Multiple clinical trials investigate the therapeutic applications and comparative efficacy of fumaric acid formulations across Phase 2 through Phase 4 studies and non-interventional evaluations. Research targets dermatological, autoimmune, metabolic, and hematologic conditions, including plaque psoriasis, psoriasis vulgaris, pustular palmoplantar psoriasis, cutaneous lupus erythematosus, type 2 diabetes mellitus, diabetic neuropathies, and beta-thalassemia. Sponsored by academic institutions, university hospitals, and pharmaceutical entities such as Eli Lilly and Company, LEO Pharma, and Bristol-Myers Squibb, these trials display recruitment statuses ranging from active recruitment and enrollment by invitation to completed status.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05567458 | Recruiting | Beta-thalassemia |
Bristol-Myers Squibb |
2022-10-17 | Phase 2 |
| NCT05278559 | Enrolling by invitation | HIV/AIDS |
Centre for Sexual Health and HIV/AIDS Research Zimbabwe|European and Developing Countries Clinical Trials Partnership (EDCTP) |
2022-03-24 | -- |
| NCT05247034 | Recruiting | Diabetic Neuropathies |
Anahuac University|Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado |
2021-06-04 | Not Applicable |
| NCT04208529 | Enrolling by invitation | Beta-Thalassemia|Thalassemia|Sickle Cell Disease|Hematologic Diseases|Hemoglobinopathies|Genetic Diseases Inborn|Sickle Cell Anemia |
Vertex Pharmaceuticals Incorporated|CRISPR Therapeutics |
2021-01-20 | Phase 3 |
| NCT03331835 | COMPLETED | Psoriasis Vulgaris |
LEO Pharma |
2017-11-03 | PHASE4 |
| NCT02951533 | COMPLETED | Psoriasis |
Janssen-Cilag G.m.b.H |
2016-12-12 | PHASE3 |
| NCT02634801 | COMPLETED | Plaque Psoriasis |
Eli Lilly and Company |
2016-01-20 | PHASE3 |
| NCT02474082 | COMPLETED | Psoriasis |
Novartis Pharmaceuticals |
2015-04 | PHASE3 |
| NCT01321164 | COMPLETED | Plaque Psoriasis |
Medical University of Vienna |
2011-04 | PHASE3 |
| NCT01352988 | COMPLETED | Lupus Erythematosus, Cutaneous |
University Hospital Muenster |
2011-07 | PHASE2 |
| NCT01088165 | UNKNOWN | Psoriasis; Cardiovascular Diseases; Diabetes Mellitus, Type 2 |
Medical University of Vienna |
2010-05 | PHASE4 |
| NCT00811005 | UNKNOWN | Pustular Palmoplantar Psoriasis |
Medical University of Vienna |
2008-10 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
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>).