ZX-7101A / Zenshine Pharma - LARVOL DELTA

Study to Evaluate the Pharmacokinetics and Relative Bioavailability of Metabolites in Healthy Chinese Adult Males (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Nanjing Zenshine Pharmaceuticals | Not yet recruiting ➔ Completed

Trial completion • Infectious Disease

Study to Evaluate the Pharmacokinetics and Relative Bioavailability of Metabolites in Healthy Chinese Adult Males (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Nanjing Zenshine Pharmaceuticals

New P1 trial • Infectious Disease

ZX-7101A-210: Study to Assess the Safety and Efficacy of ZX-7101A in Children Aged 5-11 Years with Influenza (clinicaltrials.gov) - P3 | N=180 | Recruiting | Sponsor: Nanjing Zenshine Pharmaceuticals | Not yet recruiting ➔ Recruiting | N=12 ➔ 180

Enrollment change • Enrollment open • Infectious Disease • Influenza • Respiratory Diseases

ZX-7101A-207: Study to Assess the Safety and Efficacy of ZX-7101A in Adolescents with Influenza (clinicaltrials.gov) - P3 | N=361 | Completed | Sponsor: Nanjing Zenshine Pharmaceuticals | Recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Corrigendum to Efficacy and safety of ZX-7101A, an inhibitor of influenza cap-dependent endonuclease, in adults with uncomplicated influenza: a randomized, double-blind, placebo-controlled phase 2/3 trial. (PubMed, Clin Microbiol Infect) - No abstract available

Clinical • P2/3 data • Infectious Disease • Influenza • Respiratory Diseases

Safety, tolerability, and pharmacokinetics of a novel anti-influenza agent ZX-7101A tablets in healthy Chinese participants: a first-in-human phase I clinical study. (PubMed, Int J Antimicrob Agents) - "These findings support 40 mg and 80 mg of ZX-7101A tablets as single dose regimens for use in phase II/III clinical trials. This study was registered at chinadrugtrials.org.cn (identifier: CTR20212778)."

Journal • P1 data • PK/PD data • Infectious Disease • Influenza • Respiratory Diseases

Pharmacokinetic Characteristics of Subjects with Hepatic Insufficiency and Healthy Subjects (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Nanjing Zenshine Pharmaceuticals | Recruiting ➔ Completed | N=32 ➔ 16 | Trial completion date: Dec 2024 ➔ Aug 2024 | Trial primary completion date: Jun 2023 ➔ Feb 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Hepatitis C • Infectious Disease • Influenza • Liver Failure • Respiratory Diseases

A Study to Assess the Effect of Itraconazole Capsules on the Pharmacokinetics of ZX-7101A Tablets in Healthy Adult Subjects in China (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Nanjing Zenshine Pharmaceuticals | Not yet recruiting ➔ Completed

Trial completion

A Study to Evaluate the Efficacy and Safety of ZX-7101A Tablets in Adults with Uncomplicated Influenza (clinicaltrials.gov) - P2/3 | N=900 | Completed | Sponsor: Nanjing Zenshine Pharmaceuticals | Recruiting ➔ Completed | N=210 ➔ 900

Enrollment change • Trial completion • Infectious Disease • Influenza • Respiratory Diseases

Substance Balance Study of [14C]ZX-7101A in Healthy Adult Male Subjects in China (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Nanjing Zenshine Pharmaceuticals | Not yet recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

ZX-7101A-208: A Study to Evaluate Drug-drug Interaction of ZX-7101A Tablets and Oseltamivir Phosphate Capsules in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Nanjing Zenshine Pharmaceuticals | Recruiting ➔ Completed | Trial primary completion date: Apr 2024 ➔ Dec 2023

Trial completion • Trial primary completion date

ZX-7101A-207: Study to Assess the Safety and Efficacy of ZX-7101A in Adolescents with Influenza (clinicaltrials.gov) - P3 | N=360 | Recruiting | Sponsor: Nanjing Zenshine Pharmaceuticals | Not yet recruiting ➔ Recruiting | Trial completion date: Nov 2024 ➔ Mar 2025 | Trial primary completion date: Sep 2024 ➔ Jan 2025

Enrollment open • Trial completion date • Trial primary completion date • Infectious Disease • Influenza • Respiratory Diseases

Efficacy and safety of ZX-7101A, an inhibitor of influenza cap-dependent endonuclease, in adults with uncomplicated influenza: a randomised, double-blind, placebo-controlled phase 2/3 Trial. (PubMed, Clin Microbiol Infect) - "ZX-7101A was an effective treatment for influenza with a single dose of either 40mg or 80mg, with more rapid alleviation of influenza symptoms versus placebo. No safety concerns were identified with single-dose treatment of ZX-7101A."

