Drugs / Emixustat

Trials 8

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT02130531 Apr 2014 → Sep 2015 age-related macular degeneration, diffuse secondary choroid atrophy Kubota Vision Inc. Completed No outcome recorded
Phase 1 NCT00942240 Jul 2009 → Apr 2010 — Kubota Vision Inc. Completed No outcome recorded
Phase 1 NCT00703183 May 2008 → Jun 2009 — Kubota Vision Inc. Completed No outcome recorded
Phase 23 trials · 1 missed
Phase 2 NCT03033108 Jan → Nov 2017 Stargardt disease, degeneration of macula and posterior pole Kubota Vision Inc. Completed No outcome recorded
Phase 2 NCT02753400 May 2016 → Nov 2017 proliferative diabetic retinopathy Kubota Vision Inc. Completed Missed primary
Phase 2 NCT01002950 Oct 2009 → Jun 2012 diffuse secondary choroid atrophy, dry age related macular degeneration Kubota Vision Inc. Completed No outcome recorded
Phase 2/31 trial · 1 missed
Phase 2/3 NCT01802866 Feb 2013 → Apr 2016 diffuse secondary choroid atrophy Kubota Vision Inc. Completed Missed primary
Phase 31 trial
Phase 3 NCT03772665 Jan 2019 → Jun 2022 Stargardt disease Kubota Vision Inc. Completed No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2013-05-09 Otsuka Pharmaceutical Development & Commercialization, Inc. Results Acucela and Otsuka Pharmaceutical Announce Phase IIa Clinical Results of Emixustat Hydrochloride (ACU-4429) in Patients with Geographic Atrophy (GA) Associated with Dry Age-related Macular Degeneration (AMD) at ARVO 2013 Annual Meeting otsuka.co.jp ↗
today announced results from a recently completed phase IIa study of emixustat hydrochloride in patients with geographic atrophy (GA) associated with dry age-related macular degeneration (AMD.)
2010-03-17 Otsuka Pharmaceutical Development & Commercialization, Inc. Regulatory Otsuka Pharmaceutical and Acucela Receive FDA Fast Track Designation for ACU-4429 in Patients with Dry AMD Novel, Oral Therapy in Phase 2 Clinical Trial for Dry AMD, A Leading Cause of Blindness in People Over Age 50 otsuka.co.jp ↗

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 10 sources stand behind the page.

FieldValueCited text
Known as Emixustat “PURPOSE: To determine whether emixustat hydrochloride (emixustat) reduces the rate of enlargement of geographic atrophy (GA) compared with placebo in subjects with age-related...” PMID 29716784 ↗ Apr 2018
3

NCT03033108 ↗

NCT03772665 ↗

NCT02130531 ↗

Known as ACU-4429 ClinicalTrials.gov intervention name — accepted as the source's own label NCT00703183 ↗
2

NCT01002950 ↗

NCT00942240 ↗

Known as ACU-4429 HCL ChEMBL registry synonym — accepted as the source's own label CHEMBL2107821 ↗
Known as ACU-4429 HYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL2107821 ↗
Known as ACU-4429, Emixustat HCl “ACU-4429, Emixustat HCl” NCT02753400 ↗
Known as Emixustat HCl “Emixustat HCl Tablet” NCT02130531 ↗
Known as emixustat hydrochloride “This is a multi-center, randomized, masked, multiple-dose, crossover study of the pharmacokinetics of emixustat hydrochloride (HCl) in subjects with geographic atrophy (GA)...” NCT02130531 ↗
1

NCT02753400 ↗

Action Inhibit “RPE65 inhibition” PMID 33214244 ↗ Nov 2020
Modality Small molecule “an orally available small molecule” PMID 33214244 ↗ Nov 2020
Route Oral “administered as a single dose, orally” NCT00703183 ↗
Target RPE65 “targets the retinal pigment epithelium-specific 65 kDa protein (RPE65)” PMID 33214244 ↗ Nov 2020