Synagis(palivizumab)
Synagis (palivizumab) is an antibody pharmaceutical. Palivizumab was first approved as Synagis on 1998-06-19. It is used to treat respiratory syncytial virus infections in the USA. It has been approved in Europe to treat respiratory syncytial virus infections.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
Trade Name
FDA
EMA
Synagis (discontinued: Synagis)
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)
Palivizumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Synagis | palivizumab | Orphan Medical | N-103770 RX | 2004-07-23 | 2 products |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| synagis | Biologic Licensing Application | 2021-11-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| respiratory syncytial virus infections | EFO_1001413 | D018357 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| S9562 | Home injectable therapy, palivizumab, including administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem |
Clinical
Clinical Trials
32 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung diseases | D008171 | HP_0002088 | J98.4 | — | 1 | — | 1 | — | 2 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Respiratory syncytial virus infections | D018357 | EFO_1001413 | — | 1 | 3 | 6 | — | 8 | 16 |
| Infections | D007239 | EFO_0000544 | — | — | 2 | 3 | — | 5 | 8 |
| Virus diseases | D014777 | — | B34 | — | 2 | 4 | — | 4 | 8 |
| Communicable diseases | D003141 | — | — | — | 2 | 2 | — | 4 | 6 |
| Premature birth | D047928 | EFO_0003917 | O60 | — | 2 | 1 | — | 3 | 5 |
| Congenital heart defects | D006330 | HP_0001627 | Q24.9 | — | 2 | 1 | — | 2 | 4 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 2 | 1 | — | 2 | 4 |
| Bronchiolitis | D001988 | HP_0011950 | — | 1 | — | 1 | — | — | 2 |
| Respiratory syncytial viruses | D012136 | — | — | — | — | 1 | — | 1 | 2 |
| Bronchopulmonary dysplasia | D001997 | — | P27.8 | — | 1 | 1 | — | — | 1 |
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Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | 1 | — | — | — | — | 1 |
| Colitis | D003092 | EFO_0003872 | K52.9 | 1 | — | — | — | — | 1 |
| Ulcer | D014456 | MPATH_579 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Asthma | D001249 | EFO_0000270 | J45 | — | — | — | — | 2 | 2 |
| Respiratory sounds | D012135 | HP_0010307 | R06.1 | — | — | — | — | 2 | 2 |
| Respiratory tract infections | D012141 | — | J06.9 | — | — | — | — | 2 | 2 |
| Bronchial hyperreactivity | D016535 | — | — | — | — | — | — | 1 | 1 |
| Recurrence | D012008 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Palivizumab |
| INN | palivizumab |
| Description | Immunoglobulin G 1 (human-mouse monoclonal MEDI-493y1-chain antiÂrespiratory syncytial virus protein F), disulfide with human-mouse monocional MEDI-493 x-chain, dimer |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >2HWZ:H|Immunoglobulin Fab heavy chain
QVTLRESGPALVKPTQTLTLTCTFSGFSLSTSGMSVGWIRQPPGKALEWLADIWWDDKKDYNPSLKSRLTISKDTSANQV
VLKVTNMDPADTATYYCARSMITNWYFDVWGAGTTVTVSSASTKGPSVFPLAPSSAAAAGGTAALGCLVKDYFPEPVTVS
WNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTH
>2HWZ:L|Immunoglobulin Fab light chain
DIQMTQSPSTLSASVGDRVTITCKCQLSVGYMHWYQQKPGKAPKLLIYDTSKLASGVPSRFSGSGSGTAFTLTISSLQPD
DFATYYCFQGSGYPFTFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQE
SVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC |
Identifiers
| PDB | 2HWZ |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201586 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00110 |
| UNII ID | DQ448MW7KS (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
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Synagis – AbbVie
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Synagis – AstraZeneca
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,378 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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16,179 adverse events reported
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