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Lanabecestat - AstraZeneca

Drug Profile

Lanabecestat - AstraZeneca

Alternative Names: AZD3293; LY 3314814

Latest Information Update: 23 Oct 2019

At a glance

  • Originator Astex Pharmaceuticals; AstraZeneca
  • Developer AstraZeneca; Eli Lilly and Company
  • Class Antidementias; Imidazoles; Pyridines; Small molecules; Spiro compounds
  • Mechanism of Action BACE1 protein inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Alzheimer's disease

Most Recent Events

  • 14 Jul 2019 Efficacy data from the phase II/III AMARANTH trial presented at the Alzheimer's Association International Conference 2019 (AAIC-2019)
  • 22 Jul 2018 Pharmacokinetics and adverse events data from a phase I trial (In volunteers) presented at the Alzheimer's Association International Conference (AAIC-2018)
  • 28 Jun 2018 Eli Lilly in collaboration with AstraZeneca withdrew a phase I trial for Hepatic impairment in healthy volunteers in USA prior to enrolment (NCT03499041)

Development Overview

Introduction

Lanabecestat (AZD 3293) is an orally administered small-molecule being developed by AstraZeneca for the treatment of Alzheimer's disease (AD). The compound inhibits the amyloid precursor protein secretase, β-secretase cleaving enzyme 1 (BACE 1), which is a key protein involved in the formation of myelin sheaths in peripheral nerve cells and in the pathogenesis of Alzheimer's disease. The enzyme inhibition prevents the build up of β-amyloid to slow or stop the progression of the disease. Phase III development is underway worldwide for tablet formulation. Phase I development of an IV formulation is underway in the UK.

Lanabecestat is a lead candidate from a research programme being conducted by Astex Pharmaceuticals (a subsidiary of Otsuka Pharmaceuticals) and AstraZeneca for the development of amyloid precursor protein secretase inhibitors [see ADIS insight drug profile 800018476].

Astex Pharmaceuticals was acquired by Otsuka Pharmaceuticals in October 2013 [1] .

As at November 2017, no recent reports of development had been identified for phase-I development in Alzheimer's-disease in USA (PO, Liquid).

Company Agreements

In September 2014, Eli Lilly and Company and AstraZeneca entered into an agreement to co-develop and commercialize AZD3293 being developed as a potential treatment for Alzheimer's disease. Under the terms of the agreement, Eli Lilly and Company will pay AstraZeneca upto $US500 million in development and regulatory milestone payments. Eli Lilly and Company will recognize the initial milestone of $US50 million (pre-tax) or approximately $US.03 per share (after-tax) payment as a charge to earnings in the third quarter of 2014. Eli Lilly and Company will lead clinical development while working with researchers from AstraZeneca's Innovative Medicines Unit for neuroscience, while AstraZeneca will be responsible for manufacturing. Both companies will take joint responsibility for commercialization of AZD3293 and will share all future costs equally for the development and commercialization of AZD3293, as well as net global revenues post launch. [2]

AstraZeneca and Eli Lilly and Company entered into a collaboration, in September 2014, to co-develop and co-commercialise lanabecestat for the treatment of Alzheimer's disease. AstraZeneca will receive a milestone payment of up to $US500 million from Lilly, with first payment of $US50 million expected in the first half of 2015. As per the agreement, AstraZeneca will be involved in the manufacturing of this small molecule and Lilly will be responsible for the clinical development. Both the companies will jointly commercialise lanabecestat and share all the costs related to the development and commercialisation, along with the net global revenues on the sale of the product [2] [3] .

In March 2003, Astex Pharmaceuticals entered into a collaboration with AstraZeneca to develop amyloid precursor protein secretase inhibitors. Under the terms of agreement, AstraZeneca will provide milestone payments and royalties on successfully commercialised products to Astex Pharmaceuticals [4] .

Key Development Milestones

In August 2016, the US FDA granted fast-track designation to lanabecestat for the treatment of Alzheimer's disease [5] .

In June 2018, Astrazeneca and Eli Lilly and Company discontinued the global phase III DAYBREAK-ALZ trial which was designed to evaluate the safety and efficacy of lanabecestat in patients with mild Alzheimer's dementia. The decision was based on recommendations by an independent data monitoring committee as it was unlikely to meet its primary end point upon completion and therefore be stopped for futility (16024; I8D-MC-AZET; EudraCT2015-005625-39; NCT02783573) [6] . The primary endpoint of the trial was change from baseline on ADAS-Cog13. The randomised, double-blinded, placebo-controlled and delayed-start trial was initiated in July 2016, and enrolled approximately 1899 patients in the US, Belgium, Canada, China, Czech Republic, Denmark, France, Germany, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russia, Spain, Taiwan and the UK [7] [8] .

