CLINICAL TRIALS PROFILE FOR DIMETHYL FUMARATE

All Clinical Trials for DIMETHYL FUMARATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00420212 ↗	Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis	Completed	Biogen	Phase 3	2007-01-01	To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. To determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for the disease to get worse. The purpose of this study is also to determine the safety of BG00012 and how well it is tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used to assess MS.
NCT00451451 ↗	Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis	Completed	Biogen	Phase 3	2007-06-01	To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. Other goals of the study are to determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for MS to get worse. Other objectives of the study are to determine the safety and tolerability of BG00012, as well as the effect it may have on tests and evaluations used to assess MS. Additionally, glatiramer acetate is being used to compare its benefits and risks with placebo and BG00012.
NCT00835770 ↗	BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)	Completed	Biogen	Phase 3	2009-02-03	The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test.
NCT01156311 ↗	BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis	Completed	Biogen	Phase 2	2010-06-01	The primary objective of the study is to evaluate the safety and tolerability of BG00012 (dimethyl fumarate) administered in combination with interferon b (IFNß) or glatiramer acetate (GA) in participants with relapsing-remitting multiple sclerosis (RRMS).
NCT01568112 ↗	Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate	Completed	Biogen	Phase 3	2012-04-01	The primary objective of the study is to evaluate whether premedication with 325 mg microcoated aspirin (ASA) tablet or a slow-titration dosing schedule of BG00012 reduces the incidence and severity of flushing and GI events following oral administration of BG00012 dosed at 240 mg twice a day (BID) in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BG00012 when administered orally as a 240 mg BID dose regimen with and without 325 mg ASA premedication or following a slow-titration dosing schedule in healthy volunteers.
NCT01815723 ↗	Efficacy Study on Dimethyl Fumarate to Treat Moderate to Severe Plaque Psoriasis	Withdrawn	Forward-Pharma GmbH	Phase 3	2016-06-01	This multicenter, randomised, double-dummy, Fumaderm® and placebo-controlled, parallel-group study will compare the efficacy and safety of 500 mg of FP187 (250 mg twice daily) compared to 720 mg Fumaderm® (240 mg three times daily) over 20 weeks of treatment. After an initial wash-out non-drug treatment phase of 1 to 6 weeks, all patients will receive allocated Study treatment up-titrated to the relevant dose level (i.e., 500 mg daily FP187, 720 mg daily Fumaderm®, or placebo). The up-titration to full dose will last 4 weeks for FP187 and 9 weeks for Fumaderm®. After 20 weeks of treatment, all patients will be asked to enter a separate open label treatment protocol expected to continue for up to 5 years.
NCT01838668 ↗	An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)	Completed	Biogen	Phase 3	2013-03-28	This is a multicenter study conducted in 2 parts: The primary objective in Part I of this study is to determine the efficacy of BG00012 (dimethyl fumarate, DMF) on inflammatory brain magnetic resonance imaging (MRI) lesion activity (Gadolinium-enhancing lesions) when compared with placebo from 4 scans performed at Weeks 12, 16, 20, and 24 in participants with Relapsing Remitting Multiple Sclerosis (RRMS) including participants from the Asia-Pacific region. The secondary objectives in Part I of this study in this study population are to determine whether BG00012, when compared with placebo over 24 weeks, is effective in reducing the cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24; reducing the number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Week 24 compared with Baseline. The primary objective in Part II (open label) of this study is to evaluate the long-term safety profile of BG00012 in eligible participants from Part I.

Clinical Trial Conditions for DIMETHYL FUMARATE

Condition Name

Condition Name for DIMETHYL FUMARATE
Intervention	Trials
Multiple Sclerosis	22
Relapsing-Remitting Multiple Sclerosis	13
Multiple Sclerosis, Relapsing-Remitting	12
Relapsing Remitting Multiple Sclerosis	6

Condition MeSH

Condition MeSH for DIMETHYL FUMARATE
Intervention	Trials
Multiple Sclerosis	53
Sclerosis	45
Multiple Sclerosis, Relapsing-Remitting	30
Ischemic Stroke	3

Clinical Trial Locations for DIMETHYL FUMARATE

Trials by Country

Trials by Country for DIMETHYL FUMARATE
Location	Trials
United States	385
France	42
Canada	34
Germany	30
United Kingdom	30

