SYNAGIS

(Palivizumab)

Phase 3Monoclonal antibody

SSwedish Orphan Biovitrum

SYNAGIS is one of 108 small molecule programs targeting Bronchiolitis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

107

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

BronchiolitisActive, not recruiting

Respiratory Syncytial Virus InfectionActive, not recruiting

PneumoniaActive, not recruiting

Congenital Heart DiseaseActive, not recruiting

BronchiolitisPhase 3

Active, not recruiting

Respiratory Syncytial Virus InfectionPhase 2/Phase 3

Active, not recruiting

PneumoniaPhase 3

Active, not recruiting

Congenital Heart DiseasePhase 2

Active, not recruiting

Competition

Competitive Landscape

547 competitors in Pneumonia

#DrugCompanyPhaseTrials

SYNAGIS

SSwedish Orphan Biovitrum

Phase 3

1 2

Jakafi

Incyte

Preclinical

1 3

Primaquine

Sanofi

Preclinical

1 4

Acanya

Pfizer

Preclinical

1 5

Avlosulfon

AAlmirall, S.A.

Preclinical

4 6

Primsol

CConrado Roberto Hoffmann Filho

Preclinical

2 7

Virazole

CConrado Roberto Hoffmann Filho

Preclinical

2 8

Advil

KKenvue Brands

Preclinical

2 9

Gantanol

CConrado Roberto Hoffmann Filho

Preclinical

2 10

Prograf

VVeloxis Pharmaceuticals

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Respiratory Syncytial Virus (RSV)2 trials

Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT04938830·1,003 enrolled

Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00129766·6,635 enrolled

Efficacy1 trial

Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated With RSV

Completed·MmAbxience Research S.L.·Phase 1·NCT04540627·56 enrolled

Pneumonia1 trial

Ribavirin With or Without Monoclonal Antibody Therapy in Treating Patients Who Develop RSV Pneumonia Following Peripheral Stem Cell Transplantation

Completed·FFred Hutchinson Cancer Center·Phase 3·NCT00014391

Respiratory Syncytial Virus (RSV) Infection1 trial

A Study to Assess the Safety and Effectiveness of Palivizumab Administered to Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus

Completed· AbbVie logo

AbbVie·Phase 3·NCT02968173·50 enrolled

Respiratory Syncytial Virus1 trial

A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children

Completed· AstraZeneca logo

AstraZeneca·Phase 2/3·NCT03959488·925 enrolled

5 more indications

Respiratory Syncytial Virus Infection1 trial

Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children

Completed·AAbbott·Phase 2/3·NCT01006629·100 enrolled

Immune1 trial

Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis)

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT00233064·417 enrolled

Bronchiolitis1 trial

"Palivizumab Therapy for RSV-bronchiolitis"

Completed·HHamad Medical Corporation·Phase 3·NCT02442427·420 enrolled

Congenital Heart Disease1 trial

A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00538785·1,236 enrolled

Immunocompromised1 trial

Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions

Completed· AbbVie logo

AbbVie·Phase 3·NCT01466062·28 enrolled

Regulatory

FDA Approval Timeline[4]

Jun 19, 1998

SYNAGIS

BLA BLA103770

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Palivizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Palivizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Palivizumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA103770). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Swedish Orphan Biovitrum company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: SSwedish Orphan Biovitrum

SYNAGIS

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Respiratory Syncytial Virus (RSV)2 trials

Efficacy1 trial

Pneumonia1 trial

Respiratory Syncytial Virus (RSV) Infection1 trial

Respiratory Syncytial Virus1 trial

Respiratory Syncytial Virus Infection1 trial

Immune1 trial

Bronchiolitis1 trial

Congenital Heart Disease1 trial

Immunocompromised1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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