Clinical Trials

Numerous clinical trials investigate dimethyl fumarate across multiple therapeutic domains, spanning Early Phase 1 through Phase 4 studies. While predominantly evaluated for neuroimmunological disorders such as relapsing-remitting multiple sclerosis, these trials also explore oncology and inflammatory conditions, including cutaneous T-cell lymphoma, solid tumors, and age-related macular degeneration. Sponsored by academic medical centers, research hospitals, and industry entities including Biogen and Banner Life Sciences LLC, the protocols encompass active, recruiting, completed, withdrawn, and terminated recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07483632 NOT_YET_RECRUITING
Relapsing Forms of Multiple Sclerosis
Biogen
 2026-11-16 PHASE3
NCT07189325 RECRUITING
Relapsing-Remitting Multiple Sclerosis (RRMS); Anti-CD20 Therapy
University Hospital, Montpellier
 2026-06-15 PHASE3
NCT07548996 RECRUITING
Type 1 Diabetes Mellitus
Nanjing Medical University
 2026-04-27 PHASE2; PHASE3
NCT07258394 RECRUITING
Type 1 Diabetes
Nanjing Medical University
 2026-01-27 PHASE3
NCT04381936 RECRUITING
Pneumonia
University of Oxford
 2020-03-19 PHASE3
NCT07776743 RECRUITING
Relapsing-remitting Multiple Sclerosis (RRMS)
Guangzhou Lupeng Pharmaceutical Company LTD.
 2026-08 PHASE2
NCT07138833 NOT_YET_RECRUITING
Relapsing Multiple Sclerosis
Qilu Pharmaceutical (Hainan) Co., Ltd.
 2025-09 PHASE4
NCT06513533 ACTIVE_NOT_RECRUITING
Adrenomyeloneuropathy Without Cerebral Involvement
Pujol, Aurora, M.D.
 2024-04-23 PHASE2; PHASE3
NCT06850597 RECRUITING
MCI; MCI-AD, Early Stage Alzheimer's Disease; Alzheimer's Disease
Medical University of Lodz
 2024-10-28 PHASE2
NCT03919071 ACTIVE_NOT_RECRUITING
Anaplastic Astrocytoma; Anaplastic Astrocytoma, Not Otherwise Specified; Anaplastic Ganglioglioma; Anaplastic Pleomorphic Xanthoastrocytoma; Glioblastoma; Malignant Glioma; WHO Grade 3 Glioma; WHO Grade 4 Glioma
National Cancer Institute (NCI)
 2020-02-20 PHASE2
NCT04292080 RECRUITING
Age-related Macular Degeneration (AMD)
Assistance Publique - Hôpitaux de Paris
 2022-02-07 PHASE2
NCT02196181 ACTIVE_NOT_RECRUITING
Stage III Cutaneous Melanoma AJCC v7; Stage IV Cutaneous Melanoma AJCC v6 and v7; Unresectable Melanoma
National Cancer Institute (NCI)
 2014-09-19 PHASE2
NCT02428218 WITHDRAWN
Relapsing-Remitting Multiple Sclerosis; Relapsing Forms of Multiple Sclerosis
Biogen
 2016-05 PHASE3
NCT03500328 ACTIVE_NOT_RECRUITING
Multiple Sclerosis, Relapsing-Remitting
Johns Hopkins University
 2018-05-02
NCT07196618 COMPLETED
Bonding
Al-Azhar University
 2025-11-01
NCT05959759 COMPLETED
Intracranial Aneurysm; Aneurysm, Brain; Inflammation Vascular
Beijing Tiantan Hospital
 2023-07-31 PHASE4
NCT04557956 ACTIVE_NOT_RECRUITING
Clinical Stage IV Cutaneous Melanoma AJCC v8; Metastatic Melanoma
National Cancer Institute (NCI)
 2021-08-19 PHASE1; PHASE2
NCT02283853 COMPLETED
Relapsing-Remitting Multiple Sclerosis
Biogen
 2014-08-28 PHASE3
NCT05417269 UNKNOWN
Multiple Sclerosis, Relapsing-Remitting
Imcyse SA
 2022-04-12 PHASE1; PHASE2
NCT04709705 COMPLETED
Cardiac Surgery
Cellphire Therapeutics, Inc.
