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Drug

Dimethyl fumarate

Approved · EMA
ClassKelch-like ECH-associated protein 1 inhibitorEmerging researchLate-stage development
Also known as (E)-But-2-enedioic acid dimethyl ester, Dimethyl trans-ethylenedicarboxylate, Fumaric acid, dimethyl ester, Tecfidera+5 more

(E)-But-2-enedioic acid dimethyl ester, Dimethyl trans-ethylenedicarboxylate, Fumaric acid, dimethyl ester, Tecfidera, trans-Butenedioic acid dimethyl ester, Dimethylfumarat, 1,2-bis(methoxycarbonyl)-trans-ethylene, Dimethylfumarate, trans-1,2-Ethylenedicarboxylic acid dimethyl ester.

RxNorm1373478ChEMBLCHEMBL2107333ATCL04AX07UNIIFO2303MNI2
2
Research papers
5
Active clinical trials
KEAP1
Primary target
15
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Effect of Dimethyl Fumarate Administered to Patients With Adrenomyeloneuropathy: a Multicenter, Placebo Controlled, Phase IIb/III Trial

Clinical trial2026-06-17Results expected Q1 2028 · ClinicalTrials.gov

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

Clinical trial2026-05-19Results posted · ClinicalTrials.gov

Randomised Evaluation of COVID-19 Therapy

Clinical trial2026-04-21Results expected Q3 2028 · ClinicalTrials.gov

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

Clinical trial2026-03-19Results expected Q3 2034 · ClinicalTrials.gov

Long-Term Analysis of DImethyl Fumarate, to Slow the Growth of Areas of Geographic Atrophy

Clinical trial2026-02-04Results expected Q2 2027 · ClinicalTrials.gov

A Phase I/II Dose Escalation/Adaptive Design Study to Evaluate the Safety and Efficacy of IMCY-0141 in Patients With Relapsing Remitting-Multiple Sclerosis (RR-MS)

Clinical trial2025-05-23Primary completion · ClinicalTrials.gov

Approval: Dimethyl fumarate Accord (EMA)

Regulatory2024-04-22EMA

Approval: Dimethyl fumarate Mylan (EMA)

Regulatory2024-04-22EMA

Approval: Dimethyl fumarate Neuraxpharm (EMA)

Regulatory2024-04-22EMA

Market withdrawal: Dimethyl fumarate Accord (EMA)

Regulatory2023-12-13EMA

SARS-CoV2-mediated suppression of NRF2-signaling reveals potent antiviral and anti-inflammatory activity of 4-octyl-itaconate and dimethyl fumarate.

Research2020-10-02Nature communications

Targeting immunometabolism as an anti-inflammatory strategy.

Research2020-03-04Cell research

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Dimethyl fumarate
Aliases & brands
(E)-But-2-enedioic acid dimethyl esterDimethyl trans-ethylenedicarboxylateFumaric acid, dimethyl esterTecfideratrans-Butenedioic acid dimethyl esterDimethylfumarat1,2-bis(methoxycarbonyl)-trans-ethyleneDimethylfumaratetrans-1,2-Ethylenedicarboxylic acid dimethyl ester
RxNorm CUI
1373478
ChEMBL ID
CHEMBL2107333
ATC codes
L04AX07
UNII
FO2303MNI2
Primary mechanism
Kelch-like ECH-associated protein 1 inhibitor
Regulatory jurisdictions
emamhra

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Kelch-like ECH-associated protein 1
KEAP1 · Q14145
INHIBITORKelch-like ECH-associated protein 1 inhibitor

Regulatory timeline

15 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2014-01-30
Latest approval
2024-04-22
Authorities
EMA · MHRA
Total events
15
emaEuropean Medicines Agency· 12 events
2024-04-22Approval
Approval: Dimethyl fumarate Mylan (EMA)

Indication: Dimethyl fumarate Mylan is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

Evidence ↗
2024-04-22Approval
Approval: Dimethyl fumarate Accord (EMA)

Indication: Dimethyl fumarate Accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

Evidence ↗
2024-04-22Approval
Approval: Dimethyl fumarate Neuraxpharm (EMA)

