teriflunomide
teriflunomide: developed by 1 company · 6 clinical trials tracked · 1 FDA decision.
teriflunomide evidence translation
What we can confirm
1 FDA record · 6 tracked trials
What it means
What to watch
Prepared research question
How could teriflunomide → SNY affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence3 indications · 1 study sponsors
Related indications
Study sponsors
Development Pipeline (2)
| Company | Phase |
|---|---|
| Sanofi (SNY) Relapsing Multiple Sclerosis; Multiple Sclerosis | Phase 4 |
| Sanofi (SNY) | Approved |
Clinical Trials (6)
An Interventional, Phase 3 Extension Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Relapsing Multiple Sclerosis, Primary Progressive Multiple Sclerosis, or Nonrelapsing Secondary Progressive Multiple Sclerosis
Primary endpoint: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs leading to permanent study intervention discontinuation
Master Protocol of Two Independent, Randomized, Double-blind, Phase 3 Studies Comparing Efficacy and Safety of Frexalimab (SAR441344) to Teriflunomide in Adult Participants With Relapsing Forms of Multiple Sclerosis
Primary endpoint: Annualized relapse rate (ARR) during the study period assessed by protocol defined adjudicated relapses
A Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label Remibrutinib
Primary endpoint: Annualized relapse rate (ARR) of confirmed relapses [Core Part]
A Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label Remibrutinib
Primary endpoint: Annualized relapse rate (ARR) of confirmed relapses [Core Part]
A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis
Primary endpoint: Annualized Relapse Rate (ARR) as Assessed by Confirmed Protocol-defined Adjudicated Relapses
Evaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese RMS Patients Treated With Teriflunomide 14 mg Once Daily for 24 Weeks
Primary endpoint: PK exposure: Cmax
FDA Decisions1 records
Frequently asked questions
Who is developing teriflunomide?
teriflunomide is being developed by Sanofi.
How many clinical trials involve teriflunomide?
BioSniper tracks 6 clinical trials involving teriflunomide.
What is teriflunomide's latest FDA decision?
The most recent tracked FDA decision for teriflunomide is Approval for 1 INDICATIONS AND USAGE AUBAGIO ® is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. AUBAGIO is a pyrimidine synthesis inhibitor indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. ( 1 ), dated September 12, 2012.