In June 2018, Astrazeneca and Eli Lilly and Company discontinued the global phase III AMARANTH trial of lanabecestat for the treatment of early alzheimer's disease as it was unlikely to meet its primary end point upon completion and therefore be stopped for futility. The decision was based on recommendations by an independent data monitoring committee (IDMC) [6] . The phase III portion of the phase II/III AMARANTH study was initiated following the recommendation of IDMC, in April 2016 (D5010C00009; NCT02245737; EudraCT2014-002601-38). AstraZeneca, in September 2014, initiated the 2-year, pivotal phase II/III AMARANTH trial to investigate the safety, efficacy, tolerability and pharmacokinetics of lanabecestat tablets in patients with early stage of Alzheimer's disease. The primary endpoint of the trial was change from baseline on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13). The randomised, double-blind, placebo-controlled trial enrolled approximately 2218 patients, in the US, Argentina, Australia, Belgium, Canada, France, Germany, Hungary, Italy South Korea, Poland, Puerto Rico, Japan, Romania, Spain, Sweden and the UK [2] [9] . Initiation of the phase III portion triggered a $US100 million milestone payment to AstraZeneca [10] [7] [11] [12] . In June 2018, Astrazeneca and Eli Lilly and Company also discontinued extension phase III AMARANTH trial of lanabecestat in patients with early Alzheimer's disease [6] . The study was initiated in March 2017, that was designed to evaluate the efficacy of lanabecestat in patients with early Alzheimer's disease dementia at the time of entry into study I8D-MC-AZES (16557; I8D-MC-AZFD; EudraCT2016-003440-36; NCT02972658). The delayed-start, randomised, double-blind, parallel trial enrolled approximately 1400 patients in the US, the UK, Australia, Belgium, Canada, France, Germany, Hungary, Italy, Japan, South Korea, Poland, Puerto Rico, Romania and Spain [13] . In July 2019, AstraZeneca and Eli Lilly presented the efficacy data from AMARANTH trial at Alzheimer's Association International Conference 2019 (AAIC-2019) [14] [15] .

Eli Lilly and Company and AstraZeneca, in June 2018, withdrawn a phase I trial prior to enrolment because phase III studies not likely to meet primary endpoints (16007; I8D-MC-AZEN; NCT03545087). The open label trial was designed to evaluate the pharmacokinetics of lanabecestat, in subjects with kidney impairment, in the US [16] .

In June 2018, Eli Lilly and Company and AstraZeneca withdrawn a phase I trial prior to enrolment as phase III studies not likely to meet primary endpoints (16004; I8D-MC-AZEK; NCT03506399). The open label trial was designed to evaluate the effect of oral contraceptive (birth control pill) on the blood level of lanabecestat when both are given together in healthy female subjects, in Singapore [17] .

Eli Lilly and Company, in June 2018, withdrawn a phase I trial prior to enrolment because phase III studies not likely to meet primary endpoints (16003; I8D-MC-AZEJ; NCT03499041). The open label trial was designed to evaluate the safety and pharmacokinetics of lanabecestat, in subjects with hepatic impairment, in the US [18] .

In February 2018, Eli Lilly and Company in collaboration with AstraZeneca completed a phase I bioavailability study of lanabecestat, in healthy subjects using an intravenous tracer method (15993; I8D-MC-AZEP; NCT03222427; EudraCT2017-001181-18). The open label trial was initiated in January 2018 and enrolled 8 volunteers in the UK [19] .

In May 2017, Eli Lilly and Company and AstraZeneca completed a phase I trial that assessed the effect of lanabecestat on the pharmacokinetics of rosuvastatin in Caucasian healthy volunteers (15994; I8D-MC-AZEB; NCT03019549). The open-label, crossover, non-randomised trial, initiated in January 2017, enrolled 42 volunteers in the US. In July 2018, Eli Lilly and Company reported that pharmacokinetics of rosuvastatin were not affected by lanabecestat [20] [21] . In July 2018, Eli Lilly and Company presented pharmacokinetics and adverse events data from the trial at the Alzheimer's Association International Conference (AAIC-2018) [22] .

Eli Lilly and Company in collaboration with AstraZeneca completed phase I trial in March 2016, which investigated the bioequivalence and food effect of two different tablet formulations of lanabecestat in healthy volunteers (16001; I8D-MC-AZEH; NCT02663128). The randomised trial initiated in January 2016, enrolled 18 volunteers in the US [23] .

In January 2016, Eli Lilly and Company, in collaboration with AstraZeneca, completed a phase I trial that assessed drug-drug interaction between lanabecestat and dabigatran etexilate in healthy volunteers (15997; I8D-MC-AZEE; NCT02568397). The open-label trial that initiated in October 2015, enrolled 60 volunteers in the US [24] .

