drugset
Drugs / Elenbecestat
last change Jan 2020 re-read 9 days ago

Elenbecestat

also known as E2609

Small molecule targets BACE1 via inhibition

Developed for
Alzheimer disease
Investigated by
Eisai Inc. · Biogen

Trials 11

today NCT03055962 · Ph 1 NCT02956486 · Ph 3 NCT02859207 · Ph 1 NCT02322021 · Ph 2 NCT02222324 · Ph 1 NCT02207790 · Ph 1 NCT01975636 · Ph 1 NCT01716897 · Ph 1 NCT01600859 · Ph 1 NCT01511783 · Ph 1 NCT01294540 · Ph 1
20112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 19 trials
Phase 1 NCT03055962 Feb → Mar 2017 — Eisai Inc. Completed No outcome recorded
Phase 1 NCT02859207 Aug → Dec 2016 Alzheimer disease Eisai Inc. Completed No outcome recorded
Phase 1 NCT02222324 Aug → Oct 2014 — Eisai Inc. Completed No outcome recorded
Phase 1 NCT02207790 Jul → Aug 2014 — Eisai Inc. Completed No outcome recorded
Phase 1 NCT01975636 Jun → Nov 2013 — Eisai Inc. Completed No outcome recorded
Phase 1 NCT01716897 Oct → Dec 2012 Alzheimer disease Eisai Inc. Completed No outcome recorded
Phase 1 NCT01600859 Jul 2012 → Sep 2013 Alzheimer disease Eisai Inc. Completed No outcome recorded
Phase 1 NCT01511783 Dec 2011 → Jul 2012 — Eisai Inc. Completed No outcome recorded
Phase 1 NCT01294540 Dec 2010 → Oct 2011 Alzheimer disease Eisai Inc. Completed No outcome recorded
Phase 21 trial · 1 met primary
Phase 2 NCT02322021 Nov 2014 → Dec 2019 Alzheimer disease Eisai Inc. Terminated Met primary
Phase 31 trial · 1 missed
Phase 3 NCT02956486 Oct 2016 → Jan 2020 Alzheimer disease Eisai Inc. Terminated Missed primary
Comparator or background therapy1 trial
Phase 1 NCT02055703 Comparator Jan → Apr 2014 — Eisai Inc. Completed No outcome recorded

News releases announcing trial results or a regulatory action · 10

DateIssuerRelease
2019-09-13 Eisai Inc. Results EISAI AND BIOGEN TO DISCONTINUE PHASE III CLINICAL STUDIES OF BACE INHIBITOR ELENBECESTAT IN EARLY ALZHEIMER’S DISEASE Discontinuation of studies based on Data Safety Monitoring Board recommendation eisai.com ↗
2019-07-19 Eisai Inc. Results LATEST TRENDS OF TREATMENT FOR ALZHEIMER’S DISEASE IN SESSIONS AND SYMPOSIUM AT ALZHEIMER’S ASSOCIATION INTERNATIONAL CONFERENCE (AAIC) 2019 eisai.com ↗
In its most recent review the DSMB recommended the continuation of the elenbecestat Phase 3 MISSION AD 1 and 2 studies without modification.
2019-07-18 Eisai Inc. Results EISAI PRESENTS NONCLINICAL RESEARCH RESULTS OF ELENBECESTAT OF WITHOUT SIGNIFICANT EFFECTS ON SYNAPTIC FUNCTION IN BRAIN BY SPINAL DENSITIY EVALUATION AT EFFECTIVE DOSE TO DECREASE AMYLOID BETA LEVEL IN CEREBROSPINAL FLUID AT AAIC 2019 eisai.com ↗
2018-07-26 Eisai Inc. Results EISAI AND BIOGEN PRESENT DETAILED RESULTS FROM PHASE II CLINICAL STUDY OF ELENBECESTAT IN MCI AND MILD TO MODERATE ALZHEIMER’S DISEASE AT ALZHEIMER’S ASSOCIATION INTERNATIONAL CONFERENCE (AAIC) 2018 eisai.com ↗
2018-07-25 Biogen Results Eisai and Biogen Present Detailed Results From Phase II Clinical Study of Elenbecestat in MCI and Mild to Moderate Alzheimer’s Disease at Alzheimer’s Association International Conference (AAIC) 2018 biogen.com ↗
2018-06-05 Eisai Inc. Results PHASE II CLINICAL STUDY OF ELENBECESTAT DEMONSTRATES SAFETY AND TOLERABILITY IN MCI AND MILD TO MODERATE ALZHEIMER’S DISEASE AT 18-MONTHS RESULTS OF THE PHASE II STUDY DEMONSTRATED A STATISTICALLY SIGNIFICANT DIFFERENCE IN AMYLOID BETA IN BRAIN eisai.com ↗
A numerical slowing of decline in functional clinical scales of a potentially clinically important difference was also observed, although this effect was not statistically significant.
2016-12-12 Eisai Inc. Results EISAI PRESENTS LATEST DATA ON BACE INHIBITOR ELENBECESTAT（E2609） AT 9TH CLINICAL TRIALS ON ALZHEIMER'S DISEASE eisai.com ↗
A correlation between plasma concentration of elenbecestat and the decrease in CSF Aβ(1-x) was observed, which overlapped with exposure-response models combining data from this study and Phase Ⅰ clinical study data (figure 1).
2016-11-18 Eisai Inc. Regulatory U.S. FDA GRANTS FAST TRACK DESIGNATION FOR THE DEVELOPMENT OF EISAI’S BACE INHIBITOR E2609 FOR EARLY ALZHEIMER’S DISEASE eisai.com ↗
“We are excited that the FDA has granted Fast Track designation to E2609” said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer of the Eisai Neurology Business Group.
2016-08-09 Eisai Inc. Regulatory U.S. FDA CONFIRMS SUFFICIENT DATA TO ADVANCE INVESTIGATIONAL BACE INHIBITOR E2609 FOR TREATMENT OF EARLY ALZHEIMER'S DISEASE TO PHASE Ⅲ PLANNING UNDERWAY TOWARDS PHASE Ⅲ STUDY INITIATION IN FY2016 eisai.com ↗
2012-07-19 Eisai Inc. Results EISAI PRESENTS FIRST CLINICAL DATA FOR BACE INHIBITOR E2609 AT ALZHEIMER’S ASSOCIATION INTERNATIONAL CONFERENCE 2012 eisai.com ↗
The two E2609 Phase I studies presented at the AAIC 2012 comprised a single oral ascending dose study (Study A001-001) which showed Aβ levels reduction in plasma, and a 14-day multiple oral ascending dose study (Study A001-002) which showed dose-dependent increase of E2609 PK level and statistically significant reduction of Aβ levels in cerebrospinal fluid (CSF).

All press releases naming this drug 16 releases

DateIssuerRelease

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 13 sources stand behind the page.

FieldValueCited text
Known as Elenbecestat ClinicalTrials.gov intervention name — accepted as the source's own label NCT02956486 ↗
Known as E2609 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02222324 ↗
10

NCT01600859 ↗

NCT01716897 ↗

NCT03055962 ↗

NCT01511783 ↗

NCT02859207 ↗

NCT02322021 ↗

NCT01975636 ↗

NCT02207790 ↗

NCT02055703 ↗

NCT01294540 ↗
Action Inhibit “Beta-secretase 1 inhibitor” CHEMBL4204869 ↗
Modality Small molecule — CHEMBL4204869 ↗
Route Oral “E2609 orally at varying ascending doses” NCT01294540 ↗
Target BACE1 “Beta-secretase 1 inhibitor” CHEMBL4204869 ↗