Monomethyl fumarate
How it works: Calming and slowing immune cells →
Bafiertam
EU: Approved nationally (not via EMA)US: FDA approved 2020
- Molecule type
- Small molecule
- Mechanism (ChEMBL)
- Kelch-like ECH-associated protein 1 inhibitor
- Targets
- Kelch-like ECH-associated protein 1
Approvals
- USBafiertam · Approved28 April 2020 Source
Safety communications
None recorded.
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.
935 reports in total, 127 marked serious.
- Flushing350
- Pruritus110
- Product dose omission issue83
- Nausea76
- Abdominal discomfort65
- Erythema65
- Abdominal pain upper51
- Fatigue47
- Diarrhoea46
- Rash44
Trials
Other trials (5)
Completed small trials, dose-finding studies and trials in other diseases.
- Observational Study of Persistence on Bafiertam Treatment in Routine C
Terminated · Relapsing MS · Stopped
- Observational Study in Patients With Relapsing-Remitting Multiple Scle
Withdrawn · Relapsing MS · Stopped
- Bioequivalence Study of Bafiertam 190 mg and Vumerity® 462 mg Delayed-
Completed · Phase 1 · Relapsing MS · No results found
- Study to Compare GI Tolerability Following Oral Administration of Bafi
Completed · Phase 1 · MS (type not specified) · No results found
- Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Te
Completed · Phase 1 · Relapsing MS · Results posted, not judged
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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