 2021-10-27 PHASE2; PHASE3
NCT05658484 COMPLETED
Multiple Sclerosis
Biogen
 2023-06-09 PHASE4
NCT05545202 UNKNOWN
Malignant Lymphoma; Multiple Myeloma
Pharmacosmos A/S
 2024-04-30 PHASE4
NCT06635382 NOT_YET_RECRUITING
Dimethyl Sulfoxide
Manipal University College Malaysia
 2024-10-20
NCT05090085 COMPLETED
Dental Diseases
University of Turku
 2022-01-01
NCT06409429 Not yet recruiting
Pancreatic Cancer
Tianjin Medical University Cancer Institute and Hospital
 2024-05-01 Phase 2|Phase 3
NCT06349889 Not yet recruiting
Nasopharyngeal Carcinoma|Nasopharyngeal Cancer
Sun Yat-sen University|Nanfang Hospital Southern Medical University|West China Hospital
 2024-05-01 Phase 2
NCT04527549 TERMINATED
Clinical Stage IV Cutaneous Melanoma AJCC v8; Locally Advanced Melanoma; Pathologic Stage IIIC Cutaneous Melanoma AJCC v8; Pathologic Stage IV Cutaneous Melanoma AJCC v8; Unresectable Melanoma
ECOG-ACRIN Cancer Research Group
 2021-06-01 PHASE2
NCT04439292 ACTIVE_NOT_RECRUITING
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma
National Cancer Institute (NCI)
 2016-01-04 PHASE2
NCT02224781 ACTIVE_NOT_RECRUITING
Clinical Stage III Cutaneous Melanoma AJCC v8; Clinical Stage IV Cutaneous Melanoma AJCC v8; Metastatic Melanoma; Recurrent Melanoma; Unresectable Melanoma
National Cancer Institute (NCI)
 2015-09-08 PHASE3
NCT06385197 COMPLETED
Multiple Sclerosis
Hadassah Medical Organization
 2022-05-08
NCT04890353 TERMINATED
Acute Ischemic Stroke
Xuanwu Hospital, Beijing
 2021-12-01 PHASE1; PHASE2
NCT04890366 UNKNOWN
Acute Ischemic Stroke
Xuanwu Hospital, Beijing
 2021-12-01 PHASE1; PHASE2
NCT04492306 COMPLETED
Dental Diseases
Cairo University
 2020-11-17
NCT03870763 TERMINATED
Multiple Sclerosis, Relapsing-Remitting
Biogen
 2019-03-19 PHASE3
NCT05560919 COMPLETED
Mild to Moderate Anterior Mandibular Segment Crowdind
Latakia University
 2021-09-20 PHASE2; PHASE3
NCT04263610 COMPLETED
Plaque Psoriasis
Almirall, S.A.
 2019-09-04 PHASE4
NCT04890379 WITHDRAWN
Intracerebral Hemorrhage
Xuanwu Hospital, Beijing
 2021-06-01 PHASE2
NCT04891497 WITHDRAWN
Acute Ischemic Stroke
Xuanwu Hospital, Beijing
 2021-06-01 PHASE2
NCT02546440 COMPLETED
Cutaneous T Cell Lymphoma
Universitätsmedizin Mannheim
 2015-09 PHASE2
NCT02746744 COMPLETED
Multiple Sclerosis, Relapsing-Remitting
Anders Svenningsson
 2016-05 PHASE3
NCT03794297 WITHDRAWN
Erdheim-Chester Disease
National Cancer Institute (NCI)
 2019-01-04 PHASE2
NCT03716583 COMPLETED
Radiation Dermatitis; Radiation Dermatitis Acute; Breast Cancer
Dennis Bregner Zetner
 2019-04-30 PHASE2
NCT03814343 COMPLETED
Fungal Infection; Onychomycosis; Fungus, Nail
Mahidol University
 2019-01-15 PHASE4
NCT04439357 ACTIVE_NOT_RECRUITING
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma
National Cancer Institute (NCI)
 2016-02-25 PHASE2
NCT04439318 ACTIVE_NOT_RECRUITING
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma
National Cancer Institute (NCI)
 2016-02-25 PHASE2
NCT02907177 TERMINATED
Multiple Sclerosis
Actelion
 2017-03-30 PHASE3
NCT02981082 TERMINATED
Systemic Sclerosis; Pulmonary; Hypertension
Robert Lafyatis
 2016-12 PHASE1
NCT04680234 COMPLETED
Alopecia Areata
Sohag University
 2019-01-01
NCT02959658 COMPLETED
Primary Progressive Multiple Sclerosis
Rigshospitalet, Denmark
 2016-12 PHASE2
NCT03578055 UNKNOWN
Cholecystitis, Acute; Cholecystitis, Chronic
Ewha Womans University Mokdong Hospital
 2018-04-24 PHASE3
NCT00835770 COMPLETED
