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dimethyl fumarate

Trade name: tecfidera

Small moleculeapproved

Approved

Mar 27, 2013

Dimethyl fumarate (DMF) is the methyl ester of fumaric acid and is named after the earth smoke plant. Dimethyl fumarate combined with three other fumaric acid esters (FAEs) is solely licensed in Germany as an oral therapy for psoriasis. Since 2013, it has been approved by the U.S. Food and Drug Administration (FDA) as a treatment option for adults with relapsing multiple sclerosis. In 2017, an oral formulation of dimethyl fumarate was approved for medical use in the European Union as a treatment for moderate-to-severe plaque psoriasis. Dimethyl fumarate is thought to have immunomodulatory properties without causing significant immunosuppression. — Wikipedia

Clinical trial activity

74 trials · 54 clinical orgs · 21 marketing orgs

Phase 1
15
Phase 2
37
Phase 3
23
Phase 4
20

Earliest trial started Oct 1, 2004 (NCT00168701)

Timeline

2000s

  1. Jan 1, 2004

    Biogen — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2007

    Biogen — Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2009

    Biogen — Earliest Phase 1 Sponsor(trial)

2010s

  1. Mar 27, 2013

    Biogen-IDEC — Earliest FDA Approval

  2. Mar 27, 2013

    Biogen-IDEC — NDA Organization

  3. Mar 27, 2013

    Biogen — Marketing Organization

  4. Nov 9, 2018

    Shilpa Medicare Ltd. — Marketing Organization

  5. Nov 16, 2018

    Accord Research — Marketing Organization

  6. Nov 21, 2018

    Zydus Discovery DMCC — Marketing Organization

  7. Dec 11, 2018

    Lupin — Marketing Organization

  8. Jan 22, 2019

    TWi Biotechnology, Inc. — Marketing Organization

  9. Oct 7, 2019

    Glenmark Pharmaceuticals — Marketing Organization

2020s

  1. Aug 17, 2020

    Mylan — Marketing Organization

  2. Sep 24, 2020

    Amneal Pharmaceuticals — Marketing Organization

  3. Sep 24, 2020

    Cipla — Marketing Organization

  4. Sep 24, 2020

    Hetero Labs Ltd — Marketing Organization

  5. Sep 24, 2020

    MSN Laboratories — Marketing Organization

  6. Sep 24, 2020

    Alkem Labs Ltd — Marketing Organization

  7. Mar 26, 2021

    Sola Pharms — Marketing Organization

  8. Mar 26, 2021

    Pharmathen S.A. — Marketing Organization

  9. Dec 21, 2021

    Sawai Pharmaceutical — Marketing Organization

  10. Oct 18, 2022

    Prinston Inc — Marketing Organization

  11. Dec 22, 2022

    Aurobindo Pharma — Marketing Organization

  12. Jun 26, 2024

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  13. Jan 6, 2025

    Torrent Pharmaceuticals Limited — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedMar 27, 2013

Chemistry & pharmacology

Loading structure…

SMILES

COC(=O)/C=C/C(=O)OC
Mol. weight
144.13 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

First in class

Sources

Also known as

  • 1,2-bis(methoxycarbonyl)-trans-ethylene
  • 1,2-bis(methoxycarbonyl)-trans-ethylene
  • azl-0211089
  • azl-0211089
  • bg00012
  • bg00012
  • bg-12
  • boletic acid dimethyl ester
  • dimethyl (e) butenedioate
  • dimethyl fumar
  • dimethyl fumar
  • dimethylfumarate
  • dimethylfumarate
  • dimethyl fumarate
  • dimethyl fumarate
  • dimethyl fumarate
  • dimethyl fumarate
  • dimethyl fumarate
  • dimethyl fumarate
  • dimethyl fumarate
  • dimethyl fumarate
  • dimethyl fumarate
  • dimethyl fumarate
  • dimethyl fumarate
  • dimethyl fumarate
  • dimethyl trans-ethylenedicarboxylate
  • dimethyl trans-ethylenedicarboxylate
  • (e)-but-2-enedioic acid dimethyl ester
  • (e)-but-2-enedioic acid dimethyl ester
  • fp187
  • fumaric acid, dimethyl ester
  • fumaric acid, dimethyl ester
  • las41008
  • lasw1835
  • methyl fumarate
  • tecfidera
  • tecfidera
  • tecfidera
  • tecfidera
  • trans-1,2-ethylenedicarboxylic acid dimethyl ester
  • trans-1,2-ethylenedicarboxylic acid dimethyl ester
  • trans-butenedioic acid dimethyl ester
  • trans-butenedioic acid dimethyl ester

