TheraRadar
Data updated: May 26, 2026

TECFIDERA (dimethyl fumarate)

Trial Activity: Declining 4 active trials
CNS Approved 2013-03-27

TECFIDERA is indicated for the treatment of Clinically isolated syndrome; Relapsing-remitting multiple sclerosis; Active secondary progressive multiple sclerosis.

Source: FDA Label • Biogen
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How TECFIDERA Works

The precise mechanism by which dimethyl fumarate exerts its therapeutic effect in multiple sclerosis is unknown. The drug and its metabolite, monomethyl fumarate (MMF), have been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway, which is involved in the cellular response to oxidative stress. Additionally, MMF has been identified as a nicotinic acid receptor agonist in laboratory settings.

Source: FDA Label

Development Insights

Biogen conducting 25 trials (56%)
26 indications explored (Broad Platform)
→ multiple sclerosis (11 trials)
→ relapsing-remitting multiple sclerosis (10 trials)
→ multiple sclerosis, relapsing-remitting (10 trials)
4
Indications
--
Phase 3 Trials
13
Years on Market

Details

Status
Prescription
First Approved
2013-03-27
Patent Cliff
2020
Revenue
$112M (Q4-2025)

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
CAPSULE, DELAYED RELEASE

Companies

Biogen
Active Ingredient: DIMETHYL FUMARATE

TECFIDERA Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
50 FDA actions from 2013 to 2024 · 3 indication expansions
Mar 2024 SUPPL
Label · Labeling
FDA Letter Label
Dec 2023 SUPPL
Label · Labeling
FDA Letter Label
Feb 2023 SUPPL
Efficacy
FDA Letter Label

What TECFIDERA Treats

3 indications

TECFIDERA is approved for 3 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Clinically isolated syndrome
  • Relapsing-remitting multiple sclerosis
  • Active secondary progressive multiple sclerosis
Source: FDA Label

TECFIDERA Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

3

Same target(s) AND same indication — head-to-head.

DIROXIMEL FUMARATE
ZYDUS
2025 4 indic.
BAFIERTAM
BANNER LIFE
2020 1 indic.

MoA expansion candidates

1

Same target(s), different indications — where else is this mechanism being explored?

SKYCLARYS
Biogen
2023 1 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

OCREVUS ZUNOVO
Roche
2024 1 indic.
TYRUKO
Novartis
2023 2 indic.
Unlock 9 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in TECFIDERA's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TECFIDERA treats. First-in-class if their pivotal trials read out positive.

Frexalimab SAR441344
Sanofi
CD40LG · monoclonal antibody (anti-CD40L, Fc-engineered to avoid platelet activation) · 4 Phase 3 trials

Drugs Similar to TECFIDERA

3 of 13

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

BRIUMVI
UBLITUXIMAB-XIIY
3 shared
TG THERAPEUTICS, INC
Shared indications:
Clinically isolated syndromeRelapsing-remitting multiple sclerosisActive secondary progressive multiple sclerosis
GILENYA
FINGOLIMOD HYDROCHLORIDE
3 shared
Novartis
Shared indications:
Clinically isolated syndromeRelapsing-remitting multiple sclerosisActive secondary progressive multiple sclerosis
KESIMPTA
OFATUMUMAB
3 shared
Novartis
Shared indications:
Clinically isolated syndromeRelapsing-remitting multiple sclerosisActive secondary progressive multiple sclerosis
View all 13 similar drugs Pro
📋

