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dimethyl

Generic: DIMETHYL FUMARATE·Brand: DIMETHYL FUMARATE, TECFIDERA

dimethyl: developed by 1 company · 4 clinical trials tracked · 1 FDA decision.

dimethyl evidence translation

What we can confirm

1 FDA record · 4 tracked trials

What it means

Source-backed records connect dimethyl to BIIB; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could dimethyl → BIIB affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence3 indications · 0 study sponsors

Related indications

Relapsing Forms of Multiple Sclerosis; Relapsing-Remitting Multiple Sclerosis; Multiple SclerosisMultiple SclerosisPneumonia

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (1)
CompanyPhase
BIOGEN INC. (BIIB)
Relapsing Forms of Multiple Sclerosis; Relapsing-Remitting M…
Phase 3
Clinical Trials (4)

A Phase 3 Study With an Open-Label Extension in Pediatric Participants to Evaluate the Safety, Efficacy, and Pharmacokinetics of Diroximel Fumarate and Dimethyl Fumarate for the Treatment of Relapsing Forms of Multiple Sclerosis

NCT07483632·Phase 3·BIIB
Not yet recruiting

Primary endpoint: TP Cohort A and OLE Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation

InterventionalRandomizedquadruple185 targetStarted 2026-11Completion 2035-06Biogen

Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry

NCT05658497·BIIB
Recruiting

Primary endpoint: Number of Major Congenital Malformations (MCMs)

Observational908 targetStarted 2023-10Completion 2032-078 sites · Australia, Germany, Ireland, Spain…Biogen

Randomised Evaluation of COVID-19 Therapy

NCT04381936·Phase 3
Recruiting

Primary endpoint: Community-acquired pneumonia: All-cause mortality (with subsidiary analyses of cause of death and of death at various timepoints following discharge)

InterventionalRandomizedopen70,000 targetStarted 2020-03Completion 2038-0916 sites · Belgium, Estonia, France, Ghana…University of Oxford

Open-Label, Randomized, Multicenter, Multiple-Dose, Active-Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension

NCT02283853·Phase 3·BIIB
Completed

Primary endpoint: Part 1: Proportion of Participants Free of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans

InterventionalRandomizedopen156 enrolledStarted 2014-08Completion 2025-0750 sites · Belgium, Bulgaria, Canada, Czechia…Biogen
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE TECFIDERA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. TECFIDERA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 )(BIIB)FDA ↗
NDA204063Type 1 - New Molecular EntityStandardOralCapsule, Delayed Release

Frequently asked questions

Who is developing dimethyl?

dimethyl is being developed by BIOGEN INC..

How many clinical trials involve dimethyl?

BioSniper tracks 4 clinical trials involving dimethyl.

What is dimethyl's latest FDA decision?

The most recent tracked FDA decision for dimethyl is Approval for 1 INDICATIONS AND USAGE TECFIDERA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. TECFIDERA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 ), dated March 27, 2013.