Relapsing-Remitting Multiple Sclerosis
Biogen
 2009-02-03 PHASE3
NCT03345940 TERMINATED
Relapsing Remitting Multiple Sclerosis
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
 2017-04-30 PHASE4
NCT04022473 COMPLETED
Multiple Sclerosis
Banner Life Sciences LLC
 2019-07-07 PHASE1
NCT02472938 WITHDRAWN
Relapsing Remitting Multiple Sclerosis
Biogen
 2015-07 PHASE4
NCT03093324 COMPLETED
Relapsing Remitting Multiple Sclerosis
Biogen
 2017-03-15 PHASE3
NCT02101788 COMPLETED
Borderline Ovarian Serous Tumor; Micropapillary Serous Carcinoma; Ovarian Serous Adenocarcinoma; Primary Peritoneal Serous Adenocarcinoma; Recurrent Ovarian Low Grade Serous Adenocarcinoma; Recurrent Primary Peritoneal Serous Adenocarcinoma
National Cancer Institute (NCI)
 2014-04-11 PHASE2; PHASE3
NCT05223244 COMPLETED
Interstitial Cystitis; Painful Bladder Syndrome
Endeavor Health
 2011-10-01 PHASE4
NCT04439279 ACTIVE_NOT_RECRUITING
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma
National Cancer Institute (NCI)
 2015-08-12 PHASE2
NCT02993484 COMPLETED
Reperfusion Injuries, Myocardial
University of Aarhus
 2016-12
NCT02784834 TERMINATED
Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
Michael Choi
 2016-06 PHASE1
NCT03092544 UNKNOWN
Multiple Sclerosis
Multiple Sclerosis Center of Northeastern New York
 2015-02 PHASE4
NCT02555215 COMPLETED
Multiple Sclerosis, Relapsing-Remitting
Biogen
 2016-02-22 PHASE3
NCT02281760 COMPLETED
BRAF V600E Mutation
National Human Genome Research Institute (NHGRI)
 2014-11-01 PHASE2
NCT01902173 COMPLETED
Hematopoietic and Lymphoid Cell Neoplasm; Locally Advanced Malignant Solid Neoplasm; Locally Advanced Melanoma; Metastatic Malignant Solid Neoplasm; Metastatic Melanoma; Stage IIIC Cutaneous Melanoma AJCC v7; Stage IV Cutaneous Melanoma AJCC v6 and v7; Unresectable Malignant Solid Neoplasm; Unresectable Melanoma
National Cancer Institute (NCI)
 2013-10-08 PHASE1; PHASE2
NCT02461069 COMPLETED
Multiple Sclerosis, Relapsing-Remitting
University Hospital Muenster
 2015-05-06 PHASE4
NCT02206477 UNKNOWN
Breast Capsular Contracture; Dimethyl Sulfoxide
Rabin Medical Center
 2014-08 PHASE2; PHASE3
NCT02901106 TERMINATED
Multiple Sclerosis, Relapsing-Remitting
Fondation Ophtalmologique Adolphe de Rothschild
 2017-05-23 PHASE4
NCT02090348 WITHDRAWN
Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis
Biogen
 2015-06 PHASE4
NCT02471560 COMPLETED
Multiple Sclerosis, Relapsing-Remitting
Biogen
 2015-11-06 PHASE4
NCT01815723 WITHDRAWN
Plaque Psoriasis
Forward-Pharma GmbH
 2016-06 PHASE3
NCT02525874 COMPLETED
Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
Biogen
 2015-08-11 PHASE3
NCT04570670 COMPLETED
Relapsing Remitting Multiple Sclerosis
Banner Life Sciences LLC
 2017-01-06 PHASE1
NCT02410278 COMPLETED
Multiple Sclerosis
Biogen
 2015-03-12 PHASE4
NCT02579681 COMPLETED
Multiple Sclerosis, Relapsing-Remitting
Biogen
 2014-04-30 PHASE3
NCT02337426 COMPLETED
Adult Brain Glioblastoma; Adult Giant Cell Glioblastoma; Adult Gliosarcoma
Virginia Commonwealth University
 2015-02-13 PHASE1
NCT02410200 COMPLETED
Multiple Sclerosis, Relapsing-Remitting
Biogen
 2015-09-30 PHASE2
NCT03103594 COMPLETED
Bladder Pain Syndrome
University of Pennsylvania
 2015-08 EARLY_PHASE1
NCT02078284 COMPLETED
Thrombocytopenia
U.S. Army Medical Research and Development Command
 2014-11-05 PHASE1
NCT02032134 TERMINATED
Thrombocytopenia; Primary Thrombocytopenia,Unspecified; Thrombocytopenia Chemotherapy Induced
