ONO-7684 / Ono Pharmaceutical - LARVOL DELTA

ONO-7684 a Novel Oral FXIa Inhibitor: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in a First-in-human Study. (PubMed, Br J Clin Pharmacol) - "The data generated in this FIH study demonstrate the promising potential of oral FXIa inhibition and ONO-7684 for indications requiring anticoagulation."

Clinical • Journal • P1 data • PK/PD data

[VIRTUAL] First-in-Human Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of ONO-7684, an Oral Small Molecule Factor XIa Inhibitor in Healthy Subjects (ISTH 2020) - P1 | "ONO-7684 showed favourable tolerability, PK and PD suitable for further clinical development as a novel antithrombotic agent. Sponsored by: Ono Pharmaceutical Co. Ltd., Japan"

Clinical • P1 data • PK/PD data • Cardiovascular • Hematological Disorders • Thrombosis • F2

A Two-Part Study to Assess the Safety, Tolerability, PK and PD of ONO-7684 in Healthy Adult Volunteers (clinicaltrials.gov) - P1; N=72; Completed; Sponsor: Ono Pharmaceutical Co. Ltd; Recruiting ➔ Completed

Clinical • Trial completion

A Two-Part Study to Assess the Safety, Tolerability, PK and PD of ONO-7684 in Healthy Adult Volunteers (clinicaltrials.gov) - P1; N=100; Recruiting; Sponsor: Ono Pharmaceutical Co. Ltd; Trial completion date: Jul 2019 ➔ Nov 2019; Trial primary completion date: Jul 2019 ➔ Nov 2019

Clinical • Trial completion date • Trial primary completion date

Investigation of Pharmacodynamic Biomarkers and Neutralizers for ONO-7684 (ONO-5450598), an Oral FXIa Inhibitor (ISTH 2019) - "NovoSeven (recombinant FVIIa) and FEIBA (anti-inhibitor coagulant complex) neutralized the anticoagulant effect of ONO-7684, but Kcentra (prothrombin complex concentrate) did not. aPTT and FXIa inhibitory activity are potential pharmacodynamic biomarkers for ONO-7684 and neither were affected by the reagent used. NovoSeven and FEIBA may be used when the anticoagulant activity of ONO-7684 needs to be neutralized."

Biomarker • PK/PD data