AP31969 / Acesion - LARVOL DELTA

The present and future of antiarrhythmic drugs. (PubMed, JRSM Cardiovasc Dis) - "Flecainide, propafenone, and dronedarone have demonstrated their reliable efficacy and safety, even in patients with structural heart disease, which should allow clinicians to reduce their reliance on amiodarone. Previous concerns regarding the proarrhythmic risk of dofetilide and ibutilide are currently managed through careful patient selection and adequate QT interval monitoring. Novel targeted AADs are advancing through the development pipeline, of which etripamil and landiolol have already been approved. Other emerging drugs, such as SK channel blockers (AP30663 and AP31969), RyR2 blockers, CaMKII inhibitors, and TASK-1 blockers (doxapram), are aligned with the new paradigm of atrial fibrillation that focuses on triggers and re-entry...Developing concepts such as atrial cardiomyopathy allows clinicians to characterize substrate objectively, in order to assess disease severity and individualize antiarrhythmic treatment. The future of antiarrhythmic therapy will be..."

Journal • Atrial Fibrillation • Cardiomyopathy • Cardiovascular • Heart Failure

Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: Acesion Pharma | Active, not recruiting ➔ Completed

Trial completion

END-AF-1: Clinical Randomised Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Acesion Pharma

Trial initiation date • Atrial Fibrillation • Cardiovascular

Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole (clinicaltrials.gov) - P1 | N=28 | Active, not recruiting | Sponsor: Acesion Pharma | Recruiting ➔ Active, not recruiting

Enrollment closed

Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Acesion Pharma | Not yet recruiting ➔ Recruiting

Enrollment open

Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: Acesion Pharma | Trial completion date: Sep 2026 ➔ May 2026

Trial completion date

Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: Acesion Pharma

New P1 trial

AP31969-M201: Clinical Randomised Phase 2 Trial of AP31969 versus Placebo for Rhythm Control of Atrial Fibrillation. (clinicaltrialsregister.eu) - P1/2 | N=180 | Recruiting | Sponsor: Acesion Pharma ApS

New P1/2 trial • Atrial Fibrillation • Cardiovascular

Acesion Pharma launches phase 2 trial of AP31969 in atrial fibrillation (PharmaTimes) - "The company said the first participants have now entered the randomised, double‑blind, placebo‑controlled study, which will recruit 200 patients across eight European countries and is expected to complete in the first quarter of 2027....The trial’s primary efficacy endpoint is atrial fibrillation burden, defined as the percentage of time a participant spends in atrial fibrillation."

Trial completion date • Trial status • Atrial Fibrillation

END-AF-1: Clinical Randomised Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Acesion Pharma

New P2 trial • Atrial Fibrillation • Cardiovascular

Single Ascending Dose, Multiple Ascending Dose, Food Effect Study With AP31969 (clinicaltrials.gov) - P1 | N=92 | Completed | Sponsor: Acesion Pharma | Recruiting ➔ Completed

Trial completion

Single Ascending Dose, Multiple Ascending Dose, Food Effect Study with AP31969 (clinicaltrials.gov) - P1 | N=124 | Recruiting | Sponsor: Acesion Pharma | Trial completion date: Sep 2024 ➔ Feb 2025 | Trial primary completion date: Sep 2024 ➔ Feb 2025

Trial completion date • Trial primary completion date

Single Ascending Dose, Multiple Ascending Dose, Food Effect Study With AP31969 (clinicaltrials.gov) - P1 | N=124 | Recruiting | Sponsor: Acesion Pharma | Trial completion date: May 2024 ➔ Sep 2024 | Trial primary completion date: May 2024 ➔ Sep 2024

Trial completion date • Trial primary completion date

Single Ascending Dose, Multiple Ascending Dose, Food Effect Study With AP31969 (clinicaltrials.gov) - P1 | N=124 | Recruiting | Sponsor: Acesion Pharma | Not yet recruiting ➔ Recruiting

Enrollment open

Single Ascending Dose, Multiple Ascending Dose, Food Effect Study With AP31969 (clinicaltrials.gov) - P1 | N=124 | Not yet recruiting | Sponsor: Acesion Pharma

New P1 trial