ZSP1273 / Guangdong Zhongsheng Pharma - LARVOL DELTA

Efficacy and Safety of ZSP1273 in Children 12-17 Years Old With Influenza A (clinicaltrials.gov) - P3 | N=150 | Recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd

New P3 trial • Infectious Disease • Influenza • Respiratory Diseases

Efficacy and Safety of ZSP1273 in Children 2-11 Years Old With Influenza A (clinicaltrials.gov) - P3 | N=114 | Not yet recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd

New P3 trial • Infectious Disease • Influenza • Respiratory Diseases

Pharmacokinetics，Safety and Efficacy of ZSP1273 in Children 2-17 Years Old With Influenza A (clinicaltrials.gov) - P2 | N=72 | Completed | Sponsor: Guangdong Raynovent Biotech Co., Ltd | Recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Jul 2025 | Trial primary completion date: Nov 2025 ➔ Jun 2025

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

Pharmacokinetic insights of onradivir in influenza treatment to inform pediatric dosing selection in clinical trial. (PubMed, Drug Metab Dispos) - "Onradivir (ZSP1273) is a novel antiviral agent with broad-spectrum activity, favorable pharmacokinetics, and potential for treating influenza virus infections...SIGNIFICANCE STATEMENT: This study establishes the first population pharmacokinetic model for onradivir, identifying weight, health status, and sex as key covariates without necessitating dose adjustments. It provides weight-based pediatric dosing suggestions (200-600 mg once daily) in a pediatric clinical trial."

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

Efficacy and safety of onradivir in adults with acute uncomplicated influenza A infection in China: a multicentre, double-blind, randomised, placebo-controlled and oseltamivir-controlled, phase 3 trial. (PubMed, Lancet Respir Med) - P3 | "Onradivir has similar curative efficacy to oseltamivir for acute, uncomplicated influenza infections in adult patients, with an acceptable safety profile. At a time when reduced susceptibility to antiviral drugs is a growing concern, this study indicates that onradivir could be an alternative antiviral option or a candidate for use in combination with other antiviral agents for uncomplicated IAV infection."

Journal • P3 data • Infectious Disease • Influenza • Respiratory Diseases

ZSP1273-23-14: Pharmacokinetics of ZSP1273 in Participants With Severe Kidney Disease (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Guangdong Raynovent Biotech Co., Ltd | Recruiting ➔ Completed

Trial completion • Nephrology • Renal Disease

Pharmacokinetics，Safety and Efficacy of ZSP1273 in Children 2-17 Years Old With Influenza A (clinicaltrials.gov) - P2 | N=72 | Recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Influenza • Respiratory Diseases

A phase I, single-center, randomized, open-label, three-period crossover study to evaluate the drug-drug interaction between ZSP1273 and oseltamivir in healthy Chinese subjects. (PubMed, Antimicrob Agents Chemother) - P1 | "Considering the rapid metabolism of oseltamivir into the active metabolite oseltamivir carboxylate and the minor impact of co-administration on the pharmacokinetic parameters of oseltamivir carboxylate, it is believed that no clinically significant drug-drug interaction was observed with the combination of these two drugs. During the trial, the safety and tolerability of both combination therapy and monotherapy were good, with no increased safety risks observed from the combination therapy.CLINICAL TRIALSThis study is registered with ClinicalTrials.gov as NCT05108051."

Journal • Infectious Disease • Influenza • Respiratory Diseases

Pharmacokinetic and Safety Study of ZSP1273 Tablets in Elderly and Young Subjects (ChiCTR) - P1 | N=32 | Sponsor: Sir Run Run Hospital, Nanjing Medical University; Sir Run Run Hospital, Nanjing Medical University

New P1 trial • Infectious Disease • Influenza • Respiratory Diseases

Pharmacokinetics，Safety and Efficacy of ZSP1273 in Children 2-17 Years Old With Influenza A (clinicaltrials.gov) - P2 | N=72 | Not yet recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd

New P2 trial • Infectious Disease • Influenza • Respiratory Diseases

Safety and efficacy of onradivir in adults with acute uncomplicated influenza A infection: a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial. (PubMed, Lancet Infect Dis) - P2 | "Onradivir showed a safety profile comparable to placebo, as well as higher efficacy than placebo in ameliorating influenza symptoms and lowering the viral load in adult patients with uncomplicated influenza infection, especially the onradivir 600 mg once per day regimen."

Journal • P2 data • Infectious Disease • Influenza • Respiratory Diseases

ZSP1273-23-14: Pharmacokinetics of ZSP1273 in Participants With Severe Kidney Disease (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd

New P1 trial • Nephrology • Renal Disease

Drug-durg Interaction of ZSP1273 With Digoxin, Rosuvastatin,Itraconazole and Probenecid (clinicaltrials.gov) - P1 | N=49 | Completed | Sponsor: Guangdong Raynovent Biotech Co., Ltd | Recruiting ➔ Completed

Trial completion

Bioavailability Study in Healthy Participants, 200mg Tablets ZSP1273 Versus 200mg Granules ZSP1273 (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Guangdong Raynovent Biotech Co., Ltd | Recruiting ➔ Completed

Trial completion

Bioavailability Study in Healthy Participants, 200mg Tablets ZSP1273 Versus 200mg Granules ZSP1273 (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd

New P1 trial

Pharmacokinetics of ZSP1273 in Elder Participants (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Guangdong Raynovent Biotech Co., Ltd

New P1 trial

A Drug Interaction Study Assess the Effects of ZSP1273 Tablets on the Pharmacokinetics of Warfarin and Midazolam (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: Guangdong Raynovent Biotech Co., Ltd | Active, not recruiting ➔ Completed | Trial completion date: Nov 2023 ➔ Aug 2023

Trial completion • Trial completion date

Drug-durg Interaction of ZSP1273 With Digoxin, Rosuvastatin,Itraconazole and Probenecid (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd

New P1 trial

Pharmacokinetics of ZSP1273 in Participants With Hepatic Impairment (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Guangdong Raynovent Biotech Co., Ltd | Active, not recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Jul 2023

Trial completion • Trial completion date • Hepatology

Mass Balance Study of [14C]ZSP1273 in Healthy Adult Male Subjects in China (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Guangdong Raynovent Biotech Co., Ltd | Active, not recruiting ➔ Completed

Trial completion

A Drug Interaction Study Assess the Effects of ZSP1273 Tablets on the Pharmacokinetics of Warfarin and Midazolam (clinicaltrials.gov) - P1 | N=28 | Active, not recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd

New P1 trial

A Study of ZSP1273 Tablets in Patients With Acute Uncomplicated Influenza A (clinicaltrials.gov) - P3 | N=750 | Completed | Sponsor: Guangdong Raynovent Biotech Co., Ltd | Active, not recruiting ➔ Completed | Trial completion date: Sep 2023 ➔ May 2023

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

Pharmacokinetics of ZSP1273 in Participants With Hepatic Impairment (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Hepatology

A Study of ZSP1273 Tablets in Patients With Acute Uncomplicated Influenza A (clinicaltrials.gov) - P3 | N=744 | Active, not recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Jun 2022 ➔ Sep 2023 | Trial primary completion date: Jun 2022 ➔ Mar 2023

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

Mass Balance Study of [14C]ZSP1273 in Healthy Adult Male Subjects in China (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: Guangdong Raynovent Biotech Co., Ltd

New P1 trial