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
Sheffield Teaching Hospitals NHS Foundation Trust	3
EMD Serono	3

Sponsor Type

Sponsor Type for Tecfidera
Sponsor	Trials
Industry	51
Other	36
INDIV	1

Last updated: May 22, 2026

Tecfidera (dimethyl fumarate) clinical trials update, market analysis and launch/exclusivity projection for generics and biosimilars

Executive summary: Tecfidera (dimethyl fumarate, DMF) is an orally dosed fumarate indicated for relapsing forms of multiple sclerosis (RMS). Clinical activity is concentrated on switching, safety/real-world outcomes, and comparative effectiveness versus other oral MS agents, not on new “blockbuster” indications. From an IP and regulatory lens, Tecfidera’s near-term market risk is driven primarily by generic dimethyl fumarate entry (and the continued migration of payers to lower-cost fumarate and non-fumarate orals), while “biosimilar” risk is not applicable because DMF is a small molecule. The highest revenue pressure comes from US generic competition and price compression, with residual differentiation tied to formulation/manufacturing and patient support programs.

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What is the latest clinical trial update for Tecfidera (dimethyl fumarate) in multiple sclerosis?

Featured snippet answer: Recent Tecfidera clinical development is focused on comparative and real-world evidence, adherence and tolerability, lab-monitoring safety endpoints (lymphopenia), and how DMF performs versus other oral disease-modifying therapies (DMTs) in routine practice.

Which trial types dominate Tecfidera’s current evidence base?

Clinical updates for Tecfidera typically fall into four buckets:

1. Switching studies and pragmatic trials
   • Patients transition between oral DMTs (DMF to another oral, or another oral to DMF), with emphasis on MRI lesion accrual, relapse rates, and safety signals such as lymphocyte dynamics.
2. Safety and monitoring optimization
   • Trials and postmarketing studies examine how clinicians manage lymphopenia, infection risk, and lab monitoring intervals.
3. Comparative effectiveness
   • Evidence increasingly comes from head-to-head or “active comparator” designs within broader registries, because DMF’s core mechanism and indications are mature.
4. Real-world outcomes
   • Registries quantify treatment persistence, switching, and drug survival, which map to payer and provider decisions.

What endpoints are most used in Tecfidera updates?

• Lymphopenia incidence and nadir
• Infection outcomes (with a focus on serious infections)
• MRI activity (new/enlarging T2 lesions, gadolinium-enhancing lesions)
• Relapse rates
• Treatment persistence and discontinuation reasons

How do recent evidence themes translate to labeling-relevant risk?

Across fumarates, the clinical development theme is consistent: balance efficacy with hematologic safety. For Tecfidera specifically, clinical updates typically reinforce:

• The need for ongoing absolute lymphocyte count (ALC) monitoring
• Risk stratification for patients with prior immunosuppression or prolonged lymphopenia

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What is the current market size and revenue trajectory for Tecfidera (dimethyl fumarate) through 2030?

Featured snippet answer: Tecfidera’s revenue trajectory is characterized by sustained decline in the US after generic erosion, with global growth constrained by competition from other oral MS therapies and switching to newer branded and generic equivalents.

US revenue exposure drivers

• Generic competition pricing and channel penetration
• Payer formulary positioning for fumarates versus newer oral options
• Patient out-of-pocket cost sensitivity
• Persistence and adherence under lower-cost switching strategies

Global market dynamics

• Differential generic adoption by territory
• Local formulary policy and tender economics
• Availability of oral MS formularies and uptake of alternatives (S1P modulators, other fumarates, and later-generation agents)

2030 projection framework for Tecfidera

A practical projection for Tecfidera through 2030 typically assumes:

• Continued unit erosion from generic channel share shifts
• Gradual decline in net pricing as pharmacy benefit management tightens preferred product lists
• Modest residual sales from patients remaining on fumarates due to tolerance history, prescriber preference, and brand or patient support programs where still used

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How does Tecfidera compare with other oral multiple sclerosis drugs on efficacy and safety?

Featured snippet answer: Tecfidera remains competitive on average relapse reduction and MRI stabilization versus placebo, but in current formularies it faces margin pressure from faster uptake oral classes and tolerability-driven switching behavior.

Comparative positioning

• Versus S1P modulators: DMF is generally used with a distinct safety tradeoff profile that emphasizes lymphopenia monitoring rather than branded S1P risks.
• Versus other orals and generics: DMF competes more on cost and clinician familiarity once generic equivalents are available.

Safety and tolerability comparison points that affect switching

• GI intolerance (flush, dyspepsia)
• ALC trends
• Infection risk management practices
• Treatment adherence impact (real-world persistence)

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When does Tecfidera lose exclusivity in the US and what patent dates matter most?

Featured snippet answer: The exclusivity and patent landscape for Tecfidera has matured; primary commercial risk now reflects generic entry timing and market authorization rather than future biologics-style exclusivity. The decisive business variable is whether remaining US patent barriers block specific generic versions and packaging/formulation, or whether generic competition is already established.

What “exclusivity” concept is relevant for Tecfidera?

Tecfidera is a small molecule. The main protection categories historically include:

• New drug approval-related exclusivities (if applicable historically)
• Patent claims on composition, formulation, and methods of use
• Carve-outs that can still drive Paragraph IV litigation around specific claim scope

What dates drive generic entry in practice?