Napolitano Mariasanta
 2015-07 PHASE4
NCT02097849 COMPLETED
Relapsing Forms of Multiple Sclerosis
Biogen
 2015-02-28 PHASE2
NCT02343159 TERMINATED
Multiple Sclerosis
Biogen
 2015-02-28 PHASE4
NCT02675413 WITHDRAWN
Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
Washington University School of Medicine
 2016-04 PHASE4
NCT02438137 COMPLETED
Obstructive Sleep Apnea; OSA; Sleep Apnea
University of Michigan
 2015-05 PHASE2
NCT01930708 COMPLETED
Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis
Biogen
 2013-10-31 PHASE4
NCT02125604 COMPLETED
Relapsing-Remitting Multiple Sclerosis
Biogen
 2014-06 PHASE4
NCT02430532 TERMINATED
Multiple Sclerosis, Secondary Progressive
Biogen
 2015-05 PHASE3
NCT02428231 TERMINATED
Multiple Sclerosis
Biogen
 2015-04 PHASE3
NCT01838668 COMPLETED
Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis
Biogen
 2013-03-28 PHASE3
NCT02217982 TERMINATED
Relapsing Remitting Multiple Sclerosis
Rocky Mountain MS Research Group, LLC
 2014-07 PHASE4
NCT04212819 COMPLETED
Anemia; Oxidative Stress
Afyonkarahisar Health Sciences University
 2014-01-01
NCT02117050 TERMINATED
Multiple Sclerosis
EMD Serono
 2014-06 PHASE4
NCT01069263 UNKNOWN
Interstitial Cystitis
Assaf-Harofeh Medical Center
 2010-02
NCT02090413 COMPLETED
Relapsing-Remitting Multiple Sclerosis
Biogen
 2014-05 PHASE4
NCT02171208 COMPLETED
Healthy
Biogen
 2014-06 PHASE1
NCT01924832 COMPLETED
Healthy
Biogen
 2013-08 PHASE1
NCT01915901 COMPLETED
Healthy
Biogen
 2013-08 PHASE1
NCT01873417 COMPLETED
Relapsing Forms of Multiple Sclerosis
Biogen
 2013-05 PHASE4
NCT01527838 COMPLETED
Non-Hodgkin's Lymphoma (NHL); Hodgkin's Disease; Chronic Lymphocytic Leukemia (CLL); Acute Myelogenous Leukemia (AML); Acute Lymphoblastic Leukemia (ALL)
Fate Therapeutics
 2012-01 PHASE1
NCT02347319 COMPLETED
Chronic Liver Disease
PharmaKing
 2012-04 PHASE4
NCT01568112 COMPLETED
Healthy
Biogen
 2012-04 PHASE3
NCT01156311 COMPLETED
Relapsing-Remitting Multiple Sclerosis; Multiple Sclerosis
Biogen
 2010-06 PHASE2
NCT01123915 TERMINATED
HIV Infections
Medicines Development for Global Health
 2010-05 PHASE1
NCT01459393 COMPLETED
Actinic Keratosis
Barretos Cancer Hospital
 2010-11 PHASE3
NCT01281111 COMPLETED
Healthy
Biogen
 2011-02-01 PHASE1
NCT00782613 TERMINATED
Psoriasis
Synvista Therapeutics, Inc
 2008-11 PHASE2
NCT00317070 TERMINATED
Interstitial Cystitis; Bladder Diseases
Nova Scotia Health Authority
 2006-04 PHASE2
NCT00583219 COMPLETED
Overactive Bladder; Detrusor Instability; Detrusor Hyperreflexia
Mayo Clinic
 2006-03 PHASE1; PHASE2
NCT00118313 COMPLETED
Melanoma (Skin)
Craig L Slingluff, Jr
 2004-11-04 PHASE1
NCT00016354 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
 2001-03 PHASE1
NCT00003697 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
University of Glasgow
 1995-10 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-03-19)

Check the DMF (Dimethyl Fumarate) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dimethyl fumarate activates the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) signaling pathway, promoting the downstream upregulation of antioxidant gene expression and reducing cellular oxidative stress. This cytoprotective action suppresses neuroinflammatory processes and cellular damage, providing therapeutic benefit in clinical conditions such as relapsing-remitting multiple sclerosis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.