In September 2015, Eli Lilly and Company initiated an open label phase I drug interaction trial to evaluate the effect of oral lanabecestat on the pharmacokinetics efficacy of warfarin (16008; I8D-MC-AZEO; NCT02540668). International normalised ratio (INR) was used to measure the blood clotting time. The primary outcome of the study was to evaluate the amount of warfarin getting into the blood and the time required for it to leave the body. The trial enrolled 17 healthy volunteers in the US, and was completed in December 2015 [25] .

In March 2014, AstraZeneca completed a two-part, multiple ascending dose phase I trial of lanabecestat solution in healthy elderly volunteers and patients with mild-to-moderate Alzheimer's disease (D5010C00002; NCT01795339). The trial evaluated the safety, tolerability, pharmacokinetics and effects on biomarkers in plasma and cerebrospinal fluid. The trial enrolled 47 subjects in the US [26] .

AstraZeneca completed a phase I trial in August 2015, which evaluated the pharmacokinetics of lanabecestat and evaluated the effect of lanabecestat on the pharmacokinetics of CYP3A in healthy volunteers (NCT02406261). The open-label trial enrolled 82 volunteers in the US [27] .

AstraZeneca completed a randomised, open-label, crossover, phase I trial in March 2014 that assessed the safety, tolerability and pharmacokinetics of two different tablet formulations and an oral solution of lanabecestat in healthy volunteers (D5010C00005; NCT02039180). The primary endpoints were relative bioavailability and plasma concentrations of lanabecestat and its active metabolite as assessed over 72 hours post-dose on three treatments days with a washout period of one week in between. The trial enrolled 1 patient in the US, and was initiated in February 2014 [28] .

In May 2014, AstraZeneca completed a phase I trial that assessed the effect of a single dose of lanabecestat oral solution on QTc interval, using open-label moxifloxacin as a positive control, in healthy male volunteers (D5010C00008; NCT02040987). The randomised, double-blind, placebo-controlled trial enrolled 52 subjects in the US [29] .

AstraZeneca completed a two-part phase I trial in July 2014 that assessed the safety, tolerability, pharmacokinetics and effects of single and multiple ascending doses of lanabecestat oral solution in healthy young and elderly volunteers (D5010C00003; NCT02005211). The randomised, double-blind, placebo-controlled trial enrolled 114 young and elderly subjects in Japan [30] .

A phase I trial, which investigated the pharmacokinetics of a single oral dose of 14C-labelled lanabecestat solution in healthy male volunteers was completed in May 2014 (D5010C00007; AZD3293 hADME; NCT02126514). The open-label, randomised, cross-over trial enrolled 12 subjects in the US [31] .

In December 2013, AstraZeneca initiated a phase I trial to investigate the the effect of co-administration of multiple-dose itraconazole or diltiazem on the single-dose pharmacokinetics of lanabecestat and the effects of coadministration of single- and multiple-dose lanabecestat on the single-dose pharmacokinetics of midazolam in healthy volunteers (D5010C00004; NCT02010970). The open-label trial enrolled 56 patients in the US, and was completed in February 2014 [32] .

AstraZeneca initiated a randomised, double-blind, placebo-controlled phase I trial in the US in December 2012 (D5010C00001; NCT01739647). The trial evaluated the safety, effects, and blood and urine levels of single doses of lanabecestat oral solution in healthy young and elderly volunteers. The trial enrolled 72 subjects in the US and was completed in May 2013 [33] .

Drug Properties & Chemical Synopsis

  • Route of administration IV, PO
  • Formulation Infusion, Liquid, Tablet
  • Class Antidementias, Imidazoles, Pyridines, Small molecules, Spiro compounds
  • Target BACE1 protein
  • Mechanism of Action BACE1 protein inhibitors
  • WHO ATC code

    N07X-X (Other nervous system drugs)

  • EPhMRA code

    N7D9 (All other anti-Alzheimer products)

  • Chemical name Dispiro[cyclohexane-1,2'-[2H]indene-1'(3'H),2''-[2H]imidazol]-4''-amine, 4-methoxy-5''-methyl-6'-[5-(1-propyn-1-yl)-3-pyridinyl]-, (1α,1'R,4β)-
  • Molecular formula C26 H28 N4 O
  • Chemical Structure
  • CAS Registry Number 1383982-64-6

Biomarkers Sourced From Trials

Indication Biomarker Function Biomarker Name Number of Trials

Alzheimer's disease

not specified

GM-CSF

Amyloid beta

1

1

Alzheimer's disease

Outcome Measure

Tau protein

GM-CSF

1

1

Biomarker

Drug Name Biomarker Name Biomarker Function
Lanabecestat - AstraZeneca Amyloid beta not specified
GM-CSF Outcome Measure
Tau protein Outcome Measure
For more detail, check out BiomarkerBase: the leading source of information about biomarkers used in drug development and diagnostic tests, tracking a comprehensive list of biomarker uses worldwide by over 800 companies

