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
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.
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2023/12/19 | Phase 2 | Withdrawn | |||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 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 8/26/2013 | ||
Authorised | 11/9/2022 | ||
Authorised | 11/9/2022 |
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 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
TERIFLAGIO teriflunomide 14 mg film-coated tablets blister pack | 303521 | Medicine | A | 5/24/2019 | |
TERIFLUNOMIDE GH teriflunomide 14 mg film-coated tablet blister pack | 303520 | Medicine | A | 5/24/2019 | |
TERIFLUNOMIDE HX teriflunomide 14 mg film-coated tablet blister pack | 300685 | Medicine | A | 2/26/2019 | |
TERIFLUNOMIDE SANDOZ teriflunomide 14 mg film-coated tablet blister pack | 300684 | Medicine | A | 2/26/2019 | |
PHARMACOR TERIFLUNOMIDE teriflunomide 14 mg film-coated tablets blister pack | 303522 | Medicine | A | 5/24/2019 | |
Teri-EM teriflunomide 14 mg tablet blister pack | 313677 | Medicine | A | 5/27/2020 | |
APX-TERIFLUNOMIDE teriflunomide 14 mg film-coated tablets blister pack | 406470 | Medicine | A | 8/17/2023 | |
TERIFLUNOMIDE DR.REDDY'S teriflunomide 14 mg tablet blister pack | 304233 | Medicine | A | 4/8/2019 | |
TERIFLUNOMIDE-REDDY'S teriflunomide 14 mg tablet blister pack | 304230 | Medicine | A | 4/8/2019 | |
TERIFLUNOMIDE ALEMBIC teriflunomide 14 mg film-coated tablet blister pack | 299133 | Medicine | A | 1/7/2019 |
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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