Clinical • Journal • P2/3 data • Infectious Disease • Influenza • Respiratory Diseases

QTc-7101: A Study to Evaluate the Effect of a Single Oral Dose of ZX-7101A on the QTc Interval in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Nanjing Zenshine Pharmaceuticals | Not yet recruiting ➔ Completed | Trial completion date: May 2024 ➔ Dec 2023

Trial completion • Trial completion date • Infectious Disease • Influenza • Respiratory Diseases

ZX-7101A-210: Study to Assess the Safety and Efficacy of ZX-7101A in Children Aged 5-11 Years with Influenza (clinicaltrials.gov) - P3 | N=12 | Not yet recruiting | Sponsor: Nanjing Zenshine Pharmaceuticals

New P3 trial • Infectious Disease • Influenza • Respiratory Diseases

ZX-7101A-207: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial of ZX-7101A Tablets to Evaluate the Efficacy and Safety in the Treatment of Uncomplicated Influenza in Adolescents (clinicaltrials.gov) - P3 | N=360 | Not yet recruiting | Sponsor: Nanjing Zenshine Pharmaceuticals

New P3 trial • Infectious Disease • Influenza • Respiratory Diseases

ZX-7101A-208: A Study to Evaluate Drug-drug Interaction of ZX-7101A Tablets and Oseltamivir Phosphate Capsules in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Nanjing Zenshine Pharmaceuticals

New P1 trial

A Study to Assess the Effect of Itraconazole Capsules on the Pharmacokinetics of ZX-7101A Tablets in Healthy Adult Subjects in China (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Nanjing Zenshine Pharmaceuticals

New P1 trial

Study to Assess the Safety, Tolerability and Pharmacokinetics of ZX-7101A and the Food Effect in Healthy Volunteers (clinicaltrials.gov) - P1 | N=66 | Completed | Sponsor: Nanjing Zenshine Pharmaceuticals | Recruiting ➔ Completed | Trial completion date: Jul 2022 ➔ Dec 2022 | Trial primary completion date: Apr 2022 ➔ Aug 2022

Trial completion • Trial completion date • Trial primary completion date

QTc-7101: A Study to Evaluate the Effect of a Single Oral Dose of ZX-7101A on the QTc Interval in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Nanjing Zenshine Pharmaceuticals

New P1 trial • Infectious Disease • Influenza • Respiratory Diseases

PA-E18G substitution in influenza A virus confers resistance to ZX-7101, a cap-dependent endonuclease inhibitor. (PubMed, Virol Sin) - "The CEN inhibitor, baloxavir marboxil (BXM), was approved in Japan and the US in 2018 and several other countries subsequently...Herein, we comprehensively characterized the in vitro and in vivo antiviral activities of ZX-7101A, an analogue of BXM...Reverse genetic and sequencing analysis demonstrated that a single E18G substitution in the PA subunit contributed to the reduced susceptibility to both ZX-7101 and BXA. Taken together, our results not only characterized a new CEN inhibitor of IAV but also identified a novel amino acid substitution responsible for CEN inhibitor resistance, which provides critical clues for future drug development and drug resistance surveillance."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Substance Balance Study of [14C]ZX-7101A in Healthy Adult Male Subjects in China (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Nanjing Zenshine Pharmaceuticals

New P1 trial • Infectious Disease • Influenza • Respiratory Diseases

Pharmacokinetic Characteristics of Subjects With Hepatic Insufficiency and Healthy Subjects (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Nanjing Zenshine Pharmaceuticals

New P1 trial • Hepatitis C • Infectious Disease • Influenza • Liver Failure • Respiratory Diseases

A Study to Evaluate the Efficacy and Safety of ZX-7101A Tablets in Adults With Uncomplicated Influenza (clinicaltrials.gov) - P2/3 | N=210 | Recruiting | Sponsor: Nanjing Zenshine Pharmaceuticals

New P2/3 trial • Infectious Disease • Influenza • Respiratory Diseases

Study to Assess the Safety, Tolerability and Pharmacokinetics of ZX-7101A and the Food Effect in Healthy Volunteers (clinicaltrials.gov) - P1 | N=66 | Recruiting | Sponsor: Nanjing Zenshine Pharmaceuticals

New P1 trial