Tecfidera

(dimethyl fumarate)

ApprovedSmall molecule

Dimethyl fumarate is used to treat relapsing forms of multiple sclerosis (MS), a disease where the immune system attacks nerve cells. It helps reduce the frequency of relapses and slow the progression of disability.[2] Tecfidera is currently approved and in use across 14 indications[4].[1]

Tecfidera is one of 328 small molecule programs targeting Multiple Sclerosis. It is currently in Approved.

Indications

Total Trials

Active Trials

327

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Multiple SclerosisCompleted

Immune System DiseaseActive, not recruiting

Cutaneous T-Cell LymphomaApproved

Chronic Progressive Multiple SclerosisApproved

Rheumatoid ArthritisApproved

Chronic Lymphocytic LeukemiaApproved

Psoriatic ArthritisApproved

LymphopeniaActive, not recruiting

Relapsing-Remitting Multiple SclerosisCompleted

Multiple SclerosisApproved

Completed

Immune System DiseaseApproved

Active, not recruiting

Cutaneous T-Cell LymphomaApproved

Approved

Chronic Progressive Multiple SclerosisApproved

Approved

Rheumatoid ArthritisApproved

Approved

Chronic Lymphocytic LeukemiaApproved

Approved

Psoriatic ArthritisApproved

Approved

LymphopeniaPreclinical

Active, not recruiting

Relapsing-Remitting Multiple SclerosisApproved

Completed

Showing 10 of 14 indications

Competition

Competitive Landscape

181 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Tecfidera

Biogen

Approved

75 2

Actos

Takeda

Preclinical

2 3

Celexa

AbbVie

Preclinical

1 4

Voltaren

Cataflam

Plaquenil

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 8

Velcade

SShilpa Grover, MD, MPH

Preclinical

2 9

Vancocin

HHikma Pharmaceuticals LLC

Preclinical

1 10

Pneumococcal Conjugate Vaccine

Novartis

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 2Recruiting

Cognitive Impairment

NCT06850597

Q2 2028

Phase 2/3Recruiting

Adrenomyeloneuropathy

NCT06513533

Q3 2028

Post-ApprovalNot yet recruiting

Multiple Sclerosis

NCT07138833

Q4 2028

Phase 2Recruiting

Relapsing Remitting Multiple Sclerosis (RRMS)

NCT07776743

Phase 3Recruiting

Type 1 Diabetes Mellitus

NCT07258394

Clinical

Trials by Indication[1]

Multiple Sclerosis26 trials

Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.

Completed· Biogen logo

Biogen·Phase 2·NCT02097849·71 enrolled

Biogen Multiple Sclerosis Pregnancy Exposure Registry

Completed· Biogen logo

Biogen··NCT01911767·408 enrolled

A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)

Active, not recruiting· Biogen logo

Biogen··NCT05767736·10,500 enrolled

Show 23 more trials

BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)

Completed· Biogen logo

Biogen·Phase 3·NCT00835770·1,736 enrolled

Investigation of the Effect of Dimethyl Fumarate on T Cells in Patients With Relapsing Remitting Multiple Sclerosis

Completed·UUniversity Hospital Muenster·Phase 4·NCT02461069·67 enrolled

A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes

Completed· Biogen logo

Biogen·Phase 4·NCT01930708·1,114 enrolled

IMCY-0141 Safety and Efficacy in Multiple Sclerosis - ISEMIS Study

Active, not recruiting·IImcyse SA·Phase 1/2·NCT05417269·150 enrolled

RItuximab Versus FUmarate in Newly Diagnosed Multiple Sclerosis.

Completed·AAnders Svenningsson·Phase 3·NCT02746744·200 enrolled

Study to Explore the Onset of Efficacy on Magnetic Resonance Disease Activity of BG00012 (Dimethyl Fumarate) in Patients With Relapsing remitTing Multiple Sclerosis

Withdrawn· Biogen logo

Biogen·Phase 4·NCT02472938

Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).