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
Alzheimer's disease - In adults, In the elderly Phase III Australia, Belgium, Canada, France, Germany, Hungary, Italy, Poland, Puerto Rico, Romania, South Korea, Spain, USA (fast track), United Kingdom PO / Tablet AstraZeneca, Eli Lilly and Company 08 Apr 2016
Alzheimer's disease - In adults, In the elderly Phase III Japan PO / Tablet AstraZeneca 08 Apr 2016
Alzheimer's disease - In volunteers Phase I United Kingdom IV / Infusion AstraZeneca, Eli Lilly and Company 15 Jan 2018
Alzheimer's disease - - No development reported (I) USA PO / Liquid AstraZeneca 04 Nov 2017

Priority Development Status

Type Region Indication
Fast Track US Alzheimer's disease

Commercial Information

Involved Organisations

Organisation Involvement Countries
Astex Pharmaceuticals Originator USA
AstraZeneca Originator United-Kingdom
AstraZeneca Owner United-Kingdom
Astex Pharmaceuticals Owner USA
Eli Lilly and Company Collaborator World

Credit Suisse Market Status

Indication Region Company Phase Expected Launch Year Probability of Success% Patent Expiry Year Expected Generic Entry Last Update
Alzheimer's disease Wrld (50% US) - Development Stopped - - - - 22 Oct 2018

Scientific Summary

Pharmacokinetics

In a phase I trial, co-administration of lanabecestat did not affect the pharmacokinetics of rosuvastatin and breast cancer resistance protein (BCRP) activity in healthy caucasians male and female volunteers (n=26). On day eight, there were no statistically significant differences in Cmax, AUC or tmax between rosuvastatin administered alone or coadministered with lanabecestat. Geometric mean Vss/F, Vz/F, CL/F and t1/2 were also similar when rosuvastatin administered alone or in combination with lanabecestat. There was no clinically meaningful differences observed in AUCτ,ss or Cmax between lanabecestat administered alone and lanabecestat co-administered with rosuvastatin. There was no discernible differences observed in exposure ratios of rosuvastatin between volunteers with or without the polymorphisms. The open-label, crossover, non-randomised trial evaluated effect of multiple doses of lanabecestat at 50mg on pharmacokinetics of rosuvastatin (20mg) in healthy caucasians volunteers. Volunteers with polymorphisms associated with impaired OATP1B1 (c.521T>C) or BCRP activity (c.421C>A and c.34G>A) were excluded [22] [21] .

Adverse Events

In a phase I trial, there were no safety concerns reported with multiple doses of lanabecestat at 50mg when co-administered with rosuvastatin (20mg) in healthy caucasians male and female volunteers (n=26) [22] [21] .

Therapeutic Trials

Treatment with lanabecestat resulted in reduced amyloid beta levels in the cerebrospinal fluid, in phase I trials in patients with Alzheimer's disease and healthy subjects [7] .

In a phase II/III AMARANTH trial, the administration of lanabecestat in patients with Alzheimer’s disease (AD) (mild cognitive impairment [MCI] due to AD and mild AD dementia) demonstrated that the at baseline, patients with MCI performed significantly better on all efficacy measures compared with those with mild AD (p< 0.001 ). Over the 104 week trial, patients with MCI had a slower rate of progression on all efficacy measures compared to subjects with mild AD. Treatment with lanabecestat in MCI patients showed worse performance on most efficacy measures compared with placebo, whereas patients with mild AD did not show these same treatment differences. An efficacy measures included a cognitive worsening on Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) was observed for both lanabecestat dose groups (20 mg or 50 mg) across multiple time points for the Total Scale Score (p < 0.05), the Immediate Memory Index Score (p < 0.05), and the Visuospatial/Constructional Index Score (p < 0.05). No differences were observed between either dose group and placebo for Delayed Memory and Attention Index Scores. The language index score showed an improvement in performance for the 20 mg dose group at week 45 (p < 0.05). Digit symbol showed worsening on all timepoints for the 50 mg dose group (p< 0.001 and p < 0.05) and worsening at week 26 and week 52 for the 20 mg dose group (p <0.001 and p < 0.05). A performance improvement was observed on the letter and category fluency tests for both dose groups (p< 0.001 and p < 0.05). The trial randomised 2218 patients of which 1362 (61%) were diagnosed with mild AD dementia and 856 (39%) with MCI due to AD [15] [14] [9]

