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Aubagio

(Teriflunomide)

ApprovedSmall molecule

Teriflunomide is used to treat multiple sclerosis by reducing inflammation and suppressing immune cells that damage nerves. It helps control MS symptoms but does not cure the disease.[2] Aubagio is currently approved and in use across 8 indications[4].[1]

Aubagio is one of 192 small molecule programs targeting Immune Thrombocytopenia. It is currently in Approved.

8

Indications

54

Total Trials

9

Active Trials

191

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

6

Patents

Pipeline

Status by Indication[4][1]

Indication

Immune ThrombocytopeniaRecruiting

Familial HyperlipidemiaActive, not recruiting

Kidney DiseaseApproved

Autoimmune Thrombocytopenic PurpuraApproved

Rheumatoid ArthritisApproved

Hepatitis B Virus InfectionApproved

HAM/TSPRecruiting

Multiple SclerosisCompleted

Immune ThrombocytopeniaPhase 2

Recruiting

Familial HyperlipidemiaApproved

Active, not recruiting

Kidney DiseaseApproved

Approved

Autoimmune Thrombocytopenic PurpuraApproved

Approved

Rheumatoid ArthritisApproved

Approved

Hepatitis B Virus InfectionApproved

Approved

HAM/TSPPreclinical

Recruiting

Multiple SclerosisApproved

Completed

Competition

Competitive Landscape

181 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Aubagio

Actos

Celexa

Plaquenil

Jazz Pharmaceuticals

Voltaren

Cataflam

Velcade

SShilpa Grover, MD, MPH

Vancocin

HHikma Pharmaceuticals LLC

Nsaids

Disalcid

JJoslin Diabetes Center

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

Timeline

Expected Milestones

Q2 2027

Phase 3Active, not recruiting

Multiple Sclerosis

NCT06141473

Q3 2027

Phase 3Active, not recruiting

Relapsing Multiple Sclerosis

NCT04586023

Q4 2027

Phase 3Active, not recruiting

Relapsing Multiple Sclerosis

NCT04586010

Phase 2Recruiting

Immune Thrombocytopenia

NCT07065968

Q2 2029

Phase 3Active, not recruiting

Relapsing Multiple Sclerosis

NCT06372145

Clinical

Trials by Indication[1]

Multiple Sclerosis28 trials

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

Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS)

Completed·TTG Therapeutics, Inc.·Phase 3·NCT03277248·545 enrolled

Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis

Completed· Sanofi logo

Sanofi·Phase 2·NCT00475865·123 enrolled

Show 25 more trials

A Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period

Completed·—·Phase 3·NCT02587195·5 enrolled

Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis

Completed· Sanofi logo

Sanofi·Phase 3·NCT00134563·1,088 enrolled

An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis

Completed· Sanofi logo

Sanofi·Phase 3·NCT00751881·1,169 enrolled

Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

Completed· Sanofi logo

Sanofi·Phase 2·NCT01487096·179 enrolled

Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 )

Completed·TTG Therapeutics, Inc.·Phase 3·NCT03277261·549 enrolled

Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis

Completed· Sanofi logo

Sanofi·Phase 3·NCT02201108·166 enrolled

Comparative Study of the Efficacy and Safety of BCD-132 With Teriflunomide and Placebo in Multiple Sclerosis

Completed·BBiocad·Phase 2·NCT04056897·271 enrolled

An International, Multicenter, Randomized, Double-Blind, Double-Masked Study of the Efficacy and Safety of BCD-132 (JSC BIOCAD, Russia) Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis

Completed·BBiocad·Phase 3·NCT05385744·336 enrolled

Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients

Completed· Sanofi logo

Sanofi·Phase 4·NCT01895335·1,001 enrolled

Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis

Completed· Sanofi logo

Sanofi·Phase 3·NCT00622700·618 enrolled

A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

Completed· Sanofi logo

Sanofi·Phase 3·NCT00883337·324 enrolled

Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis

Completed· Sanofi logo

Sanofi·Phase 2·NCT00489489·118 enrolled

Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis

Completed· Sanofi logo

Sanofi·Phase 2·NCT00811395·182 enrolled

Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02425644·1,133 enrolled

Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)

Completed· Sanofi logo

Sanofi·Phase 3·NCT04410991·899 enrolled

Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis

Completed· Novartis logo

Novartis·Phase 3·NCT02792218·930 enrolled

Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.

Completed· Novartis logo

Novartis·Phase 3·NCT02792231·955 enrolled

Long Term Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses

Completed· Sanofi logo

Sanofi·Phase 2·NCT00228163·147 enrolled

Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis

Completed·JJan Lycke·Phase 4·NCT04129736·12 enrolled

Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis

Completed· Sanofi logo

Sanofi·Phase 3·NCT01863888·70 enrolled

To Evaluate the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis

Completed· Sanofi logo

Sanofi·Phase 4·NCT03856619·121 enrolled

Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide

Completed· Sanofi logo

Sanofi·Phase 2·NCT01403376·128 enrolled

Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1)

Completed· Sanofi logo

Sanofi·Phase 3·NCT04410978·974 enrolled

Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta

Terminated· Sanofi logo

Sanofi·Phase 3·NCT01252355·534 enrolled

Master Protocol of Two Independent, Randomized, Double-blind, Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) to Teriflunomide in Adult Participants With Relapsing Forms of Multiple Sclerosis

