dimethyl fumarate
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | TECFIDERA | — | 2014-12-03 – 2023-02-10 | fda.gov ↗ |
| Approved | EU (EMA) | Tecfidera | — | 2014-01-30 | europa.eu ↗ |
| Approved | US (FDA) | TECFIDERA | — | 2013-03-27 | fda.gov ↗ |
Trials 55 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT02955693 | Sep → Oct 2016 | psoriasis | Almirall, S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02784834 | Jun 2016 → Feb 2019 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Michael Choi | Terminated | No outcome recorded |
| Phase 1 | NCT02337426 | Feb 2015 → Nov 2016 | adult glioblastoma, giant cell glioblastoma, gliosarcoma | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 1 | NCT01924832 | Aug 2013 → Apr 2014 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT01915901 | Aug → Dec 2013 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT01453426 | Jan → Apr 2012 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT01281111 | Feb → Mar 2011 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT00837785 | Feb → Oct 2009 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT04890366 | Dec 2021 → Dec 2022 | ischemic stroke | Xuanwu Hospital, Beijing | Unknown | No outcome recorded |
| Phase 1/2 | NCT04890353 | Dec 2021 → Feb 2023 | ischemic stroke | Xuanwu Hospital, Beijing | Terminated | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT06850597 | Oct 2024 → Dec 2027 expected | Alzheimer disease | Medical University of Lodz | Recruiting | No outcome recorded |
| Phase 2 | NCT04292080 | Feb 2022 → Apr 2027 expected | dry age related macular degeneration | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 2 | NCT04891497 | Jun → Dec 2021 | ischemic stroke | Xuanwu Hospital, Beijing | Withdrawn | No outcome recorded |
| Phase 2 | NCT04890379 | Jun → Dec 2021 | intracerebral hemorrhage | Xuanwu Hospital, Beijing | Withdrawn | No outcome recorded |
| Phase 2 | NCT02410200 | Sep 2015 → Sep 2016 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT02546440 | Sep 2015 → Sep 2021 | primary cutaneous T-cell lymphoma | University Medical Center Mannheim | Completed | No outcome recorded |
| Phase 2 | NCT02097849 | Feb 2015 → May 2016 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT01156311 | Jun 2010 → Mar 2012 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT00168701 | Oct 2004 → Mar 2006 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT07548996 | Apr 2026 → Dec 2028 expected | type 1 diabetes mellitus | Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06513533 | Apr 2024 → Mar 2028 expected | adrenomyeloneuropathy | Pujol, Aurora, M.D. | Active not recruiting | No outcome recorded |
| Phase 317 trials | ||||||
| Phase 3 | NCT07483632 | Nov 2026 → Jul 2034 expected | multiple sclerosis | Biogen | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07189325 | Jun 2026 → Jun 2031 expected | relapsing-remitting multiple sclerosis | University Hospital, Montpellier | Recruiting | No outcome recorded |
| Phase 3 | NCT07258394 | Jan 2026 → Dec 2028 expected | type 1 diabetes mellitus | Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 3 | NCT03870763 | Mar 2019 → Jul 2022 | relapsing-remitting multiple sclerosis | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT02428218 | May 2016 → Jan 2027 | relapsing-remitting multiple sclerosis | Biogen | Withdrawn | No outcome recorded |
| Phase 3 | NCT02555215 | Feb 2016 → Sep 2018 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT02525874 | Aug 2015 → Apr 2017 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT02430532 | May 2015 → Jan 2016 | secondary progressive multiple sclerosis | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT02428231 | Apr → Dec 2015 | multiple sclerosis | Biogen | Terminated | No outcome recorded |
| Phase 3 | NCT02283853 | Aug 2014 → Jul 2025 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT02579681 | Apr 2014 → Dec 2016 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT01838668 | Mar 2013 → Jun 2015 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT01726933 | Nov 2012 → Oct 2014 | psoriasis | Almirall, S.A. | Completed | No outcome recorded |
| Phase 3 | NCT01568112 | Apr → Oct 2012 | — | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT00835770 | Feb 2009 → Nov 2019 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT00451451 | Jun 2007 → Aug 2011 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT00420212 | Jan 2007 → Feb 2011 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 416 trials | ||||||
| Phase 4 | NCT07138833 | Sep 2025 → Apr 2028 expected | multiple sclerosis | Qilu Pharmaceutical (Hainan) Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05959759 | Jul → Dec 2023 | brain aneurysm | Beijing Tiantan Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05658484 | Jun 2023 → Mar 2025 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT04263610 | Sep 2019 → Feb 2022 | psoriasis | Almirall, S.A. | Completed | No outcome recorded |