Future Events

Expected Date Event Type Description Updated
31 Dec 2020 Regulatory Status AstraZeneca announces intention to submit regulatory applications for Alzheimer's disease in USA, European Union and Japan in 2020 (AstraZeneca pipeline, July 2017) 10 Jul 2017
30 Jun 2018 Trial Update Eli Lilly and AstraZeneca plans a phase I trial for Renal failure in USA in 2018 (NCT03545087) (700296401) 12 Jul 2018
14 Jun 2018 Trial Update Eli Lilly in collaboration with AstraZeneca plans a phase I trial for healthy volunteers in Singapore (700295210), (NCT03506399) 12 Jul 2018
01 May 2018 Trial Update Eli Lilly in collaboration with AstraZeneca plans a phase I trial for Hepatic impairment in healthy volunteers in USA (700294990), (NCT03499041) 12 Jul 2018
17 Nov 2017 Trial Update Eli Lilly plans a phase I trial in Healthy volunteers in United Kingdom (NCT03222427) 02 Feb 2018

Development History

Event Date Update Type Comment
14 Jul 2019 Scientific Update Efficacy data from the phase II/III AMARANTH trial presented at the Alzheimer's Association International Conference 2019 (AAIC-2019) [14] [15] Updated 23 Oct 2019
22 Oct 2018 Financial Update Credit Suisse financial data update Updated 04 Nov 2018
22 Jul 2018 Scientific Update Pharmacokinetics and adverse events data from a phase I trial (In volunteers) presented at the Alzheimer's Association International Conference (AAIC-2018) [22] Updated 08 Oct 2018
28 Jun 2018 Trial Update Eli Lilly in collaboration with AstraZeneca withdrew a phase I trial for Hepatic impairment in healthy volunteers in USA prior to enrolment (NCT03499041) Updated 12 Jul 2018
28 Jun 2018 Trial Update Eli Lilly in collaboration with AstraZeneca withdrew a phase I trial in healthy volunteers in Singapore prior to enrolment (NCT03506399) Updated 12 Jul 2018
28 Jun 2018 Trial Update Eli Lilly in collaboration with AstraZeneca withdrew a phase I trial in Renal failure patients in USA prior to enrolment (NCT03545087) Updated 12 Jul 2018
24 Jun 2018 Biomarker Update Biomarkers information updated Updated 31 Aug 2018
12 Jun 2018 Trial Update AstraZeneca and Eli Lilly discontinous phase III AMARANTH and DAYBREAK-ALZ trial in Alzheimer' disease (PO) worldwide due to futility to meet primary end point [6] (NCT02783573) Updated 13 Jun 2018
08 Jun 2018 Trial Update Eli Lilly and AstraZeneca plans a phase I trial for Renal failure in USA in 2018 (NCT03545087) Updated 12 Jul 2018
24 Apr 2018 Trial Update Eli Lilly in collaboration with AstraZeneca plans a phase I trial for healthy volunteers in Singapore , (NCT03506399) Updated 12 Jul 2018
17 Apr 2018 Trial Update Eli Lilly in collaboration with AstraZeneca plans a phase I trial for Hepatic impairment in healthy volunteers in USA , (NCT03499041) Updated 12 Jul 2018
16 Feb 2018 Trial Update Eli Lilly and AstraZeneca completes a phase I trial in healthy volunteers in United Kingdom (PO) (NCT03222427) Updated 16 Mar 2018
15 Jan 2018 Phase Change - I Phase-I clinical trials in Alzheimer's disease (In volunteers) in United Kingdom (IV) (NCT03222427) Updated 02 Feb 2018
15 Jan 2018 Trial Update Eli Lilly and AstraZeneca initiates enrolment in a phase I trial in healthy volunteers in United Kingdom (PO) (NCT03222427) Updated 02 Feb 2018
04 Nov 2017 Phase Change - No development reported No recent reports of development identified for phase-I development in Alzheimer's-disease in USA (PO, Liquid) Updated 04 Nov 2017
24 Jul 2017 Trial Update Eli Lilly plans a phase I trial in Healthy volunteers in United Kingdom (NCT03222427) Updated 02 Feb 2018
10 Jul 2017 Regulatory Status AstraZeneca announces intention to submit regulatory applications for Alzheimer's disease in USA, European Union and Japan in 2020 (AstraZeneca pipeline, July 2017) Updated 10 Jul 2017
22 May 2017 Trial Update Eli Lilly and AstraZeneca completes a phase I drug-interaction trial in Healthy volunteers in USA (PO) (NCT03019549) Updated 28 Jun 2017
15 Mar 2017 Trial Update Eli Lilly and AstraZeneca initiates enrolment in an extension phase III trial for Alzheimer's Disease (In adults, In the elderly) in USA (PO) (NCT02972658) Updated 29 Mar 2017
25 Jan 2017 Other Chemical structure information added Updated 25 Jan 2017
12 Jan 2017 Trial Update Eli Lilly and AstraZeneca initiate enrolment in a phase I drug-interaction trial in Healthy volunteers in USA (PO) (NCT03019549) Updated 10 Feb 2017
11 Jan 2017 Trial Update Eli Lilly and AstraZeneca plan a phase I drug-interaction trial in Healthy volunteers in USA (PO) (NCT03019549) Updated 16 Jan 2017
21 Nov 2016 Trial Update Eli Lilly and AstraZeneca plan an extension phase III trial for Alzheimer's Disease (In adults, In the elderly) in USA, United Kingdom, Australia, Belgium, Canada, France, Germany, Hungary, Italy, Japan, South Korea, Poland, Romania and Spain (PO) (NCT02972658) Updated 25 Nov 2016
22 Aug 2016 Regulatory Status AZD 3293 receives Fast Track designation for Alzheimer's disease [PO,Tablet] in USA [5] Updated 23 Aug 2016
01 Jun 2016 Trial Update Eli Lilly in collaboration with AstraZeneca initiates enrolment in the phase III DAYBREAK-ALZ trial for Alzheimer's disease in USA (NCT02783573) Updated 12 Jul 2016
08 Apr 2016 Phase Change - III Phase-III clinical trials in Alzheimer's disease in USA, Japan, Australia, Belgium, Canada, France, Germany, Hungary, Italy, South Korea, Poland, Romania, Spain, Puerto Rico, United Kingdom (PO) [7] Updated 12 Apr 2016
