Diroximel Fumarate Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Diroximel Fumarate comprises 13 peer-reviewed publications across 13 journals, 10 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Inflammation. Most recent publication: Mechanism of action and therapeutic potential of dimethyl fumarate in ischemic stroke., J Neurosci Res, 2023.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. Multiple-informant ranking of the disabling effects of different health conditions in 14 countries. WHO/NIH Joint Project CAR Study Group.
    Ustün TB, Rehm J, Chatterji S, et al. · Lancet · 1999
    PubMed: PMID 10408486 · NCT06957808 (FORTUNE) · Inflammation
  2. Mechanism of action and therapeutic potential of dimethyl fumarate in ischemic stroke.
    Owjfard M, Karimi F, Mallahzadeh A, et al. · J Neurosci Res · 2023
    PubMed: PMID 37183360 · NCT06957808 (FORTUNE) · Inflammation
  3. Fumaric acid esters exert neuroprotective effects in neuroinflammation via activation of the Nrf2 antioxidant pathway.
    Linker RA, Lee DH, Ryan S, et al. · Brain · 2011
    PubMed: PMID 21354971 · NCT06957808 (FORTUNE) · Inflammation
  4. Determinants of treatment response in first-episode psychosis: an 18F-DOPA PET study.
    Jauhar S, Veronese M, Nour MM, et al. · Mol Psychiatry · 2020
    PubMed: PMID 29679071 · NCT06957808 (FORTUNE) · Inflammation
  5. A systematic review and meta-analysis of recovery in schizophrenia.
    Jääskeläinen E, Juola P, Hirvonen N, et al. · Schizophr Bull · 2014
    PubMed: PMID 23172003 · NCT06957808 (FORTUNE) · Inflammation
  6. Alteration patterns of peripheral concentrations of cytokines and associated inflammatory proteins in acute and chronic stages of schizophrenia: a systematic review and network meta-analysis.
    Halstead S, Siskind D, Amft M, et al. · Lancet Psychiatry · 2023
    PubMed: PMID 36863384 · NCT06957808 (FORTUNE) · Inflammation
  7. Long-term safety and efficacy of dimethyl fumarate for up to 13 years in patients with relapsing-remitting multiple sclerosis: Final ENDORSE study results.
    Gold R, Arnold DL, Bar-Or A, et al. · Mult Scler · 2022
    PubMed: PMID 34465252 · NCT06957808 (FORTUNE) · Inflammation
  8. A translational EEG-based approach to assess modulation of long-lasting NMDAR-dependent synaptic plasticity.
    Burgdorf JS, Christian EP, Sørensen L, et al. · Psychopharmacology (Berl) · 2020
    PubMed: PMID 31392357 · NCT06957808 (FORTUNE) · Inflammation

