Clinical Trials

Numerous clinical trials evaluate the therapeutic and diagnostic utility of Monomethyl Fumarate across conditions such as relapsing-remitting multiple sclerosis, essential hypertension, lupus nephritis, and colonic dysplasia. Spanning Early Phase 1 through Phase 3, these studies feature recruitment statuses ranging from completed and recruiting to withdrawn and not yet recruiting. Research is supported by commercial sponsors like Banner Life Sciences LLC alongside institutional entities such as Regional Hospital Holstebro and Assistance Publique - Hopitaux de Paris.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07198659 RECRUITING
Unresectable Pancreatic Cancer
The First Affiliated Hospital of Air Force Medicial University
 2025-07-14 EARLY_PHASE1
NCT03500328 ACTIVE_NOT_RECRUITING
Multiple Sclerosis, Relapsing-Remitting
Johns Hopkins University
 2018-05-02
NCT06014658 RECRUITING
Cancer
MBrace Therapeutics
 2023-11-07 PHASE1; PHASE2
NCT03449251 UNKNOWN
Cardiovascular Diseases; Type 2 Diabetes Mellitus
Cambridge University Hospitals NHS Foundation Trust
 2018-03-28 PHASE2
NCT05755048 UNKNOWN
Breast Cancer
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
 2023-03-28 PHASE3
NCT05858970 Not yet recruiting
Optical Biopsy|Colonic Dysplasia|Diagnostic Accuracy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
 2024-04-01 --
NCT06066957 Recruiting
Cytomegalovirus Infections|Transplant-Related Disorder
University of Pennsylvania|Merck Sharp & Dohme LLC
 2024-04-04 Phase 2
NCT05538208 Recruiting
Lupus Nephritis
Children''s Hospital Medical Center Cincinnati|National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)|Genentech Inc.
 2024-01 Phase 2
NCT04776473 Recruiting
Intra-articular Fracture of the Mandibular Condyle
Assistance Publique - Hôpitaux de Paris
 2023-05-03 Not Applicable
NCT01791816 COMPLETED
Vasovagal Syncope; Postural Tachycardia Syndrome
New York Medical College
 2013-02 EARLY_PHASE1
NCT05181215 COMPLETED
Relapsing Remitting Multiple Sclerosis
Banner Life Sciences LLC
 2021-05-14 PHASE1
NCT04022473 COMPLETED
Multiple Sclerosis
Banner Life Sciences LLC
 2019-07-07 PHASE1
NCT03446612 TERMINATED
Anaemia
GlaxoSmithKline
 2019-01-10 PHASE2
NCT04570670 COMPLETED
Relapsing Remitting Multiple Sclerosis
Banner Life Sciences LLC
 2017-01-06 PHASE1
NCT01860911 COMPLETED
Obesity; Insulin Resistance
Mayo Clinic
 2013-04 PHASE1
NCT01689090 COMPLETED
Diabetes Mellitus Type 1; Diabetic Maculopathy
University of Aarhus
 2012-11
NCT00406731 WITHDRAWN
Ocular Physiology; Optic Disk; Regional Blood Flow
Medical University of Vienna
 2008-01 PHASE2
NCT02245165 COMPLETED
Gastrointestinal Motility Disorder; Disturbance of Salivary Secretion
Uppsala University
 2013-06 PHASE1
NCT01617551 UNKNOWN
Essential Hypertension
Regional Hospital Holstebro
 2012-03
NCT00166166 TERMINATED
Hyperlipidemia
Emory University
 2002-07 PHASE2
NCT00914394 TERMINATED
Healthy
Medical University of Vienna
 2010-10
NCT01070940 COMPLETED
Healthy
Regional Hospital Holstebro
 2010-02 PHASE1
NCT00806741 COMPLETED
Healthy
Medical University of Vienna
 2009-09
NCT00759707 COMPLETED
Peripheral Arterial Disease
Brigham and Women's Hospital
 2006-04
NCT00708357 TERMINATED
Ocular Physiology; Regional Blood Flow
Medical University of Vienna
 2005-05 EARLY_PHASE1
NCT00345150 COMPLETED
Hypertension
Regional Hospital Holstebro
 PHASE1
NCT00005107 UNKNOWN
Cirrhosis; Liver Cirrhosis
National Center for Research Resources (NCRR)
 PHASE1
NCT00345137 COMPLETED
ADPKD; Glomerulonephritis
Regional Hospital Holstebro
 PHASE1
NCT00344734 COMPLETED
Congestive Heart Failure
Regional Hospital Holstebro
 PHASE1
NCT00431665 COMPLETED
Renal Circulation; Renal Plasma Flow; Glomerular Filtration Rate; Fatty Acids, Nonesterified
Medical University of Vienna
 1999-07
NCT00344916 COMPLETED
Liver Cirrhosis
Regional Hospital Holstebro
 PHASE1
NCT00431392 COMPLETED
Regional Blood Flow; Ocular Physiology
Medical University of Vienna
 2001-09 PHASE2

(data from https://clinicaltrials.gov, updated on 2025-09-30)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Monomethyl Fumarate acts as a potent agonist of GPR109A, thereby modulating downstream intracellular signaling pathways to attenuate oxidative stress, mitochondrial dysfunction, apoptosis, and autophagy. By suppressing these destructive cellular cascades and preserving tissue integrity, Monomethyl Fumarate demonstrates clinical relevance for mitigating neuroinflammatory pathology in 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.