Clinical Trial Registry

45 trials
Trial Sponsor ID Phase Status Title
NCT04381936 RECOVERY NDPHRECOVERY 2020-001113-21, ISRCTN50189673 Ph 3 recruiting Randomised Evaluation of COVID-19 Therapy
NCT07483632 VOYAGE 272MS304 2023-509409-60 Ph 3 not yet recruiting A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)
NCT02283853 CONNECT results posted 109MS306 2013-002318-11 Ph 3 completed Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
NCT05658484 109MS424 Ph 4 completed A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China
NCT02975349 results posted MS200527-0086 2016-001448-21 Ph 2 terminated A Study of Efficacy and Safety of M2951 in Participants With Relapsing Multiple Sclerosis
NCT06850597 010622 2022-002171-11 Ph 2 recruiting Efficacy and Safety of Dimethyl Fumarate Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's Disease
NCT06513533 XAMNDMFAP2022 2021-003826-65 Ph 2, Ph 3 recruiting Dimethyl Fumarate in Adrenomyeloneuropathy
NCT04890353 haojunwei4 Ph 1, Ph 2 terminated Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke
NCT04891497 haojunwei5 Ph 2 withdrawn Combination of the Immune Modulator Dimethyl Fumarate With Intraarterial Treatment in Acute Ischemic Stroke
NCT04890379 haojunwei2 Ph 2 withdrawn Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage
NCT03870763 results posted 800MS301 2018-000516-22 Ph 3 terminated Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants
NCT02546440 DMF-CTCL EudraCT-Number: 2014-000924-11 Ph 2 completed Study on Therapy With Dimethylfumarate (DMF) in Patients With Cutaneous T Cell Lymphoma (CTCL)
NCT02739542 ARISE results posted 102014-019 Ph 4 completed Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS)
NCT02746744 RIFUND-MS EudraCT 2015-004116-38 Ph 3 completed RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis.
NCT02471560 TECONGUT NOR-BGT-14-10665 2015-001197-18 Ph 4 completed Tecfidera and the Gut Microbiota
NCT00835770 ENDORSE results posted 109MS303 2008-004753-14 Ph 3 completed BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
NCT02959658 FUMAPMS FUMAPMS2016 Ph 2 completed Dimethyl Fumarate Treatment of Primary Progressive Multiple Sclerosis
NCT03093324 results posted ALK8700-A302 2017-001294-16 Ph 3 completed A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2
NCT02410278 MITIGATE results posted 109MS414 Ph 4 completed Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera
NCT01930708 PROTEC 109MS408 2013-001656-35 Ph 4 completed A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes
NCT04022473 BLS-11-109 Ph 1 completed Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy Volunteers
NCT02555215 results posted 109MS311 2015-003282-29 Ph 3 completed Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
NCT03345940 PRAG-MS 2017-000559-26 Ph 4 terminated Fingolimod Versus Dimethyl-fumarate in Multiple Sclerosis
NCT02784834 results posted 151657 Ph 1 terminated Dimethylfumarate (DMF) in Relapsed/Refractory CLL/SLL
NCT02337426 MCC-13-09950 NCI-2014-02619, HM20003022 Ph 1 completed Dimethyl Fumarate, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
NCT02525874 results posted 109MS310 2015-001973-42 Ph 3 completed Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).
NCT02901106 SURV-SEP JAB_2016_17 Ph 4 terminated Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate
NCT01838668 109MS305 2013-004533-32 Ph 3 completed An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
NCT02461069 DIMAT-MS DIMAT-MS 2014-003481-25, U1111-1164-2476 Ph 4 completed Investigation of the Effect of Dimethyl Fumarate on T Cells in Patients With Relapsing Remitting Multiple Sclerosis
NCT02410200 FOCUS results posted 109MS202 2014-005003-24 Ph 2 completed Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS
NCT02097849 results posted 109MS307 Ph 2 completed Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.
NCT02438137 results posted HUM00080121 Ph 2 completed Dimethyl Fumarate for Obstructive Sleep Apnea
NCT02343159 results posted 109MS413 Ph 4 terminated Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.
NCT02428231 TITRATION results posted 109MS416 2014-004562-22 Ph 3 terminated Tecfidera Slow-Titration Study
NCT02579681 StarTec ITA-BGT-12-10389 2013-001422-25, 109MS410 Ph 3 completed Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012
NCT02430532 INSPIRE results posted 109MS308 2014-003021-18 Ph 3 terminated BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis
NCT02125604 TOLERATE results posted 109MS407 2013-001486-17 Ph 4 completed Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In Germany
NCT01156311 EXPLORE results posted 109MS201 Ph 2 completed BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis
NCT02090413 ASSURE results posted 109MS406 2013-001895-40 Ph 4 completed Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate-Treated Participants With Relapsing-Remitting Multiple Sclerosis
NCT01815723 FP187-301 2012-005685-35 Ph 3 withdrawn Efficacy Study on Dimethyl Fumarate to Treat Moderate to Severe Plaque Psoriasis
NCT02675413 201511112 Ph 4 withdrawn Mechanisms of Action of Dimethyl Fumarate (Tecfidera) in Relapsing MS
NCT02428218 109MS309 2014-005624-98 Ph 3 withdrawn Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
NCT02472938 PROMPT BIIT0115 ITA-BGT-14-10682 Ph 4 withdrawn Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple Sclerosis
NCT02090348 TECNERGY 109MS405 2013-001025-53, DEN-BGT-13-10413 Ph 4 withdrawn Study to Evaluate Fatigue in Participants With Relapsing Remitting Multiple Sclerosis When Treated With Dimethyl Fumarate
NCT01924832 109HV111 EUDRA CT NO: 2013-002048-96 Ph 1 completed BG00012 Regional Absorption Study
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

TECFIDERA FDA Label Details

Indications & Usage

FDA Label (PDF)

TECFIDERA is indicated for the treatment of Clinically isolated syndrome; Relapsing-remitting multiple sclerosis; Active secondary progressive multiple sclerosis.

View full patent landscape →
9 OB patents · 3 families · 133 international docs across 30 countries

TECFIDERA Patents & Exclusivity

Latest Patent: Nov 2035

Patents (9 active)

US10959972 Expires Nov 16, 2035
US11129806 Expires Nov 16, 2035
US11007166 Expires Nov 16, 2035
US11007167 Expires Nov 16, 2035
US11246850 Expires Nov 16, 2035
US10391160 Expires Mar 13, 2035
US10555993 Expires Mar 13, 2035
US10994003 Expires Mar 13, 2035
US8399514 Expires Feb 7, 2028
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for TECFIDERA

Revenue Insights

  • • Q4-2025: $112M
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2020
  • • 36 active patents

Trial Analysis

  • • 45 total trials
  • • Stage: Declining

Competitive Landscape

  • • 13 similar drugs
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA204063 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment