Last reviewed · How we verify
Tecfidera
At a glance
| Generic name | Tecfidera |
|---|---|
| Also known as | dimethyl fumarate, Dimethyl fumarate |
| Sponsor | EMD Serono Research & Development Institute, Inc. |
| Target | Hydroxycarboxylic acid receptor 2, Kelch-like ECH-associated protein 1 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Approved indications
- Plaque psoriasis
- Relapsing remitting multiple sclerosis
Common side effects
- Flushing
- Abdominal pain
- Diarrhea
- Nausea
- Vomiting
- Dyspepsia
- Elevated hepatic transaminases
- Eosinophilia
Serious adverse events
- Progressive multifocal leukoencephalopathy
- Anaphylaxis
- Angioedema
- Herpes zoster infection
- Serious opportunistic infections
- Acute pancreatitis
- Gastrointestinal perforation
- Gastrointestinal ulceration
- Gastrointestinal obstruction
- Gastrointestinal hemorrhage
Key clinical trials
- A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS) (PHASE3)
- Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
- A Non-interventional Study Evaluating Clinical Utility and Implications on Improved Patient Management of Serum Neurofilament as a Prognostic Marker for Disease Activity in Patients With Relapsing Multiple Sclerosis
- A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis
- Clinical Study for Dimethyl Fumarate in Preserving Islet β-Cell Function in Type 1 Diabetes Mellitus (PHASE3)
- Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS (PHASE3)
- Study of the Mechanisms of Action of Cladribine in Multiple Sclerosis (NA)
- Long-Term Analysis of DImethyl Fumarate, to Slow the Growth of Areas of Geographic Atrophy (PHASE2)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |