acetate (FlecIH-103)” PMID 40132102 ↗ Mar 2025 |
| Known as | NSC-719273 | ChEMBL registry synonym — accepted as the source's own label CHEMBL652 ↗ |
| Known as | Tambocor | “dronedarone - Multaq™ OR flecainide - Tambocor™ OR propafenone - Rytmonorm™ OR sotalol - Sotacor™” NCT05939076 ↗2“Flecainide: Tambocor or Flecainide EG 100mg b.i.d., Apocard R 100 to 200mg overdose (OD)” NCT03437356 ↗ “flecainide (Tambocor ®) 100 mg twice daily” NCT02051621 ↗ |
| Action | Inhibit | “a classical INa blocker, which will be more effective to terminate AF episodes with slower activation rates.” NCT03005366 ↗1“Sodium channel protein type V alpha subunit blocker” CHEMBL652 ↗ |
| Modality | Small molecule | — CHEMBL652 ↗ |
| Route | Intravenous | “2 mg/kg iv in 10 minutes” NCT00702117 ↗ |
| Target | SCN5A | “Sodium channel protein type V alpha subunit blocker” CHEMBL652 ↗ |