Nirsevimab 100mg/1ml solution for injection pre-filled syringes
Requires a prescription from a doctor or prescriber
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Beyfortus 100mg/1ml solution for injection pre-filled syringes
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
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SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 25 · Randomised trials: 9 · 2020–2026
Showing the 50 most relevant studies, sorted by most relevant.
E. Simões, S. Madhi, W. Muller, et al.
The Lancet. Child & Adolescent Health, 2023
Dewan Md. Sumsuzzman, Zhen Wang, Joanne M Langley, et al.
The Lancet. Child & adolescent health, 2025
Daira Trusinska, Bohee Lee, Sohail Ferdous, et al.
eClinicalMedicine, 2025
Bohee Lee, Daira Trusinska, Sohail Ferdous, et al.
Thorax, 2025
Background The long-acting monoclonal antibody nirsevimab and respiratory syncytial virus (RSV) vaccines became available for prevention of severe RSV-associated disease in 2023. While clinical trials showed good efficacy and safety, their restrictive inclusion criteria, small sample sizes and short follow-up limit generalisability. We aimed to summarise real-world evidence on the effectiveness and safety of nirsevimab, RSV maternal vaccine and RSV vaccines for older adults. Methods A living systematic review and meta-analysis, with 5 monthly updated searches in three databases was performed. Eligible studies were published from 1 December 2022 to 10 March 2025. Meta-analyses for the effectiveness of nirsevimab and RSV vaccines were carried out using random-effects model. Safety data were summarised narratively. Results A total of 50 publications, covering approximately 7.6 million people, were included. Nirsevimab showed 80.7% effectiveness (95% CI: 75.7% to 85.7%; seven studies) against RSV-related emergency department visits, 80.7% (95% CI: 76.1% to 85.2%; 17 studies) against hospital admissions and 75.6% (95% CI: 63.3% to 87.9%; eight studies) against intensive care unit admissions. The effectiveness of RSV vaccines for older adults against RSV-related hospital admissions was 79.6% (95% CI: 73.8% to 85.3; three studies). No effectiveness data were available for RSV maternal vaccine. No severe adverse events were reported for nirsevimab, while RSV vaccines in older adults had fewer than 10 Guillain-Barré syndrome cases per million doses. No severe adverse events were reported for RSV maternal vaccine, although evidence was limited. Conclusions Our review demonstrated high effectiveness of nirsevimab in reducing RSV-related healthcare utilisation in infants and a favourable safety profile. More evidence is needed for evaluating RSV vaccines in pregnant people and older adults. PROSPERO registration number CRD42025643585.
Abstract licence: CC BY-NC
M. Tanashat, M. Abuelazm, A. Manasrah, et al.
Baylor University Medical Center Proceedings, 2025
Hsin-Chweng Lien, Chi-Hone Lien, Tzu-Yu Liu, et al.
Pediatrics and neonatology, 2025
MSc Moritz Wick, PhD Anna C. Meyer, PhD Oliver Damm, et al.
Open Forum Infectious Diseases, 2025
Jefferson M. Jones, K. Fleming-Dutra, M. Prill, et al.
Morbidity and Mortality Weekly Report, 2023
S. Drysdale, Katrina Cathie, F. Flamein, et al.
The New England journal of medicine, 2023
You Li, Harish Nair, Han Zhang, et al.
BMJ Open Respiratory Research, 2026
- Respiratory Syncytial Virus Infections
- Antiviral Agents
- Research Design
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
69 days
Mechanism
Nirsevimab is a recombinant human immunoglobulin G1 kappa (IgG1ĸ) long-acting mo…
Food interactions
None known
Human targets
None mapped
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
25-300 mg
Half-life
69 days
[L44146]
Volume of distribution
249 mL
Metabolism
[L44146]
Elimination
Clearance
3.38 mL
[L44146]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
On November 2022, nirsevimab was approved by the EMA for the prevention of RSV lower respiratory tract disease in newborns and infants.[L44146] Nirsevimab was also approved by Health Canada on April 19, 2023 and by the FDA in July 17, 2023 for the same indication.[L46392][L47461]
[L44146][L46392]
Additionally, Nirsevimab is also approved in Canada and the US for use in infants up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
[L46392][L47456]
These infants include, but are not limited to, those with chronic lung disease of prematurity, hemodynamically significant congenital heart disease, immunocompromised states, Down syndrome, cystic fibrosis, neuromuscular disease, and congenital airway anomalies.
[L46392]
Known interactions with other medicines. Always consult a healthcare professional.
Showing 2 of 2 interactions
[L44146]
Nirsevimab binds to a highly conserved epitope of the RSV prefusion F protein, inhibiting the membrane fusion step in the viral entry process. This allows nirsevimab to neutralize various RSV A and B strains and block cell-to-cell fusion. Nirsevimab has also been modified with a triple amino acid substitution (M257Y/S259T/T261E YTE) in the Fc region to extend serum half-life from the typical 21–28 days to approximately 69 days.[L44146][A254571]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L44146]
[L44146]
[L44146]
[L44146]
[L44146]
[L44146]
ATC J06BD08
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Nirsevimab
DrugBank citations
If you use DrugBank data in your research, please cite:
- DrugBank 6.02024Recommended citationKnox C., Wilson M., Klinger C.M., et alDrugBank 6.0: the DrugBank Knowledgebase for 2024Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275
- DrugBank 5.02018Wishart D.S., Feunang Y.D., Guo A.C., et alDrugBank 5.0: a major update to the DrugBank database for 2018Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082
- DrugBank 4.02014Law V., Knox C., Djoumbou Y., et alDrugBank 4.0: shedding new light on drug metabolismNucleic Acids Res. 2014 Jan 142(1):D1091-7
- DrugBank 3.02011Knox C., Law V., Jewison T., et alDrugBank 3.0: a comprehensive resource for 'omics' research on drugsNucleic Acids Res. 2011 Jan39(Database issue):D1035-41
- DrugBank 2.02008Wishart D.S., Knox C., Guo A.C., et alDrugBank: a knowledgebase for drugs, drug actions and drug targets.Nucleic Acids Research2008 Jan36(Database issue):D901-6
- DrugBank 1.02006Wishart D.S., Knox C., Guo A.C., et alDrugBank: a comprehensive resource for in silico drug discovery and exploration.Nucleic Acids Research2006 Jan 134(Database issue):D668-72