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BEYFORTUS (NIRSEVIMAB-ALIP)
BEYFORTUS (generic name: NIRSEVIMAB-ALIP) is a Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC] drug developed by ASTRAZENECA AB. It is currently FDA-approved for Prevention of respiratory Syncytial Virus (RSV) lower respiratory tract disease.
Beyfortus is a monoclonal antibody used to prevent RSV infections, lower respiratory tract infections, and adverse events following immunization. It is administered as a routine immunization, and its effectiveness is being evaluated in clinical trials.
At a glance
| Generic name | NIRSEVIMAB-ALIP |
|---|---|
| Sponsor | ASTRAZENECA AB |
| Drug class | Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC] |
| Target | Fusion glycoprotein F0 |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
Approved indications
- Prevention of respiratory Syncytial Virus (RSV) lower respiratory tract disease
Common side effects
- Rash
- Injection site reactions
Key clinical trials
- A Prospective, Randomized, Open-label Phase 4 Study of the Immunology and Safety of Maternal RSV Vaccination (ABRYSVO (TM)), Infant Nirsevimab (BEYFORTUS (TM)) Immunization, or Both Products During th (Phase 4)
- A Phase 4, Open-label, Single-arm Clinical Study to Describe Safety and Efficacy Outcomes Associated With the Use of Nirsevimab in Neonates and Infants Born During or Entering Their First Respiratory (Phase 4)
- Real-World Effectiveness of Nirsevimab Against RSV-Related and All-Cause Respiratory Tract Infections in Chinese Infants: A Multicenter Cohort Study (N/A)
- Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization (N/A)
- A Prospective, Single-arm, Non-interventional, Multi-center, Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea (N/A)
- Effectiveness And Impact of Nirsevimab In A Nationwide Immunization Program During The 2024 Winter Campaign In Chile (Nirse-CL) (N/A)
- BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study) (N/A)
- Safety of Simultaneous Administration of Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody With Routine Childhood Immunizations in Infants (Phase 4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BEYFORTUS CI brief — competitive landscape report
- BEYFORTUS updates RSS · CI watch RSS
- ASTRAZENECA AB portfolio CI
Frequently asked questions about BEYFORTUS
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Related
- Drug class: All Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC] drugs
- Target: All drugs targeting Fusion glycoprotein F0
- Manufacturer: ASTRAZENECA AB — full pipeline
- Therapeutic area: All drugs in Metabolic
- Indication: Drugs for Prevention of respiratory Syncytial Virus (RSV) lower respiratory tract disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing