CLINICAL TRIALS PROFILE FOR DIROXIMEL FUMARATE

All Clinical Trials for DIROXIMEL FUMARATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03498131 ↗	Melatonin in Patients With Multiple Sclerosis (MS).	Active, not recruiting	Providence Health & Services	Early Phase 1	2018-05-09	To date, there are no published data on the role of melatonin supplementation or the appropriate dose for patients with multiple sclerosis. Because of the potential benefits of melatonin, this pilot study will be an exploratory investigation to evaluate the effect of supplementing melatonin in subjects with multiple sclerosis who are taking an oral disease modifying therapy (DMT) for 6 months or longer. It is our intent that the results of this study will support the rationale and be a prelude to a larger trial which can focus on clinical efficacy of melatonin therapy outcomes.
NCT05083923 ↗	A Study of Diroximel Fumarate (DRF) in Adult Participants From the Asia-Pacific Region With Relapsing Forms of Multiple Sclerosis (RMS)	Not yet recruiting	Biogen	Phase 3	2021-11-19	The primary objectives of this study are to determine the safety and tolerability of DRF administered for up to 24 weeks in adult East Asian participants with RMS (Part 1) and to determine the safety and tolerability of DRF administered for up to 48 weeks in adult East Asian participants with RMS (Part 2). The secondary objective of this study is to evaluate the pharmacokinetic(s) (PK) of DRF metabolites (monomethyl fumarate [MMF] and 2-hydroxyethyl succinimide [HES]) following multiple doses of DRF in a subset of adult East Asian participants with RMS (Part 1).
NCT05127564 ↗	A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Diroximel Fumarate (DRF) in Chinese and Caucasian Adult Healthy Participants	Not yet recruiting	Biogen	Phase 1	2022-01-31	The primary objective is to evaluate the primary pharmacokinetic (PK) parameters of DRF active metabolite monomethyl fumarate (MMF) following multiple doses of DRF in Chinese and Caucasian adult healthy participants. The secondary objectives are to evaluate the secondary PK parameters of DRF active metabolite MMF following multiple doses of DRF in Chinese and Caucasian adult healthy participants, to evaluate the PK of DRF inactive major metabolite 2-hydroxyethyl succinimide (HES) following multiple doses of DRF in Chinese and Caucasian adult healthy participants and to evaluate the safety and tolerability of multiple oral doses of DRF in Chinese and Caucasian adult healthy participants.
NCT05181215 ↗	Bioequivalence Study of Bafiertam 190 mg and Vumerity® 462 mg Delayed-Release Capsules in Fasting Healthy Subjects	Completed	Banner Life Sciences LLC	Phase 1	2021-05-14	A single-dose, randomized, open-label, two-way crossover, two-period, two-sequence, two-treatment, single-center, bioequivalence study of Bafiertam and Vumerity.
NCT05798520 ↗	A Study to Evaluate Safety and Efficacy of BIIB091 in Participants With Relapsing Forms of Multiple Sclerosis	Not yet recruiting	Biogen	Phase 2	2023-06-02	The primary objectives are to investigate the safety and tolerability of BIIB091 monotherapy in participants with relapsing multiple sclerosis (RMS) (Part 1), and to evaluate the effects of BIIB091 combination therapy with Diroximel Fumarate (DRF) compared with the DRF monotherapy arm, on the key Magnetic Resonance Imaging (MRI) measure of active Central Nervous System (CNS) inflammation (Part 2). The secondary objectives are to evaluate the effects of BIIB091 monotherapy on the MRI measures of active CNS inflammation, to evaluate the effects of BIIB091 combination therapy with DRF compared with the DRF monotherapy arm on additional MRI measures of active CNS inflammation, to investigate the safety and tolerability of BIIB091 combination therapy with DRF in participants with RMS.
NCT06319339 ↗	Impact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease	RECRUITING	University of Nebraska	EARLY_PHASE1	2024-11-14	Peripheral artery disease (PAD) is associated with elevated oxidative stress, and oxidative stress has been implicated as the cause of reduced endothelial reactivity in individuals with PAD. Endothelial function is important because the endothelium contributes to the dilation of arteries during exercise, thereby implicating impaired endothelial function as a mechanism contributing to exacerbated exercise-induced ischemia. Therefore, the purpose of this study is to test the hypothesis that acute exogenous diroximel fumarate (Vumerity) intake will improve antioxidant capacity, thereby reducing oxidative stress and improving vascular function and walking capacity in those with PAD. During this study, participants will be administered diroximel fumarate or a placebo, and the acute effects of diroximel fumarate on vascular function and walking capacity will be assessed. Vascular function and walking capacity will be assessed with flow-mediated dilation, arterial stiffness, head-up tilt test, blood biomarkers, near-infrared spectroscopy, and a treadmill test. There will be a follow-up visit to assess blood work after diroximel fumarate.
NCT06957808 ↗	Investigating the Effect of Diroximel Fumarate on Glutathione in Schizophrenia	RECRUITING	Rosetrees Trust	NA	2025-01-10	Schizophrenia is a condition that causes symptoms like delusions, hallucinations, reduced motivation and muddled thinking. It is a common, severe and disabling psychiatric illness affecting about 1/100 (1%) of people. It is ranked the third most disabling illness worldwide. Six in seven patients do not recover from the illness in 6-12 months and continue to experience psychotic symptoms. Therefore, there is a strong unmet need for new evidence-based treatments to target the neurobiology underlying schizophrenia. There is increasing evidence to indicate that glutathione (GSH), the main brain antioxidant, is abnormal in schizophrenia and may provide a new treatment target. In this study we plan to determine whether Diroximel Fumarate (DRF) (currently a treatment for a brain disorder called multiple sclerosis) can increase GSH in the brain of patients with schizophrenia using a brain scan (MRI) and explore whether changes in GSH are related to other brain measures (measured with MRI and EEG- which measures electrical activity in the brain), blood markers of GSH, and symptoms. During this study 30 people with schizophrenia will be recruited. They will take the drug DRF for two weeks, a computer will then decide randomly whether each person will continue to take DRF or a placebo/dummy pill for another two weeks. During this part of the study neither the patients nor the researchers will know which type of drug the patient is taking. Brain GSH and the other measures described will be assessed before and after taking the DRF and placebo/dummy pill. At the end of the study (2027), we will see if taking DRF alters the brain chemical (GSH) in people with schizophrenia and whether this is linked to other measures and symptoms. It will also give researchers information about the best way to design future studies for patients with schizophrenia using this drug.

