Beyfortus(nirsevimab)
Beyfortus (nirsevimab) is an antibody pharmaceutical. Nirsevimab was first approved as Beyfortus on 2022-10-31.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Beyfortus
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Nirsevimab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Beyfortus | nirsevimab-alip | AstraZeneca | N-761328 RX | 2023-07-17 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| beyfortus | Biologic Licensing Application | 2025-09-26 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
29 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory syncytial virus infections | D018357 | EFO_1001413 | — | 1 | 3 | 3 | 1 | 5 | 12 |
| Immunization | D007114 | — | — | — | — | 2 | 1 | — | 3 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | 1 | — | 1 |
| Fever | D005334 | — | R50.9 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | — | 1 | — | 4 | 5 |
| Respiratory tract infections | D012141 | — | J06.9 | — | — | 2 | — | — | 2 |
| Healthy volunteers/patients | — | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory syncytial viruses | D012136 | — | — | 3 | — | — | — | 3 | 6 |
| Virus diseases | D014777 | — | B34 | 1 | — | — | — | 1 | 2 |
| Metapneumovirus | D029121 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bronchiolitis | D001988 | — | — | — | — | — | — | 2 | 2 |
| Communicable diseases | D003141 | — | — | — | — | — | — | 2 | 2 |
| Viral bronchiolitis | D001990 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | Nirsevimab |
| INN | nirsevimab |
| Description | Nirsevimab, sold under the brand name Beyfortus, is a human recombinant monoclonal antibody with activity against respiratory syncytial virus (RSV). It is a respiratory syncytial virus (RSV) F protein‑directed fusion inhibitor that is designed to bind to the fusion protein on the surface of the RSV virus.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1989556-22-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297575 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB16258 |
| UNII ID | VRN8S9CW5V (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
ÂŁ
â‚Ł
Beyfortus – AstraZeneca
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 1,270 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
997 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use