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.
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
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 | Recruiting | |||
2023/11/21 | Phase 3 | Recruiting | |||
2022/05/23 | Phase 3 | Completed | |||
2021/12/14 | Phase 3 | Recruiting | |||
2021/12/07 | Phase 3 | Recruiting | |||
2021/03/19 | Phase 1 | Completed | Oslo University Hospital |
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 | 11/9/2022 | ||
Authorised | 8/26/2013 | ||
Authorised | 11/9/2022 | ||
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 |
|---|---|---|---|---|---|
| Teriflunomide Tablets | 国药准字HJ20250010 | 化学药品 | 片剂 | 1/14/2025 | |
| Teriflunomide Tablets | 国药准字H20244879 | 化学药品 | 片剂 | 9/10/2024 | |
| Teriflunomide Tablets | 国药准字HJ20180038 | 化学药品 | 片剂 | 6/7/2023 | |
| Teriflunomide Tablets | 国药准字H20213974 | 化学药品 | 片剂 | 12/31/2021 | |
| Teriflunomide Tablets | 国药准字HJ20180039 | 化学药品 | 片剂 | 6/7/2023 | |
| Teriflunomide Tablets | 国药准字H20244038 | 化学药品 | 片剂 | 6/18/2024 |
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 |