CLINICAL TRIALS PROFILE FOR TECFIDERA

All Clinical Trials for TECFIDERA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00273364 ↗	Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized Study	Completed	Sheffield Teaching Hospitals NHS Foundation Trust	Phase 2	2005-11-16	Multiple sclerosis (MS) is at onset an immune-mediated demyelinating disease. In most cases, it starts as a relapsing-remitting disease with distinct attacks and no symptoms between flares. Over years or decades, virtually all cases transition into a progressive disease in which insidious and slow neurologic deterioration occurs with or without acute flares. Relapsing-remitting disease is often responsive to immune suppressive or modulating therapies, while immune based therapies are generally ineffective in patients with a progressive clinical course. This clinical course and response to immune suppression, as well as neuropathology and neuroimaging studies, suggest that disease progression is associated with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune mediated demyelination. Therefore, immune based therapies, in order to be effective, need to be started early in the disease course while MS is predominately an immune-mediated and inflammatory disease. While current immune based therapies delay disability, no intervention has been proven to prevent progressive disability. We propose, as a randomized study, autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rabbit antithymocyte globulin (rATG) versus FDA approved standard of care (i.e. interferon, glatiramer acetate, mitoxantrone, natalizumab, fingolimod, or tecfidera) in patients with inflammatory (relapsing) MS despite treatment with alternate approved therapy.
NCT00273364 ↗	Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized Study	Completed	University of Sao Paulo	Phase 2	2005-11-16	Multiple sclerosis (MS) is at onset an immune-mediated demyelinating disease. In most cases, it starts as a relapsing-remitting disease with distinct attacks and no symptoms between flares. Over years or decades, virtually all cases transition into a progressive disease in which insidious and slow neurologic deterioration occurs with or without acute flares. Relapsing-remitting disease is often responsive to immune suppressive or modulating therapies, while immune based therapies are generally ineffective in patients with a progressive clinical course. This clinical course and response to immune suppression, as well as neuropathology and neuroimaging studies, suggest that disease progression is associated with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune mediated demyelination. Therefore, immune based therapies, in order to be effective, need to be started early in the disease course while MS is predominately an immune-mediated and inflammatory disease. While current immune based therapies delay disability, no intervention has been proven to prevent progressive disability. We propose, as a randomized study, autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rabbit antithymocyte globulin (rATG) versus FDA approved standard of care (i.e. interferon, glatiramer acetate, mitoxantrone, natalizumab, fingolimod, or tecfidera) in patients with inflammatory (relapsing) MS despite treatment with alternate approved therapy.
NCT00273364 ↗	Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized Study	Completed	Uppsala University	Phase 2	2005-11-16	Multiple sclerosis (MS) is at onset an immune-mediated demyelinating disease. In most cases, it starts as a relapsing-remitting disease with distinct attacks and no symptoms between flares. Over years or decades, virtually all cases transition into a progressive disease in which insidious and slow neurologic deterioration occurs with or without acute flares. Relapsing-remitting disease is often responsive to immune suppressive or modulating therapies, while immune based therapies are generally ineffective in patients with a progressive clinical course. This clinical course and response to immune suppression, as well as neuropathology and neuroimaging studies, suggest that disease progression is associated with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune mediated demyelination. Therefore, immune based therapies, in order to be effective, need to be started early in the disease course while MS is predominately an immune-mediated and inflammatory disease. While current immune based therapies delay disability, no intervention has been proven to prevent progressive disability. We propose, as a randomized study, autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rabbit antithymocyte globulin (rATG) versus FDA approved standard of care (i.e. interferon, glatiramer acetate, mitoxantrone, natalizumab, fingolimod, or tecfidera) in patients with inflammatory (relapsing) MS despite treatment with alternate approved therapy.
NCT00273364 ↗	Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized Study	Completed	Northwestern University	Phase 2	2005-11-16	Multiple sclerosis (MS) is at onset an immune-mediated demyelinating disease. In most cases, it starts as a relapsing-remitting disease with distinct attacks and no symptoms between flares. Over years or decades, virtually all cases transition into a progressive disease in which insidious and slow neurologic deterioration occurs with or without acute flares. Relapsing-remitting disease is often responsive to immune suppressive or modulating therapies, while immune based therapies are generally ineffective in patients with a progressive clinical course. This clinical course and response to immune suppression, as well as neuropathology and neuroimaging studies, suggest that disease progression is associated with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune mediated demyelination. Therefore, immune based therapies, in order to be effective, need to be started early in the disease course while MS is predominately an immune-mediated and inflammatory disease. While current immune based therapies delay disability, no intervention has been proven to prevent progressive disability. We propose, as a randomized study, autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rabbit antithymocyte globulin (rATG) versus FDA approved standard of care (i.e. interferon, glatiramer acetate, mitoxantrone, natalizumab, fingolimod, or tecfidera) in patients with inflammatory (relapsing) MS despite treatment with alternate approved therapy.
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).

