Drug

Palivizumab

Approved · EMA

Emerging researchLate-stage development

Also known as Synagis.

RxNorm194279UNIIDQ448MW7KS

Research papers

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab- Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease

Clinical trial2026-05-08Results posted · ClinicalTrials.gov

A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)

Clinical trial2023-09-21Results posted · ClinicalTrials.gov

A Double-Blind, Randomised, Placebo-Controlled Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated With Respiratory Syncytial Virus (RSV)

Clinical trial2021-10-04Results posted · ClinicalTrials.gov

A Prospective, International, Multicenter, Open-Label, Non-Controlled Study of Safety and Effectiveness of Palivizumab, in Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus

Clinical trial2018-03-13Results posted · ClinicalTrials.gov

Treatment of Respiratory Syncytial Virus Bronchiolitis in Young Infants With Humanized Monoclonal Antibody: A Randomized Clinical Trial (Palivizumab Study)

Clinical trial2018-02-01Completed · ClinicalTrials.gov

A Pivotal Phase 3 Study of MEDI-524 (Numax; Motavizumab), an Enhanced Potency Humanized RSV Monoclonal Antibody, for the Prophylaxis of Serious RSV Disease in High-Risk Children

Clinical trial2013-08-28Results posted · ClinicalTrials.gov

Multi-center, Open-label, Uncontrolled Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions

Clinical trial2013-06-17Results posted · ClinicalTrials.gov

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Children With Hemodynamically Significant Congenital Heart Disease

Clinical trial2012-02-16Results posted · ClinicalTrials.gov

A Prospective, Multicenter, Open-label, Non-comparative Study of Safety and Efficacy of Synagis in Children at High Risk of Severe Respiratory Syncytial Virus Infection in the Russian Federation

Clinical trial2011-07-19Results posted · ClinicalTrials.gov

Motavizumab for prophylaxis of respiratory syncytial virus in high-risk children: a noninferiority trial.

Research2009-12-14Pediatrics

A Randomized Double-Blind Placebo-Controlled Phase III Study To Evaluate The Safety And Efficacy Of Palivizumab Combined With Aerosolized Ribavirin Compared To Ribavirin Alone To Treat RSV Pneumonia In Patients With Bone Marrow Transplants (BMT)

Clinical trial2001-10-01Completed · ClinicalTrials.gov

Approval: Synagis (EMA)

Regulatory1999-08-13EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Palivizumab

Aliases & brands

Synagis

RxNorm CUI

194279

UNII

DQ448MW7KS

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

1999-08-13

Latest approval

1999-08-13

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

1999-08-13Approval

Approval: Synagis (EMA)

Indication: Synagis is indicated for the prevention of serious lower-respiratory-tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk… Show full indication

Synagis is indicated for the prevention of serious lower-respiratory-tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease: children born at 35 weeks of gestation or less and less than six months of age at the onset of the RSV season; children less than two years of age and requiring treatment for bronchopulmonary dysplasia within the last six months; children less than two years of age and with haemodynamically significant congenital heart disease.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.