08 Apr 2016 Scientific Update Efficacy data from phase I trials in Alzheimer's disease released by Eli Lilly and AstraZeneca [7] Updated 12 Apr 2016
08 Apr 2016 Trial Update Eli Lilly and AstraZeneca plan the phase III DAYBREAK trial in Alzheimer's disease [7] Updated 12 Apr 2016
01 Mar 2016 Trial Update Eli Lilly and Company completes a a phase I trial in Healthy volunteers in USA (NCT02663128) Updated 20 Apr 2016
31 Jan 2016 Trial Update Eli Lilly and Company completes a phase I drug interaction trial in Healthy volunteers in USA (NCT02568397) Updated 04 Feb 2016
21 Jan 2016 Trial Update Eli Lilly plans a phase I bioequivalence trial in Healthy volunteers in USA (NCT02663128) Updated 02 Feb 2016
01 Jan 2016 Trial Update Eli Lilly and Company initiates enrolment in a phase I trial in Healthy volunteers in USA (NCT02663128) Updated 20 Apr 2016
01 Dec 2015 Trial Update Eli Lilly and Company completes a phase I drug interaction trial in Healthy volunteers in USA (NCT02540668) Updated 29 Dec 2015
16 Oct 2015 Trial Update Eli Lilly and Company initiates enrolment in a phase I drug-drug interaction trial in Healthy volunteers in USA (NCT02568397) Updated 09 Nov 2015
02 Oct 2015 Trial Update Eli Lilly and Company plans a phase I drug-drug interaction trial in Healthy volunteers in USA (NCT02568397) Updated 10 Oct 2015
01 Sep 2015 Trial Update Eli Lilly and Company initiates enrolment in a phase I pharmacokinetics trial in Healthy volunteers in USA (NCT02540668) Updated 10 Oct 2015
01 Sep 2015 Phase Change - II/III Phase-II/III clinical trials in Alzheimer's disease (In adults, In the elderly) in Japan, USA, Australia, Belgium, France, Germany, Hungary, Italy, South Korea, Poland, Spain, Romania, United Kingdom, Puerto Rico and Canada (PO) (EudraCT2014-002601-38; NCT02245737) Updated 08 Sep 2015
01 Sep 2015 Trial Update Eli Lilly plans a phase I drug-interaction trial in Healthy Volunteers in USA (NCT02540668) Updated 08 Sep 2015
01 Aug 2015 Trial Update AstraZeneca completes a phase I trial in Healthy volunteers in USA (NCT02406261) Updated 24 Sep 2015
01 Apr 2015 Trial Update AstraZeneca initiates enrolment in a phase I trial in Healthy volunteers in USA (NCT02406261) Updated 04 Jun 2015
16 Sep 2014 Licensing Status AstraZeneca and Eli Lilly agree to co-develop and commercialise AZD 3293 worldwide for Alzheimer's disease [2] Updated 19 Sep 2014
01 Sep 2014 Phase Change - II/III Phase-II/III clinical trials in Alzheimer's disease in USA (PO) Updated 11 Nov 2014
31 May 2014 Trial Update AstraZeneca completes a phase I trial in Healthy volunteers in USA (NCT02126514) Updated 04 Jul 2014
01 May 2014 Trial Update AstraZeneca initiates a phase I trial in Healthy volunteers in USA (NCT02126514) Updated 04 Jul 2014
01 May 2014 Trial Update AztraZeneca completes a phase I cardiac safety trial in Healthy volunteers in USA (NCT02040987) Updated 04 Jul 2014
28 Apr 2014 Trial Update AstraZeneca plans a phase I trial for Healthy volunteers in the US (NCT02126514) Updated 06 May 2014
01 Mar 2014 Trial Update AstraZeneca completes a phase I trial in Alzheimer's disease in USA (NCT01795339) Updated 11 Jun 2014
10 Feb 2014 Phase Change - I Phase-I clinical trials in Alzheimer's disease in USA (PO, new tablet formulation) Updated 03 Mar 2014
01 Feb 2014 Trial Update AstraZeneca completes a phase I trial in Healthy volunteers in the US (NCT02010970) Updated 06 May 2014
31 Jan 2014 Trial Update AstraZeneca initiates enrolment in a phase I cardiac safety trial in Healthy volunteers in USA (NCT02040987) Updated 03 Mar 2014
29 Jan 2014 Active Status Review AztraZeneca plans a phase I cardiac safety trial in Healthy volunteers in USA (NCT02040987) Updated 29 Jan 2014
16 Jan 2014 Trial Update AstraZeneca plans a phase I pharmacokinetics trial in Healthy volunteers in the USA (NCT02039180) Updated 24 Jan 2014
04 Dec 2013 Trial Update AstraZeneca plans a phase I trial for Healthy young & elderly volunteers in Japan (NCT02005211) Updated 11 Dec 2013
01 Dec 2013 Phase Change - I Phase-I clinical trials in Alzheimer's disease (in volunteers) in Japan (PO) Updated 24 Jan 2014
01 Dec 2013 Trial Update AstraZeneca initiates enrolment in a phase I trial for Healthy volunteers in USA (NCT02010970) Updated 24 Jan 2014
11 Oct 2013 Company Involvement Astex Pharmaceuticals has been acquired by Otsuka Pharmaceuticals Updated 17 Oct 2013
31 May 2013 Trial Update AstraZeneca completes a phase I trial in Healthy young & elderly volunteers in USA (NCT01739647) Updated 30 Aug 2013
22 Mar 2013 Trial Update AstraZeneca initiates enrolment in a phase I trial for Alzheimer's disease in USA (NCT01795339) Updated 23 Apr 2013
18 Feb 2013 Trial Update AstraZeneca plans a phase I trial for Alzheimer's disease in USA (NCT01795339) Updated 06 Mar 2013
01 Dec 2012 Phase Change - I Phase-I clinical trials in Alzheimer's disease (in volunteers) in USA (PO) Updated 06 Mar 2013
30 Nov 2012 Trial Update AstraZeneca plans a phase I trial for Alzheimer's disease (in volunteers) in USA (NCT01739647) Updated 29 Jan 2013
25 Oct 2010 Active Status Review Preclinical development is ongoing in United Kingdom Updated 29 Jan 2013
10 Sep 2008 Active Status Review Preclinical development is ongoing in United Kingdom Updated 29 Jan 2013
01 Jun 2006 Active Status Review This programme is still in active development Updated 29 Jan 2013
03 Mar 2003 Phase Change - Preclinical Preclinical trials in Alzheimer's disease in United Kingdom (PO) Updated 29 Jan 2013