Completed· Biogen logo

Biogen·Phase 3·NCT02525874·218 enrolled

Monitoring of Patients Followed for a Multiple Sclerosis and Treated by Dimethyl-fumarate

Terminated·FFondation Ophtalmologique Adolphe de Rothschild·Phase 4·NCT02901106·11 enrolled

Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)

Completed· Biogen logo

Biogen·Phase 3·NCT02555215·20 enrolled

A Tolerability Study of ALKS 8700 in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS) EVOLVE-MS-2

Completed· Biogen logo

Biogen·Phase 3·NCT03093324·506 enrolled

BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis

Completed· Biogen logo

Biogen·Phase 2·NCT01156311·108 enrolled

Study to Evaluate Whether a Medication Event Monitoring System (MEMS) Can Improve Adherence to Tecfidera Treatment in Multiple Sclerosis Patients.

Terminated· Biogen logo

Biogen·Phase 4·NCT02343159·84 enrolled

A Study of Dimethyl Fumarate (DMF) in Relapsing Forms of Multiple Sclerosis (RMS) Participants in China

Completed· Biogen logo

Biogen·Phase 4·NCT05658484·60 enrolled

An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)

Completed· Biogen logo

Biogen·Phase 3·NCT01838668·225 enrolled

Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera

Completed· Biogen logo

Biogen·Phase 4·NCT02410278·102 enrolled

Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012

Completed· Biogen logo

Biogen·Phase 3·NCT02579681·221 enrolled

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)

Not yet recruiting· Biogen logo

Biogen·Phase 3·NCT07483632·185 enrolled

Fingolimod Versus Dimethyl-fumarate in Multiple Sclerosis

Terminated·FFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta·Phase 4·NCT03345940·55 enrolled

Examining the Risk of Skin Cancer in Multiple Sclerosis Patients Using Fingolimod: a Population-Based Study

Completed·UUniversity of British Columbia··NCT06705608·4,000 enrolled

Effects of Dimethyl Fumarate on Cognitive Performance and Brain Abnormalities in Multiple Sclerosis.

Completed·IIRCCS Centro Neurolesi Bonino Pulejo··NCT05811949·52 enrolled

A Phase IV Study of Dimethyl Fumarate Enteric-coated Capsules for Relapsing Multiple Sclerosis (RMS)

Not yet recruiting·QQilu Pharmaceutical (Hainan) Co., Ltd.·Phase 4·NCT07138833·50 enrolled

Study to Evaluate Fatigue in Participants With Relapsing Remitting Multiple Sclerosis When Treated With Dimethyl Fumarate

Withdrawn· Biogen logo

Biogen·Phase 4·NCT02090348

Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry

Recruiting· Biogen logo

Biogen··NCT05658497·908 enrolled

Relapsing-Remitting Multiple Sclerosis6 trials

Phase 4 Study of Effect of Aspirin on Flushing in Dimethyl Fumarate-Treated Participants With Relapsing-Remitting Multiple Sclerosis

Completed· Biogen logo

Biogen·Phase 4·NCT02090413·241 enrolled

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

Terminated· Biogen logo

Biogen·Phase 3·NCT03870763·11 enrolled

Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)

Withdrawn· Biogen logo

Biogen·Phase 3·NCT02428218

Show 3 more trials

Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)

Completed· Biogen logo

Biogen·Phase 3·NCT02283853·156 enrolled

Gastrointestinal Tolerability Study Of Dimethyl Fumarate In Participants With Relapsing-Remitting Multiple Sclerosis In Germany

Completed· Biogen logo

Biogen·Phase 4·NCT02125604·214 enrolled

Effectiveness and Safety of Generic Delayed-Release Dimethyl Fumarate (Sclera® or Marovarex ®, Hikma) in Routine Medical Practice in the Treatment of Relapsing-Remitting Multiple Sclerosis in MENA Region

Completed·HHikma Pharmaceuticals LLC··NCT04468165·160 enrolled

Ischemic stroke3 trials

Combination of the Immune Modulator Dimethyl Fumarate With Alteplase in Acute Ischemic Stroke

