sisunatovir (PF-07923568) / LianBio, Pfizer - LARVOL DELTA

A Study to Learn About the Effects of Multiple Doses of Sisunatovir on People With Respiratory Syncytial Virus (RSV) Infection (clinicaltrials.gov) - P2 | N=66 | Completed | Sponsor: Pfizer | Phase classification: P2a ➔ P2

Phase classification • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV (clinicaltrials.gov) - P1 | N=10 | Terminated | Sponsor: Pfizer | N=108 ➔ 10 | Trial completion date: Apr 2025 ➔ Sep 2024 | Recruiting ➔ Terminated | Trial primary completion date: Apr 2025 ➔ Sep 2024; Study discontinued due to business reasons. There were no safety concerns in the decision to stop study and no changes to sponsor's assessment of the risk-benefit profile for participants who received sisunatovir in the study

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Pediatrics • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Learn About the Study Medicine Sisunatovir in Adults With Respiratory Syncytial Virus (RSV) Infection (clinicaltrials.gov) - P2/3 | N=16 | Terminated | Sponsor: Pfizer | Active, not recruiting ➔ Terminated; Study discontinued due to business reasons. There were no safety concerns in the decision to stop study and no changes to sponsor's assessment of the risk-benefit profile for participants who received sisunatovir in the study.

Trial termination • Congestive Heart Failure • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Learn About the Study Medicine Sisunatovir in Adults With Respiratory Syncytial Virus (RSV) Infection (clinicaltrials.gov) - P2/3 | N=6 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=2715 ➔ 6 | Trial completion date: Mar 2026 ➔ Sep 2024 | Trial primary completion date: Mar 2026 ➔ Sep 2024

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Congestive Heart Failure • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Systematic Review of the Efficacy and Safety of RSV-Specific Monoclonal Antibodies and Antivirals in Development. (PubMed, Rev Med Virol) - "Results from 59 studies were extracted, covering efficacy and safety data on six mAbs (motavizumab, motavizumab-YTE, nirsevimab, ALX-0171, suptavumab, clesrovimab) and 12 AV therapies (ALN-RSV01, RSV604, presatovir, MDT-637, lumicitabine, IFN-α1b, rilematovir, enzaplatovir, AK0529, sisunatovir, PC786, EDP-938). Moving forward, passive immunisation and treatment options for RSV infection will play a significant role in reducing the health burden of RSV, complementing recent advancements in vaccine development. TRIAL REGISTRATION: PROSPERO registration: CRD42022376633."

Journal • Review • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • IFNA1

A Study to Learn How a Medicine That Reduces Stomach Acid Affects the Level of Sisunatovir in the Blood of Healthy Adults. (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion

A Study to Learn How the Body Processes the Study Medicine Called PF-07923568 in People With Loss of Kidney Function (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Pfizer | Recruiting ➔ Completed | N=24 ➔ 16

Enrollment change • Trial completion • Renal Disease

A Study to Learn How a Medicine That Reduces Stomach Acid Affects the Level of Sisunatovir in the Blood of Healthy Adults. (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=16 ➔ 40

Enrollment change • Enrollment closed

A Study to Learn About the Study Medicine Sisunatovir in Adults With Respiratory Syncytial Virus (RSV) Infection (clinicaltrials.gov) - P2/3 | N=2375 | Recruiting | Sponsor: Pfizer | Trial completion date: Aug 2025 ➔ Mar 2026 | Trial primary completion date: Aug 2025 ➔ Mar 2026

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

A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV (clinicaltrials.gov) - P1 | N=108 | Recruiting | Sponsor: Pfizer | Trial completion date: Oct 2024 ➔ Apr 2025 | Trial primary completion date: Oct 2024 ➔ Apr 2025

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

A Study to Compare How the Study Medicine (PF-07923568) is Processed in Participants With Different Levels of Loss of Liver Function to Healthy Participants. (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: Pfizer | Recruiting ➔ Completed

Trial completion • Hepatology

A Study to Learn How a Medicine That Reduces Stomach Acid Affects the Level of Sisunatovir in the Blood of Healthy Adults. (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Pfizer | Active, not recruiting ➔ Recruiting | Trial completion date: Feb 2024 ➔ Jun 2024 | Trial primary completion date: Feb 2024 ➔ Jun 2024

Enrollment open • Trial completion date • Trial primary completion date

A Study to Compare Different Preparations of Sisunatovir in Healthy Adult Participants. (clinicaltrials.gov) - P1 | N=25 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion

A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV (clinicaltrials.gov) - P1 | N=108 | Recruiting | Sponsor: Pfizer | Initiation date: Nov 2023 ➔ Feb 2024

Trial initiation date • Infectious Disease • Pediatrics • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Compare How the Study Medicine (PF-07923568) is Processed in Participants With Different Levels of Loss of Liver Function to Healthy Participants. (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Pfizer | Active, not recruiting ➔ Recruiting

Enrollment open • Hepatology

A Study to Compare Different Preparations of Sisunatovir in Healthy Adult Participants. (clinicaltrials.gov) - P1 | N=25 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Learn How a Medicine That Reduces Stomach Acid Affects the Level of Sisunatovir in the Blood of Healthy Adults. (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study to Compare How the Study Medicine (PF-07923568) is Processed in Participants With Different Levels of Loss of Liver Function to Healthy Participants. (clinicaltrials.gov) - P1 | N=8 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=28 ➔ 8

Enrollment change • Enrollment closed • Hepatology

A Study to Learn How the Study Medicine Called Sisunatovir is Tolerated and Acts in the Bodies of Chinese Healthy Adults. (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

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

A Study to Investigate the Effects of Sisunatovir on QTc Interval in Healthy Adult Participants. (clinicaltrials.gov) - P1 | N=43 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion

A Study to Learn About the Study Medicine Sisunatovir in Adults With Respiratory Syncytial Virus (RSV) Infection (clinicaltrials.gov) - P2/3 | N=2715 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open • Congestive Heart Failure • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Compare Different Preparations of Sisunatovir in Healthy Adult Participants. (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Pfizer | N=12 ➔ 24 | Trial completion date: Nov 2023 ➔ Mar 2024 | Trial primary completion date: Nov 2023 ➔ Mar 2024

Enrollment change • Trial completion date • Trial primary completion date

A Study to Learn How the Study Medicine Called Sisunatovir is Tolerated and Acts in the Bodies of Chinese Healthy Adults. (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Apr 2024 ➔ Jan 2024 | Trial primary completion date: Apr 2024 ➔ Jan 2024

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

A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV (clinicaltrials.gov) - P1 | N=108 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting | Phase classification: P1b ➔ P1

Enrollment open • Phase classification • Infectious Disease • Pediatrics • Pneumonia • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study to Learn How a Medicine That Reduces Stomach Acid Affects the Level of Sisunatovir in the Blood of Healthy Adults. (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open