BEYFORTUS (nirsevimab-alip)
BEYFORTUS is a monoclonal antibody indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease. It is administered to neonates and infants who are born during or entering their first RSV season. Additionally, the treatment is approved for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. This therapeutic serves as a preventative measure for pediatric populations at risk of RSV-related complications.
How BEYFORTUS Works
BEYFORTUS functions as a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor. As a monoclonal antibody, it targets the F protein on the surface of the virus to exhibit anti-RSV activity. By binding to this protein, the drug inhibits the virus's ability to fuse with and enter host cells. This mechanism prevents the virus from establishing an infection that leads to lower respiratory tract disease.
Details
- Status
- Prescription
- First Approved
- 2023-07-17
- Revenue
- $758M (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
BEYFORTUS Approval History
What BEYFORTUS Treats
1 indicationsBEYFORTUS is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Respiratory Syncytial Virus Lower Respiratory Tract Disease
BEYFORTUS Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06551506 | 24-0003 5UM1AI148684-04 | Ph 4 | completed | The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization, or Both Products |
Active Pipeline
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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.
BEYFORTUS FDA Label Details
Indications & Usage
FDA Label (PDF)BEYFORTUS is indicated for the treatment of Respiratory Syncytial Virus Lower Respiratory Tract Disease.
Pro Intelligence Preview
Deep insights for BEYFORTUS
Revenue Insights
- • Q4-2025: $758M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.