Unknown status·XXuanwu Hospital, Beijing·Phase 1/2·NCT04890366·50 enrolled

Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke

Terminated·XXuanwu Hospital, Beijing·Phase 1/2·NCT04890353·2 enrolled

Combination of the Immune Modulator Dimethyl Fumarate With Intraarterial Treatment in Acute Ischemic Stroke

Withdrawn·XXuanwu Hospital, Beijing·Phase 2·NCT04891497

Effectiveness2 trials

Effectiveness of DMF and Its Impact on PROs in Suboptimal GA Responders With RMS

Completed· Biogen logo

Biogen··NCT01903291·333 enrolled

Effectiveness of DMF (Dimethyl Fumarate) and Its Impact on PROs (Patient Reported Outcomes) in Treatment-Naive or Suboptimal IFN (Interferon) or GA (Glatiramer Acetate) Responders With RRMS (ImPROve)

Terminated· Biogen logo

Biogen··NCT02323269·24 enrolled

Gut Microbiota2 trials

Impact of Tecfidera on Gut Microbiota

Unknown status·VVirginia Simnad··NCT02736279·25 enrolled

Tecfidera and the Gut Microbiota

Completed· Biogen logo

Biogen·Phase 4·NCT02471560·36 enrolled

30 more indications

Secondary Progressive Multiple Sclerosis1 trial

BG00012 and Delay of Disability Progression in Secondary Progressive Multiple Sclerosis

Terminated· Biogen logo

Biogen·Phase 3·NCT02430532·58 enrolled

Psoriasis1 trial

Efficacy Study on Dimethyl Fumarate to Treat Moderate to Severe Plaque Psoriasis

Withdrawn·FForward-Pharma GmbH·Phase 3·NCT01815723

Lymphopenia1 trial

Real World Analysis on Lymphocyte Reconstitution After Lymphopenia in Participants Treated by Tecfidera

Completed· Biogen logo

Biogen··NCT04756687·1,507 enrolled

RRMS1 trial

Investigating Indirect Mechanism of Neuroprotection of Tecfidera® (Dimethyl Fumarate) in RRMS and Progressive Patients

Unknown status·MMultiple Sclerosis Center of Northeastern New York·Phase 4·NCT03092544·57 enrolled

Absorption1 trial

BG00012 Regional Absorption Study

Completed· Biogen logo

Biogen·Phase 1·NCT01924832·32 enrolled

Observational Study1 trial

Dimethyl Fumarate (DMF) Observational Study

Completed· Biogen logo

Biogen··NCT02047097·5,487 enrolled

Cognitive impairment1 trial

Efficacy and Safety of Dimethyl Fumarate Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's Disease

Recruiting·MMedical University of Lodz·Phase 2·NCT06850597·30 enrolled

Relapsed/Refractory1 trial

Dimethylfumarate (DMF) in Relapsed/Refractory CLL/SLL

Terminated·MMichael Choi·Phase 1·NCT02784834·2 enrolled

Obstructive Sleep Apnea1 trial

Dimethyl Fumarate for Obstructive Sleep Apnea

Completed·UUniversity of Michigan·Phase 2·NCT02438137·65 enrolled

Oral1 trial

Relationship Between Oral DMT Burden and Adherence in MS

Enrolling by invitation·MMonash University··NCT04676204·323 enrolled

COVID-191 trial

Randomised Evaluation of COVID-19 Therapy

Recruiting·UUniversity of Oxford·Phase 3·NCT04381936·70,000 enrolled

Outcome1 trial

Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab)

