Last update 17 Apr 2025

Dimethyl fumarate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(E)-But-2-enedioic acid dimethyl ester, 1,2-bis(methoxycarbonyl)-trans-ethylene, BG-12 oral fumarate
+ [27]
Target
Action
stimulants
Mechanism
Nrf2 stimulants(Nuclear factor erythroid 2-related factor 2 stimulants)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (27 Mar 2013),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (South Korea), Overseas New Drugs Urgently Needed in Clinical Settings (China)
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Structure/Sequence

Molecular FormulaC6H8O4
InChIKeyLDCRTTXIJACKKU-ONEGZZNKSA-N
CAS Registry624-49-7

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Plaque psoriasis
European Union
23 Jun 2017
Plaque psoriasis
Iceland
23 Jun 2017
Plaque psoriasis
Liechtenstein
23 Jun 2017
Plaque psoriasis
Norway
23 Jun 2017
Multiple Sclerosis
Japan
19 Dec 2016
Multiple Sclerosis, Relapsing-Remitting
European Union
30 Jan 2014
Multiple Sclerosis, Relapsing-Remitting
Iceland
30 Jan 2014
Multiple Sclerosis, Relapsing-Remitting
Liechtenstein
30 Jan 2014
Multiple Sclerosis, Relapsing-Remitting
Norway
30 Jan 2014
Multiple sclerosis relapse
United States
27 Mar 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Multiple Sclerosis, Secondary ProgressivePhase 3
United States
01 May 2015
Multiple Sclerosis, Secondary ProgressivePhase 3
Belgium
01 May 2015
Multiple Sclerosis, Secondary ProgressivePhase 3
Czechia
01 May 2015
Multiple Sclerosis, Secondary ProgressivePhase 3
Netherlands
01 May 2015
Multiple Sclerosis, Secondary ProgressivePhase 3
Poland
01 May 2015
Multiple Sclerosis, Secondary ProgressivePhase 3
Slovakia
01 May 2015
FlushingPhase 3
United States
01 Apr 2012
Multiple Sclerosis, Primary ProgressivePhase 2
Denmark
01 Dec 2016
Rheumatoid ArthritisPhase 2
Australia
01 Dec 2008
Rheumatoid ArthritisPhase 2
Canada
01 Dec 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
1,429
(Patients with lymphopenia)
tkynvsvhff(zmmvygmszb) = nluqcudwsp osuqgcltod (isvkboirea )
Positive
01 Apr 2025
Phase 3
-
(Patients < 50 years old)
cjbynoqciz(dfevwqrexv) = aulbqdoani qzcmrvegpt (uaoipypvgy )
Positive
21 Nov 2024
(Patients ≥ 50 years old)
cjbynoqciz(dfevwqrexv) = ekajcuipzx qzcmrvegpt (uaoipypvgy )
Phase 4
341
shsavbtxlw(hvkulymbop) = dtxqutdqqv dgzhibttzl (mlwtdoryur )
Positive
11 Nov 2024
(Standard of Care (SoC))
shsavbtxlw(hvkulymbop) = htwzqrulbh dgzhibttzl (mlwtdoryur )
Not Applicable
-
pfzwwefnbb(owrfgzcvgv) = ukemrihtuk ugrjqztahh (zafcslunre )
-
14 May 2024
Not Applicable
-
Fumarates
(Black)
teshhxitcf(rkpnqewvhf) = dphkvbnvxh gdcnbiiyal (wxqjdfbbum, 73.7–80.3)
-
09 Apr 2024
Fumarates
(Hispanic)
teshhxitcf(rkpnqewvhf) = lfhiweueep gdcnbiiyal (wxqjdfbbum, 71.0–80.0)
Not Applicable
-
Fumarates
(Black)
cxoxunefcr(mwxluljrwk) = smygggljyf qhoakauraq (ibwfflsvdd )
-
01 Mar 2024
Fumarates
(Hispanic)
cxoxunefcr(mwxluljrwk) = bkasxjxcdg qhoakauraq (ibwfflsvdd )
Not Applicable
-
qbejqznlvl(oatubttfpv) = vqktmrlclh npvyoytoym (xroakgwqrm )
-
29 Feb 2024
Not Applicable
29
pxdewcjrei(brwbyqbnyf) = The incidence of lymphopenia (ALC <910) in this cohort of PwMS who transitioned from DMF to DRF increased from 24% at baseline to 52% 12 months after treatment change. zergqrcbla (ceqtiloiox )
Positive
01 Oct 2023
Not Applicable
110
rqcilcjdfg(eztyskoums) = nlmzbpkkaj xglgxcayjh (dgwqeumrjz, 0.09)
-
30 Sep 2023
rqcilcjdfg(eztyskoums) = zwivjqvjym xglgxcayjh (dgwqeumrjz, 0.05)
Phase 3
118
DMF treatment
dcfztcfbgs(xiywmytdhg) = tndncbuccb zzsqwqktpd (jdzslofnfm )
Positive
30 Sep 2023
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