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Teriflunomide

Generic Name
Teriflunomide
Brand Names
Aubagio, Teriflunomide Accord, Teriflunomide Mylan
Drug Type
Small Molecule
Chemical Formula
C12H9F3N2O2
CAS Number
163451-81-8
Unique Ingredient Identifier
1C058IKG3B
Background

Teriflunomide is the active metabolite of leflunomide, and it acts as an immunomodulatory agent by inhibiting pyrimidine synthesis. It is marketed under the name Aubagio® and is indicated for the treatment of multiple sclerosis, specifically relapsing forms. The FDA label states an important warning about the risk of hepatoxicity and teratogenicity for patients using teriflunomide.

Indication

Used in the treatment of relapsing forms of multiple sclerosis (MS).

Associated Conditions
Multiple Sclerosis
Clinical Trials
Related News

Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis

Phase 1
Recruiting
Conditions
HAM/TSP
Interventions
First Posted Date
2021-03-16
Last Posted Date
2025-04-10
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Target Recruit Count
24
Registration Number
NCT04799288
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Relationship Between Oral DMT Burden and Adherence in MS

First Posted Date
2020-12-19
Last Posted Date
2022-08-31
Lead Sponsor
Monash University
Target Recruit Count
323
Registration Number
NCT04676204
Locations
🇦🇺

Monash University, Melbourne, Victoria, Australia

Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)

Phase 3
Active, not recruiting
Conditions
Relapsing Multiple Sclerosis
Interventions
Drug: Placebo
First Posted Date
2020-10-14
Last Posted Date
2025-03-17
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
751
Registration Number
NCT04586023
Locations
🇮🇹

NCL Institute Neuroscience, Roma, Lazio, Italy

🇮🇹

Irccs A.O.U.San Martino Ist, Genova, Liguria, Italy

🇮🇹

Fond. Istituto Neurologico C.Besta, Milano, Lombardia, Italy

and more 104 locations

A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS)

Phase 3
Active, not recruiting
Conditions
Relapsing Multiple Sclerosis
Interventions
Drug: Placebo
First Posted Date
2020-10-14
Last Posted Date
2025-03-17
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
746
Registration Number
NCT04586010
Locations
🇨🇭

Inselspital Bern Medizin Neurologie, Bern, Switzerland

🇨🇭

Ospedale Regionale di Lugano - Civico, Lugano, Switzerland

🇹🇳

Hopital Razi, Mannouba, Tunisia

and more 157 locations

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

Phase 3
Active, not recruiting
Conditions
Relapsing Multiple Sclerosis
Interventions
Drug: Placebo to match Tolebrutinib
First Posted Date
2020-06-01
Last Posted Date
2024-04-19
Lead Sponsor
Sanofi
Target Recruit Count
900
Registration Number
NCT04410991
Locations
🇺🇸

CHI Saint Joseph Medical Group Neurology-Site Number:8400110, Lexington, Kentucky, United States

🇮🇳

Investigational Site Number :3560005, Chandigarh, India

🇷🇺

Investigational Site Number :6430007, Moscow, Russian Federation

and more 183 locations

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

Phase 3
Active, not recruiting
Conditions
Relapsing Multiple Sclerosis
Interventions
Drug: Placebo to match Tolebrutinib
First Posted Date
2020-06-01
Last Posted Date
2024-04-19
Lead Sponsor
Sanofi
Target Recruit Count
900
Registration Number
NCT04410978
Locations
🇺🇸

University of Texas Southwestern Medical Center-Site Number:8400077, Dallas, Texas, United States

🇺🇸

Meridian Clinical Research-Site Number:8400003, Savannah, Georgia, United States

🇧🇬

Investigational Site Number :1000001, Sofia, Bulgaria

and more 176 locations

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

Phase 4
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2020-06-01
Last Posted Date
2022-04-13
Lead Sponsor
Sanofi
Target Recruit Count
82
Registration Number
NCT04410965
Locations
🇨🇳

Investigational Site Number, China, China

Study of Evobrutinib in Participants With RMS (evolutionRMS 2)

Phase 3
Terminated
Conditions
Relapsing Multiple Sclerosis
Interventions
First Posted Date
2020-04-08
Last Posted Date
2025-03-21
Lead Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Target Recruit Count
1166
Registration Number
NCT04338061
Locations
🇺🇸

Research Site 730, Raleigh, North Carolina, United States

🇵🇱

Research Site 269, Wroclaw, Poland

🇺🇸

Research Site 752, Cullman, Alabama, United States

and more 275 locations

Study of Evobrutinib in Participants With RMS (evolutionRMS 1)

Phase 3
Terminated
Conditions
Relapsing Multiple Sclerosis
Interventions
Drug: Placebo (match to Evobrutinib)
Drug: Placebo (match to Teriflunomide)
First Posted Date
2020-04-08
Last Posted Date
2024-04-29
Lead Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Target Recruit Count
1124
Registration Number
NCT04338022
Locations
🇺🇸

Research Site 612, Farmington Hills, Michigan, United States

🇦🇹

Research Site 151, Innsbruck, Austria

🇦🇹

Research Site 153, Vienna, Austria

and more 276 locations

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

Phase 4
Completed
Conditions
Multiple Sclerosis, Pharmacokinetics
Interventions
First Posted Date
2019-10-17
Last Posted Date
2022-12-12
Lead Sponsor
Jan Lycke
Target Recruit Count
12
Registration Number
NCT04129736
Locations
🇸🇪

MS Centre, Gothenburg, Vastra Gotaland, Sweden

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