Completed· Biogen logo

Biogen··NCT02159573·530 enrolled

Pediatric1 trial

Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS

Completed· Biogen logo

Biogen·Phase 2·NCT02410200·22 enrolled

Intracerebral Hemorrhage1 trial

Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage

Withdrawn·XXuanwu Hospital, Beijing·Phase 2·NCT04890379

Adrenomyeloneuropathy1 trial

Dimethyl Fumarate in Adrenomyeloneuropathy

Recruiting·—·Phase 2/3·NCT06513533·40 enrolled

ART1 trial

Tecfidera Lymphocyte Chart Review

Completed· Biogen logo

Biogen··NCT02519413·483 enrolled

AIN1 trial

Tecfidera and MRI for Brain Energy in MS

Terminated·OOregon Health and Science University··NCT02644083·4 enrolled

Lymphoma1 trial

Study on Therapy With Dimethylfumarate (DMF) in Patients With Cutaneous T Cell Lymphoma (CTCL)

Completed·UUniversitätsmedizin Mannheim·Phase 2·NCT02546440·25 enrolled

Imaging1 trial

Tecfidera Diffusion Tensor Imaging

Completed·UUniversity at Buffalo··NCT02686684·115 enrolled

Glioblastoma Multiforme1 trial

Dimethyl Fumarate, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Completed·VVirginia Commonwealth University·Phase 1·NCT02337426·12 enrolled

Pulmonary Arterial Hypertension1 trial

Dimethyl Fumarate (DMF) in Systemic Sclerosis-Associated Pulmonary Arterial Hypertension

Terminated·RRobert Lafyatis·Phase 1·NCT02981082·6 enrolled

MPA1 trial

Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy Subjects

Completed·BBanner Life Sciences LLC·Phase 1·NCT04570670·50 enrolled

Gastrointestinal1 trial

PeptoBismol® Use to Reduce Gastrointestinal Events in Healthy Volunteers Receiving DMF [Tecfidera®] Twice Daily

Completed· Biogen logo

Biogen·Phase 1·NCT01915901·175 enrolled

Type 1 Diabetes Mellitus1 trial

Clinical Study for Dimethyl Fumarate in Preserving Islet β-Cell Function in Type 1 Diabetes Mellitus

Recruiting·NNanjing Medical University·Phase 3·NCT07258394·90 enrolled

Quality of Life1 trial

Study to Assess Resource Utilization and Quality of Life of Patients With RRMS Treated With Tecfidera in Greece

Completed·GGenesis Pharma CNS & Specialty··NCT03101735·455 enrolled

Geographic Atrophy1 trial

Long-Term Analysis of DImethyl Fumarate, to Slow the Growth of Areas of Geographic Atrophy

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT04292080·90 enrolled

Primary Progressive Multiple Sclerosis1 trial

Dimethyl Fumarate Treatment of Primary Progressive Multiple Sclerosis

Completed·RRigshospitalet, Denmark·Phase 2·NCT02959658·54 enrolled

Relapsing Remitting Multiple Sclerosis (RRMS)1 trial

A Phase IIa Clinical Study to Evaluate the Efficacy and Safety of Rocbrutinib (LP-168), an Oral BTK Inhibitor, in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)

Recruiting·GGuangzhou Lupeng Pharmaceutical Company LTD.·Phase 2·NCT07776743·30 enrolled

Aneurysm1 trial

Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms: a Double Blind Randomized Controlled Trail

Completed·BBeijing Tiantan Hospital·Approved·NCT05959759·60 enrolled

Unspecified7 trials

A Healthy Volunteer Study to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial Manufacturers

Completed· Biogen logo

Biogen·Phase 1·NCT02171208·80 enrolled

Teriflunomide Tecfidera LMCE

Completed·UUniversity at Buffalo··NCT03526224·120 enrolled

Tecfidera Slow-Titration Study

Terminated· Biogen logo

Biogen·Phase 3·NCT02428231·62 enrolled

Show 4 more trials

Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEP

Completed· Biogen logo

Biogen··NCT04221191·353 enrolled

Mechanisms of Action of Dimethyl Fumarate (Tecfidera) in Relapsing MS

Withdrawn·WWashington University School of Medicine·Phase 4·NCT02675413

Study of Utilization Patterns of Dimethyl Fumarate in Germany

Completed· Biogen logo

Biogen··NCT02969304·930 enrolled

Alternate Dosing Regimens of BG00012 in Healthy Volunteers

Completed· Biogen logo

Biogen·Phase 1·NCT01281111·56 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 27, 2013