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

TrialIndicationPrimary endpointArmValue
NCT05083923—Part 1: Number of Participants With Abnormal Shift in 12-Lead Electrocardiogram (ECG) Values
Baseline (Day 1) to Week 24
Cohort 1: Japanese Participants5 Participants
Cohort 2: Chinese Participants3 Participants
NCT05083923—Part 1: Number of Participants With Clinically Relevant Abnormalities in Vital Sign Parameters
Baseline (Day 1) to Week 24
Cohort 1: Japanese Participants13 Participants
Cohort 1: Japanese Participants8 Participants
Cohort 1: Japanese Participants8 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants1 Participants
Cohort 1: Japanese Participants4 Participants
Cohort 1: Japanese Participants9 Participants
Cohort 1: Japanese Participants2 Participants
Cohort 1: Japanese Participants2 Participants
Cohort 1: Japanese Participants1 Participants
Cohort 1: Japanese Participants2 Participants
Cohort 1: Japanese Participants4 Participants
Cohort 1: Japanese Participants3 Participants
Cohort 1: Japanese Participants3 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants1 Participants
Cohort 2: Chinese Participants1 Participants
Cohort 2: Chinese Participants1 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants4 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants5 Participants
Cohort 2: Chinese Participants2 Participants
Cohort 2: Chinese Participants2 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants3 Participants
Cohort 2: Chinese Participants2 Participants
NCT05083923—Part 1: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Events
Baseline (Day 1) to Week 24
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants1 Participants
NCT05083923—Part 1: Number of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters
Baseline (Day 1) to Week 24
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants1 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants7 Participants
Cohort 1: Japanese Participants1 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants2 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants5 Participants
Cohort 1: Japanese Participants3 Participants
Cohort 1: Japanese Participants3 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants25 Participants
Cohort 1: Japanese Participants15 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants2 Participants
Cohort 1: Japanese Participants1 Participants
Cohort 1: Japanese Participants1 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants7 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 2: Chinese Participants3 Participants
Cohort 2: Chinese Participants3 Participants
Cohort 2: Chinese Participants1 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants1 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants1 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants2 Participants
Cohort 2: Chinese Participants1 Participants
Cohort 2: Chinese Participants11 Participants
Cohort 2: Chinese Participants0 Participants
NCT05083923—Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Baseline (Day 1) up to Week 24 (for prematurely discontinued participants, AEs were reported up to 2 weeks post discontinuation)
Cohort 1: Japanese Participants3 Participants
Cohort 1: Japanese Participants50 Participants
Cohort 2: Chinese Participants5 Participants
Cohort 2: Chinese Participants45 Participants
NCT05083923—Part 2: Number of Participants With Abnormal Shift in 12-Lead ECG Values
Baseline (Day 1) to Week 48
Cohort 1: Japanese Participants7 Participants
Cohort 2: Chinese Participants5 Participants
NCT05083923—Part 2: Number of Participants With C-SSRS Events
Baseline (Day 1) to Week 48
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants2 Participants
Cohort 2: Chinese Participants0 Participants
NCT05083923—Part 2: Number of Participants With Clinically Relevant Abnormalities in Vital Sign Parameters
Baseline (Day 1) to Week 48
Cohort 1: Japanese Participants5 Participants
Cohort 1: Japanese Participants3 Participants
Cohort 1: Japanese Participants4 Participants
Cohort 1: Japanese Participants14 Participants
Cohort 1: Japanese Participants3 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants3 Participants
Cohort 1: Japanese Participants13 Participants
Cohort 1: Japanese Participants7 Participants
Cohort 1: Japanese Participants6 Participants
Cohort 1: Japanese Participants9 Participants
Cohort 1: Japanese Participants1 Participants
Cohort 1: Japanese Participants12 Participants
Cohort 1: Japanese Participants6 Participants
Cohort 2: Chinese Participants2 Participants
Cohort 2: Chinese Participants2 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants7 Participants
Cohort 2: Chinese Participants3 Participants
Cohort 2: Chinese Participants1 Participants
Cohort 2: Chinese Participants1 Participants
Cohort 2: Chinese Participants1 Participants
Cohort 2: Chinese Participants5 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants6 Participants
Cohort 2: Chinese Participants7 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants1 Participants
NCT05083923—Part 2: Number of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters
Baseline (Day 1) to Week 48
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants4 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants1 Participants
Cohort 1: Japanese Participants3 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants20 Participants
Cohort 1: Japanese Participants3 Participants
Cohort 1: Japanese Participants7 Participants
Cohort 1: Japanese Participants2 Participants
Cohort 1: Japanese Participants28 Participants
Cohort 1: Japanese Participants8 Participants
Cohort 1: Japanese Participants5 Participants
Cohort 1: Japanese Participants6 Participants
Cohort 1: Japanese Participants7 Participants
Cohort 1: Japanese Participants1 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants2 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 1: Japanese Participants0 Participants
Cohort 2: Chinese Participants2 Participants
Cohort 2: Chinese Participants11 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants16 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants2 Participants
Cohort 2: Chinese Participants2 Participants
Cohort 2: Chinese Participants4 Participants
Cohort 2: Chinese Participants1 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants4 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants1 Participants
Cohort 2: Chinese Participants0 Participants
Cohort 2: Chinese Participants3 Participants
NCT05083923—Parts 1 and 2: Number of Participants With TEAEs and TESAEs
From Day 1 up to the end of the study (up to Week 50)
Cohort 1: Japanese Participants6 Participants
Cohort 1: Japanese Participants52 Participants
Cohort 2: Chinese Participants47 Participants
Cohort 2: Chinese Participants6 Participants

Publications by year

1999–2023: 13 publications.