Clinical Trial Conditions for TECFIDERA

Condition Name

Condition Name for TECFIDERA
Intervention	Trials
Multiple Sclerosis	24
Relapsing-Remitting Multiple Sclerosis	13
Multiple Sclerosis, Relapsing-Remitting	9
Relapsing Remitting Multiple Sclerosis	5

Condition MeSH

Condition MeSH for TECFIDERA
Intervention	Trials
Multiple Sclerosis	51
Sclerosis	43
Multiple Sclerosis, Relapsing-Remitting	27
Multiple Sclerosis, Chronic Progressive	4

Clinical Trial Locations for TECFIDERA

Trials by Country

Trials by Country for TECFIDERA
Location	Trials
United States	360
France	40
Canada	27
United Kingdom	25
Germany	22

Trials by US State

Trials by US State for TECFIDERA
Location	Trials
Texas	17
California	16
North Carolina	16
New York	16
Washington	15

Clinical Trial Progress for TECFIDERA

Clinical Trial Phase

Clinical Trial Phase for TECFIDERA
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	19
Phase 3	11

Clinical Trial Status

Clinical Trial Status for TECFIDERA
Clinical Trial Phase	Trials
Completed	29
Terminated	14
Withdrawn	4

Clinical Trial Sponsors for TECFIDERA

Sponsor Name

Sponsor Name for TECFIDERA
Sponsor	Trials
Biogen	39
EMD Serono	3
Sheffield Teaching Hospitals NHS Foundation Trust	3

Sponsor Type

Sponsor Type for TECFIDERA
Sponsor	Trials
Industry	51
Other	36
OTHER_GOV	1

Clinical Trials Update, Market Analysis, and Projection for Tecfidera

Last updated: October 28, 2025

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Introduction

Tecfidera (dimethyl fumarate) remains a cornerstone in the treatment landscape for relapsing-remitting multiple sclerosis (RRMS). Since its initial approval by the U.S. Food and Drug Administration (FDA) in 2013, Tecfidera has maintained a prominent position amid evolving therapeutic options. This article provides a comprehensive analysis of recent clinical trial developments, current market dynamics, and future projections shaping Tecfidera’s trajectory through 2028.

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Clinical Trials Update

Recent and Ongoing Clinical Trials

Since 2021, multiple clinical trials have aimed to enhance the understanding of Tecfidera’s efficacy, safety, and potential expanded indications. Notably:

• DEFINE and CONFIRM Trials (Post-approval Studies): These pivotal phase III trials established Tecfidera’s efficacy in reducing relapse rates and MRI activity. Follow-up studies continue to evaluate long-term safety and disease progression. Data from longer extension studies (e.g., ENDORSE extension) confirm sustained efficacy over 7-10 years, with manageable safety profiles.

• Upcoming Studies on Neuroprotection and Disease Modification: Trials such as EVOLVE-MS-1 investigate Tecfidera's neuroprotective properties, exploring its potential to slow brain atrophy beyond conventional relapse reduction. These studies seek regulatory guidance on label expansion for broader neuroprotective claims.

• Comparative Effectiveness Trials: Recent head-to-head comparisons with other first-line agents (e.g., Aubagio, Gilenya) underscore Tecfidera’s favorable tolerability profile, with ongoing trials aiming to define precise positioning within MS treatment algorithms.

• Investigational Uses: Early-phase trials assess Tecfidera’s efficacy in other autoimmune or neurodegenerative conditions, including psoriasis and possibly Parkinson’s disease, although these are at nascent stages.

Safety and Pharmacovigilance

Post-market surveillance continues to reinforce Tecfidera’s safety. Notable concerns persist regarding lymphopenia and the risk of progressive multifocal leukoencephalopathy (PML). Recent data suggest lymphocyte monitoring protocols enhance safety. The FDA’s ongoing safety review indicates an emphasis on maintaining a favorable benefit-risk balance, especially in longer-term use.

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Market Analysis

Current Market Position

Tecfidera’s global sales peaked at approximately $3.0 billion in 2019, driven by its once-daily oral administration and substantial market share among oral MS therapies. However, recent years have seen a plateau or slight decline, influenced by emerging competitors with novel mechanisms and biosimilars.

• Market Share Dynamics: As of 2022, Tecfidera holds roughly 12-15% of the global MS treatment market, down from its peak share of ~20%. The shift is partly attributable to the introduction of repositioned drugs like Vumerity (diroximel fumarate) and generic dimethyl fumarate formulations, which offer similar efficacy with improved tolerability or reduced costs.

• Key Geographic Markets: The U.S. remains the largest market, with European and Asian markets demonstrating steady growth due to expanding diagnosis and treatment rates. Regulatory agencies in Europe have maintained Tecfidera’s approval, supporting ongoing sales.

• Pricing and Reimbursement: Tecfidera is positioned as a premium-priced therapy, with costs averaging $70,000–$80,000 annually in the U.S. Reimbursement remains robust, though payers increasingly favor cost-effective alternatives.