For DMF, the practical drivers are:

• Patent expiration for key Orange Book listings
• Whether generics launch “at risk” or after resolving litigation
• Settlement agreements that can delay specific generic products

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What patents protect Tecfidera (dimethyl fumarate) in the US Orange Book?

Featured snippet answer: Tecfidera’s protected space has historically included composition and formulation claims listed in the Orange Book, with potential claim scope for salts, polymorphs, manufacturing processes, and patient-use dosing regimens.

How to read the Orange Book risk for Tecfidera

For market access decisions, the key is mapping:

• Orange Book listed patents → claim scope
• ANDA Paragraph IV certifications → which patents are contested
• Court outcomes/settlements → whether particular generics launch at launch date

Market relevance

Even after core patent loss, remaining formulation or method claims can:

• limit “authorized” generics
• force design-around (dose form, manufacturing process, or claim non-infringement)
• support delayed settlement launch timelines

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Which companies are challenging Tecfidera with Paragraph IV ANDAs and what were the outcomes?

Featured snippet answer: Multiple generic manufacturers have filed ANDAs for dimethyl fumarate over time, with Paragraph IV certifications driving district court challenges and settlements in the US.

What matters for business decisions

• Whether a generic product is authorized for launch on specific dates
• Settlement terms (triggering the launch, allowable label claims, and permitted exclusivity waivers)
• Any product-specific injunctions or at-risk decisions that affect launch timing

Litigation pattern risk

For mature small molecules, litigation often reduces to:

• claim construction that narrows infringement
• settlements tied to calendar dates rather than ongoing injunctions
• continued dispute of peripheral formulation or method claims

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What formulations and dosage forms are covered for Tecfidera and do generics face design-around risks?

Featured snippet answer: Tecfidera is an oral delayed-release formulation; generic risk assessments focus on whether ANDA products reproduce the relevant dissolution profile, release characteristics, and manufacturing controls.

Formulation claim clusters that typically drive design-around

• Delayed-release characteristics
• Excipients and processing steps
• Manufacturing method claims
• Stability and release-rate specifications

How formulation risk affects market entry

Design-around barriers typically influence:

• launch timing
• regulatory approval delays
• product switching inertia in payers and providers who prefer assured supply and demonstrated bioequivalence

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Is there biosimilar competition risk for Tecfidera (dimethyl fumarate)?

Featured snippet answer: No. Tecfidera is a small molecule. Biosimilar pathways do not apply.

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What generic entry risks exist for Tecfidera in the US and what is the likely competitive landscape?

Featured snippet answer: Generic competition is the main near-to-mid term risk and it is already structurally embedded through multiple approved dimethyl fumarate ANDA products. The remaining risk is not “if” generic entry occurs but:

• the speed of additional launches,
• the degree of payer substitution,
• and any remaining IP barriers specific to particular ANDA products.

Competitive landscape: what to model

• Number of generic SKUs by strength and package size
• Net pricing trajectory under competitive PBM bidding
• Rebates and formulary placement mechanisms
• Launch sequences tied to settlement and patent carve-outs

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How does Tecfidera’s clinical and market outlook compare with other fumarates and oral MS DMTs?

Featured snippet answer: Tecfidera’s clinical profile is stable but its market position increasingly tracks generic pricing versus ongoing competition from branded and generic orals in the broader MS class.

Key comparison axes

• relapse and MRI control versus alternatives
• ALC safety management behavior
• payer tiering and cost
• patient persistence and switch rates

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Key takeaways

• Tecfidera clinical development is largely mature evidence work: safety monitoring, adherence, comparative effectiveness, and real-world outcomes.
• The commercial outlook is driven by generic dimethyl fumarate erosion and payer channel substitution rather than new label expansions.
• Biosimilar risk does not apply because dimethyl fumarate is a small molecule.
• Remaining IP relevance is mostly about whether specific formulation or method claims delay particular generic product launches or constrain design-around.

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FAQs

1) What safety monitoring requirements are most linked to Tecfidera real-world discontinuation?

Lymphocyte count monitoring and downstream infection-risk management are the most common driver categories in routine practice.

2) How do treatment persistence trends for Tecfidera affect payer contracting?

Persistence affects net share by strengthening or weakening payer leverage in formulary renegotiations, especially where switching is easy.

3) Are there differences between generic and brand dimethyl fumarate that matter clinically?

Differences that can matter are formulation and patient tolerability linked to delayed-release behavior and excipient profiles, but clinical comparability is generally supported through bioequivalence expectations.

4) What’s the main driver of Tecfidera market share change versus other oral MS therapies?

Net cost after rebates and formulary tier status typically outweighs incremental clinical differences in mature lines.

5) Does Tecfidera have any “new indication” pipeline risk or upside?

For a mature RMS DMT with established indications, near-term upside is typically incremental via evidence generation rather than major label expansion.

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References

1. FDA. (n.d.). Drug Trials Snapshots: Tecfidera (dimethyl fumarate). U.S. Food and Drug Administration.
2. EMA. (n.d.). Tecfidera: EPAR summary. European Medicines Agency.
3. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Tecfidera, dimethyl fumarate). U.S. Food and Drug Administration.
4. ClinicalTrials.gov. (n.d.). Search results for dimethyl fumarate multiple sclerosis trials. U.S. National Library of Medicine.