Trials by US State

Trials by US State for DIMETHYL FUMARATE
Location	Trials
California	18
Florida	17
Texas	17
North Carolina	16
New York	16

Clinical Trial Progress for DIMETHYL FUMARATE

Clinical Trial Phase

Clinical Trial Phase for DIMETHYL FUMARATE
Clinical Trial Phase	Trials
PHASE4	1
PHASE2	2
Phase 4	20

Clinical Trial Status

Clinical Trial Status for DIMETHYL FUMARATE
Clinical Trial Phase	Trials
Completed	36
Terminated	12
RECRUITING	7

Clinical Trial Sponsors for DIMETHYL FUMARATE

Sponsor Name

Sponsor Name for DIMETHYL FUMARATE
Sponsor	Trials
Biogen	47
Xuanwu Hospital, Beijing	4
Banner Life Sciences LLC	2

Sponsor Type

Sponsor Type for DIMETHYL FUMARATE
Sponsor	Trials
Industry	59
Other	45
NETWORK	1

Clinical Trials Update, Market Analysis, and Future Projections for Dimethyl Fumarate

Last updated: October 25, 2025

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Introduction

Dimethyl fumarate (DMF), marketed as Tecfidera by Biogen, has established itself as a cornerstone in the treatment of relapsing-remitting multiple sclerosis (RRMS). Originally approved by the U.S. Food and Drug Administration (FDA) in 2013, it has seen consistent clinical development and evolving market dynamics. As new developments emerge and the competitive landscape shifts, a comprehensive analysis of the current clinical trial landscape, market position, and future projections becomes essential for stakeholders ranging from pharmaceutical companies to healthcare investors.

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Clinical Trials Landscape for Dimethyl Fumarate

Ongoing and Recent Clinical Trials

The clinical evaluation of DMF extends beyond its initial indications, with research focused on expanding its therapeutic applications. According to ClinicalTrials.gov, over 40 studies involving DMF are active or completed, spanning indications including multiple sclerosis, psoriasis, and potential neuroprotective effects.

• Multiple Sclerosis (MS): The most extensive and mature data center around MS. Recent trials have explored the efficacy of DMF in secondary progressive MS (SPMS) and primary progressive MS (PPMS). For instance, the ongoing PROTECT-MS trial assesses neuroprotective effects when used early in RRMS to prevent remyelination failure [1].

• Psoriasis and Dermatological Conditions: Some early-phase trials are evaluating DMF's efficacy in psoriasis, leveraging its immunomodulatory properties. A phase II trial demonstrated promising results, although further validation is needed before regulatory approval [2].

• Neuroprotective and Other Indications: Preclinical studies suggest DMF may exert neuroprotective effects via Nrf2 pathway activation, prompting trials in Parkinson's disease and Alzheimer's disease models. However, these are predominantly at preclinical or early-phase stages.

Safety and Efficacy Data Updates

Recent trials reinforce the safety profile established in initial approvals. A 2022 post-marketing surveillance study involving over 10,000 patients reaffirmed common adverse events such as flushing, gastrointestinal disturbances, and lymphopenia but confirmed a manageable risk profile with proper monitoring [3].

Efficacy data continue to support DMF’s role in reducing annualized relapse rate (ARR) in RRMS. The DEFINE and ENDORSE trials reported a 50-55% reduction in ARR and significant MRI lesion reduction, underpinning its status as a first-line DMT (Disease-Modifying Therapy) [4].

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Market Analysis

Current Market Size

The global MS therapeutics market, valued at approximately USD 23 billion in 2022, has seen DMF commanding around 15-20% market share, primarily driven by its oral administration advantages over injectable therapies. The strong brand recognition of Tecfidera, combined with its proven efficacy, sustains its dominant position.

Competitive Landscape

While DMF maintains its market leadership, it faces intense competition from:

• Ocrelizumab (Ocrevus): The first approved B-cell depleting monoclonal antibody, offering efficacy in PPMS.
• Siponimod (Mayzent): An S1P receptor modulator targeting active SPMS.
• Cladribine (Mavenclad): A nucleoside analog with immunosuppressive properties.

Emerging oral therapies like Evobrutinib and BAF312 (Siponimod) threaten to pressurize DMF's market share. Nonetheless, DMF’s favorable safety profile and established long-term data sustain its positioning.

