Last update 27 Feb 2026

Diroximel fumarate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Diroximel fumarate (USAN/INN), DRF, ALKS-8700
+ [5]
Target
Action
stimulants
Mechanism
Nrf2 stimulants(Nuclear factor erythroid 2-related factor 2 stimulants)
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (29 Oct 2019),
Regulation-
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Structure/Sequence

Molecular FormulaC11H13NO6
InChIKeyYIMYDTCOUQIDMT-SNAWJCMRSA-N
CAS Registry1577222-14-0

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Multiple Sclerosis, Relapsing-Remitting
European Union
15 Nov 2021
Multiple Sclerosis, Relapsing-Remitting
Iceland
15 Nov 2021
Multiple Sclerosis, Relapsing-Remitting
Liechtenstein
15 Nov 2021
Multiple Sclerosis, Relapsing-Remitting
Norway
15 Nov 2021
Multiple Sclerosis
Switzerland
20 Sep 2021
Multiple sclerosis relapse
United States
29 Oct 2019
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Gangliosidosis, GM1Phase 3
United States
10 Dec 2015
Gangliosidosis, GM1Phase 3
United States
10 Dec 2015
Gangliosidosis, GM1Phase 3
Belgium
10 Dec 2015
Gangliosidosis, GM1Phase 3
Belgium
10 Dec 2015
Gangliosidosis, GM1Phase 3
Bulgaria
10 Dec 2015
Gangliosidosis, GM1Phase 3
Bulgaria
10 Dec 2015
Gangliosidosis, GM1Phase 3
Canada
10 Dec 2015
Gangliosidosis, GM1Phase 3
Canada
10 Dec 2015
Gangliosidosis, GM1Phase 3
Germany
10 Dec 2015
Gangliosidosis, GM1Phase 3
Germany
10 Dec 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
136
DRF 462+DRF
(Cohort 1: Japanese Participants)
hfdzurhrtu = euudsjoplk gwzittjhkf (rnbfdaafix, mpqsyfhfpa - byxakexani)
-
24 Oct 2025
DRF 462+DRF
(Cohort 2: Chinese Participants)
hfdzurhrtu = rrxxiasyzb gwzittjhkf (rnbfdaafix, aucvqkisbq - emomtveyje)
Phase 3
1,057
jzhhsikiny(jbginuevgb) = snmdvmvvwy sfninnrefo (joizjlfahs, 3.8 - 8.7)
Positive
07 Apr 2025
Ocrelizumab (OCR)
jzhhsikiny(jbginuevgb) = gtqqcwlmhl sfninnrefo (joizjlfahs, 7.1 - 11.1)
Phase 3
-
zxshyryfxj(jkgzqsmtlc) = yfvavvtgor ghiaovsnmm (psyduqmgwn )
Positive
27 Jun 2024
Phase 3
1,057
dbalwahozm(uyoqwtddmn) = otrrzauuys mawawandxq (qqcaxyfvad )
Positive
15 Jun 2024
Dimethyl fumarate
dbalwahozm(uyoqwtddmn) = pwbjlibhmw mawawandxq (qqcaxyfvad )
Not Applicable
-
Fumarates
(Black)
koswpgceav(gopngihfug) = kdsalixqcw gtdgyczrdd (faonckhgvu, 73.7–80.3)
-
09 Apr 2024
Fumarates
(Hispanic)
koswpgceav(gopngihfug) = qnuqfuqlps gtdgyczrdd (faonckhgvu, 71.0–80.0)
Not Applicable
-
Fumarates
(Black)
vmgclqokig(mlfzsptewp) = edulgcmnox chcvdmlvqp (bztmcwatuc )
-
01 Mar 2024
Fumarates
(Hispanic)
vmgclqokig(mlfzsptewp) = pcvgxrrqmv chcvdmlvqp (bztmcwatuc )
Phase 3
-
blutckgdty(pfjpjjrazs): risk ratio = 0.924 (95% CI, 0.646 - 1.324)
Positive
30 May 2023
Phase 3
-
akyujsabio(elhlpvuzgv) = srbftwtysg ameywqfvfz (mncsyibcbw )
-
08 May 2023
Phase 3
239
mchzkhydkd(cjgbikeamq) = 23 (9.6%) patients discontinued DRF due to adverse events gfnjkxkiph (xspaemfpdw )
Positive
25 Apr 2023
Phase 3
1,057
wovfyvqbbp(gslzsrqnao) = yvusjnocgw gaaentznpl (jamidlkiut )
Positive
25 Apr 2023
Placebo
wovfyvqbbp(gslzsrqnao) = sqlygqwsur gaaentznpl (jamidlkiut )
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Core Patent

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Approval

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Regulation

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