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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

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

Phase 3
Completed
Conditions
Relapsing Multiple Scelrosis
Interventions
Drug: Teriflunomide-matching placebo capsules
Drug: Matching placebo of ofatumumab subcutaneous injections
First Posted Date
2016-06-07
Last Posted Date
2021-11-22
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
955
Registration Number
NCT02792231
Locations
🇬🇧

Novartis Investigative Site, London, United Kingdom

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

Phase 3
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2015-10-27
Last Posted Date
2023-03-22
Lead Sponsor
Centre Hospitalier Universitaire de Nice
Target Recruit Count
5
Registration Number
NCT02587195
Locations
🇫🇷

CHU de Lille, Lille, France

🇫🇷

CHU de Nice, Nice, France

🇫🇷

CHU de Montpellier, Montpellier, France

and more 2 locations

Teriflunomide Observational Effectiveness Study

Completed
Conditions
Relapsing Remitting Multiple Sclerosis
Interventions
First Posted Date
2015-07-07
Last Posted Date
2021-08-18
Lead Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Target Recruit Count
106
Registration Number
NCT02490982
Locations
🇨🇦

CHUM, Montréal, Quebec, Canada

Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis

Phase 3
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2015-04-24
Last Posted Date
2025-03-30
Lead Sponsor
Actelion
Target Recruit Count
1133
Registration Number
NCT02425644
Locations
🇮🇱

Investigator Site 4006, Jerusalem, Israel

🇵🇹

Investigator Site 1604, Porto, Portugal

🇲🇽

Investigator Site 7410, Chihuahua, Mexico

and more 159 locations

Rapid Elimination Procedure of Teriflunomide With Colestipol Hydrochloride

Phase 1
Terminated
Conditions
Healthy Volunteers
Teriflunomide Elimination
Interventions
First Posted Date
2014-10-13
Last Posted Date
2020-04-03
Lead Sponsor
Derrick Scott Robertson
Target Recruit Count
14
Registration Number
NCT02263547
Locations
🇺🇸

USF Carol and Frank Morsani Center for Advanced Healthcare, Tampa, Florida, United States

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

Phase 3
Completed
Conditions
Multiple Sclerosis
Interventions
Drug: Placebo
First Posted Date
2014-07-25
Last Posted Date
2025-02-06
Lead Sponsor
Genzyme, a Sanofi Company
Target Recruit Count
166
Registration Number
NCT02201108
Locations
🇺🇸

North Central Neurology Associates, PC Site Number : 840003, Cullman, Alabama, United States

🇺🇸

Raleigh Neurology Associates Site Number : 840004, Raleigh, North Carolina, United States

🇨🇳

Investigational Site Number : 156007, Changsha, China

and more 54 locations

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

Phase 1
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2014-01-28
Last Posted Date
2014-08-21
Lead Sponsor
Sanofi
Target Recruit Count
12
Registration Number
NCT02046629
Locations
🇨🇳

Investigational Site Number 156001, Shanghai, China

MAIN STUDY: SWITCH SUB-STUDY: SWITCH-JCV

Phase 4
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2013-10-28
Last Posted Date
2023-01-30
Lead Sponsor
Providence Health & Services
Target Recruit Count
55
Registration Number
NCT01970410
Locations
🇺🇸

Phoenix Neurological Associates, Ltd, Phoenix, Arizona, United States

🇺🇸

Multiple Sclerosis Center of Northeastern New York, Latham, New York, United States

🇺🇸

Providence Multiple Sclerosis Center, Portland, Oregon, United States

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

Phase 4
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2013-07-10
Last Posted Date
2016-12-06
Lead Sponsor
Sanofi
Target Recruit Count
1001
Registration Number
NCT01895335
Locations
🇺🇸

Investigational Site Number 840003, Canton, Ohio, United States

🇺🇸

Investigational Site Number 840037, Fullerton, California, United States

🇺🇸

Investigational Site Number 840104, Hialeah, Florida, United States

and more 166 locations

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

Phase 3
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2013-05-29
Last Posted Date
2015-03-13
Lead Sponsor
Sanofi
Target Recruit Count
70
Registration Number
NCT01863888
Locations
🇧🇪

Investigational Site Number 056003, Sijsele-Damme, Belgium

🇧🇪

Investigational Site Number 056002, Overpelt, Belgium

🇩🇪

Investigational Site Number 276-002, Ulm, Germany

and more 7 locations
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