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 patie...

Indication

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

Associated Conditions
Multiple Sclerosis
Associated Therapies
-
Clinical Trials
Related News

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

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)

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

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
Drug: Teriflunomide
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

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
Drug: ponesimod
Drug: teriflunomide
First Posted Date
2015-04-24
Last Posted Date
2023-01-04
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

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
Drug: Teriflunomide
First Posted Date
2014-07-25
Last Posted Date
2024-08-29
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

MAIN STUDY: SWITCH SUB-STUDY: SWITCH-JCV

Phase 4
Completed
Conditions
Multiple Sclerosis
Interventions
Drug: teriflunomide
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
Drug: Teriflunomide
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

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

First Posted Date
2011-12-07
Last Posted Date
2012-10-04
Lead Sponsor
Sanofi
Target Recruit Count
179
Registration Number
NCT01487096
Locations
🇨🇦

Canada, Toronto, Ontario, Canada

🇫🇷

sanofi-aventis France, Lyon, France

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