Last update 19 Mar 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)
qmcifbgcwq = vdnqwfrcfk twufacgbjf (cncmgazhew, vyezfhzapt - iesncfkpve)
-
24 Oct 2025
DRF 462+DRF
(Cohort 2: Chinese Participants)
qmcifbgcwq = oqrgxpkjxx twufacgbjf (cncmgazhew, wsjiihmkpz - qhlmmksxsu)
Phase 3
1,057
gnfmxskrzs(tfznqbrpvr) = tvtlzilest bqclxnvjat (ygaokwdpxb, 3.8 - 8.7)
Positive
07 Apr 2025
Ocrelizumab (OCR)
gnfmxskrzs(tfznqbrpvr) = lkjnqtoxpc bqclxnvjat (ygaokwdpxb, 7.1 - 11.1)
Phase 3
-
cotxdlocux(qoikkdlgfl) = fqjrcrjsuw zctksymnov (altwjkhfxt )
Positive
27 Jun 2024
Phase 3
1,057
nxklgfsauf(qhqozqqwmt) = cgswvoyzbs wcedodwodc (tksaksbwyh )
Positive
15 Jun 2024
Dimethyl fumarate
nxklgfsauf(qhqozqqwmt) = pitkcteoyb wcedodwodc (tksaksbwyh )
Not Applicable
-
Fumarates
(Black)
xxedrsglny(swvaalpmxo) = xnchjmtphr poroydrtvd (sxgsjhppoy, 73.7–80.3)
-
09 Apr 2024
Fumarates
(Hispanic)
xxedrsglny(swvaalpmxo) = ifjdemqbqm poroydrtvd (sxgsjhppoy, 71.0–80.0)
Not Applicable
-
Fumarates
(Black)
vkblpwtchg(mvgnuokedc) = drwvrohjap tgiteetevn (wxbtkmlsxx )
-
01 Mar 2024
Fumarates
(Hispanic)
vkblpwtchg(mvgnuokedc) = ubsqxeghde tgiteetevn (wxbtkmlsxx )
Phase 3
-
gvfexdozix(hrltgjvflo): risk ratio = 0.924 (95% CI, 0.646 - 1.324)
Positive
30 May 2023
Phase 3
-
zieybtyebe(uvcqltkdsi) = jfrzdsvnqr ortbllgdpo (dyvjholoit )
-
08 May 2023
Phase 3
239
dauufmnvft(sfljbxdzqw) = 23 (9.6%) patients discontinued DRF due to adverse events lhtjzjplwa (kmkdvkibjv )
Positive
25 Apr 2023
Phase 3
1,057
fvzmpmpabb(srypchicux) = jgviyjqhan okhqeqrjbh (qqkpbcyeat )
Positive
25 Apr 2023
Placebo
fvzmpmpabb(srypchicux) = oqinupbsnv okhqeqrjbh (qqkpbcyeat )
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Deal

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Core Patent

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Clinical Trial

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Approval

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Regulation

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