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Priya Life Science Compound trial record
Compound · clinical trials

Flecainide clinical trials

Also listed in trial records as C01B C04, Tambocor
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 4 trials in our France, Belgium, Norway and South Korea registers that name Flecainide as an intervention. Synced 10 Nov 2026
4Current trials
1Recruiting now
4Lead sponsors
4Country registers
At a glance

Flecainide is named as an intervention in 4 current clinical trials in our France, Belgium, Norway and South Korea registers. 1 is recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Assistance Publique - Hôpitaux de Paris (1). The most-studied condition is Atrial Fibrillation (AF). The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.

Where Flecainide is approved

All regulators →

Of the three regulators tracked here, the first to approve Flecainide was the US, on 31 Oct 1985.

USUnited States (FDA)
31 Oct 1985
Tambocor
NDA018830 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
No new-drug Notice of Compliance since 1994
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

What health systems spend on Flecainide

All medicines →
ENNHS England
£3.0m
483,809 items dispensed, Sep 2025 to Aug 2026
+17% on the previous 12 months
Net ingredient cost, community prescriptions
USUS Medicaid
$2.0m
93,507 prescriptions in 2025 · Flecainide Acetate
-6% on 2024
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

How Flecainide works

All drug targets →
  • Sodium channel protein type V alpha subunit blocker Blocker
    Target: SCN5A sodium voltage-gated channel alpha subunit 5
    ChEMBL only
Diseases it has been tested for in clinical trials, by furthest phase
  • Supraventricular tachycardiaPhase 3
  • Ventricular arrhythmiaPhase 3
  • Atrial fibrillationPhase 3
  • Atrial flutterPhase 3
  • Coronary artery disorderPhase 3
  • Andersen-Tawil syndromePhase 2
  • Parkinson diseasePhase 2
  • Premature ventricular contractionPhase 2
  • Arrhythmogenic right ventricular cardiomyopathyPhase 2
  • NarcolepsyPhase 2
14 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL652, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 2560, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Flecainide

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Flecainide

ATC code
C01BC04
ChEMBL
CHEMBL652
DrugBank
DB01195
PubChem CID
3356
CAS number
54143-55-4
FDA UNII
K94FTS1806
Wikidata
Q421381
Wikipedia
Flecainide

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

Trials by status

  • Recruiting125%
  • Not yet open125%
  • Active, closed250%

Trials by phase

  • Phase 3250%
  • Phase 4250%
01

Clinical trials of Flecainide

4 trials
StudyPhaseStatusLead sponsorRegisters
Flecainide Safety in Patients With Coronary Artery Disease and Atrial Fibrillation
NCT07405671 · ClinicalTrials.gov ↗ · Atrial Fibrillation (AF), Coronary Artery Disease
Phase 4 Recruiting Universitaire Ziekenhuizen KU Leuven Belgium
Dronedarone Rhythm Intervention for Early Atrial Fibrillation
NCT07270848 · ClinicalTrials.gov ↗ · Atrial Fibrillation (AF)
Phase 4 Not yet open Inha University Hospital South Korea
Assessment of Flecainide to Lower the Patent Foramen Ovale Closure Risk of Atrial Arrhythmia or Tachycardia
NCT05213104 · ClinicalTrials.gov ↗ · Patent Foramen Ovale, Atrial Arrhythmia, Cryptogenic Stroke
Phase 3 Active, closed Assistance Publique - Hôpitaux de Paris France
Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse
NCT05631730 · ClinicalTrials.gov ↗ · Mitral Valve Prolapse, Ventricular Arrhythmias and Cardiac Arrest
Phase 3 Active, closed Oslo University Hospital Norway

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Flecainide in the EU trials register (CTIS)

1 trial

Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Flecainide. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.

StudyPhaseStatusSponsorCountries
AVISO - Assessment of Flecainide versus Bisoprolol as First-Line Treatment for Premature Ventricular Contractions: a Multicenter Randomized Clinical Trial
2025-524584-20-00 · Cardiovascular Diseases
Phase 3 Authorised Assistance Publique Hopitaux De Paris France
03

Flecainide across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

5 single-substance products containing Flecainide on the HPRA medicines list.

All 5 Irish products →

Supply shortages

No entry for Flecainide in the EMA, FDA or German BfArM shortage lists we track.

04

Conditions studied with Flecainide

7 conditions
Atrial Fibrillation (AF)2Patent Foramen Ovale1Atrial Arrhythmia1Cryptogenic Stroke1Coronary Artery Disease1Mitral Valve Prolapse1Ventricular Arrhythmias and Cardiac Arrest1
05

Sponsors

lead sponsor per trial
Lead sponsorTrials
Assistance Publique - Hôpitaux de Paris1
Universitaire Ziekenhuizen KU Leuven1
Oslo University Hospital1
Inha University Hospital1
06

By country register

RegisterTrialsRecruiting
Clinical trials in France10
Clinical trials in Belgium11
Clinical trials in Norway10
Clinical trials in South Korea10
EU register (CTIS)1—

A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.

07

Related compounds

08

Questions about Flecainide trials

How many clinical trials are testing Flecainide?

4 current trials in our France, Belgium, Norway and South Korea registers name Flecainide (also registered as C01B C04) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.

Are Flecainide trials recruiting patients?

Yes. 1 of the 4 trials is recruiting: 1 with sites in Belgium. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Flecainide clinical trials?

Assistance Publique - Hôpitaux de Paris (1), Universitaire Ziekenhuizen KU Leuven (1), Oslo University Hospital (1) and Inha University Hospital (1). The number in brackets is how many trials each organisation leads.

Is Flecainide licensed in Ireland?

Yes. The HPRA medicines list includes 5 single-substance products containing Flecainide, for example Flecainide 100mg Tablets (Teva B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Flecainide shortage?

Not in the lists we track: Flecainide has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Flecainide works or whether it is effective, and it is not medical advice.

Approvals, shortages and trials, every Friday

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Flecainide works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Flecainide (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.