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

A phase I study to evaluate the effect of hepatic impairment on the pharmacokinetics and safety of suraxavir marboxil: a novel oral antiviral for influenza. (PubMed, Antimicrob Agents Chemother) - P1 | "Suraxavir marboxil (GP681, abbreviated as suraxavir) is a novel, orally active small-molecule polymerase acidic (PA) inhibitor for the treatment of influenza...A single 40-mg dose of suraxavir was safe and well tolerated in subjects with mild or moderate hepatic impairment. No dose adjustment is required for these populations.CLINICAL TRIALSThis study is registered with ClinicalTrials.gov as NCT05814926."

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

Physiologically based pharmacokinetic (PBPK) modeling of drug-drug interactions between suraxavir marboxil and CYP3A4 inhibitors: Quantitative prediction of pharmacokinetic effects on active metabolite GP1707D07. (PubMed, Pharm Sci Adv) - "Simulations using the validated model predicted a substantial increase in GP1707D07 exposure when co-administered with moderate inhibitors fluconazole (AUC ratio 2.820; Cmax ratio 1.509) and verapamil (AUC ratio 2.347; Cmax ratio 1.645), comparable to the effect of itraconazole. Consequently, clinical monitoring and potential dose adjustment of GP681 are recommended when co-administered with strong inhibitors and the moderate inhibitors. The study demonstrates the utility of PBPK modeling for efficient and predictive DDI assessment of complex prodrug systems, guiding the safe clinical use of GP681."

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

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