Aducanumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2021
- First approval year
- 2021
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Aducanumab
- aduhelm
- Aduhelm
- aducanumab
- Aducanumab
- Aducanumab (BIIB037)
- aducanumab [INN]
- ADUCANUMAB [JAN]
- Aducanumab [MI]
- ADUCANUMAB [USAN]
- Aducanumab [WHO-DD]
- aducanumab avwa
- Aducanumab avwa
- Aducanumab avwa [WHO-DD]
- aducanumab avwa who dd
- aducanumab inn
- aducanumab jan
- aducanumab mi
- aducanumab usan
- aducanumab who dd
- Aducanumab-avwa
- biib 037
- BIIB-037
- biib037
- BIIB037
- immunoglobulin g1 anti human beta amyloid human monoclonal biib037 heavy chain disulfide with human monoclonal biib037 kappa chain dimer
- IMMUNOGLOBULIN G1, ANTI-(HUMAN .BETA.-AMYLOID) (HUMAN MONOCLONAL BIIB037 HEAVY CHAIN), DISULFIDE WITH HUMAN MONOCLONAL BIIB037 .KAPPA.-CHAIN, DIMER
- CAS registry numbers
- 1384260-65-4
- ChEMBL ID
- CHEMBL3039540
- FDA ingredient codes (UNII)
- 105J35OE21
- N06DX03
- N07
Sources for recorded values
- 2557217
- 2557218
- Applicant
- BIOGEN INC
- Approval date
- 7 Jun 2021
- Application number
- BLA761178
- Status
- application_withdrawn
- Status date
- 20 Apr 2022
- Product number
- EMEA/H/C/005558
- Authorisation holder
- Biogen Netherlands B.V.
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Alzheimer Disease
European medicines record
- Patents
- 0
- Designations
- 3
- First in class
- Yes
- Fast track
- Yes
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- Yes
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- aducanumab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- Amyloid-beta A4 protein binding agent
- Action type
- BINDING_AGENT
- Target
- Amyloid-beta precursor protein
- Protein identifier
- P05067
- Action
- Binding
- Action type
- Binding
- Target
- amyloid β
- Gene symbol
- amyloid β
- Median affinity
- 9.4
- Affinity units
- pEC50
- Primary target
- Yes
Open Targets mechanisms
- Mechanism
- Amyloid-beta A4 protein binding agent
- Action type
- BINDING AGENT
- Target
- Amyloid-beta precursor protein
- Condition
- Dementia
- Highest recorded phase
- 4
- Condition identifier
- HP:0000726
- Subject identifier
- D003704
- Condition
- Alzheimer Disease
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0004975
- Subject identifier
- D000544
- Condition identifier
- MONDO_0001627
- Condition identifier
- MONDO_0001627
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0004975
- Condition identifier
- MONDO_0004975
- Highest recorded phase
- 4
Warnings
- Warning
- Black Box Warning
Open Targets warnings
- Warning
- Black Box Warning
- Country
- United States
- NCT01397539
- NCT02434718
- NCT02477800
- NCT02484547
- NCT02782975
- NCT04241068
- NCT05310071
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Organism
- Homo sapiens
- Sequence
- QVQLVESGGGVVQPGRSLRLSCAASGFAFSSYGMHWVRQAPGKGLEWVAVIWFDGTKKYYTDSVKGRFTISRDNSKNTLYLQMNTLRAEDTAVYYCARDRGIGARRGPYYMDVWGKGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPG
- Component
- Light chain
- Type
- Protein
- Organism
- Homo sapiens
- Sequence
- DIQMTQSPSSLSASVGDRVTITCRASQSISSYLNWYQQKPGKAPKLLIYAASSLQSGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQSYSTPLTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
Related records
Trials (13)
- 221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease
- 221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease
- A Study of Aducanumab in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease Dementia to Evaluate the Safety of Continued Dosing in Participants With Asymptomatic Amyloid-Related Imaging Abnormalities
- A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)
- A Study to Assess Absolute Bioavailability of Aducanumab in Healthy Volunteers
- A Study to Assess the Pharmacokinetic (PK) Comparability of 2 Fixed Subcutaneous (SC) Doses of Aducanumab (BIIB037) With a Single, Weight-Based Intravenous (IV) Dose in Healthy Volunteers
- A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205
- A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease
- Absolute Bioavailability of a Single, Fixed Subcutaneous Dose of Aducanumab in Healthy Participants
- Multiple Dose Study of Aducanumab (BIIB037) (Recombinant, Fully Human Anti-Aβ IgG1 mAb) in Participants With Prodromal or Mild Alzheimer's Disease
- Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for Mild Cognitive Impairment or Mild Alzheimer's Disease Undergoing Standard of Care Monoclonal Antibody (mAb) Therapy
- Single and Multiple Ascending Dose Study of Aducanumab (BIIB037) in Japanese Participants With Alzheimer's Disease
- Single Ascending Dose Study of BIIB037 in Participants With Alzheimer's Disease
Approved for (2)
Targets (1)
- APP Amyloid-beta A4 protein binding agent