Aducanumab
Aduhelm (aducanumab) is an antibody pharmaceutical. Aducanumab was first approved as Aduhelm on 2021-06-07. It is used to treat alzheimer disease in the USA. The pharmaceutical is active against amyloid-beta precursor protein.
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Events
FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| mental disorders | D001523 |
Trade Name
FDA
EMA
Aduhelm
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| aduhelm | Biologic Licensing Application | 2023-08-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| alzheimer disease | EFO_0000249 | D000544 | F03 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J0172 | Injection, aducanumab-avwa, 2 mg |
Clinical
Clinical Trials
14 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 4 | 1 | 4 | — | 1 | 10 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dementia | D003704 | EFO_0003862 | F03 | — | 1 | — | — | — | 1 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Aducanumab |
| INN | aducanumab |
| Description | Aducanumab (human mab) |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >6CNR:H|Aducanumab heavy chain
QVQLVESGGGVVQPGRSLRLSCAASGFAFSSYGMHWVRQAPGKGLEWVAVIWFDGTKKYYTDSVKGRFTISRDNSKNTLY
LQMNTLRAEDTAVYYCARDRGIGARRGPYYMDVWGKGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEP
VTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSC
>6CNR:L|Aducanumab light chain
DIQMTQSPSSLSASVGDRVTITCRASQSISSYLNWYQQKPGKAPKLLIYAASSLQSGVPSRFSGSGSGTDFTLTISSLQP
EDFATYYCQQSYSTPLTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ
ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC |
Identifiers
| PDB | 6CNR, 6CO3 |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3039540 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB12274 |
| UNII ID | 105J35OE21 (ChemIDplus, GSRS) |
Target
Agency Approved
APP
APP
Organism
Homo sapiens
Gene name
APP
Gene synonyms
A4, AD1
NCBI Gene ID
Protein name
amyloid-beta precursor protein
Protein synonyms
ABPP, Alzheimer disease amyloid A4 protein homolog, Alzheimer disease amyloid protein, amyloid beta (A4) precursor protein, amyloid beta A4 protein, Amyloid precursor protein, Amyloid-beta (A4) precursor protein, Amyloid-beta A4 protein, APPI, beta-amyloid peptide, beta-amyloid peptide(1-40), beta-amyloid peptide(1-42), beta-amyloid precursor protein, Cerebral vascular amyloid peptide, CVAP, peptidase nexin-II, PN-II, PreA4, Protease nexin-II, testicular tissue protein Li 2
Uniprot ID
Mouse ortholog
App (11820)
amyloid-beta precursor protein (Q99K32)
Alternate
No data
Variants
No data
Financial
Revenue by drug
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Aduhelm – Biogen
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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 5,286 documents
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Safety
Black-box Warning
Black-box warning for: Aduhelm
Adverse Events
Top Adverse Reactions
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535 adverse events reported
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