HEC96719 / HEC Pharm - LARVOL DELTA

A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of HEC96719 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (clinicaltrials.gov) - P2 | N=68 | Completed | Sponsor: Sunshine Lake Pharma Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Sep 2023 | Trial primary completion date: Dec 2023 ➔ Sep 2023

Trial completion • Trial completion date • Trial primary completion date • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of HEC96719 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (clinicaltrials.gov) - P2 | N=78 | Recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd. | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Hepatology • Non-alcoholic Steatohepatitis

HEC96719, a novel tricyclic farnesoid X receptor agonist for treatment of non-alcoholic steatohepatitis: results of preclinical study and phase I trial (EASL-ILC 2022) - P1 | "For the selected compound with the most favorable properties, i.e. HEC96719, we further analyzed its effect on FXR in terms of selectivity and efficacy, and determined its efficacy in various animal models of NASH and liver fibrosis in comparison with obeticholic acid. These data on pharmacokinetic properties, efficacy and safety profiles overall indicate that HEC96719 is a promising drug candidate for NASH treatment. Planned clinical studies arewarranted to further evaluate these effects."

P1 data • Preclinical • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Non-alcoholic Steatohepatitis • FGF19

HEC96719, a novel FXR agonist,inhibits HBV infection in vitro and in vivo (EASL-ILC 2022) - "The novel FXR agonist HEC96719 has strong inhibitory effect against HBV replication in PHH cells and AAV/HBV mice, thus represent a promising agent for HBV cure."

Preclinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation

A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of HEC96719 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (clinicaltrials.gov) - P2 | N=78 | Recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd.

New P2 trial • Hepatology • Non-alcoholic Steatohepatitis

Discovery of a tricyclic farnesoid X receptor agonist HEC96719, a clinical candidate for treatment of non-alcoholic steatohepatitis. (PubMed, Eur J Med Chem) - "HEC96719 exhibits excellent potency superior to GW4064 and obeticholic acid in in vitro and in vivo assays of FXR activation. It also shows higher FXR selectivity and more favorable tissue distribution dominantly in liver and intestine. Preclinical data on pharmacokinetic properties, efficacy, and safety profiles overall indicate that HEC96719 is a promising drug candidate for NASH treatment."

Clinical • Journal • Fibrosis • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Immunology • Liver Cancer • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • Oncology • Solid Tumor

The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy Subjects (clinicaltrials.gov) - P1; N=73; Completed; Sponsor: Sunshine Lake Pharma Co., Ltd.; Recruiting ➔ Completed

Clinical • Trial completion • Hepatology • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • FGF19

Multiple Dose Safety, Tolerability, PK，PD and Food Effect Study of HEC96719 in Healthy Adult Subjects (clinicaltrials.gov) - P1; N=66; Completed; Sponsor: Sunshine Lake Pharma Co., Ltd.; Recruiting ➔ Completed; Trial completion date: Apr 2021 ➔ Dec 2020; Trial primary completion date: Mar 2021 ➔ Dec 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date • Hepatology • Non-alcoholic Steatohepatitis

The Tolerability , Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy Adult Subjects (clinicaltrials.gov) - P1; N=64; Completed; Sponsor: Sunshine Lake Pharma Co., Ltd.; Recruiting ➔ Completed

Clinical • Trial completion • Hepatology • Non-alcoholic Steatohepatitis

Multiple Dose Safety, Tolerability, PK，PD and Food Effect Study of HEC96719 in Healthy Adult Subjects (clinicaltrials.gov) - P1; N=76; Recruiting; Sponsor: Sunshine Lake Pharma Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hepatology • Non-alcoholic Steatohepatitis

Multiple Dose Safety, Tolerability, PK，PD and Food Effect Study of HEC96719 in Healthy Adult Subjects (clinicaltrials.gov) - P1; N=76; Not yet recruiting; Sponsor: Sunshine Lake Pharma Co., Ltd.

Clinical • New P1 trial • Hepatology • Non-alcoholic Steatohepatitis

The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy Subjects (clinicaltrials.gov) - P1; N=96; Recruiting; Sponsor: Sunshine Lake Pharma Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hepatology • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • FGF19

The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy Subjects (clinicaltrials.gov) - P1; N=96; Not yet recruiting; Sponsor: Sunshine Lake Pharma Co., Ltd.

Clinical • New P1 trial • Hepatology • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • FGF19

The Tolerability , Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy Adult Subjects (clinicaltrials.gov) - P1; N=64; Recruiting; Sponsor: Sunshine Lake Pharma Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Newly added product (clinicaltrials.gov) - P1, NASH

Pipeline update