Drugs / monomethyl fumarate

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) BAFIERTAM 2020-04-28 fda.gov

Trials 3 · a red edge is where a trial was stopped

20172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT04022473 Jul → Oct 2019 multiple sclerosis Banner Life Sciences LLC Completed No outcome recorded
Phase 1 NCT04570670 Jan → Feb 2017 relapsing-remitting multiple sclerosis Banner Life Sciences LLC Completed No outcome recorded
Phase 41 trial
Phase 4 NCT03535298 Jan 2019 → Jul 2027 expected relapsing-remitting multiple sclerosis The Cleveland Clinic Active not recruiting No outcome recorded

Evidence & citations 12 cited values

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

FieldValueCited text
Known as monomethyl fumarate “Bafiertam (monomethyl fumarate)” NCT03535298
1

NCT04570670

Known as Bafiertam ClinicalTrials.gov intervention name — accepted as the source's own label NCT04022473
Known as Bafiertam (monomethyl fumarate) Bafiertam (monomethyl fumarate)NCT03535298
Known as Fumarate de monomethyle ChEMBL registry synonym — accepted as the source's own label CHEMBL589586
Known as Fumarato de monometilo ChEMBL registry synonym — accepted as the source's own label CHEMBL589586
Known as Fumaric acid monomethyl ester ChEMBL registry synonym — accepted as the source's own label CHEMBL589586
Known as MMF “The primary objective of this study was to assess the bioequivalence of the test product (Bafiertam; BLS-11; monomethyl fumarate) 190 mg versus Tecfidera® (dimethyl fumarate)...” NCT04570670
Known as NSC-523835 ChEMBL registry synonym — accepted as the source's own label CHEMBL589586
Action Inhibit “Kelch-like ECH-associated protein 1 inhibitor” CHEMBL589586
Modality Small molecule CHEMBL589586
Route Oral “Secondary objective of this study is to compare the safety and tolerability of Bafiertam™ and Tecfidera® when administered orally following bioequivalent dose regimens in...” NCT04022473
Target KEAP1 “Kelch-like ECH-associated protein 1 inhibitor” CHEMBL589586