ADC189 / Simcere, Jiaxing AnDiCon Biotech - LARVOL DELTA

Oral ADC189 for Adults and Adolescents with Uncomplicated Influenza. (PubMed, J Infect) - P2/3 | "A single-dose ADC189 shorten the time to the resolution of symptoms among adults and adolescents with uncomplicated influenza, without evident safety concerns. (Funded by Jiaxing AnDiCon Biotech Co., Ltd, Zhejiang, China; ChiCTR number, 20230137, and ClinicalTrials. gov number, NCT06342921.)."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Comparative Bioavailability Study of Tablet and Granule Formulations of ADC189 and the Study of Ultra-high Dose (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd | Recruiting ➔ Completed

Trial completion

ADC189 Tablets on Influenza A Virus Infection/Influenza B Virus Infection (clinicaltrials.gov) - P2/3 | N=749 | Completed | Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd | Recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

A Drug-Drug Interaction (DDI) Study of ADC189 With Itraconazole in Healthy, Adult Subjects (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd | Recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Sep 2024

Trial completion • Trial completion date

To Compare the Safety and PK/ PD Characteristics of ADC189 Between Hepatic Impairment and Normal Hepatic Function Subjects (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd | Recruiting ➔ Completed | N=32 ➔ 16 | Trial completion date: Oct 2024 ➔ Jun 2024 | Trial primary completion date: Sep 2024 ➔ Jun 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Hepatology • Infectious Disease • Influenza • Respiratory Diseases

Study of Pharmacokinetics and Metabolism on [(14)C]ADC189 (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd | Recruiting ➔ Completed | Trial completion date: Jul 2024 ➔ Feb 2024 | Trial primary completion date: Jun 2024 ➔ Feb 2024

Trial completion • Trial completion date • Trial primary completion date

Inhibition of cap-dependent endonuclease in influenza virus with ADC189: a pre-clinical analysis and phase I trial. (PubMed, Front Med) - "In our study, its antiviral efficacy was evaluated in vitro and in vivo, and compared with baloxavir marboxil and oseltamivir. ADC189 demonstrated excellent antiviral efficacy both in vitro and in vivo. It was safe, well-tolerated, and had favorable pharmacokinetic characteristics in healthy volunteers, supporting its potential for single oral dosing in clinical practice."

Journal • P1 data • Preclinical • Infectious Disease • Influenza • Respiratory Diseases

A Drug-Drug Interaction (DDI) Study of ADC189 With Itraconazole in Healthy, Adult Subjects (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd

New P1 trial

Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenza (clinicaltrials.gov) - P3 | N=165 | Recruiting | Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd

New P3 trial • Infectious Disease • Influenza • Respiratory Diseases

To Compare the Safety and PK/ PD Characteristics of ADC189 Between Hepatic Impairment and Normal Hepatic Function Subjects (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd

New P1 trial • Hepatology • Infectious Disease • Influenza • Respiratory Diseases

Comparative Bioavailability Study of Tablet and Granule Formulations of ADC189 and the Study of Ultra-high Dose (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd

New P1 trial

Study of Pharmacokinetics and Metabolism on [(14)C]ADC189 (clinicaltrials.gov) - P1 | N=6 | Recruiting | Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd

New P1 trial

ADC189 Tablets on Influenza A Virus Infection/Influenza B Virus Infection (clinicaltrials.gov) - P2/3 | N=675 | Recruiting | Sponsor: Jiaxing AnDiCon Biotech Co.,Ltd

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