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Drug

Teriflunomide

Approved · EMA
Emerging researchLate-stage developmentCooling momentum

Also known as Aubagio, Teriflunomida, (Z)-2-cyano-alpha,alpha,alpha-trifluoro-3-hydroxy-p-crotonotoluidide, Teriflunomidum.

RxNorm1310520ChEMBLCHEMBL973UNII1C058IKG3B
7
Research papers
8
Active clinical trials
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-07-23Primary completion · ClinicalTrials.gov

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

Clinical trial2026-07-23Primary completion · ClinicalTrials.gov

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

Clinical trial2026-06-22Results expected Q4 2027 · ClinicalTrials.gov

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

Clinical trial2026-05-14Results expected Q2 2027 · ClinicalTrials.gov

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

Clinical trial2026-02-13Results expected Q2 2029 · ClinicalTrials.gov

Approval: Teriflunomide Accord (EMA)

Regulatory2022-11-09EMA

Approval: Teriflunomide Viatris (previously Teriflunomide Mylan) (EMA)

Regulatory2022-11-09EMA

The results of a 24-month controlled, prospective study of relapsing multiple sclerosis patients at risk for progressive multifocal encephalopathy, who switched from prolonged use of natalizumab to teriflunomide.

Research2021-10-01Multiple sclerosis journal - experimental, translational and clinical

Reducing return of disease activity in patients with relapsing multiple sclerosis transitioned from natalizumab to teriflunomide: 12-month interim results of teriflunomide therapy.

Research2019-01-16Multiple sclerosis journal - experimental, translational and clinical

Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial.

Research2014-01-23The Lancet. Neurology

Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial.

Research2013-10-14Multiple sclerosis (Houndmills, Basingstoke, England)

Approval: Aubagio (EMA)

Regulatory2013-08-26EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Teriflunomide
Aliases & brands
AubagioTeriflunomida(Z)-2-cyano-alpha,alpha,alpha-trifluoro-3-hydroxy-p-crotonotoluidideTeriflunomidum
RxNorm CUI
1310520
ChEMBL ID
CHEMBL973
UNII
1C058IKG3B
Regulatory jurisdictions
ema

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2013-08-26
Latest approval
2022-11-09
Authorities
EMA
Total events
3
emaEuropean Medicines Agency· 3 events
2022-11-09Approval
Approval: Teriflunomide Viatris (previously Teriflunomide Mylan) (EMA)
Indication: Teriflunomide Mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple… Show full indication

Teriflunomide Mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 of the SmPC for important information on the population for which efficacy has been established).  

Evidence ↗
2022-11-09Approval
Approval: Teriflunomide Accord (EMA)
Indication: Teriflunomide Accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please… Show full indication

Teriflunomide Accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).

Evidence ↗
2013-08-26Approval
Approval: Aubagio (EMA)
Indication: AUBAGIO is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section… Show full indication

AUBAGIO is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

42 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
42
registered trials across all phases
LATEST COMPLETION 2024
8
Active studies
2
Recruiting
28
Late-stage (III+)
27
Completed
7
Discontinued
PHASE DISTRIBUTIONn = 42
Phase 11Phase 1 / 22Phase 211Phase 324Phase 44

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

MAIN STUDY: Switching Relapsing Multiple Sclerosis Patients Treated With Natalizumab at Risk for Progressive Multifocal Leukoencephalopathy to Teriflunomide: Is This Safe and Effective? SUB-STUDY: Analysis of JCV Antibody Index in MS Patients Treated With Teriflunomide

CompletedPH IVProvidence Health & Servicesn=552022

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

CompletedPH IVSanofin=822021

Determination of Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis Treated With Teriflunomide 14 mg Daily.

CompletedPH IVJan Lycken=122021

A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients

CompletedPH IVKey trialSanofin=1,0012015

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 recruitingPH IIIKey trialNovartis Pharmaceuticalsn=1,0072030

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients With Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension

CompletedPH IIIGenzyme, a Sanofi Companyn=1662024

A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis

CompletedPH IIISanofin=9742024

A Phase IIa, Double-blind, Randomised, Placebo-controlled Study on the Efficacy and Tolerability of a 14-day Treatment With Teriflunomide vs. Placebo in Subjects With Coeliac Disease Undergoing a 3-day Gluten Challenge

CompletedPH I/IIOslo University Hospitaln=152023

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

CompletedPH IIIBiocadn=3362023

Multi-center, Randomized, Double-blinded Study of Teriflunomide® in Radiologically Isolated Syndrome (RIS) The TERIS Study

CompletedPH IIICentre Hospitalier Universitaire de Nicen=1252022

MAIN STUDY: Switching Relapsing Multiple Sclerosis Patients Treated With Natalizumab at Risk for Progressive Multifocal Leukoencephalopathy to Teriflunomide: Is This Safe and Effective? SUB-STUDY: Analysis of JCV Antibody Index in MS Patients Treated With Teriflunomide

CompletedPH IVProvidence Health & Servicesn=552022

Research activity

7 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20112021
Most influential

Randomized trial of oral teriflunomide for relapsing multiple sclerosis.

The New England journal of medicine · 2011 · 666 cites

Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial.

The Lancet. Neurology · 2014 · 395 cites

Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial.

Multiple sclerosis (Houndmills, Basingstoke, England) · 2014 · 228 cites

Teriflunomide effect on immune response to influenza vaccine in patients with multiple sclerosis.

Neurology · 2013 · 97 cites

Teriflunomide added to interferon-β in relapsing multiple sclerosis: a randomized phase II trial.

Neurology · 2012 · 56 cites

Reducing return of disease activity in patients with relapsing multiple sclerosis transitioned from natalizumab to teriflunomide: 12-month interim results of teriflunomide therapy.

Multiple sclerosis journal - experimental, translational and clinical · 2019 · 6 cites
Recent papers

The results of a 24-month controlled, prospective study of relapsing multiple sclerosis patients at risk for progressive multifocal encephalopathy, who switched from prolonged use of natalizumab to teriflunomide.

Multiple sclerosis journal - experimental, translational and clinical · 2021 · 5 cites

Reducing return of disease activity in patients with relapsing multiple sclerosis transitioned from natalizumab to teriflunomide: 12-month interim results of teriflunomide therapy.

Multiple sclerosis journal - experimental, translational and clinical · 2019 · 6 cites

Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial.

The Lancet. Neurology · 2014 · 395 cites

Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a randomised, controlled phase 3 trial.

Multiple sclerosis (Houndmills, Basingstoke, England) · 2014 · 228 cites

Teriflunomide effect on immune response to influenza vaccine in patients with multiple sclerosis.

Neurology · 2013 · 97 cites

Teriflunomide added to interferon-β in relapsing multiple sclerosis: a randomized phase II trial.

Neurology · 2012 · 56 cites
Journals, researchers & institutions
Top journals
  • Multiple sclerosis journal - experimental, translational and clinical2
  • Neurology2
  • Multiple sclerosis (Houndmills, Basingstoke, England)1
  • The Lancet. Neurology1
  • The New England journal of medicine1
Leading researchers
  • Freedman MS5
  • Comi G4
  • Confavreux C4
  • Kappos L4
  • Olsson TP4
  • Truffinet P4
  • Wolinsky JS4
  • O'Connor P3
Leading institutions
free-text, unnormalised
  • Providence Multiple Sclerosis Center2
  • University of Toronto2
  • Icahn School of Medicine at Mount Sinai1
  • Karolinska Institute1
  • McGill University1
  • Multiple Sclerosis Center of Northeastern New York1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.