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT06141473·1,655 enrolled

Relapsing Multiple Sclerosis5 trials

A Phase III Multicenter Randomized, Double-blind, Double-dummy, Parallel-group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Adult Patients With Relapsing Multiple Sclerosis

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04586023·751 enrolled

A Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label Remibrutinib

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05147220·1,000 enrolled

A Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label Remibrutinib

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05156281·1,007 enrolled

Show 2 more trials

An Interventional, Phase 3 Extension Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Relapsing Multiple Sclerosis, Primary Progressive Multiple Sclerosis, or Nonrelapsing Secondary Progressive Multiple Sclerosis

Active, not recruiting· Sanofi logo

Sanofi·Phase 3·NCT06372145·2,500 enrolled

A Phase III Multicenter Randomized, Double-blind, Double-dummy, Parallel-group Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Adult Patients With Relapsing Multiple Sclerosis

Active, not recruiting· Roche logo

Roche·Phase 3·NCT04586010·746 enrolled

Immune Thrombocytopenia4 trials

Teriflunomide for Steroid-resistant/Relapse Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital·Phase 2·NCT06190145·40 enrolled

Teriflunomide Plus High-dose Dexamethasone as First-line Treatment in Newly Diagnosed Primary Immune Thrombocytopenia

Withdrawn·PPeking University People's Hospital·Phase 2·NCT06176235

The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)

Recruiting·PPeking University People's Hospital·Phase 2·NCT07065968·132 enrolled

Show 1 more trial

The Combination of Teriflunomide and Danazol for Steroid-resistant/Relapse Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital·Phase 2·NCT06176911·124 enrolled

ART2 trials

Study of Evobrutinib in Participants With RMS (evolutionRMS 2)

Terminated· Merck & Co. logo

Merck & Co.·Phase 3·NCT04338061·1,166 enrolled

Study of Evobrutinib in Participants With RMS (evolutionRMS 1)

Terminated· Merck & Co. logo

Merck & Co.·Phase 3·NCT04338022·1,124 enrolled

Effectiveness1 trial

Teriflunomide Observational Effectiveness Study

Completed·—··NCT02490982·106 enrolled

12 more indications

Biomarkers1 trial

Biomarkers and Disease Activity in Patients Treated With Teriflunomide (Aubagio)

Completed·MMcGill University··NCT03561402·24 enrolled

AIN1 trial

MAIN STUDY: SWITCH SUB-STUDY: SWITCH-JCV

Completed·PProvidence Health & Services·Phase 4·NCT01970410·55 enrolled

BCG1 trial

Evaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese RMS Patients Treated With Teriflunomide 14 mg Once Daily for 24 Weeks

Completed· Sanofi logo

Sanofi·Phase 4·NCT04410965·82 enrolled

RRMS1 trial

Mechanistic Studies of Teriflunomide in RRMS

Completed·UUniversity of Michigan··NCT03464448·30 enrolled

Observational Study1 trial

An Observational Study on Teriflunomide-exposed Pregnancies

Completed· Sanofi logo

Sanofi··NCT03198351·220 enrolled

Double-blind1 trial

Randomized, Double-blinded Study of Treatment:Teriflunomide, in Radiologically Isolated Syndrome

Completed·—·Phase 3·NCT03122652·125 enrolled

Renal Impairment1 trial

Pharmacokinetic and Tolerability Study of 14 mg Single Dose of Teriflunomide in Subjects With Severe Renal Impairment

Completed· Sanofi logo

Sanofi·Phase 1·NCT01239459·16 enrolled

Relapsing-Remitting Multiple Sclerosis1 trial

Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis

Completed· Sanofi logo

Sanofi·Phase 3·NCT00803049·742 enrolled

Celiac Disease1 trial

Teriflunomide vs. Placebo During Gluten Challenge in Celiac Disease

Completed·OOslo University Hospital·Phase 1/2·NCT04806737·15 enrolled

Oral1 trial

Relationship Between Oral DMT Burden and Adherence in MS

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

HAM/TSP1 trial

Phase I/II Study of Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis

Recruiting·NNational Institute of Neurological Disorders and Stroke (NINDS)·Preclinical·NCT04799288·24 enrolled

Unspecified3 trials

Teriflunomide Tecfidera LMCE

Completed·UUniversity at Buffalo··NCT03526224·120 enrolled

Rapid Elimination Procedure of Teriflunomide With Colestipol Hydrochloride

Terminated·DDerrick Scott Robertson·Phase 1·NCT02263547·14 enrolled

A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese Volunteers

Completed· Sanofi logo

Sanofi·Phase 1·NCT02046629·12 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 12, 2012

AUBAGIO

NDA NDA202992

Sources

References

[1]
ClinicalTrials.gov — 54 trial records for Teriflunomide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Aubagio drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Teriflunomide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Teriflunomide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA202992). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Aubagio. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Dihydroorotate Dehydrogenase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Sanofi

Patent Landscape[6]

Patent Cliff

Mar 12, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

6794410Sep 12, 2026

6794410*PEDMar 12, 2027

8802735Sep 14, 2030

8802735*PEDMar 14, 2031

9186346Feb 4, 2034

1 more patents

9186346*PEDAug 4, 2034

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