TECFIDERA

NDA NDA204063

Mar 27, 2013

TECFIDERA

NDA NDA204063

Aug 20, 2013

TECFIDERA

NDA NDA204063

Aug 18, 2014

TECFIDERA

NDA NDA204063

Nov 14, 2014

TECFIDERA

NDA NDA204063

Dec 3, 2014

TECFIDERA

NDA NDA204063

Dec 3, 2014

TECFIDERA

NDA NDA204063

Dec 3, 2014

TECFIDERA

NDA NDA204063

Mar 6, 2015

TECFIDERA

NDA NDA204063

Jun 16, 2015

TECFIDERA

NDA NDA204063

Jul 14, 2015

TECFIDERA

NDA NDA204063

Oct 16, 2015

TECFIDERA

NDA NDA204063

Dec 24, 2015

TECFIDERA

NDA NDA204063

Feb 29, 2016

TECFIDERA

NDA NDA204063

Jan 19, 2017

TECFIDERA

NDA NDA204063

Dec 15, 2017

TECFIDERA

NDA NDA204063

Jul 10, 2019

TECFIDERA

NDA NDA204063

Dec 11, 2019

TECFIDERA

NDA NDA204063

Feb 5, 2020

TECFIDERA

NDA NDA204063

Jan 29, 2021

TECFIDERA

NDA NDA204063

Feb 10, 2022

TECFIDERA

NDA NDA204063

Sep 29, 2022

TECFIDERA

NDA NDA204063

Sep 29, 2022

TECFIDERA

NDA NDA204063

Feb 10, 2023

TECFIDERA

NDA NDA204063

Dec 13, 2023

TECFIDERA

NDA NDA204063

Mar 12, 2024

TECFIDERA

NDA NDA204063

Sources

References

[1]
ClinicalTrials.gov — 75 trial records for dimethyl fumarate. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tecfidera drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — dimethyl fumarate compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for dimethyl fumarate. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA204063). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Tecfidera. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Biogen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Kelch-Like ECH-Associated Protein 1 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Biogen

Patent Landscape[6]

Patent Cliff

Feb 7, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8399514Feb 7, 2028

10994003Mar 13, 2035

10555993Mar 13, 2035

10391160Mar 13, 2035

11007167Nov 16, 2035

4 more patents

11246850Nov 16, 2035

10959972Nov 16, 2035

11129806Nov 16, 2035

11007166Nov 16, 2035

Tecfidera

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2027

Q2 2028

Q3 2028

Q4 2028

Trials by Indication[1]

Multiple Sclerosis26 trials

Relapsing-Remitting Multiple Sclerosis6 trials

Ischemic stroke3 trials

Effectiveness2 trials

Gut Microbiota2 trials

Secondary Progressive Multiple Sclerosis1 trial

Psoriasis1 trial

Lymphopenia1 trial

RRMS1 trial

Absorption1 trial

Observational Study1 trial

Cognitive impairment1 trial

Relapsed/Refractory1 trial

Obstructive Sleep Apnea1 trial

Oral1 trial

COVID-191 trial

Outcome1 trial

Pediatric1 trial

Intracerebral Hemorrhage1 trial

Adrenomyeloneuropathy1 trial

ART1 trial

AIN1 trial

Lymphoma1 trial

Imaging1 trial

Glioblastoma Multiforme1 trial

Pulmonary Arterial Hypertension1 trial

MPA1 trial

Gastrointestinal1 trial

Type 1 Diabetes Mellitus1 trial

Quality of Life1 trial

Geographic Atrophy1 trial

Primary Progressive Multiple Sclerosis1 trial

Relapsing Remitting Multiple Sclerosis (RRMS)1 trial

Aneurysm1 trial

Unspecified7 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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