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
-

Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide

First Posted Date
2011-07-27
Last Posted Date
2016-02-18
Lead Sponsor
Sanofi
Target Recruit Count
128
Registration Number
NCT01403376
Locations
🇦🇹

Investigational Site Number 040001, Wien, Austria

🇨🇦

Investigational Site Number 124002, London, Canada

🇨🇦

Investigational Site Number 124003, Greenfield Park, Canada

and more 11 locations

Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta

First Posted Date
2010-12-03
Last Posted Date
2014-06-09
Lead Sponsor
Sanofi
Target Recruit Count
534
Registration Number
NCT01252355
Locations
🇨🇴

Investigational Site Number 170001, Barranquilla, Colombia

🇨🇴

Investigational Site Number 170007, Bogota, Colombia

🇪🇪

Investigational Site Number 233002, Tallinn, Estonia

and more 182 locations

A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis

First Posted Date
2009-04-17
Last Posted Date
2016-06-13
Lead Sponsor
Sanofi
Target Recruit Count
324
Registration Number
NCT00883337
Locations
🇧🇪

Investigational Site Number 056003, Bruxelles, Belgium

🇧🇪

Investigational Site Number 056001, Gent, Belgium

🇨🇿

Investigational Site Number 203004, Jihlava, Czech Republic

and more 51 locations

Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis

First Posted Date
2008-12-19
Last Posted Date
2012-12-31
Lead Sponsor
Sanofi
Target Recruit Count
182
Registration Number
NCT00811395
Locations
🇬🇧

Sanofi-Aventis Administrative Office, Guildford, United Kingdom

An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-09-12
Last Posted Date
2016-07-07
Lead Sponsor
Sanofi
Target Recruit Count
1169
Registration Number
NCT00751881
Locations
🇺🇸

Sanofi-Aventis Investigational Site Number 840020, Charleston, West Virginia, United States

🇺🇸

Sanofi-Aventis Investigational Site Number 840060, Syracuse, New York, United States

🇺🇸

Sanofi-Aventis Investigational Site Number 840078, Dayton, Ohio, United States

and more 190 locations

Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-02-25
Last Posted Date
2017-03-13
Lead Sponsor
Sanofi
Target Recruit Count
618
Registration Number
NCT00622700
Locations
🇧🇬

Investigational Site Number 5307, Sofia, Bulgaria

🇦🇺

Investigational Site Number 1405, Geelong, Australia

🇺🇸

Investigational Site Number 8953, St. Petersburg, Florida, United States

and more 128 locations

Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis

First Posted Date
2007-06-21
Last Posted Date
2012-11-06
Lead Sponsor
Sanofi
Target Recruit Count
118
Registration Number
NCT00489489
Locations
🇪🇸

Sanofi-Aventis Administrative Office, Barcelona, Spain

Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis

First Posted Date
2007-05-21
Last Posted Date
2012-11-06
Lead Sponsor
Sanofi
Target Recruit Count
123
Registration Number
NCT00475865
Locations
🇬🇧

Sanofi-Aventis Administrative Office, Guildford, United Kingdom

Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis

First Posted Date
2005-08-25
Last Posted Date
2013-01-04
Lead Sponsor
Sanofi
Target Recruit Count
1088
Registration Number
NCT00134563
Locations
🇨🇦

sanofi-aventis, Canada, Laval, Canada

🇸🇪

Sanofi-Aventis, Bromma, Sweden

🇩🇪

Sanofi-Aventis Deutschland GmbH, Berlin, Germany

and more 9 locations
© Copyright 2024. All Rights Reserved by MedPath