Drugs / Aducanumab
last change Aug 2024 re-read 2 minutes ago

Aducanumab

also known as BIIB037 · aducanumab-avwa · Aduhelm

Monoclonal antibody targets APP

Developed for
Alzheimer disease
Investigated by
Biogen · Eisai Inc.

Trials 11 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT05216887 Feb → Jul 2022 Biogen Completed No outcome recorded
Phase 1 NCT04924140 Jun → Oct 2021 Biogen Completed No outcome recorded
Phase 1 NCT02782975 May → Nov 2016 Alzheimer disease Biogen Completed No outcome recorded
Phase 1 NCT02434718 Jun 2015 → Dec 2016 Alzheimer disease Biogen Completed No outcome recorded
Phase 1 NCT01677572 Oct 2012 → Jul 2019 Alzheimer disease Biogen Terminated No outcome recorded
Phase 1 NCT01397539 Jun 2011 → Aug 2013 Alzheimer disease Biogen Completed No outcome recorded
Phase 21 trial
Phase 2 NCT03639987 Dec 2018 → Jul 2019 Alzheimer disease Biogen Terminated No outcome recorded
Phase 34 trials
Phase 3 NCT05310071 Jun 2022 → Aug 2024 Alzheimer disease Biogen Terminated No outcome recorded
Phase 3 NCT04241068 Mar 2020 → Jul 2024 Alzheimer disease Biogen Terminated No outcome recorded
Phase 3 NCT02484547 Sep 2015 → Aug 2019 Alzheimer disease Biogen Terminated No outcome recorded
Phase 3 NCT02477800 Aug 2015 → Aug 2019 Alzheimer disease Biogen Terminated No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT05469009 Background Jul 2022 → Jul 2029 expected Alzheimer disease type 1, cognitive impairment with or without cerebellar ataxia Ali Rezai Active not recruiting No outcome recorded
Phase 31 trial
Phase 3 NCT05108922 Comparator Nov 2021 → Sep 2022 Alzheimer disease Eli Lilly and Company Completed No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 14 sources stand behind the page.

FieldValueCited text
Known as Aducanumab ClinicalTrials.gov intervention name — accepted as the source's own label NCT05216887
11

NCT05310071

NCT02434718

NCT02484547

NCT02782975

NCT03639987

NCT04241068

NCT04924140

NCT05108922

NCT01677572

NCT02477800

NCT05469009

Known as aducanumab-avwa “A Phase 3, Open-Label, Parallel-Group, 2-Arm Study to Investigate Amyloid Plaque Clearance With Donanemab Compared With Aducanumab-avwa in Participants With Early Symptomatic...” NCT05108922
Known as Aduhelm ChEMBL registry synonym — accepted as the source's own label CHEMBL3039540
Known as BIIB037 “Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (Aducanumab) in Subjects With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103,...” NCT04241068
6

“Multiple Dose Study of Aducanumab (BIIB037) (Recombinant, Fully Human Anti-Aβ IgG1 mAb) in Participants With Prodromal or Mild Alzheimer's Disease” NCT01677572

“Single and Multiple Ascending Dose Study of Aducanumab (BIIB037) in Japanese Participants With Alzheimer's Disease” NCT02434718

“221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease” NCT02477800

“221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease” NCT02484547

“Aducanumab (BIIB037)” NCT03639987

NCT01397539

Modality Monoclonal antibody “BIIB037 is a fully human immunoglobulin gamma 1 (IgG1) monoclonal antibodyNCT01397539
Route Intravenous “single intravenous (IV) infusions” NCT01397539
Target APP “Amyloid-beta A4 protein binding agent” CHEMBL3039540