BLAINTRAMUSCULARVIALPriority Review
Approved
Jun 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
14
Data completeness
4/8 — Partial
Priority Review
SYNAGIS (palivizumab) by Swedish Orphan Biovitrum is fusion protein inhibitors [moa]. First approved in 1998.
Drug data last refreshed 3h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SYNAGIS (palivizumab) is a monoclonal antibody that inhibits respiratory syncytial virus (RSV) fusion protein, preventing viral entry into host cells. It is administered intramuscularly for prophylaxis of RSV lower respiratory tract disease in high-risk pediatric patients, particularly premature infants and those with congenital heart disease or chronic lung disease. This is a passive immunization agent designed to provide seasonal protection during RSV season.
$0.042BPart D
LOE ApproachingProduct is entering LOE phase with moderate commercial pressure (30%), indicating potential team restructuring and shift toward defensive commercial strategies.
Mechanism of Action
Fusion Protein Inhibitors
Pharmacologic Class:
Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (14)
Study of Palivizumab in Children With High Risk of Severe Respiratory Syncytial Virus (RSV) Disease
Started Dec 2025
21 enrolled
Respiratory Syncytial Virus (RSV)
A PK Study Comparing MB05, EU-sourced Synagis® and US-sourced Synagis® in Healthy Volunteers.
Started Jun 2022
150 enrolled
Healthy Volunteers
Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated With RSV
Started Jul 2020
56 enrolled
Healthy Adult Participants
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
Started Nov 2016
50 enrolled
Respiratory Syncytial Virus (RSV)
Observational Program to Assess Respiratory Syncytial Virus (RSV) Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis
Started Oct 2014
359 enrolled
Respiratory Syncytial Virus (RSV)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.