masulaxavir dry suspension (GP681) / Jiangxi Qingfeng Pharma, GinkgoPharma - LARVOL DELTA

A first-in-human phase I study to evaluate the safety, tolerability, and pharmacokinetics of a novel anti-influenza agent suraxavir marboxil in healthy Chinese subjects. (PubMed, Antimicrob Agents Chemother) - P1 | "Suraxavir marboxil (GP681) is a prodrug of a novel polymerase acidic protein inhibitor, and its metabolite GP1707D07 prevents the replication of influenza virus by selectively inhibiting the cap-dependent nucleic acid endonuclease of influenza virus...Based on the safety and pharmacokinetic data, 20-80 mg single oral dosing was supported for further clinical development. Food intake may slightly reduce the rate and extent of absorption of suraxavir marboxil.The study was registered on https://classic.clinicaltrials.gov/ (registration no.: NCT04729764)."

First-in-human • Journal • P1 data • PK/PD data • Infectious Disease • Influenza • Respiratory Diseases

Evaluation of drug-drug interaction between Suraxavir Marboxil (GP681) and itraconazole, and assessment of the impact of gene polymorphism. (PubMed, Front Pharmacol) - P1 | "Random forest algorithm enhances the understanding of pharmacogenetic variants involved in GP1707D07 metabolism and may serve as a potent tool for assessing gene polymorphism data in small clinical samples. clinicaltrials.gov, identifier NCT05789342."

Journal • Infectious Disease • Influenza • Respiratory Diseases • CYP1A2 • CYP2C19 • CYP3A4

Study to Assess the Tolerability, Safety and Efficacy of GP681 Powder for Oral Suspension (clinicaltrials.gov) - P1 | N=44 | Completed | Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. | Recruiting ➔ Completed

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

Study to Assess Relative Bioavailability of GP681 Formulations in Healthy Chinese Male Subjects (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. | Recruiting ➔ Completed

Trial completion

Study to Assess the Efficacy and Safety of GP681 Versus Placebo for Postexposure Prophylaxis Against Influenza (clinicaltrials.gov) - P3 | N=748 | Recruiting | Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases

Study of GP681 Tablets Compared With Placebo in Patients With Influenza at High Risk of Influenza Complications (clinicaltrials.gov) - P3 | N=328 | Recruiting | Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases

Study to Assess Relative Bioavailability of GP681 Formulations in Healthy Chinese Male Subjects (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open

Study to Assess Relative Bioavailability of GP681 Formulations in Healthy Chinese Male Subjects (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

New P1 trial

Study to Assess the Tolerability, Safety and Efficacy of GP681 Powder for Oral Suspension (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

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

Study to Assess the Efficacy and Safety of GP681 Versus Placebo for Postexposure Prophylaxis Against Influenza (clinicaltrials.gov) - P3 | N=748 | Not yet recruiting | Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

New P3 trial • Infectious Disease • Influenza • Respiratory Diseases

Study of GP681 Tablets Compared With Placebo in Patients With Influenza at High Risk of Influenza Complications (clinicaltrials.gov) - P3 | N=328 | Not yet recruiting | Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

New P3 trial • Infectious Disease • Influenza • Respiratory Diseases

GP681 in Volunteers With Hepatic Impairment Compared With Healthy Volunteers (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. | Not yet recruiting ➔ Completed | Trial completion date: Feb 2024 ➔ Oct 2023 | Trial primary completion date: Dec 2023 ➔ Aug 2023

Trial completion • Trial completion date • Trial primary completion date • Hepatology

A Study to Evaluate the Drug-drug Interactions (DDIs) of GP681 With Rosuvastatin, Digoxin, Itraconazole, Oseltamivir in Chinese Healthy Volunteers (clinicaltrials.gov) - P1 | N=54 | Completed | Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. | Recruiting ➔ Completed | Trial completion date: Jul 2023 ➔ Oct 2023 | Trial primary completion date: Jun 2023 ➔ Sep 2023

Trial completion • Trial completion date • Trial primary completion date

To Assess the Efficacy of GP681 Tablet Versus Placebo in Patients With Acute Uncomplicated Influenza Virus Infection (clinicaltrials.gov) - P3 | N=591 | Completed | Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. | Recruiting ➔ Completed

Trial completion • Infectious Disease • Influenza • Respiratory Diseases

GP681 in Volunteers With Hepatic Impairment Compared With Healthy Volunteers (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

New P1 trial • Hepatology

A Study to Evaluate the Drug-drug Interactions (DDIs) of GP681 With Rosuvastatin, Digoxin, Itraconazole, Oseltamivir in Chinese Healthy Volunteers (clinicaltrials.gov) - P1 | N=54 | Recruiting | Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

New P1 trial

To Assess the Efficacy of GP681 Tablet Versus Placebo in Patients With Acute Uncomplicated Influenza Virus Infection (clinicaltrials.gov) - P3 | N=552 | Recruiting | Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Respiratory Diseases

To Assess the Efficacy of GP681 Tablet Versus Placebo in Patients With Acute Uncomplicated Influenza Virus Infection (clinicaltrials.gov) - P3 | N=552 | Not yet recruiting | Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

New P3 trial • Infectious Disease • Respiratory Diseases

A Clinical Study on the Safety and Efficacy of GP681 Tablets in the Treatment of Uncomplicated Acute Influenza (clinicaltrials.gov) - P2 | N=216 | Completed | Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd. | Recruiting ➔ Completed | Trial primary completion date: Aug 2021 ➔ Dec 2021

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

A Phase I Mass Balance Study of [14C]GP681 in Healthy Chinese Male Volunteers (clinicaltrials.gov) - P1; N=6; Completed; Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.; Not yet recruiting ➔ Completed; Trial completion date: Mar 2022 ➔ Nov 2021; Trial primary completion date: Mar 2022 ➔ Nov 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date

A Phase I Mass Balance Study of [14C]GP681 in Healthy Chinese Male Volunteers (clinicaltrials.gov) - P1; N=6; Not yet recruiting; Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Clinical • New P1 trial

A Clinical Study on the Safety and Efficacy of GP681 Tablets in the Treatment of Uncomplicated Acute Influenza (clinicaltrials.gov) - P2; N=216; Recruiting; Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Clinical • New P2 trial • Infectious Disease • Respiratory Diseases