Drugs / Sibofimloc
last change Aug 2022 re-read 3 minutes ago

Sibofimloc

also known as EB8018 · TAK-018 · VRT-1353385

Small molecule

Developed for
Crohn disease
Investigated by
Enterome · Quotient Clinical · Takeda · Takeda Development Center Americas, Inc.

Trials 3

20172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT03709628 Mar 2018 → Nov 2019 Crohn disease Enterome Completed No outcome recorded
Phase 1 NCT02998190 Nov 2016 → Apr 2017 — Enterome Completed No outcome recorded
Phase 21 trial · 1 missed
Phase 2 NCT03943446 Aug 2020 → Aug 2022 Crohn disease Takeda Terminated Missed primary Stop: Enrollment

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2021-09-16 Enterome Results Enterome highlights Microbiome publication describing sibofimloc’s novel mechanism of action for the treatment of Crohn’s disease enterome.com ↗
In the paper, the authors showed that blocking the adhesion of overabundant FimH-expressing bacteria to the gut wall is a promising therapeutic mechanism that effectively disarms these virulent bacteria without killing them.
2017-10-27 Enterome Results Enterome’s EB8018, a first-in-class drug candidate targeting Crohn’s disease, successfully completes Phase I study in healthy volunteers enterome.com ↗
EB8018 was found to be well tolerated in healthy volunteers across a wide range of doses tested.

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 4 sources stand behind the page.

FieldValueCited text
Known as Sibofimloc “The drug being tested in this study is called TAK-018 (Sibofimloc).” NCT03943446 ↗
Known as EB8018 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03709628 ↗
1

NCT02998190 ↗

Known as TAK-018 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03943446 ↗
Known as VRT-1353385 ChEMBL registry synonym — accepted as the source's own label CHEMBL4594305 ↗
Action Inhibit “designed to block FimH” NCT02998190 ↗
Modality Small molecule “EB8018 is an oral small molecule” NCT02998190 ↗
Route Oral “Single oral dose of EB8018” NCT02998190 ↗