Bafiertam (monomethyl fumarate) for multiple sclerosis
Last updated May 30, 2025, by Lindsey Shapiro, PhD
Fact-checked by Ines Martins, PhD
What is Bafiertam for MS?
Bafiertam (monomethyl fumarate) is an oral therapy that’s approved in the U.S. for adults with relapsing forms of multiple sclerosis, such as clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS).
A disease-modifying therapy, marketed by Banner Life Sciences, Bafiertam is used to reduce relapse rates, prevent the development of new lesions, and delay disability progression among patients. It is taken twice daily as oral capsules.
The exact mechanism through which Bafiertam works in MS isn’t fully known, but its active ingredient, monomethyl fumarate (MMF), is thought to alter the activity of immune cells to reduce the inflammation that drives MS. It also exerts antioxidant effects that safeguard nerve cells against damage.
MMF is also the active ingredient in other MS therapies, including Tecfidera (dimethyl fumarate) and Vumerity (diroximel fumarate), but these medications deliver inert precursors that are converted to MMF once they reach the gastrointestinal tract.Â
Bafiertam is a bioequivalent alternative to Tecfidera, meaning it delivers the same amount of the active ingredient and is expected to have the same therapeutic effect. By directly delivering the active molecule, however, it is designed to have fewer side effects.
Therapy Snapshot
| Brand Name: | Bafiertam |
| Chemical Name: | Monomethyl fumarate |
| Usage: | Used to reduce disease activity and delay disability progression in relapsing forms of MS |
| Administration: | Oral capsules |
Who can take Bafiertam?
Bafiertam is approved in the U.S. for adults with CIS, RRMS, and active SPMS.
The medication is contraindicated for certain people:
- Those with a history of hypersensitivity reactions, which are a type of exaggerated immune responses that include allergic reactions, to MMF, dimethyl fumarate, diroximel fumarate, or any of the ingredients in Bafiertam should not take the medication.
- The medication is not recommended for anyone already taking Tecfidera, a generic formulation of Tecfidera, or Vumerity.
How is Bafiertam administered?
Bafiertam comes in delayed-release oral capsules that are taken at a recommended dose of 190 mg (two capsules) twice daily.
However, in the first week of treatment, patients usually receive half of that dose — 95 mg twice daily — before increasing to the recommended dose. Patients may sometimes temporarily go back to the lower dose if a healthcare provider recommends that strategy to ease side effects.
The capsules are swallowed whole and can be taken with or without food, although without food may be preferable if gastrointestinal side effects occur. A healthcare provider may recommend taking aspirin before Bafiertam to reduce flushing, or skin reddening.
Bafiertam in clinical trials
Bafiertam’s approval in the U.S. was based on the same Phase 3 clinical trials that supported Tecfidera’s approval, as well as Phase 1 studies that established Bafiertam’s bioequivalence to Tecfidera and its gastrointestinal side effect profile in healthy adults.
- The Phase 3 DEFINE (NCT00420212) and CONFIRM (NCT00451451) trials investigated Tecfidera against a placebo in adults with RRMS. Data showed that MMF was associated with significant reductions in relapse rates and lesions, and the medication also slowed disability progression by as much as 38% compared with the placebo.
- A bioequivalence Phase 1 trial (NCT04570670) compared the pharmacological properties of Bafiertam versus Tecfidera in healthy adults. Those findings indicated that both drugs delivered the same amount of MMF and at the same rate, establishing Bafiertam as a bioequivalent of Tecfidera.
- Another Phase 1 trial (NCT04022473), this one involving healthy adults, investigated the gastrointestinal side effects of Bafiertam versus Tecfidera. For the entire study duration, the incidence and duration of gastrointestinal symptoms tended to be lower with Bafiertam, but failed to reach statistical significance. However, the proportion of patients experiencing moderate to extreme gastrointestinal side effects was significantly lower with Bafiertam after a few weeks of treatment.
Bafiertam side effects
Data on the side effects associated with Bafiertam are based largely on Tecfidera clinical trials. The most common ones include:
- flushing
- abdominal pain
- diarrhea
- nausea.
In most cases, flushing and gastrointestinal side effects ease over time on treatment. However, for some patients, these side effects may be severe or lead to more serious complications. For those people, treatment may have to be stopped.
Other less common, but serious, side effects that may occur while on treatment with Bafiertam include:
- anaphylaxis, a severe allergic reaction that may cause swelling of the tongue and throat and be life-threatening
- serious infections, including progressive multifocal leukoencephalopathy, a potentially fatal brain infection
- low immune cell counts
- liver injury.
Healthcare providers will run blood tests to check immune cell counts and liver health before Bafiertam is started. If any complications occur during treatment, Bafiertam may have to be paused or discontinued permanently.
Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
FAQs about Bafiertam
Bafiertam received its final approval from the U.S. Food and Drug Administration in April 2020 for treating adults with relapsing forms of multiple sclerosis (MS). It is indicated for clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.
There aren’t yet adequate clinical data on the use of Bafiertam in pregnancy, but animal studies suggest it could cause fetal harm. Clinical data on the use of Tecfidera (dimethyl fumarate) — which has the same active ingredient as Bafiertam — during pregnancy did not find any increased risk of adverse effects on the mother or fetus. Patients who become or plan to become pregnant while using Bafiertam should discuss the medication’s use with their healthcare team.
No food or alcohol restrictions are noted for people using Bafiertam, according to its developer Banner Life Sciences, but people taking other medications with the same active ingredient are advised not to drink alcohol at the same time as they’re taking the medication. As both Bafiertam and alcohol can cause damage to the liver, and alcohol could exacerbate disease symptoms, patients are advised to talk with a healthcare provider about whether drinking alcohol is safe in their case.
Because each patient will have a different disease experience, responses to treatment also will vary. Patients are advised to speak with their healthcare providers about how Bafiertam may help in their case.
Neither weight gain nor hair loss were reported as side effects of Bafiertam in clinical trials, but there are reports of hair loss in people who received the therapy’s active ingredient in real-world settings. Patients who experience unanticipated effects from treatment should discuss them with their healthcare team.
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