References

  1. Otsuka Pharmaceutical Completes Acquisition of Astex Pharmaceuticals.

    Media Release
  2. Lilly and AstraZeneca announce alliance to co-develop potential treatment for Alzheimer's disease.

    Media Release
  3. AZ AND LILLY ALLIANCE TO DEVELOP BACE INHIBITOR.

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  4. Astex Pharmaceuticals Reports 2011 Third Quarter Financial Results.

    Media Release
  5. AstraZeneca and Lilly receive FDA Fast Track designation for AZD3293, an investigational treatment for early Alzheimer's disease.

    Media Release
  6. Update on Phase 3 Clinical Trials of Lanabecestat for Alzheimer's Disease.

    Media Release
  7. Eli Lilly and Company and AstraZeneca Announce Continuation of Pivotal Clinical Trial for People with Early Alzheimer's Disease.

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  8. A Randomized, Double-Blind, Placebo-Controlled and Delayed-Start Study of LY3314814 in Mild Alzheimer's Disease Dementia (The DAYBREAK Study)

    ctiprofile
  9. A 24-month, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy, Safety, Tolerability, Biomarker, and Pharmacokinetic Study of AZD3293 in Early Alzheimer's Disease

    ctiprofile
  10. AstraZeneca PLCAnnounces Q1 2016 Results.

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  11. AstraZeneca and Eli Lilly and Company initiate pivotal clinical trial for patients with early Alzheimer's disease.

    Media Release
  12. Eli Lilly and Company and AstraZeneca Initiate Pivotal Clinical Trial for Patients with Early Alzheimer's Disease.

