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
Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses
- Conditions
- Multiple Sclerosis
- Interventions
- Drug: Placebo (placebo for teriflunomide)
- 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
Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide
- Conditions
- Multiple Sclerosis
- Interventions
- 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
Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta
- Conditions
- Multiple Sclerosis Relapse
- Interventions
- 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
Pharmacokinetic and Tolerability Study of 14 mg Single Dose of Teriflunomide in Subjects With Severe Renal Impairment
- Conditions
- Renal Impairment
- Interventions
- First Posted Date
- 2010-11-11
- Last Posted Date
- 2012-03-01
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 16
- Registration Number
- NCT01239459
- Locations
- 🇩🇪
Sanofi-Aventis Administrative Office, Berlin, Germany
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
Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- Drug: Placebo (for teriflunomide)Drug: Interferon-β [IFN-β]
- 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
Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis
- First Posted Date
- 2008-12-05
- Last Posted Date
- 2017-01-30
- Lead Sponsor
- Sanofi
- Target Recruit Count
- 742
- Registration Number
- NCT00803049
- Locations
- 🇳🇱
Investigational Site Number 4604, Sittard-Geleen, Netherlands
🇺🇦Investigational Site Number 3505, Ivano-Frankovsk, Ukraine
🇺🇦Investigational Site Number 3510, Kharkiv, Ukraine
An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis
- 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
Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis
- 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
Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Interventions
- 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
Drug Development Updates
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