Dimethyl fumarate
How it works: Calming and slowing immune cells →
Tecfidera
EU: Approved in the EU since 2014US: FDA approved 2013
- Molecule type
- Small molecule
- Mechanism (ChEMBL)
- Kelch-like ECH-associated protein 1 inhibitor
- Targets
- Kelch-like ECH-associated protein 1
- Availability
- Authorised in all EU and EEA countries. Reimbursement is decided by each country.
Approvals
- USTecfidera · Approved27 March 2013 Source
- EU/EEATecfidera · Authorised30 January 2014 Source
- EU/EEADimethyl fumarate Neuraxpharm · Revoked · Generic13 May 2022 Source
- EU/EEADimethyl fumarate Polpharma · Revoked · Generic13 May 2022 Source
- EU/EEADimethyl fumarate Mylan · Revoked · Generic13 May 2022 Source
- EU/EEADimethyl fumarate Teva · Revoked · Generic12 December 2022 Source
- EU/EEADimethyl fumarate Accord · Revoked · Generic15 February 2023 Source
- EU/EEADimethyl fumarate Mylan · Authorised · Generic22 April 2024 Source
- EU/EEADimethyl fumarate Accord · Authorised · Generic22 April 2024 Source
- EU/EEADimethyl fumarate Neuraxpharm · Authorised · Generic22 April 2024 Source
- EU/EEADimherity · Application withdrawn · Generic Source
Other regulatory events
- Application withdrawn · Dimherity22 February 2022 Source
- Revoked · Dimethyl fumarate Teva13 December 2023 Source
- Revoked · Dimethyl fumarate Neuraxpharm13 December 2023 Source
- Revoked · Dimethyl fumarate Accord13 December 2023 Source
- Revoked · Dimethyl fumarate Polpharma13 December 2023 Source
- Revoked · Dimethyl fumarate Mylan13 December 2023 Source
Safety communications
- EMA safety letter (DHPC) · 12 November 2020
Tecfidera: Type II variation Source
Most-reported side effects (FDA reports)
Reports to the FDA's adverse event system (FAERS) show what people and doctors reported while taking the medicine. They do not prove the medicine caused it, and they are not rates.
3,722 reports in total, 2,266 marked serious.
- Drug ineffective392
- Flushing348
- Multiple sclerosis relapse235
- Fall228
- Fatigue179
- Diarrhoea175
- Multiple sclerosis163
- Nausea160
- Therapy interrupted130
- Gait disturbance126
Trials
Key trials
Large trials with a reported result on their main goal.
- Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfid
Terminated · Phase 3 · Relapsing MS · Stopped: safety
- An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian S
Completed · Phase 3 · Relapsing MS · Met its main goal
- BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sc
Completed · Phase 3 · Relapsing MS · Main goal was not benefit
- Efficacy and Safety Study of Oral BG00012 With Active Reference in Rel
Completed · Phase 3 · Relapsing MS · Met its main goal
- Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sc
Completed · Phase 3 · Relapsing MS · Met its main goal
Running now
- A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dime
Not yet recruiting · Phase 3 · Relapsing MS · Still running
- A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Mai
Recruiting · Phase 3 · Relapsing and progressive · Still running
- Disease Modifying Therapies Withdrawal in Inactive Relapsing-remitting
Not yet recruiting · Phase 3 · Relapsing MS · Still running
- A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Part
Running, not recruiting · MS (type not specified) · Still running
- Pregnancy Exposure Registry for Vumerity (Diroximel Fumarate)
Recruiting · Relapsing MS · Still running
- Prospective Evaluation of De-Escalation From antiCD-20 Therapies to Di
Running, not recruiting · Relapsing MS · Still running
- Disease Modifying Therapies Withdrawal in Inactive Secondary Progressi
Running, not recruiting · Phase 3 · Progressive MS · Still running
Other trials (58)
Completed small trials, dose-finding studies and trials in other diseases.
- Therapeutic Monitoring of Drugs Used in the Treatment of Multiple Scle
Status unknown · Phase 4 · MS (type not specified) · No results found
- A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Scle
Completed · Phase 4 · Relapsing MS · No results found
- Real World Analysis on Lymphocyte Reconstitution After Lymphopenia in
Completed · Relapsing MS · Paper found, not read
- Effectiveness and Safety of Generic Delayed-Release Dimethyl Fumarate
Completed · Relapsing MS · No results found
- Relationship Between Oral DMT Burden and Adherence in MS
Status unknown · MS (type not specified) · No results found
- Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Incl
Completed · Relapsing MS · Paper found, not read
- Teriflunomide Tecfidera LMCE
Completed · MS (type not specified) · Paper found, not read
- Monitoring of Patients Followed for a Multiple Sclerosis and Treated b
Terminated · Phase 4 · Relapsing and progressive · Stopped
- Fingolimod Versus Dimethyl-fumarate in Multiple Sclerosis
Terminated · Phase 4 · Relapsing MS · Stopped
- Study of Utilization Patterns of Dimethyl Fumarate in Germany
Completed · MS (type not specified) · No results found
For information only, not medical advice. Talk to your neurologist before changing treatment.
Hypotheses involving this medicine
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Lab studies
Lab studies in animals or cells. Results in animals often do not hold in people, and these studies never change the status of an idea.
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