Mindewei (deuremidevir) / Shanghai Junshi Bioscience, Vigonvita Life Sci - LARVOL DELTA

Deuremidevir Hydrobromide (VV116) is a Promising Antiviral against Human Metapneumovirus. (PubMed, Virus Res) - "In hMPV-infected mice, oral administration of VV116 significantly reduced viral loads in lung and nasal turbinate tissues in a dose-dependent manner and ameliorated virus-induced lung pathology. Our findings provide the first report of the remarkable anti-hMPV activity of VV116, supporting its therapeutic promise and warranting further clinic application."

Journal

Deuremidevir Hydrobromide Tablets (VV116) Clinical Application Demonstration Project for the Treatment of SARS-CoV-2 Infection (ChiCTR) - P=N/A | N=3347 | Sponsor: Shanghai Public Health Clinical Center; Shanghai Public Health Clinical Center

New trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

VV116 exerts potent efficacy against feline infectious peritonitis. (PubMed, Vet Microbiol) - "Marked histopathological improvement was also observed in both treated groups. Together, these findings support VV116 as a promising oral candidate for the treatment of FIP and warrant further evaluation in veterinary clinical settings."

Journal

A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children (clinicaltrials.gov) - P3 | N=498 | Recruiting | Sponsor: Simcere Pharmaceutical Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Pharmacokinetics and Safety of VV116 in Subjects With Mild or Moderate Hepatic Impairment Compared With Healthy Controls: A Phase I, Open-Label Study. (PubMed, Clin Pharmacol Drug Dev) - "VV116 (Mindvy, JT001) is a deuterated oral derivative of remdesivir hydrobromide developed for the treatment of COVID-19. No serious adverse events, deaths, or discontinuations occurred. Overall, hepatic impairment had no clinically relevant effect on VV116 pharmacokinetics, and dose adjustment appears unnecessary for patients with mild or moderate hepatic impairment."

Journal • PK/PD data • Hepatology • Infectious Disease • Liver Failure • Novel Coronavirus Disease

A Phase III Clinical Trial on the Efficacy and Safety of Deuremidevir Hydrobromide Dry Suspension for the Treatment of RSV Infection in Infants and Young Children (clinicaltrials.gov) - P3 | N=498 | Not yet recruiting | Sponsor: Simcere Pharmaceutical Co., Ltd

New P3 trial • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Evaluate the Bioavailability of Two Specifications of Oral Deuremidevir Hydrobromide for Suspension (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Vigonvita Life Sciences | Not yet recruiting ➔ Completed

Trial completion

The oral nucleoside drug VV116 is a promising candidate for treating Nipah virus infection. (PubMed, Emerg Microbes Infect) - No abstract available

Journal • Infectious Disease

A Study of Deuremidevir Hydrobromide for Suspension in Chinese Infants Hospitalized With RSV (clinicaltrials.gov) - P2 | N=60 | Completed | Sponsor: Vigonvita Life Sciences | Recruiting ➔ Completed | Trial completion date: Oct 2025 ➔ Jun 2025

Trial completion • Trial completion date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Evaluate the Bioavailability of Two Specifications of Oral Deuremidevir Hydrobromide for Suspension (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Vigonvita Life Sciences | Trial completion date: Jul 2025 ➔ Oct 2025 | Trial primary completion date: Jul 2025 ➔ Oct 2025

Trial completion date • Trial primary completion date

The Mass Balance Study of [14C]JT001 (clinicaltrials.gov) - P1 | N=7 | Completed | Sponsor: Shanghai Vinnerna Biosciences Co., Ltd. | Recruiting ➔ Completed

Trial completion

A Study of Deuremidevir Hydrobromide for Suspension in Chinese Infants Hospitalized With RSV (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Vigonvita Life Sciences | Trial primary completion date: Oct 2025 ➔ Jun 2025

Trial primary completion date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Evaluate the Bioavailability of Two Specifications of Oral Deuremidevir Hydrobromide for Suspension (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Vigonvita Life Sciences | Trial completion date: Mar 2025 ➔ Jul 2025 | Initiation date: Mar 2025 ➔ Jun 2025 | Trial primary completion date: Mar 2025 ➔ Jul 2025

Trial completion date • Trial initiation date • Trial primary completion date

A Study of Deuremidevir Hydrobromide for Suspension in Chinese Infants Hospitalized With RSV (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Vigonvita Life Sciences | Trial completion date: Jan 2025 ➔ Oct 2025 | Trial primary completion date: Jan 2025 ➔ Oct 2025

Trial completion date • Trial primary completion date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Evaluate the Bioavailability of Two Specifications of Oral Deuremidevir Hydrobromide for Suspension (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Vigonvita Life Sciences

New P1 trial

A Study of Deuremidevir Hydrobromide for Suspension in Chinese Infants Hospitalized With RSV (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Vigonvita Life Sciences | Trial primary completion date: Sep 2024 ➔ Jan 2025

Trial primary completion date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Real-World Study of JT001 for COVID-19 (clinicaltrials.gov) - P=N/A | N=7656 | Active, not recruiting | Sponsor: Shanghai Vinnerna Biosciences Co., Ltd. | Recruiting ➔ Active, not recruiting | N=20000 ➔ 7656 | Trial completion date: Aug 2024 ➔ Dec 2024 | Trial primary completion date: May 2024 ➔ Nov 2024

Enrollment change • Enrollment closed • Real-world • Real-world evidence • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Deuremidevir Hydrobromide for Suspension (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Vigonvita Life Sciences | Recruiting ➔ Completed | Trial completion date: Aug 2024 ➔ May 2024

Trial completion • Trial completion date • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Deuremidevir Hydrobromide for Suspension (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Vigonvita Life Sciences | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Deuremidevir Hydrobromide for Suspension (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Vigonvita Life Sciences

New P1 trial • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study of Deuremidevir Hydrobromide for Suspension in Chinese Infants Hospitalized With RSV (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Vigonvita Life Sciences | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study of Deuremidevir Hydrobromide for Suspension in Chinese Infants Hospitalized With RSV (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Vigonvita Life Sciences

New P2 trial • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Oral VV116 versus placebo in patients with mild-to-moderate COVID-19 in China: a multicentre, double-blind, phase 3, randomised controlled study. (PubMed, Lancet Infect Dis) - P3 | "Among patients with mild-to-moderate COVID-19, VV116 significantly reduced the time to sustained clinical symptom resolution compared with placebo, with no observed safety concerns."

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

A Real-World Study of JT001 for COVID-19 (clinicaltrials.gov) - P=N/A | N=20000 | Recruiting | Sponsor: Shanghai Vinnerna Biosciences Co., Ltd.

New trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

A Study in Elderly Chinese Subjects With Underlying Diseases (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Shanghai Vinnerna Biosciences Co., Ltd.

New P1 trial