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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

Examining the Risk of Skin Cancer in Multiple Sclerosis Patients Using Fingolimod: a Population-Based Study

Completed
Conditions
Multiple Sclerosis
Skin Cancer
Skin Cancer Melanoma
Skin Cancers - Basal Cell Carcinoma
Skin Cancer, Squamous Cell
Multiple Sclerosis (MS) - Relapsing-remitting
Interventions
First Posted Date
2024-11-26
Last Posted Date
2024-11-26
Lead Sponsor
University of British Columbia
Target Recruit Count
4000
Registration Number
NCT06705608

A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.

Phase 3
Recruiting
Conditions
Relapsing Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Progressive Relapsing Multiple Sclerosis
Interventions
First Posted Date
2024-04-17
Last Posted Date
2025-03-07
Lead Sponsor
Sanofi
Target Recruit Count
2500
Registration Number
NCT06372145
Locations
🇨🇿

Investigational Site Number : 2030008, Prague, Czechia

🇨🇿

Investigational Site Number : 2039906, Prague, Czechia

🇨🇿

Investigational Site Number : 2039905, Prague, Czechia

and more 310 locations

Teriflunomide for Steroid-resistant/Relapse Immune Thrombocytopenia

Phase 2
Recruiting
Conditions
Immune Thrombocytopenia
Interventions
First Posted Date
2024-01-05
Last Posted Date
2024-01-05
Lead Sponsor
Peking University People's Hospital
Target Recruit Count
40
Registration Number
NCT06190145
Locations
🇨🇳

Peking University Insititute of Hematology, Peking University People's Hospital, Beijing, China

The Combination of Teriflunomide and Danazol for Steroid-resistant/Relapse Immune Thrombocytopenia

Phase 2
Recruiting
Conditions
Immune Thrombocytopenia
Interventions
First Posted Date
2023-12-20
Last Posted Date
2023-12-20
Lead Sponsor
Peking University People's Hospital
Target Recruit Count
124
Registration Number
NCT06176911
Locations
🇨🇳

Peking University Insititute of Hematology, Peking University People's Hospital, Beijing, Beijing, China

Teriflunomide Plus High-dose Dexamethasone as First-line Treatment in Newly Diagnosed Primary Immune Thrombocytopenia

Phase 2
Recruiting
Conditions
Immune Thrombocytopenia
Interventions
First Posted Date
2023-12-19
Last Posted Date
2023-12-26
Lead Sponsor
Peking University People's Hospital
Target Recruit Count
132
Registration Number
NCT06176235
Locations
🇨🇳

China-Japan Friendship Hospital, Beijing, China

🇨🇳

Chinese PLA General Hospital, Beijing, China

🇨🇳

Peking University Insititute of Hematology, Peking University People's Hospital, Beijing, China

and more 7 locations

Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis

Phase 3
Recruiting
Conditions
Multiple Sclerosis
Interventions
Drug: Placebo infusion
Drug: Placebo tablet
Drug: MRI contrast-enhancing agents
First Posted Date
2023-11-21
Last Posted Date
2025-05-09
Lead Sponsor
Sanofi
Target Recruit Count
1400
Registration Number
NCT06141473
Locations
🇮🇹

Investigational Site Number : 3800014, Chieti, Italy

🇮🇹

Investigational Site Number : 3801027, Cuneo, Italy

🇮🇹

Investigational Site Number : 3800020, Verona, Italy

and more 325 locations

An International, Multicenter, Randomized, Double-Blind, Double-Masked Study of the Efficacy and Safety of BCD-132 (JSC BIOCAD, Russia) Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis

Phase 3
Completed
Conditions
Multiple Sclerosis
Interventions
First Posted Date
2022-05-23
Last Posted Date
2024-11-25
Lead Sponsor
Biocad
Target Recruit Count
336
Registration Number
NCT05385744
Locations
🇷🇺

State Budgetary Healthcare Institution of the Moscow Region M.F. Vladimirsky Moscow Regional Research and Clinical Institute, Moscow, Russian Federation

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)

Phase 3
Recruiting
Conditions
Relapsing Multiple Sclerosis
Interventions
First Posted Date
2021-12-14
Last Posted Date
2025-04-30
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
800
Registration Number
NCT05156281
Locations
🇺🇸

Neurocare Plus, Houston, Texas, United States

🇺🇸

Ctr for Neurology and Spine, Phoenix, Arizona, United States

🇺🇸

Vladimir Royter MD APMC, Hanford, California, United States

and more 57 locations

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)

Phase 3
Recruiting
Conditions
Relapsing Multiple Sclerosis
Interventions
First Posted Date
2021-12-07
Last Posted Date
2025-03-03
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
800
Registration Number
NCT05147220
Locations
🇺🇸

US Associates in Research, Miami, Florida, United States

🇺🇸

AZ Integrated Neuro and Spine, Phoenix, Arizona, United States

🇺🇸

Honor Health Research Institute, Scottsdale, Arizona, United States

and more 69 locations

Teriflunomide vs. Placebo During Gluten Challenge in Celiac Disease

Phase 1
Completed
Conditions
Celiac Disease
Interventions
First Posted Date
2021-03-19
Last Posted Date
2025-05-16
Lead Sponsor
Oslo University Hospital
Target Recruit Count
15
Registration Number
NCT04806737
Locations
🇳🇴

Dept of Gastroenterology, Oslo, Norway

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