aducanumab
Trade name: Aduhelm
Approved
Jun 7, 2021
Aducanumab, sold under the brand name Aduhelm, is an anti-amyloid drug designed to treat Alzheimer's disease. It is a monoclonal antibody that targets aggregated forms (plaque) of amyloid beta (Aβ) found in the brains of people with Alzheimer's disease to reduce its buildup. It was developed by Biogen and Eisai. Aducanumab is given via intravenous infusion. — Wikipedia
Clinical trial activity
14 trials · 6 clinical orgs · 2 marketing orgs
Earliest trial started Jun 1, 2011 (NCT01397539)
Timeline
2010s
2020s
- Jun 7, 2021
Biogen-IDEC — Earliest FDA Approval
- Jun 7, 2021
Biogen — Marketing Organization
- Jun 7, 2021
Biogen-IDEC — NDA Secondary Org
- Jun 7, 2021
Biogen-IDEC — NDA Organization
Indications
Approved for
Mechanism of action
- Beta amyloid A4 proteinBINDING AGENT
Beta amyloid A4 protein binding agent
Reduces brain disease-relevant aggregated forms of amyloid-beta (Abeta) in a dose- and time-dependent manner.
Shows >10,000-fold selectivity for aggregated Abeta over monomer
- Beta amyloid A4 proteinINHIBITOR
APP inhibitor
APP other
Reduces brain disease-relevant aggregated forms of amyloid-beta (Abeta) in a dose- and time-dependent manner.
Shows >10,000-fold selectivity for aggregated Abeta over monomer
Approval history
- approvedPriority reviewAcceleratedFast trackJun 7, 2021
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaAducanumab ↗
- ChEMBLCHEMBL3039540 ↗
- ChEMBLCHEMBL2109299 ↗
Also known as
- aducanumab
- aducanumab
- aducanumab
- aducanumab
- biib0307
- biib037
- biib037
- biib-037
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05469009 | Early Phase 1 (Phase 1) | Jul 14, 2022 | InSightec, West Virginia University |
| NCT05310071 | Phase 3 | Jun 2, 2022 | Biogen |
| NCT05216887 | Phase 1 | Feb 1, 2022 | Biogen |
| NCT05108922 | Phase 3 | Nov 16, 2021 | Eli Lilly |
| NCT04924140 | Phase 1 | Jun 30, 2021 | Biogen, Eisai |
| NCT06448962 | Phase 3 | Oct 22, 2020 | Addpharma Inc. |
| NCT04241068 | Phase 3 | Mar 31, 2020 | Biogen |
| NCT03639987 | Phase 2 | Dec 17, 2018 | Biogen |
| NCT02782975 | Phase 1 | May 1, 2016 | Biogen |
| NCT02484547 | Phase 3 | Sep 30, 2015 | Biogen |
| NCT02477800 | Phase 3 | Aug 31, 2015 | Biogen |
| NCT02434718 | Phase 1 | Jun 30, 2015 | Biogen |
| NCT01677572 | Phase 1 | Oct 5, 2012 | Biogen |
| NCT01397539 | Phase 1 | Jun 1, 2011 | Biogen |
Organizations
Research & Development (6)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Biogen | For profit | 11 | 11 | 3 | 2011 |
| Addpharma Inc. | For profit | 1 | 1 | 1 | 2020 |
| Eisai | For profit | 1 | 0 | 1 | 2021 |
| Eli Lilly | For profit | 1 | 1 | 1 | 2021 |
| InSightec | For profit | 1 | 0 | 1 | 2022 |
| West Virginia University | Academic/Hospital | 1 | 1 | 1 | 2022 |
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Biogen | For profit | MKTG | Jun 7, 2021 |
| Biogen-IDEC | For profit | NDA2 | Jun 7, 2021 |
| Biogen-IDEC | For profit | NDA | Jun 7, 2021 |