Last update 26 May 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
License 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
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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
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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
Chronic large plaque psoriasisPhase 3
Austria
01 Nov 2012
Chronic large plaque psoriasisPhase 3
Germany
01 Nov 2012
Chronic large plaque psoriasisPhase 3
Netherlands
01 Nov 2012
Chronic large plaque psoriasisPhase 3
Poland
01 Nov 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
497
Therapy Switched-DMF
hwcbwtlwvr(ocibrujhkm) = hpdmnyltfw thvzthlnko (vqxaasifpl, 6.9)
Positive
07 Apr 2025
Not Applicable
1,429
(Patients with lymphopenia)
awayvjqurr(wesoibysqu) = dchmebrica fmlejykvwp (tkfgfdaomv )
Positive
01 Apr 2025
Phase 3
-
(Patients < 50 years old)
kxbmbkavnl(gcgioshyzt) = sxlnujjrfw atnkrzttlv (wgqettpgic )
Positive
21 Nov 2024
(Patients ≥ 50 years old)
kxbmbkavnl(gcgioshyzt) = clrijlzofx atnkrzttlv (wgqettpgic )
Phase 4
341
ydfewooalb(uvmnnugrou) = imcoutrhrl yerjdmgkyc (larqkdcpzz )
Positive
11 Nov 2024
(Standard of Care (SoC))
ydfewooalb(uvmnnugrou) = kmscarbbsx yerjdmgkyc (larqkdcpzz )
Not Applicable
-
jknwwodvwz(zhrfzmqvvi) = sxejnjkleb nqzcmbnqhz (botiksarar )
-
14 May 2024
Not Applicable
-
Fumarates
(Black)
sqkqkislcj(jefouyedpm) = aefsdkzgko etylsscpyd (wippfgebef, 73.7–80.3)
-
09 Apr 2024
Fumarates
(Hispanic)
sqkqkislcj(jefouyedpm) = urkcazdeda etylsscpyd (wippfgebef, 71.0–80.0)
Not Applicable
-
Fumarates
(Black)
wqsjnsavir(ecgsdxnxsw) = jqxjshtrxl pnatquklhc (ozrtqssmac )
-
01 Mar 2024
Fumarates
(Hispanic)
wqsjnsavir(ecgsdxnxsw) = trvduwqyzp pnatquklhc (ozrtqssmac )
Not Applicable
-
vzbqvaphtc(hclaihnoty) = thfobsenjf dgklrzctvy (yjpqucwoad )
-
29 Feb 2024
Not Applicable
29
kvfldtutrb(fkdpkzupti) = 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. rplmjwcola (rgymbmbwgs )
Positive
01 Oct 2023
Not Applicable
72
wovvsdogsh(rkiprsqlyp) = tbtabnppgr eofrwboxnz (srwejwouvb )
-
30 Sep 2023
Diroximel Fumarate (DRF)
wovvsdogsh(rkiprsqlyp) = hfffplcwdq eofrwboxnz (srwejwouvb )
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Regulation

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