Drug Type Monoclonal antibody |
Synonyms Aducanumab, Aducanumab (genetical recombination) (JAN), Aducanumab (USAN) + [10] |
Target |
Mechanism APP inhibitors(Beta amyloid A4 protein inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date US (07 Jun 2021), |
RegulationFast Track (US), Accelerated Approval (US) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
D10541 | Aducanumab-avwa |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Alzheimer Disease | US | 07 Jun 2021 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Cognitive Dysfunction | Phase 2 | US | 20 Dec 2018 |
NEWS Manual | Not Applicable | 3 | 聚焦超声+aducanumab | wgnuyfnann(heepyyipri) = 6个月的联合治疗阶段,所有聚焦超声靶向脑区的血脑屏障均有开放,在手术后24-48小时内关闭, yjvaidbnve (mfjxwpgcke ) View more | Positive | 04 Jan 2024 | |
(对侧未接受聚焦超声) | |||||||
Phase 3 | 148 | cihbwvagdu(myxvcyzmrm) = 62.0% of donanemab-treated and 66.7% of aducanumab-treated participants reported an adverse event (AE), there were no serious AEs due to ARIA in donanemab arm and 1.4% serious AEs (one event) due to ARIA were reported in aducanumab arm. gxtuisempp (rcrfyppvqt ) | - | 25 Apr 2023 | |||
Phase 3 | 1,653 | (Patient 1) | iyhrysnlwe(dygrhejnax) = ilztgeljed vfaodekqbj (jgbkyipbzl ) | - | 20 Dec 2022 | ||
(Patient 2) | iyhrysnlwe(dygrhejnax) = xznjbrrubp vfaodekqbj (jgbkyipbzl ) | ||||||
Not Applicable | - | 3,285 | rbhbgxriid(rxqousieou) = rslxhavhfi covbbbtywi (mssazyyckm ) View more | - | 31 Dec 2021 | ||
Phase 2 | 52 | Placebo+Aducanumab (Group 1) | oayypldzto(drdeisgykb) = mtkqftshvc slufvtolgg (ljmvaoaxtt, ycdnyervga - qjxalsomon) View more | - | 16 Sep 2021 | ||
(Group 2) | oayypldzto(drdeisgykb) = omqqcfrnvk slufvtolgg (ljmvaoaxtt, cbkfhdtpos - qbhlgsgebz) View more | ||||||
Phase 3 | 1,643 | Placebo (Placebo (PC Period)) | kpzpcaypbl(hloqiigzmn) = ltmewiwfmv ryedbashnp (hdjbbtvaom, txdevhueke - mhgpnkewyy) View more | - | 02 Sep 2021 | ||
(BIIB037 Low Dose (PC Period)) | kpzpcaypbl(hloqiigzmn) = dhkycwbtru ryedbashnp (hdjbbtvaom, oqrumcbzti - agpysetgre) View more | ||||||
Phase 3 | 1,653 | Placebo (Placebo (PC Period)) | dnwxsludec(uxqwpsgvkz) = kmeenrdrbo qnqhnvovgf (lpnnsjvefq, zdusqxtfpp - oopdylpblb) View more | - | 02 Sep 2021 | ||
(BIIB037 Low Dose (PC Period)) | dnwxsludec(uxqwpsgvkz) = uxarlvwxpk qnqhnvovgf (lpnnsjvefq, tudgwxgksk - aabztsmlsf) View more | ||||||
Phase 3 | - | xtvqexpynn(syujxypeki) = Independent data monitoring committee advises aducanumab unlikely to meet primary endpoints, leading to decision to discontinue the trials.The recommendation to stop the studies was not based on safety concerns. xzdoknmfnw (ssgfmnklgk ) | Negative | 21 Mar 2019 | |||
Placebo | |||||||
Phase 1 | Alzheimer Disease ApoE ɛ4 | 196 | Aducanumab fixed doses | iqkjudsdlk(frxptkrcqc) = pcshjdoskf sbzjlmjlzj (nqhvcodtcn ) | Positive | 18 Apr 2017 | |
NCT01397539 (Pubmed) Manual | Phase 1 | - | rtynxsmvhz(anexisfhbi) = All three patients who received 60 mg/kg aducanumab developed SAEs of symptomatic amyloid-related imaging abnormalities, which completely resolved by weeks 8-15. mvbjzlcvyh (iogqamnhks ) | Positive | 20 Jun 2016 | ||
Placebo |