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Tecfidera (DIMETHYL FUMARATE)
Tecfidera works by activating the hydroxycarboxylic acid receptor 2, which helps to reduce inflammation and modulate the immune system.
Tecfidera (dimethyl fumarate) is a small molecule modality developed by Biogen Inc, targeting the hydroxycarboxylic acid receptor 2. It is FDA-approved for treating plaque psoriasis and relapsing-remitting multiple sclerosis. Tecfidera is available as a generic medication, with 17 generic manufacturers. Key safety considerations include gastrointestinal and hematologic adverse effects. As a commercial product, Tecfidera is no longer patented.
At a glance
| Generic name | DIMETHYL FUMARATE |
|---|---|
| Sponsor | Biogen |
| Drug class | dimethyl fumarate |
| Target | Hydroxycarboxylic acid receptor 2 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2013 |
| Annual revenue | 2800 |
Mechanism of action
The mechanism by which dimethyl fumarate (DMF) exerts its therapeutic effect in multiple sclerosis is unknown. DMF and the metabolite, monomethyl fumarate (MMF), have been shown to activate the Nuclear factor (erythroid-derived 2)-like (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress. MMF has been identified as nicotinic acid receptor agonist in vitro.
Approved indications
- Plaque psoriasis
- Relapsing remitting multiple sclerosis
Common side effects
- Flushing
- Abdominal pain
- Diarrhea
- Nausea
- Vomiting
- Pruritus
- Rash
- Albumin urine present
- Erythema
- Dyspepsia
- Aspartate aminotransferase increased
- Liver function abnormalities
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)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tecfidera CI brief — competitive landscape report
- Tecfidera updates RSS · CI watch RSS
- Biogen portfolio CI