| Phase 4 | NCT03535298 | Jan 2019 → Jul 2027 expected | relapsing-remitting multiple sclerosis | The Cleveland Clinic | Active not recruiting | No outcome recorded |
| Phase 4 | NCT02901106 | May → Oct 2017 | relapsing-remitting multiple sclerosis | Fondation Ophtalmologique Adolphe de Rothschild | Terminated | No outcome recorded |
| Phase 4 | NCT02675413 | Apr 2016 | relapsing-remitting multiple sclerosis | Washington University School of Medicine | Withdrawn | No outcome recorded |
| Phase 4 | NCT02471560 | Nov 2015 → Jun 2017 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT02683863 | Aug 2015 → Jan 2017 | multiple sclerosis | Multiple Sclerosis Center of Northeastern New York | Completed | No outcome recorded |
| Phase 4 | NCT02472938 | Jul 2015 → Jul 2019 | relapsing-remitting multiple sclerosis | Biogen | Withdrawn | No outcome recorded |
| Phase 4 | NCT02090348 | Jun 2015 → Oct 2017 | relapsing-remitting multiple sclerosis | Biogen | Withdrawn | No outcome recorded |
| Phase 4 | NCT02125604 | Jun 2014 → Feb 2016 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT02090413 | May 2014 → Feb 2015 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT01930708 | Oct 2013 → Mar 2016 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT01873417 | May → Nov 2013 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT01088165 | May 2010 → May 2013 | cardiovascular disorder, psoriasis, type 2 diabetes mellitus | Medical University of Vienna | Unknown | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04260711 | Jul 2020 → Aug 2023 | relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis | Amsterdam UMC, location VUmc | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 26 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT04022473 Comparator | Jul → Oct 2019 | multiple sclerosis | Banner Life Sciences LLC | Completed | No outcome recorded |
| Phase 1 | NCT04570670 Comparator | Jan → Feb 2017 | relapsing-remitting multiple sclerosis | Banner Life Sciences LLC | Completed | No outcome recorded |
| Phase 1 | NCT02981082 Comparator | Dec 2016 → Feb 2020 | pulmonary hypertension, systemic sclerosis | Robert Lafyatis | Terminated | No outcome recorded |
| Phase 1 | NCT02201849 Comparator | Jul → Dec 2014 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT01069913 Comparator | Oct 2009 | — | Biogen | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05417269 Comparator | Apr 2022 → May 2025 | relapsing-remitting multiple sclerosis | Imcyse SA | Unknown | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT06715605 Comparator | Apr 2025 | multiple sclerosis | University Hospital, Antwerp | Withdrawn | No outcome recorded |
| Phase 2 | NCT02975349 Comparator | Mar 2017 → Jan 2018 | relapsing-remitting multiple sclerosis | EMD Serono Research & Development Institute, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT02959658 Comparator | Dec 2016 → Dec 2019 | primary progressive multiple sclerosis | Rigshospitalet, Denmark | Completed | No outcome recorded |
| Phase 2 | NCT02438137 Comparator | May 2015 → Apr 2016 | obstructive sleep apnea syndrome | University of Michigan | Completed | No outcome recorded |
| Phase 2 | NCT00810836 Comparator | Dec 2008 → Feb 2010 | rheumatoid arthritis | Biogen | Completed | No outcome recorded |
| Phase 2 | NCT00273364 Comparator | Nov 2005 → Jan 2017 | multiple sclerosis | Northwestern University | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT06663189 Comparator | Jan 2025 → Jan 2027 expected | relapsing-remitting multiple sclerosis | University Hospital, Strasbourg, France | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04788615 Comparator | Jul 2021 → Nov 2025 | multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT04381936 Comparator | Mar 2020 → Sep 2028 expected | pneumonia | University of Oxford | Recruiting | No outcome recorded |
| Phase 3 | NCT03093324 Comparator | Mar 2017 → Jun 2019 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 3 | NCT01815723 Comparator | Jun 2016 → Jun 2017 | psoriasis | Forward-Pharma GmbH | Withdrawn | No outcome recorded |
| Phase 3 | NCT02746744 Comparator | May 2016 → Jul 2021 | relapsing-remitting multiple sclerosis | Anders Svenningsson | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT04792567 Comparator | Apr → Sep 2021 | secondary progressive multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT03331835 Comparator | Nov 2017 → Jan 2019 | psoriasis | LEO Pharma | Completed | No outcome recorded |
| Phase 4 | NCT03345940 Comparator | Apr 2017 → Oct 2019 | relapsing-remitting multiple sclerosis | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | Terminated | No outcome recorded |
| Phase 4 | NCT02739542 Comparator | Mar 2016 → Mar 2021 | multiple sclerosis | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02461069 Comparator | May 2015 → Jan 2018 | relapsing-remitting multiple sclerosis | University Hospital Muenster | Completed | No outcome recorded |
| Phase 4 | NCT02410278 Background | Mar 2015 → Feb 2017 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 4 | NCT02343159 Background | Feb 2015 → Apr 2016 | multiple sclerosis | Biogen | Terminated | No outcome recorded |
| Phase 4 | NCT03092544 Comparator | Feb 2015 → Dec 2018 | multiple sclerosis | Multiple Sclerosis Center of Northeastern New York | Unknown | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 88 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | dimethyl fumarate | “Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer...” NCT00273364 ↗68“Fumaderm® tablets (120 mg dimethyl fumarate, 87 mg ethyl hydrogen fumarate calcium salt, 5 mg ethyl hydrogen fumarate magnesium salt, 3 mg ethyl hydrogen fumarate zinc salt)” NCT03331835 ↗ “Week 2: FAE forte (DIMETHYL FUMARATE 120mg ETHYL, FUMARATE CALCIUM 87mg, ETHYL FUMARATE ZINC 3mg, ETHYL FUMARATE MAGNESIUM 5mg)starting with 0-0-1 capsule daily” NCT01088165 ↗ “TECFIDERA® (dimethyl-fumarate) has received European approval on January 30, 2014, for the treatment of adult patients with relapsing remitting MS.” NCT02901106 ↗ “Standard-of-care on first-line treatment such as interferon-beta, glatiramer acetate, teriflunomide, dimethylfumarate, ponesimod and ozanimod.” NCT06715605 ↗ “Discontinuation of patients' own disease modifying therapy (any of the interferons, glatiramer acetate, dimethylfumarate, teriflunomide)” NCT04260711 ↗ “BG-12 (dimethyl fumarate) is an oral agent approved in the United States for the treatment of relapsing forms of MS.” PMID 24131282 ↗ Oct 2013 “DMTs: Dimethylfumarate, glatirameracetate, interferon, teriflunomode according to respective SmPC” NCT04792567 ↗ “Interferon-β (IFN-β), glatiramer acetate, dimethyl fumarate, teriflunomide or diroximel fumarate” NCT06663189 ↗ “Dimethyl fumarate minimum dose of 120mg or maximum dose of 240mg twice a day” NCT04788615 ↗ “MMF (metabolite of dimethyl fumarate [DMF])” NCT02955693 ↗ “Tecfidera (dimethyl fumarate)” NCT03535298 ↗ “DMF (Dimethyl Fumarate)” NCT02683863 ↗ |
| Known as | BG-12 | “Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer...” NCT00273364 ↗1“BG-12 (dimethyl fumarate) is an oral agent approved in the United States for the treatment of relapsing forms of MS.” PMID 24131282 ↗ Oct 2013 |
| Known as | BG00012 | “Dimethyl Fumarate (BG00012)” NCT01281111 ↗9“BG00012 (DMF) (Tecfidera®.)” NCT02683863 ↗ |
| Known as | BG00012 (DMF) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01873417 ↗ |
| Known as | DMF | “INTRODUCTION: Diroximel fumarate (DRF) and dimethyl fumarate (DMF) are orally administered fumarate disease-modifying therapies (DMTs) for multiple sclerosis (MS).” PMID 38878121 ↗ Jun 20249“Dimethyl fumarate (DMF) acts as an anti-inflammatory agent by activating nuclear factor erythroid 2-related factor 2 (Nrf2) and other pathways.” NCT05959759 ↗ “In a preclinical study we showed the potential of dimethyl fumarate (DMF) to block NF-κB and, specifically, kill CTCL cells.” PMID 37217183 ↗ Aug 2023 “Tecfidera® (dimethyl fumarate [DMF]) is an approved product for the treatment of relapsing forms of multiple sclerosis.” PMID 33797063 ↗ Mar 2021 “Limited data exist for dimethyl fumarate (DMF) treatment in pediatric-onset multiple sclerosis (POMS).” PMID 36169959 ↗ Sep 2022 “Dimethyl Fumarate (DMF) is a prescription medicine used to treat relapsing multiple sclerosis.” NCT02981082 ↗ “Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation” PMID 38296965 ↗ Jan 2024 “Dimethyl fumarate (DMF) standard scheme” NCT04263610 ↗ “BG00012 (DMF) (Tecfidera®.)” NCT02683863 ↗ “LAS41008 (containing DMF)” NCT02955693 ↗ |
| Known as | DR-DMF | “Delayed-release dimethyl fumarate (DR-DMF) has cytoprotective and antiinflammatory properties and has recently been approved in the United States as an oral treatment for...” PMID 24139424 ↗ Oct 2013 |
| Known as | LAS41008 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01726933 ↗ |
| Known as | TECFIDERA | “Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer...” NCT00273364 ↗8“TECFIDERA® (dimethyl-fumarate) has received European approval on January 30, 2014, for the treatment of adult patients with relapsing remitting MS.” NCT02901106 ↗ “Dimethyl fumarate (Tecfidera®) treatment is initiated by daily administration of 120 mg Tecfidera® p.o. in the morning in week 0.” NCT02461069 ↗ “Patients will receive oral administration of Dimethyl Fumarate (Tecfidera™) 120 mg twice a day for the first week” NCT04292080 ↗ “BG00012 (DMF) (Tecfidera®.)” NCT02683863 ↗ “TECFIDERA® capsules” NCT02201849 ↗ |
| Known as | Tecfidera (dimethyl fumarate) | “Tecfidera (dimethyl fumarate)” NCT03535298 ↗ |
| Action | Inhibit | “we confirmed the NF-κB-inhibiting mechanism of DMF in the blood” PMID 37217183 ↗ Aug 2023 |
| Route | Oral | “BG-12 (dimethyl fumarate) is an oral agent approved in the United States for the treatment of relapsing forms of MS.” PMID 24131282 ↗ Oct 2013 |