HPN-01 / Hepanova - LARVOL DELTA

First-in-class oral, once-monthly IKKalpha/beta inhibitor targeting steatosis, inflammation, and fibrosis in MASH: results from a phase 1 trial (EASL 2026) - "HPN-01 demonstrated excellent safety, predictable PK, and prolonged persistence in its first-in-human trial, enabling infrequent oral dosing including once-monthly regimens. By uniquely tackling inflammation and fibrosis, gaps left by other agents, HPN-01 is differentiated as both an oral monotherapy for advanced MASH/fibrosis and a rational backbone in combination regimens (e.g., with GLP-1 agonists, THR-beta agonists, or FGF21 analogs). Its integrated mechanism, oral convenience, and strong safety profile highlight its potential as a patient-friendly therapy for advanced MASH and a strategy to reduce progression to HCC."

First-in-human • P1 data • Fibrosis • Hepatocellular Cancer • Hepatology • Immunology • Inflammation • Metabolic Dysfunction-Associated Steatohepatitis • Solid Tumor • FGF21

PHARMACOLOGICAL TARGETING OF IKKΑ FOR RESOLUTION OF STEATOSIS, INFLAMMATION, AND FIBROSIS: A MECHANISTIC DISTINCT DEVELOPMENT OF HPN-01 FOR MASH (AASLD 2025) - "HPN-01 is currently under evaluation in a U.S. Phase I clinical trial in healthy volunteers. Preclinical toxicology and initial clinical data indicate a favorable safety profile. Collectively, these findings position HPN-01 as a mechanistically distinct, first-in-class therapeutic candidate capable of addressing the multifaceted pathobiology of MASH and preventing HCC development."

Fibrosis • Genetic Disorders • Hepatitis C • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity • Solid Tumor • AFP