1999
1
2000
1
2007
1
2009
2
2011
2
2014
1
2020
2
2022
1
2023
2

Publications by indication

Inflammation (13)

  • Mechanism of action and therapeutic potential of dimethyl fumarate in ischemic stroke.
    J Neurosci Res · 2023 · PMID 37183360 · NCT06957808
  • Alteration patterns of peripheral concentrations of cytokines and associated inflammatory proteins in acute and chronic stages of schizophrenia: a systematic review and network meta-analysis.
    Lancet Psychiatry · 2023 · PMID 36863384 · NCT06957808
  • Long-term safety and efficacy of dimethyl fumarate for up to 13 years in patients with relapsing-remitting multiple sclerosis: Final ENDORSE study results.
    Mult Scler · 2022 · PMID 34465252 · NCT06957808
  • Determinants of treatment response in first-episode psychosis: an 18F-DOPA PET study.
    Mol Psychiatry · 2020 · PMID 29679071 · NCT06957808
  • A translational EEG-based approach to assess modulation of long-lasting NMDAR-dependent synaptic plasticity.
    Psychopharmacology (Berl) · 2020 · PMID 31392357 · NCT06957808

Publications by journal

Trial-results highlights

In the NCT05083923 study, Part 1 evaluated outcomes up to Week 24. For abnormal shifts in 12-lead electrocardiogram (ECG) values, there were 5 participants in the Japanese Participants cohort and 3 participants in the Chinese Participants cohort. Regarding clinically relevant abnormalities in vital sign parameters in the Japanese Participants cohort, the following counts were reported:

  • 13 participants
  • 8 participants
  • 8 participants
  • 0 participants
  • 1 participant
  • 4 participants

For Columbia Suicide Severity Rating Scale (C-SSRS) events, the Japanese Participants cohort had 0 participants, 0 participants, and 0 participants. The Chinese Participants cohort reported:

  • 0 participants
  • 0 participants
  • 1 participant

Potentially clinically significant abnormalities in laboratory parameters were observed in 1 participant within the Japanese Participants cohort, with 0 participants reported for other parameters.

Also in Part 1 of NCT05083923, treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) were reported. The Japanese Participants cohort had 3 participants with TESAEs and 50 participants with TEAEs. The Chinese Participants cohort had 5 participants with TESAEs and 45 participants with TEAEs. In Part 2 of the study, which evaluated outcomes up to Week 48, abnormal shifts in 12-lead ECG values were observed in 7 participants in the Japanese Participants cohort and 5 participants in the Chinese Participants cohort. For C-SSRS events in Part 2, the Japanese Participants cohort reported 0 participants, 0 participants, and 0 participants. The Chinese Participants cohort reported:

  • 0 participants
  • 2 participants
  • 0 participants

Clinically relevant abnormalities in vital sign parameters in the Japanese Participants cohort included:

  • 5 participants
  • 3 participants
  • 4 participants
  • 14 participants
  • 3 participants
  • 0 participants

All values are sourced from primary registry reporting; individual papers should be consulted for clinical decisions.

