hepenofovir / Xi’an XinTong Pharma - LARVOL DELTA

A Phase II/III of Hepenofovir Fumarate Tablets (HTS) for Chronic Hepatitis B (clinicaltrials.gov) - P2/3 | N=1444 | Active, not recruiting | Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd.

New P2/3 trial • Hepatitis B • Infectious Disease • Inflammation

EFFICACY AND SAFETY OF A NOVEL NUCLEOSIDE ANALOGUE HEPENOFOVIR FOR THE TREATMENT OF CHRONIC HEPATITIS B VIRUS INFECTION: INTERIM RESULTS FROM THE PHASE IC/IIb STUDY (AASLD 2023) - "In this clinical study, we aimed to assess the safety, antiviral activity, and pharmacokinetics of Hepenofovir and an active control cohort of Tenofovir alafenamide(TAF) in CHB patients. HTS was generally safe and well tolerated; the mean reductions of HBV DNA and the rates of HBV DNA reached to undetectable were dose-dependent, and were superior to those in TAF cohort. The mean reductions of HBsAg /HBeAg and ALT normalization rates were more favorable than those in TAF cohort."

Clinical • Late-breaking abstract • Hepatitis B • Hepatology • Infectious Disease • Inflammation

HTS: A Phase Ic/IIb Study to Evaluate the Efficacy，Safety and Pharmacokinetics of HST in Patients With CHB (clinicaltrials.gov) - P1/2 | N=48 | Recruiting | Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd.

New P1/2 trial

First-In-Human Study on Pharmacokinetics, Safety, and Tolerability of Single and Multiple Escalating Doses of Hepenofovir, a Novel Hepatic Targeting Prodrug of Tenofovir in Healthy Chinese Subjects. (PubMed, Front Pharmacol) - " Hepenofovir has shown a favorable safety and PK profile, which support the further evaluation of its safety and efficacy in CHB patients. Clinical trial registration number: The trial is registered at Chinese Clinical Trial website (http://www.chinadrugtrials.org.cn/index.html # CTR20191953)."

Journal • P1 data • PK/PD data • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Study to Investigate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Doses of Hepenofovir Fumarate Tablets in Healthy Volunteers. (clinicaltrials.gov) - P1; N=69; Not yet recruiting; Sponsor: Xi'an Xintong Pharmaceutical Research Co.,Ltd.

New P1 trial