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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

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

Phase 2
Completed
Conditions
Multiple Sclerosis
Interventions
Drug: Placebo (for teriflunomide)
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

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

Phase 2
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2005-09-28
Last Posted Date
2015-03-25
Lead Sponsor
Sanofi
Target Recruit Count
147
Registration Number
NCT00228163
Locations
🇨🇦

Investigational Site Number 12, Montreal, Canada

🇨🇦

Investigational Site Number 11, Montreal, Canada

🇨🇦

Investigational Site Number 17, Vancouver, Canada

and more 13 locations

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

Phase 3
Completed
Conditions
Multiple Sclerosis
Interventions
Drug: Placebo (for teriflunomide)
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
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