MedPath

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

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

Phase 2
Completed
Conditions
Multiple Sclerosis
Interventions
Biological: BCD-132, 125 mg
Biological: BCD-132, 500 mg
Drug: Placebo
First Posted Date
2019-08-14
Last Posted Date
2025-02-21
Lead Sponsor
Biocad
Target Recruit Count
271
Registration Number
NCT04056897
Locations
🇷🇺

State Budgetary Healthcare Institution of Nizhny Novgorod region "Regional Clinical Hospital N.A. Semashko, Nizhny Novgorod", Nizhny Novgorod, Russian Federation

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

Phase 4
Completed
Conditions
Relapsing Multiple Sclerosis
Interventions
First Posted Date
2019-02-27
Last Posted Date
2023-04-19
Lead Sponsor
Sanofi
Target Recruit Count
121
Registration Number
NCT03856619
Locations
🇮🇳

Investigational Site Number :026, Gurgaon, India

🇮🇳

Investigational Site Number :014, Pune, India

🇮🇳

Investigational Site Number :007, Gurgaon, India

and more 11 locations

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

Completed
Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
First Posted Date
2018-06-19
Last Posted Date
2021-03-24
Lead Sponsor
McGill University
Target Recruit Count
24
Registration Number
NCT03561402
Locations
🇨🇦

Department of Pathology, Montréal, Quebec, Canada

Teriflunomide Tecfidera LMCE

Completed
Conditions
Tecfidera
Teriflunomide
Interventions
First Posted Date
2018-05-16
Last Posted Date
2021-01-06
Lead Sponsor
University at Buffalo
Target Recruit Count
120
Registration Number
NCT03526224
Locations
🇺🇸

Buffalo Neuroimaging Analysis Center, Buffalo, New York, United States

Mechanistic Studies of Teriflunomide in RRMS

Completed
Conditions
Relapsing Remitting Multiple Sclerosis
Interventions
First Posted Date
2018-03-14
Last Posted Date
2022-12-27
Lead Sponsor
University of Michigan
Target Recruit Count
30
Registration Number
NCT03464448
Locations
🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

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

Phase 3
Completed
Conditions
Relapsing Multiple Sclerosis (RMS)
Interventions
Biological: Ublituximab
Drug: Oral Placebo
Drug: IV Placebo
First Posted Date
2017-09-11
Last Posted Date
2021-12-06
Lead Sponsor
TG Therapeutics, Inc.
Target Recruit Count
549
Registration Number
NCT03277261
Locations
🇺🇸

TG Therapeutics RMS Investigational Site, Round Rock, Texas, United States

🇺🇸

TG Therapeutics RMS Investigational Trial Site, Dallas, Texas, United States

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

Phase 3
Completed
Conditions
Relapsing Multiple Sclerosis (RMS)
Interventions
Biological: Ublituximab
Drug: Oral Placebo
Drug: IV Placebo
First Posted Date
2017-09-11
Last Posted Date
2021-12-06
Lead Sponsor
TG Therapeutics, Inc.
Target Recruit Count
545
Registration Number
NCT03277248
Locations
🇺🇸

TG Therapeutics RMS Investigational Trial site, Seattle, Washington, United States

🇺🇸

TG Therapeutics RMS Investigational Trial Site, Pittsburgh, Pennsylvania, United States

An Observational Study on Teriflunomide-exposed Pregnancies

Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2017-06-26
Last Posted Date
2023-08-28
Lead Sponsor
Sanofi
Target Recruit Count
220
Registration Number
NCT03198351
Locations
🇺🇸

University of California at San Diego-Site Number:001, San Diego, California, United States

🇨🇦

Investigational Site Number :002, Canada, Canada

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

Phase 3
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2017-04-21
Last Posted Date
2023-03-17
Lead Sponsor
Centre Hospitalier Universitaire de Nice
Target Recruit Count
125
Registration Number
NCT03122652
Locations
🇫🇷

CHRU de Montpellier, Montpellier, France

🇹🇷

Mustafa Kemal University, Antakya, Turkey

🇫🇷

CHU de Bordeaux, Bordeaux, France

and more 20 locations

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

Phase 3
Completed
Conditions
Relapsing Multiple Sclerosis
Interventions
Drug: Teriflunomide-matching placebo capsules
Drug: Matching placebo of ofatumumab subcutaneous injections
First Posted Date
2016-06-07
Last Posted Date
2021-10-01
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
930
Registration Number
NCT02792218
Locations
🇬🇧

Novartis Investigative Site, London, United Kingdom

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