Regional Market Dynamics

• North America: Accounts for roughly 55% of global sales, benefitting from reimbursement policies and high diagnosis rates.
• Europe: Also significant, with reimbursement frameworks facilitating access.
• Asia-Pacific: Rapid growth anticipated, driven by increasing MS diagnosis rates and improved healthcare infrastructure.

Pricing and Reimbursement

Tecfidera's pricing in high-income countries ranges from USD 60,000 to USD 70,000 annually per patient. Reimbursement coverage constitutes a significant factor influencing market uptake, with payers increasingly favoring cost-effective, oral treatments.

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Future Market Projections

Growth Trajectory (2023-2030)

The MS therapeutics market is expected to grow at a CAGR of approximately 6.4% from 2023 to 2030, reaching USD 35–40 billion by the end of the decade. DMF is projected to retain a substantial market share, driven by:

• Indication expansion: Trials exploring DMF for progressive forms of MS and other autoimmune conditions could open new revenue streams.
• Regulatory approvals: Successful phase III outcomes in non-MS indications will catalyze market growth.
• Global access: Expansion into emerging markets through pricing strategies and partnerships.

Innovations and Formulation Developments

Innovative formulations, such as delayed-release or cheaper generics, will influence market dynamics. Biogen's ongoing efforts to develop more tolerable versions aim to improve adherence and expand market penetration.

Competitive and Regulatory Risks

Potential generic competition is imminent, especially post-patent expiry expected around 2029. Additionally, concerns regarding lymphopenia and progressive multifocal leukoencephalopathy (PML) necessitate vigilant monitoring and could influence prescribing patterns.

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Conclusion and Key Takeaways

• Robust Clinical Evidence Reinforces Role in MS: Recent trials solidify DMF’s efficacy in reducing relapse rates and MRI lesions, with ongoing studies exploring its utility in progressive MS subtypes and other autoimmune diseases.
• Market Leadership Challenged but Resilient: Despite fierce competition and impending patent expiry, DMF maintains a significant market share through its established safety, convenient oral administration, and comprehensive data.
• Emerging Opportunities Exist: Trials into additional indications and formulations could further expand DMF’s therapeutic footprint.
• Strategic Focus Needed on Generics and Safety: Patent expiration and safety monitoring pose risks; proactive strategies in formulation innovation and pharmacovigilance are essential.
• Global Expansion Will Drive Growth: Emerging markets and regulatory approvals for new indications are poised to support sustained revenue growth.

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Key Takeaways

• Ongoing Clinical Trials: DMF research continues to evolve, with substantial progress in MS and early exploration in neurodegenerative and dermatological conditions.
• Market Positioning: While facing competition, DMF’s long-term safety data and oral delivery maintain its attractiveness.
• Future Potential: Indication expansion and formulation innovations will be key drivers of growth through 2030.
• Regulatory and Patent Strategies: Monitoring patent expiry timelines and regulatory developments will be critical for market longevity.
• Global Outreach: Expanding access in emerging regions presents lucrative opportunities amidst increasing MS diagnosis rates.

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FAQs

1. What are the latest clinical trial results for dimethyl fumarate in progressive MS?
Recent Phase III studies, including ongoing trials like PROGRESS, suggest that DMF may slow disability progression in secondary progressive MS, but conclusive data are pending, and regulatory approvals are awaited.

2. How does dimethyl fumarate compare with other oral MS therapies?
DMF demonstrates comparable efficacy to other oral agents like ozanimod and siponimod, with a favorable safety profile. It excels in long-term safety data and ease of administration but faces competition from newer agents with potentially fewer side effects.

3. Are there any new indications for dimethyl fumarate under clinical evaluation?
Yes. Trials are investigating DMF's potential in psoriasis, rheumatoid arthritis, and neurodegenerative diseases, although none have yet led to approved indications beyond MS.

4. How is the patent landscape influencing DMF’s market?
With patent expiration expected around 2029, generic versions are anticipated, which could significantly affect revenues unless patent extensions or formulation patents are secured pre-expiry.

5. What are the major safety concerns with dimethyl fumarate?
Lymphopenia and PML remain significant safety considerations. Continuous monitoring and risk mitigation strategies are integral to patient management and regulatory compliance.

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Sources:

[1] ClinicalTrials.gov. PROTECT-MS Study.
[2] Journal of Dermatological Treatment, 2021. Efficacy of DMF in Psoriasis.
[3] Post-market surveillance report, 2022.
[4] DEFINTION and ENDORSE trial data summaries, 2015-2016.