Competitive Landscape

• Emerging Oral Agents: Biogen’s own Vumerity offers a similar safety profile with fewer gastrointestinal side effects. Other agents like Mavenclad, Ozanimod, and oral B cell therapies provide competitive efficacy, often with benefits in safety or dosing convenience.

• Biotech and Biosimilar Competition: The approval of generic dimethyl fumarate products in multiple jurisdictions is poised to disrupt Tecfidera’s market share by offering lower-cost options. This trend is accelerating across European markets, with potential influence in the U.S. pending biosimilar pathways regulation.

• Regulatory and Patent Dynamics: Biogen holds several patents protecting Tecfidera’s formulation. Patent litigations and royalty disputes may delay the entry of biosimilars in key markets but generally do not preclude generic options post-expiry.

Market Drivers and Challenges

• Drivers:

  • Long-term safety profile.
  • Oral administration preferences.
  • Evidence of disease-modifying efficacy.

• Challenges:

  • Competition from newer oral and infusion therapies with better safety or efficacy profiles.
  • Patent expiry and biosimilar entry reducing revenue.

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Market Projection: 2023–2028

Forecast Overview

Based on current clinical data, market trends, and industry forecasts, Tecfidera’s global sales are projected to decline slightly over the next five years. However, continued use in established patient populations, especially in the U.S. and Europe, will sustain significant revenue streams.

Estimated Revenue

• 2023–2024: Estimated global sales decline to approximately $2.0 billion by 2024, driven by biosimilar entry and market saturation.
• 2025–2028: Stabilization expected between $1.5–$2.0 billion, owing to long-term patients and brand loyalty in certain regions.

Strategic Growth Opportunities

• Expansion into New Indications: Pending clinical success, Tecfidera may gain approval for adjunct indications such as psoriasis or systemic lupus erythematosus, expanding its market.

• Partnerships and Licensing: Collaborations with biotech firms targeting neurodegeneration may foster combination therapies, extending Tecfidera’s life cycle.

• Repositioning and Education: Emphasizing long-term safety and efficacy will be critical to maintain physician prescribing confidence amidst competitive pressures.

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Conclusion

Tecfidera continues to be a vital oral therapy for RRMS, supported by extensive clinical data and long-term safety profiles. While face mounting pressure from biosimilars and newer agents, its established efficacy and patient familiarity sustain its market relevance. Strategic investments in clinical research, expanded indications, and market differentiation will dictate Tecfidera’s trajectory through 2028.

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Key Takeaways

• Recent clinical trials reinforce Tecfidera’s durable efficacy and manageable safety profile, with ongoing research exploring neuroprotective benefits.
• The drug’s market share is gradually declining due to biosimilar competition and newer therapies, but it still commands a significant share in established MS populations.
• Biosimilar dimethyl fumarate products are expected to influence revenue trajectories, particularly in Europe and emerging markets.
• Future growth hinges on clinical expansion into new indications, strategic partnerships, and maintaining physician confidence through robust safety data.
• Long-term market stability will depend on continued innovation, payer support, and addressing safety concerns such as lymphopenia.

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FAQs

1. What is Tecfidera’s mechanism of action in multiple sclerosis?
Tecfidera (dimethyl fumarate) exerts immunomodulatory effects primarily through its activation of the NRF2 pathway, promoting cytoprotective responses against oxidative stress and reducing neuroinflammation, which helps slow disease progression in RRMS.

2. How does Tecfidera compare safety-wise with other MS therapies?
Tecfidera’s safety profile is favorable, with common side effects including flushing and gastrointestinal discomfort. Serious adverse events, such as lymphopenia risking PML, are rare but warrant monitoring. Its oral administration and tolerability make it preferred for many patients.

3. What impact will biosimilar dimethyl fumarate products have on Tecfidera's market?
Biosimilars are expected to reduce Tecfidera’s revenue in regions where they are approved, particularly Europe. They offer similar efficacy at lower costs, increasing competitive pressure but may also expand overall market size.

4. Are there any upcoming indications for Tecfidera?
Clinical trials are investigating neuroprotective and anti-inflammatory uses beyond MS, which could lead to label expansion for broader autoimmune or neurodegenerative indications if successful.

5. What are the key considerations for future investments in Tecfidera?
Investors should monitor ongoing clinical trials, patent landscapes, biosimilar developments, and emerging competitive therapies. Focusing on long-term safety data and potential new indications will be critical for sustained value.

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References

1. [1] U.S. FDA. Tecfidera (dimethyl fumarate) approval documents. 2013.
2. [2] Biogen. Annual Reports and Market Share Data (2021–2022).
3. [3] European Medicines Agency. Tecfidera review and approval status.
4. [4] MarketWatch. MS medication sales forecasts (2022–2028).
5. [5] ClinicalTrials.gov. Active and upcoming Tecfidera trials.

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Note: All projections and analyses are based on publicly available data as of the first quarter of 2023. Industry dynamics are subject to change with evolving regulatory, clinical, and market developments.