All Diroximel Fumarate publications (13)

2023 (2 papers)

  1. Mechanism of action and therapeutic potential of dimethyl fumarate in ischemic stroke.
    Owjfard M, Karimi F, Mallahzadeh A, et al. · J Neurosci Res · 2023 · Background
    PubMed: PMID 37183360 · NCT06957808 (FORTUNE) · Inflammation
  2. Alteration patterns of peripheral concentrations of cytokines and associated inflammatory proteins in acute and chronic stages of schizophrenia: a systematic review and network meta-analysis.
    Halstead S, Siskind D, Amft M, et al. · Lancet Psychiatry · 2023 · Background
    PubMed: PMID 36863384 · NCT06957808 (FORTUNE) · Inflammation

2022 (1 paper)

  1. Long-term safety and efficacy of dimethyl fumarate for up to 13 years in patients with relapsing-remitting multiple sclerosis: Final ENDORSE study results.
    Gold R, Arnold DL, Bar-Or A, et al. · Mult Scler · 2022 · Background
    PubMed: PMID 34465252 · NCT06957808 (FORTUNE) · Inflammation

2020 (2 papers)

  1. Determinants of treatment response in first-episode psychosis: an 18F-DOPA PET study.
    Jauhar S, Veronese M, Nour MM, et al. · Mol Psychiatry · 2020 · Background
    PubMed: PMID 29679071 · NCT06957808 (FORTUNE) · Inflammation
  2. A translational EEG-based approach to assess modulation of long-lasting NMDAR-dependent synaptic plasticity.
    Burgdorf JS, Christian EP, Sørensen L, et al. · Psychopharmacology (Berl) · 2020 · Background
    PubMed: PMID 31392357 · NCT06957808 (FORTUNE) · Inflammation

2014 (1 paper)

  1. A systematic review and meta-analysis of recovery in schizophrenia.
    Jääskeläinen E, Juola P, Hirvonen N, et al. · Schizophr Bull · 2014 · Background
    PubMed: PMID 23172003 · NCT06957808 (FORTUNE) · Inflammation

2011 (2 papers)

  1. Fumaric acid esters exert neuroprotective effects in neuroinflammation via activation of the Nrf2 antioxidant pathway.
    Linker RA, Lee DH, Ryan S, et al. · Brain · 2011 · Background
    PubMed: PMID 21354971 · NCT06957808 (FORTUNE) · Inflammation
  2. Decreased levels of glutathione, the major brain antioxidant, in post-mortem prefrontal cortex from patients with psychiatric disorders.
    Gawryluk JW, Wang JF, Andreazza AC, et al. · Int J Neuropsychopharmacol · 2011 · Background
    PubMed: PMID 20633320 · NCT06957808 (FORTUNE) · Inflammation

2009 (2 papers)

  1. Decreased glutathione levels and antioxidant enzyme activities in untreated and treated schizophrenic patients.
    Raffa M, Mechri A, Othman LB, et al. · Prog Neuropsychopharmacol Biol Psychiatry · 2009 · Background
    PubMed: PMID 19576938 · NCT06957808 (FORTUNE) · Inflammation
  2. Redox dysregulation, neurodevelopment, and schizophrenia.
    Do KQ, Cabungcal JH, Frank A, et al. · Curr Opin Neurobiol · 2009 · Background
    PubMed: PMID 19481443 · NCT06957808 (FORTUNE) · Inflammation

2007 (1 paper)

  1. Impaired glutathione synthesis in schizophrenia: convergent genetic and functional evidence.
    Gysin R, Kraftsik R, Sandell J, et al. · Proc Natl Acad Sci U S A · 2007 · Background
    PubMed: PMID 17921251 · NCT06957808 (FORTUNE) · Inflammation

2000 (1 paper)

  1. Schizophrenia: glutathione deficit in cerebrospinal fluid and prefrontal cortex in vivo.
    Do KQ, Trabesinger AH, Kirsten-Krüger M, et al. · Eur J Neurosci · 2000 · Background
    PubMed: PMID 11029642 · NCT06957808 (FORTUNE) · Inflammation

1999 (1 paper)

  1. Multiple-informant ranking of the disabling effects of different health conditions in 14 countries. WHO/NIH Joint Project CAR Study Group.
    Ustün TB, Rehm J, Chatterji S, et al. · Lancet · 1999 · Background
    PubMed: PMID 10408486 · NCT06957808 (FORTUNE) · Inflammation

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).