    Media Release
  13. A Randomized, Double-Blind, Delayed-Start Study of LY3314814 (AZD3293) in Early Alzheimer's Disease Dementia (Extension of Study AZES, The AMARANTH Study)

    ctiprofile
  14. Tariot PN, Selzler KJ, Wessels AM, Andersen SW, Mullen J, Zimmer JA, et al. Subgroup Populations in AMARANTH, a Randomized Phase 2/3 Study in Early Alzheimer?s Disease with Lanabecestat. AAIC-2019 2019; abstr. 35073.

    Available from: URL: https://eventpilotadmin.com/web/page.php?page=IntHtml&project=AAIC19&id=35073
  15. Stern RA, Wessels AM, Selzler KJ, Andersen SW, Mullen J, Sims JR. Performance on Exploratory Efficacy Variables in AMARANTH, a Randomized Phase 2/3 Study in Early Alzheimer?s Disease with Lanabecestat. AAIC-2019 2019; abstr. 35074.

    Available from: URL: https://eventpilotadmin.com/web/page.php?page=IntHtml&project=AAIC19&id=35074
  16. Pharmacokinetics of Lanabecestat (LY3314814) in Subjects With Impaired Renal Function

    ctiprofile
  17. Effect of Lanabecestat on the Pharmacokinetics of Ethinyl Estradiol and Levonorgestrel in Healthy Female Subjects

    ctiprofile
  18. Pharmacokinetics of LY3314814 in Subjects With Hepatic Impairment

    ctiprofile
  19. An Absolute Bioavailability Study of LY3314814 in Healthy Subjects Using an Intravenous Tracer Method

    ctiprofile
  20. Highlights from Lilly's Alzheimer's Disease Pipeline at the Alzheimer's Association International Conference(R) 2018 (AAIC(R) 2018).

    Media Release
  21. Effect of LY3314814 on the Pharmacokinetics of Rosuvastatin in Caucasian Healthy Subjects

    ctiprofile
  22. Monk SA, Andersen SW, Ayan-Oshodi M, Guo Y, Hillgren KM, James DE, et al. Lanabecestat Does Not Affect Pharmacokinetics of the BCRP Substrate Rosuvastatin. AAIC-2018 2018; abstr. 25960.

    Available from: URL: https://ep70.eventpilotadmin.com/web/planner.php?id=AAIC18
  23. A Bioequivalence and Food Effect Study in Healthy Subjects Administered 2 Different Tablet Formulations of LY3314814

    ctiprofile
  24. Effect of LY3314814 on the Pharmacokinetics of Dabigatran in Healthy Subjects

    ctiprofile
  25. Effect of LY3314814 on the Pharmacokinetics of Warfarin in Healthy Subjects

    ctiprofile
  26. A Phase I, Randomized, Double-Blind, Placebo-Controlled, Two-Part, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 in Plasma and Cerebrospinal Fluid in Healthy Male and Non-Fertile Female Elderly Volunteers and in Mild-to-Moderate Alzheimer Disease Patients

    ctiprofile
  27. A Study to Characterize LY3314814 Pharmacokinetics as a Function of Dosing Duration and to Determine the Effect of LY3314814 on the Pharmacokinetics of CYP3A Substrates in Healthy Subjects

    ctiprofile
  28. A Phase 1, Open-label, Randomized, Single-dose, 3-period Cross-over, Relative Bioavailability Study to Assess Two Solid Formulations Compared to an Oral Solution of AZD3293 in Healthy Male and Non-Fertile Female Subjects

    ctiprofile
  29. A Single-Center, Randomized, Double-Blinded, Placebo-Controlled, 4-way Cross-over Study to Assess the Effect of a Single Oral Dose of AZD3293 Administration on QTc Interval Compared to Placebo, Using Open-Label AVELOX (Moxifloxacin) as a Positive Control, in Healthy Male Subjects

    ctiprofile
  30. A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 in Healthy Japanese Male and Non-Fertile Female Volunteers Including Elderly

    ctiprofile
  31. A Phase I, Open-Label, Single-Center Study to Assess the Absorption, Metabolism, and Excretion After Oral Administration of [14C]-AZD3293 to Healthy Male Subjects

    ctiprofile
  32. A Phase I, Single-center, Open-label, 3-group, Fixed-sequence Study to Assess the Effect of Itraconazole, a Potent CYP3A4 Inhibitor, or Diltiazem, a Moderate CYP3A4 Inhibitor, on the Pharmacokinetics of AZD3293 and the Effects of AZD3293 on the Pharmacokinetics of Midazolam, a CYP3A4/CYP3A5 Substrate, in Healthy Young Male and Female Volunteers

    ctiprofile
  33. A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Effect on Biomarkers of AZD3293 Including an Open-Label Food Effect Group in Healthy Male and Non-Fertile Female Volunteers

    ctiprofile
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