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Molecule

Diroximel

Also known as diroximel fumarate
Available on requestImmunology and transplant
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Diroximel is a prescription medicine indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. MedsAcross supplies Diroximel for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

ATC classification
L04AX07 Dimethyl · Immunosuppressive drug, subgroup L04AX
US FDA first approval
29 October 2019
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Capsule
Identifiers
UNII K0N0Z40J3WCAS 1577222-14-0DrugBank DB14783Q27281786

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

VUMERITY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Source: US FDA prescribing information

How it works

The mechanism by which diroximel fumarate exerts its therapeutic effect in multiple sclerosis is unknown. MMF, the active metabolite of diroximel fumarate, has been shown to activate the nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans. The Nrf2 pathway is involved in the cellular response to oxidative stress. MMF has been identified as a nicotinic acid receptor agonist in vitro.

Source: US FDA prescribing information

Dosing overview

Blood tests are required prior to initiation of VUMERITY. Starting dose: 231 mg twice a day, orally, for 7 days. Maintenance dose after 7 days: 462 mg (administered as two 231 mg capsules) twice a day, orally. Swallow VUMERITY capsules whole and intact. Do not crush, chew, or sprinkle capsule contents on food. Avoid administration of VUMERITY with a high-fat, high-calorie meal/snack. Avoid co-administration of VUMERITY with alcohol

Source: US FDA prescribing information

Contraindications

VUMERITY is contraindicated in patients With known hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY. Reactions may include anaphylaxis and angioedema. Taking dimethyl fumarate. Known hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY. Co-administration with dimethyl fumarate

Source: US FDA prescribing information

Warnings and precautions

Anaphylaxis and Angioedema: Discontinue and do not restart VUMERITY if these occur. Progressive Multifocal Leukoencephalopathy (PML): Withhold VUMERITY at the first sign or symptom suggestive of PML. Herpes Zoster and Other Serious Opportunistic Infections: Consider withholding VUMERITY in cases of serious infection until the infection has resolved. Lymphopenia: Obtain a CBC including lymphocyte count before initiating VUMERITY, after 6 months, and every 6 to 12 months thereafter. Consider interruption of VUMERITY if lymphocyte counts <0.5 × 10 9 /L persist for more than six months. Liver Injury: Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels before initiating VUMERITY and during treatment, as clinically indicated. Discontinue VUMERITY if clinically significant liver injury induced by VUMERITY is suspected.

Source: US FDA prescribing information

Side effects

The following important adverse reactions are described elsewhere in labeling: Anaphylaxis and Angioedema Progressive Multifocal Leukoencephalopathy Herpes Zoster and Other Serious Opportunistic Infections Lymphopenia Liver Injury Flushing Serious Gastrointestinal Reactions Most common adverse reactions (incidence for dimethyl fumarate [which has the same active metabolite as VUMERITY] ≥10% and ≥2% more than placebo) were flushing, abdominal pain, diarrhea, and nausea.

Source: US FDA prescribing information

Interactions

Concomitant Dimethyl Fumarate VUMERITY is contraindicated in patients currently taking dimethyl fumarate, which is also metabolized to monomethyl fumarate. VUMERITY may be initiated the day following discontinuation of dimethyl fumarate.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Diroximel, sorted by availability.

MedicineManufacturerRegisterAvailability
Vumerity 231 mg capsuleOralBiogenUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 29 October 2019Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Diroximel available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Diroximel and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Diroximel have?

The catalogue lists 1 brand names for Diroximel, including Vumerity.

Is Diroximel approved by the US FDA?

Yes. The US FDA first approved Diroximel on 29 October 2019, according to Drugs@FDA.

Is Diroximel authorised in the European Union?

Yes. Diroximel has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Diroximel need cold chain shipping?

No listed presentation of Diroximel is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Diroximel in?

Diroximel is classified under ATC code L04AX07 (Dimethyl).

References

  1. Vumerity prescribing information (Biogen). U.S. National Library of Medicine, DailyMed. Retrieved 29 May 2025
  2. Vumerity: European public assessment report (EPAR). European Medicines Agency. Retrieved 6 August 2026

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