Vumerity (diroximel fumarate) for multiple sclerosis

Last updated June 13, 2025, by Lindsey Shapiro, PhD
Fact-checked by Inês Martins, PhD

What is Vumerity for MS?

Vumerity (diroximel fumarate) is an approved oral therapy that’s used to prevent relapses, reduce disease activity, and delay disability progression in people with relapsing forms of multiple sclerosis (MS).

Taken as twice-daily capsules, the disease-modifying treatment is approved in the U.S. for clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS).

Vumerity contains an inactive molecule called diroximel fumarate, which is converted into its active form, monomethyl fumarate (MMF), once inside the body. Although MMF’s therapeutic mechanisms remain incompletely understood, it’s believed to reduce MS-driving inflammation by altering immune cell activity, and to have antioxidant properties that protect against neuronal damage.

Vumerity is marketed by Biogen as a next-generation option to its older therapy, Tecfidera (dimethyl fumarate). Vumerity delivers a comparable amount of MMF and works similarly to Tecfidera, but has been shown to cause fewer gastrointestinal side effects.

Therapy snapshot

Who can take Vumerity?

Vumerity is approved in the U.S. to treat adults with CIS, RRMS, and active SPMS.

It is contraindicated for people:

• who have experienced hypersensitivity reactions — abnormal immune reactions that may include severe allergic reactions — to diroximel fumarate, dimethyl fumarate, or any of the ingredients in Vumerity
• who are already taking Tecfidera or a generic formulation of Tecfidera.

Vumerity is also not recommended for people with moderate or severe kidney impairment.

The medication is also approved in other countries, but indications vary. In the European Union, for example, it is only cleared for adults with RRMS.

How is Vumerity administered?

Vumerity comes in delayed-release capsules, which must be swallowed whole and intact.

The recommended maintenance dose is 462 mg, taken as two capsules twice daily, but patients usually will receive a smaller dose of 231 mg twice daily for the first week. If patients fail to tolerate the maintenance dose, they may temporarily decrease their daily dosage at a doctor’s discretion.

Vumerity capsules can be taken with or without food, but high-fat, high-calorie meals and alcohol should be avoided. A doctor may recommend taking the medication with food or aspirin to reduce the incidence or severity of flushing — warmth, redness, itching, or burning sensation in the skin — which is a common side effect of the medication.

Vumerity in clinical trials

Vumerity’s approval in the U.S. was based on efficacy data from the same Phase 3 clinical trials that supported the approval of Tecfidera, as well as other studies that compared Vumerity with Tecfidera in healthy volunteers and in people with relapsing forms of MS.

• The Phase 3 DEFINE (NCT00420212) and CONFIRM (NCT00451451) trials investigated Tecfidera against a placebo in more than 2,400 adults with RRMS. Data showed that Tecfidera significantly reduced relapse rates and lesions, while also slowing disability progression by up to 38%.
• A Phase 1 trial (NCT02201849) evaluated the safety, tolerability, and pharmacological profile of Vumerity versus Tecfidera or a placebo in healthy volunteers. Results demonstrated that Tecfidera and Vumerity delivered the same amount of MMF and worked much the same way in the body, but that Vumerity had a more favorable gastrointestinal side effect profile.
• A Phase 3 trial called EVOLVE-MS-2 (NCT03093324) then compared the safety and efficacy of Vumerity against those of Tecfidera in adults with RRMS. Consistent with the Phase 1 findings, Vumerity was associated with fewer and less severe gastrointestinal side effects and improved life quality compared with Tecfidera.
• The open-label EVOLVE-MS-1 study (NCT02634307) enrolled people who had completed the five-week treatment period in EVOLVE-MS-2 and other patients who had not participated in any Vumerity clinical trial. Over about two years of treatment, most participants remained free from relapses (82.4%) and confirmed disability progression (90.2%). The number of lesions with active inflammation, as well as new or enlarging lesions, was also reduced after two years.

Vumerity side effects

The most common side effects reported on Vumerity’s label are based on data from Tecfidera clinical trials. They include:

• flushing
• abdominal pain
• diarrhea
• nausea.

These side effects are often mild or moderate in severity and ease over time, but some people may experience serious reactions and require hospitalization. If that happens, Vumerity may have to be stopped.

Vumerity also comes with precautions for other potentially serious side effects, many of which are based largely on clinical experience with Tecfidera. If they occur, treatment may have to be paused or discontinued:

• 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 possibly fatal brain infection
• low immune cell counts, which may prompt treatment discontinuation if prolonged
• liver injury.

Blood tests to check immune cell counts and liver function are necessary before starting treatment and periodically while using Vumerity. Patients should tell their doctors about any existing health issues they have.

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