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Teriflunomide

Generic Name
Teriflunomide
Brand Names
Aubagio, Teriflunomide Accord, Teriflunomide Mylan, Teriflunomide Viatris (previously Teriflunomide Mylan)
Drug Type
Small Molecule
Chemical Formula
C12H9F3N2O2
CAS Number
163451-81-8
Unique Ingredient Identifier
1C058IKG3B

Overview

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

Research Report

Published: Jul 22, 2025

Teriflunomide (Aubagio®): A Comprehensive Pharmacological and Clinical Review for the Management of Relapsing Multiple Sclerosis

Executive Summary

Teriflunomide is an oral, once-daily, first-line disease-modifying therapy (DMT) approved for the treatment of relapsing forms of multiple sclerosis (MS). As a small molecule drug, it represents a significant evolution from the injectable platform therapies that once dominated MS management. Its primary mechanism of action is the selective and reversible inhibition of dihydroorotate dehydrogenase (DHODH), a key mitochondrial enzyme in the de novo pyrimidine synthesis pathway. This action exerts a cytostatic effect on rapidly proliferating, activated T and B lymphocytes, which are central to the autoimmune pathogenesis of MS, thereby reducing neuroinflammation. The clinical efficacy of teriflunomide has been robustly established in pivotal Phase III trials, including TEMSO and TOWER, which demonstrated significant reductions in annualized relapse rates and a slowing of disability progression compared to placebo.

Continue reading the full research report

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/15
Not Applicable
Not yet recruiting
2024/11/26
N/A
Completed
2024/04/17
Phase 3
Recruiting
2024/01/05
Phase 2
Recruiting
2023/12/20
Phase 2
Recruiting
2023/12/19
Phase 2
Withdrawn
2023/11/21
Phase 3
Recruiting
2022/05/23
Phase 3
Completed
2021/12/14
Phase 3
Recruiting
2021/12/07
Phase 3
Recruiting

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Sandoz Inc
0781-5755
ORAL
14 mg in 1 1
10/4/2022
Sandoz Inc
0781-5747
ORAL
7 mg in 1 1
10/4/2022
MSN LABORATORIES PRIVATE LIMITED
69539-032
ORAL
7 mg in 1 1
9/24/2019
Dr. Reddy's Laboratories Inc
43598-282
ORAL
7 mg in 1 1
3/21/2023
Alembic Pharmaceuticals Inc.
62332-314
ORAL
14 mg in 1 1
2/6/2023
Alembic Pharmaceuticals Inc.
62332-313
ORAL
7 mg in 1 1
2/6/2023
Natco Pharma USA LLC
69339-170
ORAL
14 mg in 1 1
1/8/2024
Mylan Pharmaceuticals Inc.
0378-0627
ORAL
7 mg in 1 1
8/24/2022
Mylan Pharmaceuticals Inc.
0378-0628
ORAL
14 mg in 1 1
8/24/2022
AvKARE
42291-830
ORAL
7 mg in 1 1
5/1/2023

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
AUBAGIO FILM-COATED TABLETS 14mg
SIN14841P
TABLET, FILM COATED
14.0mg
8/31/2015

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
EPSYRAM TABLETS 14MG
N/A
i & c (hong kong) limited
N/A
N/A
11/27/2024

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
JAMP TERIFLUNOMIDE
02504170
Tablet - Oral
14 MG
5/16/2022
PMS-TERIFLUNOMIDE
02500434
Tablet - Oral
14 MG
5/16/2022
APO-TERIFLUNOMIDE
02500639
Tablet - Oral
14 MG
5/16/2022
M-TERIFLUNOMIDE
mantra pharma inc
02523833
Tablet - Oral
14 MG
5/16/2022
MAR-TERIFLUNOMIDE
marcan pharmaceuticals inc
02500469
Tablet - Oral
14 MG
5/18/2022
AURO-TERIFLUNOMIDE
auro pharma inc
02500515
Tablet - Oral
14 MG
N/A
ACH-TERIFLUNOMIDE
02502933
Tablet - Oral
14 MG
5/19/2022
NAT-TERIFLUNOMIDE
natco pharma (canada) inc
02500310
Tablet - Oral
14 MG
5/16/2022
SANDOZ TERIFLUNOMIDE
02505843
Tablet - Oral
14 MG
5/16/2022
AUBAGIO
sanofi-aventis canada inc
02416328
Tablet - Oral
14 MG
11/15/2013

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
TERIFLUNOMIDA KRKA 14 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Krka D.D. Novo Mesto
88753
COMPRIMIDO RECUBIERTO CON PELÍCULA
Uso Hospitalario
Commercialized
TERIFLUNOMIDA DESITIN 14 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
89818
COMPRIMIDO RECUBIERTO CON PELÍCULA
Uso Hospitalario
Not Commercialized
TERIFLUNOMIDA AUROVITAS 14 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Aurovitas Spain, S.A.U.
89846
COMPRIMIDO RECUBIERTO CON PELÍCULA
Uso Hospitalario
Commercialized
THEDITRAX 14 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
89843
COMPRIMIDO RECUBIERTO CON PELÍCULA
Uso Hospitalario
Not Commercialized
AUBAGIO 7 MG COMPRIMIDOS RECUBIERTOS CON PELICULA
1130838006
COMPRIMIDO RECUBIERTO CON PELÍCULA
Uso Hospitalario
Commercialized
TERIFLUNOMIDA LICONSA 14 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
89393
COMPRIMIDO RECUBIERTO CON PELÍCULA
Uso Hospitalario
Not Commercialized
TERIFLUNOMIDA ZENTIVA 14 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
88896
COMPRIMIDO RECUBIERTO CON PELÍCULA
Uso Hospitalario
Commercialized
TERIFLUNOMIDA DR REDDYS 14 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Reddy Pharma Iberia S.A.
88843
COMPRIMIDO RECUBIERTO CON PELÍCULA
Uso Hospitalario
Commercialized
TERIFLUNOMIDA NEURAXPHARM 14 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Neuraxpharm Spain S.L.U.
89417
COMPRIMIDO RECUBIERTO CON PELÍCULA
Uso Hospitalario
Commercialized
TERIFLUNOMIDA KERN PHARMA 14 MG COMPRIMIDOS RECUBIERTOS CON PELÍCULA EFG
89341
COMPRIMIDO RECUBIERTO CON PELÍCULA
Uso Hospitalario
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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