sebaloxavir marboxil (ZX-7101A) / Zenshine Pharmaceuticals - LARVOL DELTA

From neuraminidase inhibitors to novel mechanisms: expanding therapeutic strategies against influenza. (PubMed, Front Cell Infect Microbiol) - "Suraxavir marboxil, ZX-7101A, and the first approved polymerase basic protein 2 (PB2) inhibitor, onradivir, confirm that scaffold-level optimization (incremental structural refinement within an existing drug class) can meaningfully reduce resistance emergence rates. For H5N1, preparedness relies on a single observationally supported drug class; baloxavir is absent from most national stockpiles, and no randomized trial data exists for any antiviral in human H5N1 infection. Adaptive trial infrastructure, diversified stockpiling to include next-generation CENIs, and equitable global antiviral access are the most urgent priorities in influenza therapeutics."

Journal • Review • Infectious Disease • Influenza • Respiratory Diseases

Study to Assess the Prophylactic Efficacy and Safety of Sebaloxavir Marboxil Tablets/Oral Suspension for Influenza Prevention in Household Contacts Aged ?2 Years. (clinicaltrials.gov) - P3 | N=858 | Not yet recruiting | Sponsor: Nanjing Zenshine Pharmaceuticals

New P3 trial • Infectious Disease • Influenza • Respiratory Diseases

ZX-7101A-214: Study to Assess the Safety and Efficacy of ZX-7101A for Oral Suspension in Chinese Pediatric Participants 2 to 11 Years of Age With Influenza (clinicaltrials.gov) - P3 | N=169 | Completed | Sponsor: Nanjing Zenshine Pharmaceuticals | Recruiting ➔ Completed

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

Effect of itraconazole on pharmacokinetics of ZX-7101A tablets in healthy Chinese subjects. (PubMed, Front Pharmacol) - "It is therefore not necessary to adjust the dose of ZX-7101A 40 mg when coadministered with itraconazole. http://www.chinadrugtrials.org.cn, identifier: CTR20231556."

Journal • PK/PD data

ZX-7101A-214: Study to Assess the Safety and Efficacy of ZX-7101A for Oral Suspension in Chinese Pediatric Participants 2 to 11 Years of Age With Influenza (clinicaltrials.gov) - P3 | N=168 | Recruiting | Sponsor: Nanjing Zenshine Pharmaceuticals | Not yet recruiting ➔ Recruiting

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

Antiviral strategies against H5N1: current options and emerging therapeutics. (PubMed, Infection) - "This article provides a comprehensive, up-to-date overview of antiviral agents with established or investigational activity against H5N1, including both globally approved drugs and regionally licensed compounds, such as arbidol and triazavirin in Russia and laninamivir and favipiravir in Japan...The recent regulatory approvals of onradivir, suraxavir marboxil, and ZX-7101A in China are highlighted, along with emerging antivirals in advanced development...Challenges persist around resistance monitoring, access to novel therapies, and regulatory harmonization. Expanding the antiviral armamentarium through accelerated evaluation and integration of both traditional and innovative compounds will be essential to pandemic preparedness and effective H5N1 outbreak response."

Journal • Review • 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=98 | Terminated | Sponsor: Nanjing Zenshine Pharmaceuticals | N=180 ➔ 98 | Trial completion date: Nov 2025 ➔ Jul 2025 | Recruiting ➔ Terminated; Due to the company's development strategy.

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

ZX-7101A-214: Study to Assess the Safety and Efficacy of ZX-7101A for Oral Suspension in Chinese Pediatric Participants 2 to 11 Years of Age With Influenza (clinicaltrials.gov) - P3 | N=168 | Not yet recruiting | Sponsor: Nanjing Zenshine Pharmaceuticals

New P3 trial • Infectious Disease • Influenza • Pediatrics • Respiratory Diseases

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