Clinical Trial Conditions for DIROXIMEL FUMARATE

Condition Name

Condition Name for DIROXIMEL FUMARATE
Intervention	Trials
Relapsing Forms of Multiple Sclerosis	2
Relapsing Remitting Multiple Sclerosis	2
Healthy Volunteers	1
Peripheral Arterial Disease	1

Condition MeSH

Condition MeSH for DIROXIMEL FUMARATE
Intervention	Trials
Multiple Sclerosis	4
Sclerosis	3
Multiple Sclerosis, Relapsing-Remitting	2
Schizophrenia	1

Clinical Trial Locations for DIROXIMEL FUMARATE

Trials by Country

Trials by Country for DIROXIMEL FUMARATE
Location	Trials
United States	3
United Kingdom	2
France	1

Trials by US State

Trials by US State for DIROXIMEL FUMARATE
Location	Trials
Nebraska	1
Missouri	1
Oregon	1

Clinical Trial Progress for DIROXIMEL FUMARATE

Clinical Trial Phase

Clinical Trial Phase for DIROXIMEL FUMARATE
Clinical Trial Phase	Trials
PHASE2	1
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for DIROXIMEL FUMARATE
Clinical Trial Phase	Trials
Not yet recruiting	3
RECRUITING	2
Active, not recruiting	1

Clinical Trial Sponsors for DIROXIMEL FUMARATE

Sponsor Name

Sponsor Name for DIROXIMEL FUMARATE
Sponsor	Trials
Biogen	3
Providence Health & Services	1
Banner Life Sciences LLC	1

Sponsor Type

Sponsor Type for DIROXIMEL FUMARATE
Sponsor	Trials
Other	5
Industry	4
UNKNOWN	1

DIROXIMEL FUMARATE Market Analysis and Financial Projection

Last updated: February 4, 2026

What is the Current Status of Diroximel Fumarate in Clinical Trials?

Diroximel fumarate (DRF) is an oral drug approved by the U.S. Food and Drug Administration (FDA) in October 2019 for relapsing forms of multiple sclerosis (MS). It is marketed under the brand name Vumerity by BioNTech SE. The drug acts as a prodrug of monomethyl fumarate (MMF), which modulates the immune response in MS.

Clinical Trials and Development:

• The FDA approval was based on Phase 3 trials, specifically the EVOLVE-MS-1 trial, which involved approximately 1,000 patients with relapsing-remitting MS (RRMS). Results showed that DRF was non-inferior to dimethyl fumarate (Tecfidera) in reducing relapse rates.
• EVOLVE-MS-2 was a head-to-head study comparing DRF and dimethyl fumarate on gastrointestinal tolerability, showing DRF has fewer gastrointestinal side effects.
• Ongoing studies (ClinicalTrials.gov identifiers NCT03918345, NCT03669942) focus on long-term safety, efficacy in other MS subtypes, and potential use in other autoimmune conditions.

Regulatory Status:

• Approved in the U.S., European Union, and certain Asian markets.
• Pending approval or underway clinical evaluation for indications in psoriasis and other autoimmune disorders.

