SYNAGIS (palivizumab)
SYNAGIS is indicated for the treatment of Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients with a history of premature birth (less than or equal to 35 weeks gestational age) who are 6 months of age or younger at the beginning of RSV season.; Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of RSV season.; Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of RSV season..
How SYNAGIS Works
Palivizumab is a recombinant humanized monoclonal antibody that acts as a respiratory syncytial virus (RSV) F protein inhibitor. By targeting the F protein on the surface of the virus, the drug provides specific anti-RSV activity to protect the lower respiratory tract. This mechanism prevents the virus from causing serious infection in vulnerable pediatric populations.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1998-06-19
- Routes
- N/A
- Dosage Forms
- VIAL
SYNAGIS Approval History
What SYNAGIS Treats
3 indicationsSYNAGIS is approved for 3 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients with a history of premature birth (less than or equal to 35 weeks gestational age) who are 6 months of age or younger at the beginning of RSV season.
- Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of RSV season.
- Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of RSV season.
SYNAGIS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04938830 SMART results posted | 1654-007 MK-1654-007, jRCT2031210664 | Ph 3 | completed | Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007) |
| NCT03959488 results posted | D5290C00005 2019-000201-69 | Ph 2, Ph 3 | completed | 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 |
| NCT04540627 results posted | MB05-P-01-20 | Ph 1 | completed | Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated With RSV |
| NCT02968173 Synagis Russia results posted | M15-539 2016-000221-39 | Ph 3 | completed | 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 |
| NCT02442427 | 14302/14 | Ph 3 | completed | "Palivizumab Therapy for RSV-bronchiolitis" |
| NCT01466062 results posted | M12-420 | Ph 3 | completed | Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions |
| NCT01006629 results posted | W10-664 | Ph 2, Ph 3 | completed | Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SYNAGIS FDA Label Details
Indications & Usage
FDA Label (PDF)SYNAGIS is indicated for the treatment of Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients with a history of premature birth (less than or equal to 35 weeks gestational age) who are 6 months of age or younger at the beginning of RSV season.; Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of RSV season.; Prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of RSV season..
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment