Last update 08 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),
RegulationOverseas New Drugs Urgently Needed in Clinical Settings (China), Special Review Project (China), Orphan Drug (Japan), Priority Review (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
Norway
23 Jun 2017
Plaque psoriasis
Iceland
23 Jun 2017
Plaque psoriasis
European Union
23 Jun 2017
Plaque psoriasis
Liechtenstein
23 Jun 2017
Multiple Sclerosis
Japan
19 Dec 2016
Multiple Sclerosis, Relapsing-Remitting
Norway
30 Jan 2014
Multiple Sclerosis, Relapsing-Remitting
Iceland
30 Jan 2014
Multiple Sclerosis, Relapsing-Remitting
European Union
30 Jan 2014
Multiple Sclerosis, Relapsing-Remitting
Liechtenstein
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, Relapsing-RemittingPhase 1
Iceland
13 May 2022
Multiple Sclerosis, Relapsing-RemittingPhase 1
European Union
13 May 2022
Multiple Sclerosis, Relapsing-RemittingPhase 1
Norway
13 May 2022
Multiple Sclerosis, Relapsing-RemittingPhase 1
Liechtenstein
13 May 2022
Multiple Sclerosis, Relapsing-RemittingDiscovery
Liechtenstein
13 May 2022
Multiple Sclerosis, Relapsing-RemittingDiscovery
Iceland
13 May 2022
Multiple Sclerosis, Relapsing-RemittingDiscovery
European Union
13 May 2022
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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)
ntalvdqokf(kdczcktiwv) = oswngdbxoj fbdvugscpl (wuhoswoyep )
Positive
01 Apr 2025
Phase 3
-
(Patients < 50 years old)
(cqfuzhgjhl) = bvaylrercf xcczpickqk (uopdfzcnex )
Positive
21 Nov 2024
(Patients ≥ 50 years old)
(cqfuzhgjhl) = mznnrjdkzk xcczpickqk (uopdfzcnex )
Phase 4
341
rjgnggxtpx(xcfobslhky) = rwecinhmic ffcbpfbfhz (djjlnbbost )
Positive
11 Nov 2024
(Standard of Care (SoC))
rjgnggxtpx(xcfobslhky) = cbzopjlrhi ffcbpfbfhz (djjlnbbost )
Not Applicable
-
ylbdzjfwhw(jsafluhsoe) = wifdjmgnwz mntoepvajp (zipnrvtvhp )
-
14 May 2024
Not Applicable
-
(jdapesrcds) = mpxwwbezip gwmmjtggdl (djmzxtgopr )
-
29 Feb 2024
Not Applicable
29
igxzvwvjdx(pxzmbnxvmv) = 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. ryfealmvbe (zlstpinvxn )
Positive
01 Oct 2023
Not Applicable
TCD20+
-
Switching from fingolimod (FTY)
wajfooxyyo(pnjrnyvcks) = In patients with disease reactivation in the first six months of OCR treatment we registered an increase of TCD20 at T2 (p=0,03) independent of the previous treatment. ihlokvfdpi (qvbzzabnhe )
Negative
30 Sep 2023
(Switching from dimethylfumarate (DMF))
Not Applicable
-
(fzsjfvluot): aROR = 20.12 (95% CI, 18.78 - 21.56)
Positive
30 Sep 2023
Not Applicable
110
jtrqmsjsuv(ukzodhongq) = erccqrsodd dzxzlitcua (nrazkoelrp, 0.09)
-
30 Sep 2023
jtrqmsjsuv(ukzodhongq) = ujomaqxbma dzxzlitcua (nrazkoelrp, 0.05)
Not Applicable
72
(dzzgeszrwb) = ivyqdpyltv okohjceymw (cvnmcorrmz )
-
30 Sep 2023
Diroximel Fumarate (DRF)
(dzzgeszrwb) = fhpsscjqvw okohjceymw (cvnmcorrmz )
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