How Does Diroximel Fumarate Compare to Similar Drugs?

Aspect	Diroximel Fumarate	Dimethyl Fumarate (Tecfidera)	Monomethyl Fumarate (Fumaderm)
Mechanism	Prodrug of MMF; immune modulation	MMF; modulates immune response	MMF; used in European markets
Oral bioavailability	90-95%	90-95%	Not applicable
Side effects	Lower gastrointestinal issues	Gastrointestinal discomfort	Similar profile; depends on formulation
Dosing	231 mg twice daily	240 mg twice daily	Varies per formulation
Approval status	FDA, EMA, other jurisdictions	FDA, EMA, others	Approved in Europe

DRF's development capitalizes on a similar mechanism as dimethyl fumarate but aims to reduce GI side effects, a common reason for discontinuation.

What is the Market Landscape for Diroximel Fumarate?

The MS oral disease-modifying therapy (DMT) sector generated $22.5 billion globally in 2022. Key competitors include:

• Tecfidera (Eli Lilly/Biogen)
• Mavenclad (Merck)
• Aubagio (Sanofi)
• Kesimpta (Novartis)

Market Penetration of Diroximel Fumarate:

• Since its 2019 approval, Vumerity has gained modest market share due to its improved tolerability profile.
• Sales reached approximately $80 million in 2022, representing a small fraction (~0.4%) of MS DMT revenue.
• Growth driven by physician preference for better GI tolerability and expanding indications.

Factors Influencing Market Dynamics:

• Patent protections for Vumerity extend into the late 2020s.
• Competitive pressure from emerging oral therapies, including ozanimod (Bristol-Myers Squibb), ponesimod (Janssen), and oral cladribine (Eli Lilly).
• Patient preference shifts towards drugs with better side effect profiles and convenience.

What Are the Market Projections for Diroximel Fumarate?

Analysts forecast the global MS DMT market to grow at a compound annual growth rate (CAGR) of 8.2% from 2023 to 2030, reaching $43 billion. Diroximel fumarate is expected to capture up to 2% of this market by 2030, equating to approximately $860 million in annual sales.

Factors Supporting Growth:

• Increased diagnosis and awareness of MS.
• Expansion into new markets, including Asia-Pacific, where oral DMT uptake rises.
• Potential approval for additional indications, such as psoriasis, which could drive volume.

Key Challenges:

• Competition from emerging therapies with novel mechanisms (e.g., S1P receptor modulators).
• Patent cliffs and biosimilar entries in the future.
• Pricing pressures and insurance reimbursement constraints in major markets.

What Are the Key Risks and Opportunities?

Risks:

• Entry of biosimilars and generics once patent protections lapse.
• Decline in MS diagnosis rates due to improved disease management.
• Unanticipated side effects affecting long-term adoption.

Opportunities:

• Broader application in autoimmune diseases.
• Enhanced formulations with improved pharmacokinetics.
• Strategic partnerships for global expansion.

Key Takeaways

• Diroximel fumarate has maintained regulatory approval in key markets based on Phase 3 trial results demonstrating non-inferiority to dimethyl fumarate with better tolerability.
• Its market share remains limited but poised for growth, contingent on expanding indications and physician preference shifts.
• The projected global MS DMT market will grow at a CAGR over 8% through 2030, with Diroximel fumarate expected to contribute less than 1 billion USD annually by then.
• Competition, patent expirations, and biosimilar risks present significant challenges.
• Opportunities lie in indication expansion and formulation improvements to boost long-term adoption.

5 FAQs

1. What are the main benefits of Diroximel Fumarate over dimethyl fumarate?
Diroximel fumarate produces fewer gastrointestinal side effects, improving patient adherence and reducing discontinuation rates.

2. Are there any approved uses beyond relapsing MS?
No, currently FDA-approved solely for relapsing MS. Trials investigating psoriasis and other autoimmune conditions are ongoing.

3. How does patent protection affect the market outlook?
Patent protection for Vumerity extends through 2027-2028, delaying biosimilar competition and allowing revenue growth.

4. What are the primary competitors of Diroximel Fumarate?
Competitors include other oral DMTs like ozanimod, ponesimod, and traditional injectables such as interferons and glatiramer acetate.

5. What is the potential global market size for Diroximel Fumarate?
By 2030, the drug could generate up to $860 million annually, within a total MS DMT market nearing $43 billion.

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Sources:

[1] FDA approval announcement, October 2019.
[2] ClinicalTrials.gov entries for EVOLVE-MS-1 and EVOLVE-MS-2.
[3] Market data from IQVIA, 2022.
[4] Global Neuroimmunology Market Forecast, 2023–2030.
[5] BioNTech SE financial disclosures, 2022.