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 · Approved2013-03-27 Source
- EU/EEATecfidera · Authorised2014-01-30 Source
- EU/EEADimethyl fumarate Neuraxpharm · Revoked · Generic2022-05-13 Source
- EU/EEADimethyl fumarate Polpharma · Revoked · Generic2022-05-13 Source
- EU/EEADimethyl fumarate Mylan · Revoked · Generic2022-05-13 Source
- EU/EEADimethyl fumarate Teva · Revoked · Generic2022-12-12 Source
- EU/EEADimethyl fumarate Accord · Revoked · Generic2023-02-15 Source
- EU/EEADimethyl fumarate Mylan · Authorised · Generic2024-04-22 Source
- EU/EEADimethyl fumarate Accord · Authorised · Generic2024-04-22 Source
- EU/EEADimethyl fumarate Neuraxpharm · Authorised · Generic2024-04-22 Source
- EU/EEADimherity · Application withdrawn · Generic Source
Other regulatory events
- Application withdrawn · Dimherity2022-02-22 Source
- Revoked · Dimethyl fumarate Teva2023-12-13 Source
- Revoked · Dimethyl fumarate Neuraxpharm2023-12-13 Source
- Revoked · Dimethyl fumarate Accord2023-12-13 Source
- Revoked · Dimethyl fumarate Polpharma2023-12-13 Source
- Revoked · Dimethyl fumarate Mylan2023-12-13 Source
Safety communications
- EMA safety letter (DHPC) · 2020-11-12
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.
122,556 reports in total, 40,839 marked serious.
- Flushing17,109
- Nausea8,978
- Diarrhoea8,301
- Multiple sclerosis relapse8,128
- Fatigue6,964
- Multiple sclerosis5,746
- Vomiting5,652
- Memory impairment5,572
- Gastric disorder5,551
- Abdominal pain upper5,418
Trials
Key trials
Large trials with a reported result on their main goal.
- Dimethyl fumarate, phase 3
Terminated · Phase 3 · Relapsing MS · Stopped: safety
- Dimethyl fumarate, phase 3
Completed · Phase 3 · Relapsing MS · Main goal met
- ENDORSE
Completed · Phase 3 · Relapsing MS · Not an efficacy test
- CONFIRM
Completed · Phase 3 · Relapsing MS · Main goal met
- DEFINE
Completed · Phase 3 · Relapsing MS · Main goal met
Running now
- VOYAGE
Not yet recruiting · Phase 3 · Relapsing MS · ongoing
- DESIRE MS
Recruiting · Phase 3 · Relapsing and progressive · ongoing
- TWINS
Not yet recruiting · Phase 3 · Relapsing MS · ongoing
- Dimethyl fumarate
Running, not recruiting · MS (type not specified) · ongoing
- Dimethyl fumarate
Recruiting · Relapsing MS · ongoing
- Dimethyl fumarate
Running, not recruiting · Relapsing MS · ongoing
- STOP-I-SEP
Running, not recruiting · Phase 3 · Progressive MS · ongoing
Other trials (58)
Completed small trials, dose-finding studies and trials in other diseases.
- TDM-MS
Status unknown · Phase 4 · MS (type not specified) · no_result_found
- Dimethyl fumarate, phase 4
Completed · Phase 4 · Relapsing MS · no_result_found
- Lympho-TEC
Completed · Relapsing MS · result_in_paper_unread
- Dimethyl fumarate
Completed · Relapsing MS · no_result_found
- STATURE
Status unknown · MS (type not specified) · no_result_found
- TEC-ADHERE
Completed · Relapsing MS · result_in_paper_unread
- Dimethyl fumarate
Completed · MS (type not specified) · result_in_paper_unread
- SURV-SEP
Terminated · Phase 4 · Relapsing and progressive · stopped_other
- PRAG-MS
Terminated · Phase 4 · Relapsing MS · stopped_other
- Dimethyl fumarate
Completed · MS (type not specified) · no_result_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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