Indication: Dimethyl fumarate Neuraxpharm is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 3 events
2021-01-07Safety communicationSafety
Drug Safety Update: Dimethyl fumarate (Tecfidera): updated advice on the risk of progressive multifocal leukoencephalopathy (PML) associated with mild lymphopenia
Evidence ↗
2016-04-18Safety communicationSafety
Drug Safety Update: Dimethyl fumarate (Tecfidera): updated advice on risk of progressive multifocal leukoencephalopathy
Evidence ↗
2015-03-30Safety communicationSafety
Drug Safety Update: Dimethyl fumarate (Tecfidera): fatal PML in an MS patient with severe, prolonged lymphopenia
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

54 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
54
registered trials across all phases
LATEST COMPLETION 2025
5
Active studies
4
Recruiting
32
Late-stage (III+)
28
Completed
21
Discontinued
PHASE DISTRIBUTIONn = 54
Phase 18Phase 1 / 23Phase 211Phase 2 / 31Phase 315Phase 416

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Multicenter, Postmarketing Study of Dimethyl Fumarate (Tecfidera; BG00012) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China

CompletedPH IVBiogenn=602025

Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms: a Double Blind Randomized Controlled Trail

Unknown statusPH IVBeijing Tiantan Hospitaln=602024

Multi-center, Randomized, Double-blinded Assessment of Tecfidera® in Extending the Time to a First Attack in Radiologically Isolated Syndrome (RIS) (ARISE)

CompletedPH IVUniversity of Texas Southwestern Medical Centern=872021

Phase IV, Interventional, multicenteR, Double-blind, Randomized, Placebo-controlled Study tO Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With relapsingremitTing Multiple Sclerosis

WithdrawnPH IVBiogen2020

A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects With Relapsing-Remitting Multiple Sclerosis in the Real-World Setting

CompletedPH IVKey trialBiogenn=1,1142020

Recent completions

Trials that read out recently, adding to the completed evidence base.

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

CompletedPH IIIBiogenn=1562025

A Multicenter, Postmarketing Study of Dimethyl Fumarate (Tecfidera; BG00012) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China

CompletedPH IVBiogenn=602025

Phase IIA Study on Therapy With the NF-κB Inhibiting and Apoptosis Inducing Drug Dimethylfumarate (DMF) in Patients With Cutaneous T Cell Lymphoma (CTCL)

CompletedPH IIUniversitätsmedizin Mannheimn=252022

RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis. A Randomized Phase 3 Study Comparing Rituximab With Dimethyl Fumarate in Early Relapsing-Remitting Multiple Sclerosis and Clinically Isolated Syndrome.

CompletedPH IIIAnders Svenningssonn=2002021

Multi-center, Randomized, Double-blinded Assessment of Tecfidera® in Extending the Time to a First Attack in Radiologically Isolated Syndrome (RIS) (ARISE)

CompletedPH IVUniversity of Texas Southwestern Medical Centern=872021

Dimethyl Fumarate Treatment of Primary Progressive Multiple Sclerosis

CompletedPH IIRigshospitalet, Denmarkn=542020

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Major research themes3
Autoimmune Diseases1Immunomodulation1Inflammation1
Journals, researchers & institutions
Top journals
  • Cell research1
  • Nature communications1
Leading researchers
  • Alain T1
  • Alcamí A1
  • Balachandran S1
  • Bartsch L1
  • Blay-Cadanet J1
  • Farahani E1
  • Gilchrist VH1
  • Hait A1
Leading institutions
free-text, unnormalised
  • Aarhus Research Center for Innate Immunology1
  • Aarhus University1
  • Aarhus University Hospital1
  • Children's Hospital of Eastern Ontario Research Institute1
  • Department of Clinical Medicine1
  • Fox Chase Cancer Center1

Related drugs

3 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Metformin

Studied across 2 of the same disease areas as Dimethyl fumarate in the shared literature.

2 shared diseases1 shared paper
Methotrexate

Studied across 2 of the same disease areas as Dimethyl fumarate in the shared literature.

2 shared diseases1 shared paper
Sirolimus

Studied across 2 of the same disease areas as Dimethyl fumarate in the shared literature.

2 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.