sulcardine (HBI-3000) / HUYA Bioscience - LARVOL DELTA

A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF) (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: HUYABIO International, LLC. | Trial primary completion date: Aug 2025 ➔ Dec 2025

Trial primary completion date • Atrial Fibrillation • Cardiovascular

A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF) (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: HUYABIO International, LLC. | Trial completion date: Jun 2025 ➔ Nov 2025

Trial completion date • Atrial Fibrillation • Cardiovascular

26-Week Repeated-Dose Toxicity Study of a Novel Antiarrhythmic Drug Sulcardine Sulfate in Sprague-Dawley Rats. (PubMed, J Appl Toxicol) - "Concomitant toxicokinetics showed that the drug accumulated to some extent in the animals. Consequently, the liver and lungs were identified as potential target organs, and the no observed adverse effect level (NOAEL) was determined to be 175 mg/kg."

Journal • Preclinical • Cardiovascular

A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF) (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: HUYABIO International, LLC. | Trial completion date: Dec 2024 ➔ Jun 2025 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Atrial Fibrillation • Cardiovascular

HBI-3000: Pharmacological Conversion of Atrial Fibrillation With Unique Defense Against Excessive QT Interval Prolongation (AHA 2024) - P2 | "HBI-3000 (Sulcardine) exhibits dQTcF prolongation protection in both AF and SR due to a unique pattern of channel fluxes that shortens early repolarization. This shorter dJTp interval acts as a mechanism for effectively limiting excessive QT prolongation and reducing proarrhythmic risk."

Atrial Fibrillation • Cardiovascular

HUYABIO Validates Protective Mechanism for Antiarrhythmic Drug HBI-3000 in AF Patients, Paving the Way for a New Era in Atrial Fibrillation Treatment (PRNewswire) - "HUYABIO International today announced the presentation of new patient data for HBI-3000, an antiarrhythmic drug (AAD) with a unique protective profile for the treatment of atrial fibrillation (AF), one of the most common and serious heart conditions worldwide...The AHA presentation highlights the mechanism of sulcardine's protective effect and successful demonstration of this activity in patients with active acute AF, marking a critical advancement in addressing the growing burden of this condition."

Clinical data • P2 data • Atrial Fibrillation • Cardiovascular

Sulcardine, an investigational multichannel blocker for atrial fibrillation with uniquely intense JTp inhibition to enhance safety (ESC 2024) - "Acute IV HBI-3000 administration resulted in no clinically significant safety findings, LVEF depression, or DDI with CYP2D6. Sulcardine facilitates QT prolongation, which has a therapeutic benefit in terminating AF, with simultaneous uncoupling and reversing of the JTpc interval increase, a potential mechanism for reducing proarrhythmic risk due to excessive QT prolongation."

Clinical • Atrial Fibrillation • Cardiovascular

A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF) (clinicaltrials.gov) - P2 | N=150 | Active, not recruiting | Sponsor: HUYABIO International, LLC. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Enrollment closed • Trial completion date • Trial primary completion date • Atrial Fibrillation • Cardiovascular

Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects (clinicaltrials.gov) - P1 | N=39 | Completed | Sponsor: HUYABIO International, LLC. | Recruiting ➔ Completed | N=24 ➔ 39

Enrollment change • Trial completion

Characterization of Preclinical Pharmacokinetic Properties and Prediction of Human PK Using a Physiologically Based Pharmacokinetic Model for a Novel Anti-Arrhythmic Agent Sulcardine Sulfate. (PubMed, Pharm Res) - "Our study systematically explored the pharmacokinetic characteristics of Sul and successfully developed the PBPK model to predict of its clinical PK."

Journal • PK/PD data • Preclinical

A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF) (clinicaltrials.gov) - P2; N=150; Recruiting; Sponsor: HUYA Bioscience International; Not yet recruiting ➔ Recruiting

Enrollment open • Atrial Fibrillation • Cardiovascular

Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: HUYA Bioscience International; Enrolling by invitation ➔ Recruiting

Enrollment status

A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF) (clinicaltrials.gov) - P2; N=150; Not yet recruiting; Sponsor: HUYA Bioscience International; Initiation date: Jan 2021 ➔ Apr 2021

Trial initiation date • Atrial Fibrillation • Cardiovascular

Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects (clinicaltrials.gov) - P1; N=24; Enrolling by invitation; Sponsor: HUYA Bioscience International; Not yet recruiting ➔ Enrolling by invitation

Clinical • Enrollment open

A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF) (clinicaltrials.gov) - P2; N=150; Not yet recruiting; Sponsor: HUYA Bioscience International

New P2 trial • Atrial Fibrillation • Cardiovascular

Drug-Drug Interaction Study of HBI-3000 and Paroxetine in Healthy Adult Male and Female Subjects (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: HUYA Bioscience International

Clinical • New P1 trial

HBI-3000: A Novel Drug for Conversion of Atrial Fibrillation - Phase 1 Study Results (AHA 2019) - "These data demonstrate that HBI-3000 is a potent inhibitor of multiple cardiac ion channels that play a role in onset and maintenance of AF. Its strong reduction of JTp may predict freedom from arrhythmias associated with I Kr block. Based on these results and preclinical data indicating low proarrhythmic risk, the drug is now entering Phase 2 in recent onset AF."

P1 data