yiqibuvir (HEC110114) / HEC Pharm - LARVOL DELTA

A phase Ⅲ clinical study to evaluate the efficacy and safety profile of antaitasvir phosphate combined with yiqibuvir in the treatment of adults with chronic hepatitis C (PubMed, Zhonghua Gan Zang Bing Za Zhi) - "A total of one case (0.3%) in the experimental drug group was suspended due to TEAEs (fatigue, dizziness, and myalgia), but no TEAEs occurred that led to permanent discontinuation of the drug, termination of treatment, early withdrawal, or death. The combination of antaitasvir phosphate 100 mg combined with yiqibuvir 600 mg demonstrates significant efficacy and a good safety profile in patients with CHC with genotypes 1, 2, 3, and 6, without cirrhosis or with compensated cirrhosis, who have received interferon-based treatment or have received initial treatment."

Clinical • Journal • Dyslipidemia • Fatigue • Fibrosis • Hepatitis C • Hypertriglyceridemia • Immunology • Infectious Disease • Inflammation • Metabolic Disorders • Musculoskeletal Pain • Pain

Antaitavir Hasophate Capsules Combined With Yiqibuvir Tablets in Treatment Adult Patients With Chronic Hepatitis C (clinicaltrials.gov) - P2/3 | N=514 | Completed | Sponsor: Sunshine Lake Pharma Co., Ltd. | Recruiting ➔ Completed

Trial completion • Hepatitis C • Infectious Disease • Inflammation

Antaitasvir plus Yiqibuvir for treatment of chronic hepatitis C virus infection: a phase 2/3 study (APASL 2024) - "Treatment with the pan-genotypic regimen of antaitasvir plus yiqibuvir for 12 weeks was highly effective and safe in subjects infected with HCV."

P2/3 data • Fibrosis • Hepatitis C • Hepatology • Infectious Disease • Inflammation

ADME Study of [14C] Yiqibuvir in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Sunshine Lake Pharma Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion

ADME Study of [14C] Yiqibuvir in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd.

New P1 trial

Antaitavir Hasophate Capsules Combined With Yiqibuvir Tablets in Treatment Adult Patients With Chronic Hepatitis C (clinicaltrials.gov) - P2/3 | N=520 | Recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd. | Trial completion date: Dec 2022 ➔ Apr 2023 | Trial primary completion date: Dec 2022 ➔ Apr 2023

Combination therapy • Trial completion date • Trial primary completion date • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Pharmacokinetics of Midazolam When Co-administered With HEC74647 and HEC110114 (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: Sunshine Lake Pharma Co., Ltd. | Recruiting ➔ Completed

Trial completion

Pharmacokinetics of Midazolam When Co-administered With HEC74647 and HEC110114 (clinicaltrials.gov) - P1 | N=14 | Recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open

Pharmacokinetics of Midazolam When Co-administered With HEC74647 and HEC110114 (clinicaltrials.gov) - P1 | N=14 | Not yet recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd.

New P1 trial

Antaitavir Hasophate Capsules Combined With Yiqibuvir Tablets in Treatment Adult Patients With Chronic Hepatitis C (clinicaltrials.gov) - P2/3 | N=520 | Recruiting | Sponsor: Sunshine Lake Pharma Co., Ltd.

Combination therapy • New P2/3 trial • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Drug-drug Interaction Study Between HEC74647PA Capsule and HEC110114 Tablets in Healthy Subjects (clinicaltrials.gov) - P1; N=28; Completed; Sponsor: Sunshine Lake Pharma Co., Ltd.; Recruiting ➔ Completed

Clinical • Trial completion • Hepatitis C Virus • Hepatology • Infectious Disease

The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC110114 Tablets in HCV-infected Subjects (clinicaltrials.gov) - P1/2; N=24; Completed; Sponsor: Sunshine Lake Pharma Co., Ltd.; Not yet recruiting ➔ Completed

Clinical • Trial completion • Hepatitis C Virus • Hepatology • Infectious Disease

Drug-drug Interaction Study Between HEC74647PA Capsule and HEC110114 Tablets in Healthy Subjects (clinicaltrials.gov) - P1; N=28; Recruiting; Sponsor: Sunshine Lake Pharma Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Hepatitis C Virus • Infectious Disease

Drug-drug Interaction Study Between HEC74647PA Capsule and HEC110114 Tablets in Healthy Subjects (clinicaltrials.gov) - P1; N=28; Not yet recruiting; Sponsor: Sunshine Lake Pharma Co., Ltd.; Initiation date: Apr 2020 ➔ Jul 2020

Clinical • Trial initiation date • Hepatitis C Virus • Infectious Disease

Drug-drug Interaction Study Between HEC74647PA Capsule and HEC110114 Tablets in Healthy Subjects (clinicaltrials.gov) - P1; N=28; Not yet recruiting; Sponsor: Sunshine Lake Pharma Co., Ltd.; Trial completion date: Jul 2020 ➔ Oct 2020; Trial primary completion date: Apr 2020 ➔ Jul 2020

Clinical • Trial completion date • Trial primary completion date

The Tolerability and Pharmacokinetics Study of HEC110114 Tablets in Healthy Adult Subjects (clinicaltrials.gov) - P1; N=93; Completed; Sponsor: Sunshine Lake Pharma Co., Ltd.; Recruiting ➔ Completed

Clinical • Trial completion

Drug-drug Interaction Study Between HEC74647PA Capsule and HEC110114 Tablets in Healthy Subjects (clinicaltrials.gov) - P1; N=28; Not yet recruiting; Sponsor: Sunshine Lake Pharma Co., Ltd.

Clinical • New P1 trial