Raxibacumab
N/A (raxibacumab) is an antibody pharmaceutical. Raxibacumab was first approved as N/a on 2012-12-14.
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Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
N/a
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)
Raxibacumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| N/A | raxibacumab | Emergent Manufacturing Operations Baltimore | N-125349 RX | 2012-12-14 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| raxibacumab | Biologic Licensing Application | 2021-06-14 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
raxibacumab, N/A, Emergent Manufacturing Operations Baltimore LLC | |||
| 2119-12-14 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
147 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 2 | 6 | 11 | 19 | 3 | 41 |
| Healthy volunteers/patients | — | 17 | — | — | 1 | 2 | 20 | ||
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 2 | 3 | 3 | 1 | 9 |
| Chronic renal insufficiency | D051436 | N18 | — | 1 | 2 | 2 | 2 | 7 | |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | 2 | 1 | 4 | — | 7 | |
| Heart failure | D006333 | EFO_0003144 | I50 | — | 1 | 2 | 1 | 1 | 5 |
| Metabolic syndrome | D024821 | EFO_0000195 | E88.81 | 1 | — | — | 3 | 1 | 5 |
| Coronary artery disease | D003324 | I25.1 | — | — | — | 4 | — | 4 | |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 2 | 1 | 1 | 4 |
| Proteinuria | D011507 | HP_0000093 | R80 | — | — | 1 | 3 | — | 4 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | 1 | 2 | — | 1 | 3 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | 3 | — | — | 3 |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | — | 2 | 1 | — | — | 2 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 1 | 1 | — | — | 2 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | 1 | 1 | — | — | 2 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 1 | — | 1 | 2 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | 1 | — | — | 1 |
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | — | 1 | — | — | 1 | |
| Kidney transplantation | D016030 | — | — | 1 | — | — | 1 | ||
| Oxidative stress | D018384 | EFO_1001905 | — | — | 1 | — | — | 1 |
Show 11 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypercholesterolemia | D006937 | HP_0003124 | — | 2 | — | — | — | 2 | |
| Neoplasms | D009369 | C80 | — | 1 | — | — | — | 1 | |
| Covid-19 | D000086382 | U07.1 | — | 1 | — | — | — | 1 | |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | 1 | |
| Cognitive dysfunction | D060825 | G31.84 | — | 1 | — | — | — | 1 | |
| Vasculitis | D014657 | EFO_0006803 | M31 | — | 1 | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Oligospermia | D009845 | N46.1 | — | — | — | — | 1 | 1 | |
| Teratozoospermia | D000072660 | — | — | — | — | 1 | 1 | ||
| Asthenozoospermia | D053627 | — | — | — | — | 1 | 1 | ||
| Male infertility | D007248 | EFO_0004248 | N46 | — | — | — | — | 1 | 1 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | 1 | 1 | |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | — | 1 | 1 |
| Hereditary nephritis | D009394 | EFO_0004128 | Q87.81 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | RAXIBACUMAB |
| INN | raxibacumab |
| Description | Raxibacumab (human mab) |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 565451-13-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2108638 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB08902 |
| UNII ID | 794PGL549S (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
No data
Financial
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 366 documents
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Safety
Black-box Warning
Black-box warning for: Raxibacumab
Adverse Events
Top Adverse Reactions
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32,670 adverse events reported
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