Eritoran

also known as E5564 · eritoran tetrasodium

Small molecule targets TLR4 via inhibition

Developed for: infectious disease with sepsis · pneumonia
Investigated by: Australian and New Zealand Intensive Care Research Centre · Berry Consultants · Eisai Inc. · Global Coalition for Adaptive Research · Intensive Care National Audit & Research Centre · Medical Research Institute of New Zealand
+6 more
· Nat Intensive Care Surveillance - MORU · National University Hospital, Singapore · St. Marianna University School of Medicine · UMC Utrecht · Unity Health · University of Pittsburgh Medical Center

today NCT02735707 · Ph 3 NCT00334828 · Ph 3

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 32 trials · 1 missed
Phase 3	NCT02735707	Apr 2016 → Feb 2026 overdue	pneumonia	UMC Utrecht	Recruiting	Mixed
Phase 3	NCT00334828	Jun 2006 → Jan 2011	infectious disease with sepsis	Eisai Inc.	Completed	Missed primary
Comparator or background therapy2 trials
Phase 2	NCT02321111 Comparator	Jan 2015 → Sep 2018	—	The University of Texas Health Science Center at San Antonio	Completed	No outcome recorded
Phase 2	NCT02267317 Comparator	Jan 2015 → Sep 2018	—	The University of Texas Health Science Center at San Antonio	Terminated	No outcome recorded

Date	Issuer	Release
2011-01-25	Eisai Inc.	Results PHASE Ⅲ STUDY FOR SEVERE SEPSIS TREATMENT ERITORAN (E5564) DOES NOT MEET PRIMARY ENDPOINT eisai.com ↗ The decision was based on the fact that the trial, a Phase III study conducted in patients with severe sepsis, did not meet its primary endpoint of 28-day all-cause mortality.

Date	Issuer	Release
2020-10-27	Eisai Inc.	GLOBAL COALITION FOR ADAPTIVE RESEARCH, AMGEN, AND EISAI ANNOUNCE FIRST PATIENT ENROLLED IN INTERNATIONAL COVID-19 TRIAL AMGEN AND EISAI TO PARTICIPATE IN THE IMMUNE MODULATION DOMAIN OF REMAP-COVID, AN ADAPTIVE CLINICAL TRIAL TO TEST INTERVENTIONS FOR PATIENTS HOSPITALIZED WITH COVID-19 AMGEN’S APREMILAST AND EISAI’S ERITORAN TO BE EVALUATED ACROSS MULTIPLE INTERNATIONAL TRIAL SITES WITHIN THE REMAP NETWORK eisai.com ↗
2020-10-06	Eisai Inc.	INDUSTRY-ACADEMIA-GOVERNMENT JOINT DEVELOPMENT AGREEMENT AIMING FOR DRUG DISCOVERY FOR COVID-19 UTILIZING ERITORAN AND E6011 CONCLUDED, NON-CLINICAL RESEARCH ACTIVITIES COMMENCE Adopted for the public call for AMED "Development of therapeutic drugs for the novel coronavirus infection (COVID-19)" eisai.com ↗
2020-07-01	Eisai Inc.	REMAP-CAP TO PARTNER WITH EISAI ON INNOVATIVE TRIAL TO COMBAT COVID GCAR, EISAI AND UPMC, ON BEHALF OF REMAP-CAP INVESTIGATOR NETWORK, ANNOUNCE ERITORAN’S INCLUSION IN REMAP-COVID, AN ADAPTIVE CLINICAL TRIAL TO TEST INTERVENTIONS FOR PATIENTS WITH MODERATE AND SEVERE COVID INFECTION EISAI’S ERITORAN SELECTED AS THE FIRST INVESTIGATIONAL IMMUNE MODULATION THERAPY TO BE EVALUATED ACROSS MULTIPLE INTERNATIONAL TRIAL SITES eisai.com ↗
2011-01-25	Eisai Inc.	PHASE Ⅲ STUDY FOR SEVERE SEPSIS TREATMENT ERITORAN (E5564) DOES NOT MEET PRIMARY ENDPOINT eisai.com ↗
2010-03-26	Eisai Inc.	Eisai to Continue Eritoran (E5564) Phase Ⅲ Severe Sepsis Trial eisai.com ↗

Every value below carries the sentence it was read from. 5 sources stand behind the page.

Field	Value	Cited text
Known as	eritoran	ClinicalTrials.gov intervention name — accepted as the source's own label NCT00334828 ↗ 3 NCT02321111 ↗ NCT02735707 ↗ NCT02267317 ↗
Known as	E5564	“E5564 = Eritoran” NCT02267317 ↗
Known as	eritoran tetrasodium	“Patients with severe sepsis (n = 1961) were randomized and treated within 12 hours of onset of first organ dysfunction in a 2:1 ratio with a 6-day course of either eritoran...” PMID 23512062 ↗ Mar 2013
Action	Inhibit	“blocks lipopolysaccharide (LPS) from binding at the cell surface MD2-TLR4 receptor” PMID 23512062 ↗ Mar 2013
Modality	Small molecule	“Eritoran is a synthetic lipid A antagonist that blocks lipopolysaccharide (LPS) from binding at the cell surface MD2-TLR4 receptor.” PMID 23512062 ↗ Mar 2013
Route	Intravenous	“Intravenous infusion at a total dose of 105 mg.” NCT00334828 ↗
Target	TLR4	“antagonist of MD2-TLR4” PMID 23512062 ↗ Mar 2013