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07258394Phase 3Dec 31, 2025Nanjing Medical University, Qilu Pharmaceutical Co., Ltd.
NCT07138833Phase 4Sep 30, 2025Qilu Pharmaceutical Co., Ltd.
NCT07189325Phase 3Sep 30, 2025University of Montpellier
NCT06850597Phase 2Oct 28, 2024Medical University of Lodz
NCT06513533Phase 2/Phase 3 (Phase 3)Apr 23, 2024Onofre, Aurora Pujol, M.D., Spanish Clinical Research Network, Universidad Carlos III Madrid, University of Barcelona
NCT05959759Phase 4Jul 31, 2023Capital Medical University, Henan Provincal People's Hospital
NCT05658484Phase 4Apr 13, 2023Biogen
NCT05417269Phase 1/Phase 2 (Phase 2)Apr 12, 2022ARENSIA EXPLORATORY MEDICINE, ImCyse
NCT04891497Phase 2Jun 1, 2021Capital Medical University
NCT04890353Phase 2Jun 1, 2021Capital Medical University
NCT04890379Phase 2Jun 1, 2021Capital Medical University
NCT04890366Phase 2Jun 1, 2021Capital Medical University
NCT04292080Phase 2Apr 1, 2020Assistance Publique - Hôpitaux de Paris
NCT04263610Phase 4Sep 4, 2019Almirall
NCT04022473Phase 1Jul 7, 2019Banner Life Sciences LLC, BioPharma Services
NCT03870763Phase 3Mar 19, 2019Biogen
NCT03262363Phase 2/Phase 3 (Phase 3)Aug 1, 2018Unidad de Investigacion Medica en Enfermedades Renales
NCT03255382Phase 3Aug 22, 2017AbbVie
NCT02901106Phase 4May 23, 2017Adolphe Rothschild Ophtalmologic Foundation
NCT03345940Phase 4Apr 30, 2017Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Patient-Centered Outcomes Research Institute, University of Genoa
Showing 20 of 74 trials
Page 1 / 4

Organizations

Research & Development (54)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
BiogenFor profit423542004
Capital Medical UniversityAcademic/Hospital5522021
AlmirallFor profit3332012
Banner Life Sciences LLCFor profit2212017
Forward Pharma GmbHFor profit2222010
MS Center of Northeastern New YorkAcademic/Hospital2212015
Qilu Pharmaceutical Co., Ltd.For profit2122025
AbbVieFor profit1112017
Adolphe Rothschild Ophtalmologic FoundationAcademic/Hospital1112017
AlkermesFor profit1112017
ARENSIA EXPLORATORY MEDICINEFor profit1012022
Assistance Publique - Hôpitaux de ParisAcademic/Hospital1112020
Biogen-IDECFor profit1012009
BioPharma ServicesFor profit1012019
Danderyds HospitalAcademic/Hospital1012016
Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaAcademic/Hospital1112017
GB Pharma Services & Consulting S.r.l.For profit1012015
Harrison Clinical ResearchFor profit1012012
Henan Provincal People's HospitalAcademic/Hospital1012023
Icahn School of Medicine at Mount SinaiAcademic/Hospital1012015
54 organizations
Page 1 / 3

Marketing (27)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGNov 16, 2018
Accord ResearchFor profitSYNSep 24, 2020
Alkem Labs LtdFor profitMKTGSep 24, 2020
Amneal PharmaceuticalsFor profitMKTGSep 24, 2020
Aurobindo PharmaFor profitMKTGDec 22, 2022
BiogenFor profitMKTGMar 27, 2013
BiogenFor profitSYNMar 27, 2013
Biogen-IDECFor profitNDAMar 27, 2013
CiplaFor profitMKTGSep 24, 2020
Glenmark PharmaceuticalsFor profitMKTGOct 7, 2019
Glenmark PharmaceuticalsFor profitSYNOct 6, 2020
Hetero Labs LtdFor profitMKTGSep 24, 2020
LupinFor profitMKTGDec 11, 2018
LupinFor profitSYNOct 6, 2020
MSN LaboratoriesFor profitMKTGSep 24, 2020
Macleods Pharmaceuticals, LtdFor profitMKTGJun 26, 2024
MylanFor profitMKTGAug 17, 2020
Pharmathen S.A.For profitMKTGMar 26, 2021
Prinston IncFor profitMKTGOct 18, 2022
Sawai PharmaceuticalFor profitMKTGDec 21, 2021
Shilpa Medicare Ltd.For profitMKTGNov 9, 2018
Sola PharmsFor profitMKTGMar 26, 2021
TWi Biotechnology, Inc.For profitMKTGJan 22, 2019
TWi Biotechnology, Inc.For profitSYNOct 14, 2020
Torrent Pharmaceuticals LimitedFor profitMKTGJan 6, 2025
Zydus Discovery DMCCFor profitMKTGNov 21, 2018
Zydus Discovery DMCCFor profitSYNSep 24, 2020