Dimethyl Fumarate: clinical trials recruiting now
3
Recruiting trials
5
Conditions studied
2
US states with sites
9
Countries
FDA drug label
- FDA-approved
- Yes. Dimethyl Fumarate appears in the FDA drug-label database. Marketed as Dimethyl Fumarate.
FDA-approved use
Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Dimethyl fumarate is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults ( 1 )
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control. — Biogen MA Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2020-06-23 |
Phase breakdown
Phase 2 2
Not applicable 1
Conditions being studied
| Condition | Trials |
|---|---|
| Multiple Sclerosis | 2 |
| Alzheimer's Disease | 1 |
| MCI | 1 |
| MCI-AD, Early Stage Alzheimer's Disease | 1 |
| Relapsing-remitting Multiple Sclerosis (RRMS) | 1 |
Recruiting trials involving Dimethyl Fumarate
- A Study of Rocbrutinib in PRL-Positive Relapsing-Remitting Multiple Sclerosis
- Efficacy and Safety of Dimethyl Fumarate Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's Disease
- Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
Common questions
Is Dimethyl Fumarate FDA-approved?
Yes, marketed as Dimethyl Fumarate.
How many recruiting trials involve Dimethyl Fumarate?
3 recruiting trials across 5 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.