Overview
Leflunomide is a pyrimidine synthesis inhibitor belonging to the DMARD (disease-modifying antirheumatic drug) class of drugs, which are chemically and pharmacologically very heterogeneous. Leflunomide was approved by FDA and in many other countries (e.g., Canada, Europe) in 1999.
Indication
For the management of the signs and symptoms of active rheumatoid arthritis (RA) to improve physical function and to slow the progression of structural damage associated with the disease. Has also been used for the prevention of acute and chronic rejection in recipients of solid organ trasnplants and is designated by the FDA as an orphan drug for this use.
Associated Conditions
- Juvenile Idiopathic Arthritis (JIA)
- Rheumatoid Arthritis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/11 | Phase 1 | Not yet recruiting | |||
2024/12/03 | N/A | Active, not recruiting | |||
2024/08/07 | Phase 2 | Recruiting | |||
2024/06/12 | Phase 1 | Recruiting | City of Hope Medical Center | ||
2024/01/29 | Phase 2 | Recruiting | N.N. Petrov National Medical Research Center of Oncology | ||
2024/01/29 | Phase 1 | Not yet recruiting | International Bio service | ||
2023/07/10 | Not Applicable | Recruiting | |||
2023/07/10 | Phase 1 | Recruiting | |||
2023/03/29 | Not Applicable | Recruiting | |||
2023/03/29 | Not Applicable | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| KVK-Tech, Inc. | 10702-277 | ORAL | 10 mg in 1 1 | 6/23/2025 | |
| Bryant Ranch Prepack | 71335-2256 | ORAL | 20 mg in 1 1 | 4/30/2021 | |
| Zydus Lifesciences Limited | 70771-1491 | ORAL | 10 mg in 1 1 | 9/15/2023 | |
| AvKARE | 42291-421 | ORAL | 20 mg in 1 1 | 1/9/2024 | |
| Bryant Ranch Prepack | 63629-9728 | ORAL | 10 mg in 1 1 | 4/30/2021 | |
| KVK-Tech, Inc. | 10702-278 | Oral, ORAL | 20 mg in 1 1 | 6/23/2025 | |
| Chartwell RX, LLC | 62135-794 | ORAL | 20 mg in 1 1 | 10/31/2023 | |
| sanofi-aventis U.S. LLC | 0088-2161 | ORAL | 20 mg in 1 1 | 10/4/2022 | |
| Apotex Corp. | 60505-2503 | ORAL | 20 mg in 1 1 | 12/14/2023 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-043 | ORAL | 10 mg in 1 1 | 4/19/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/27/2010 | ||
Authorised | 1/8/2010 | ||
Authorised | 9/2/1999 | ||
Authorised | 11/28/2010 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ARAVA TABLET 20 mg | SIN11400P | TABLET, FILM COATED | 20 mg | 10/14/2000 | |
| LEFLUNOMIDE MEVON FILM-COATED TABLETS 20 MG | SIN15252P | TABLET, FILM COATED | 20.00 MG | 5/31/2017 | |
| ARAVA TABLET 100 mg | SIN11401P | TABLET, FILM COATED | 100 mg | 10/14/2000 | |
| BAGEDA FILM-COATED TABLET 20MG | SIN17108P | TABLET, FILM COATED | 20.000mg | 10/8/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Leflunomide Tablets | 国药准字H20090330 | 化学药品 | 片剂 | 7/29/2019 | |
| Leflunomide Tablets | 国药准字H20223501 | 化学药品 | 片剂 | 2/9/2023 | |
| Leflunomide Tablets | 国药准字H20080054 | 化学药品 | 片剂 | 10/27/2022 | |
| Leflunomide Tablets | 国药准字HJ20240074 | 化学药品 | 片剂 | 7/30/2024 | |
| Leflunomide Tablets | 国药准字HJ20240075 | 化学药品 | 片剂 | 7/30/2024 | |
| Leflunomide Tablets | 国药准字H20060034 | 化学药品 | 片剂 | 6/5/2020 | |
| Leflunomide Tablets | 国药准字H20203195 | 化学药品 | 片剂 | 5/7/2020 | |
| Leflunomide Tablets | 国药准字H20080420 | 化学药品 | 片剂 | 5/23/2023 | |
| Leflunomide Tablets | 国药准字H20050129 | 化学药品 | 片剂 | 6/5/2020 | |
| Leflunomide Tablets | 国药准字H20050175 | 化学药品 | 片剂(薄膜衣片) | 5/19/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| LEFLUNOMIDE APOTEX leflunomide 10mg tablets blister pack | 129539 | Medicine | A | 7/14/2008 | |
| ATARIS 20 leflunomide 20mg tablet bottle | 164964 | Medicine | A | 3/25/2011 | |
| LEFLUNOMIDE-WGR leflunomide 10mg tablet bottle | 431390 | Medicine | A | 5/30/2024 | |
| APO-LEFLUNOMIDE leflunomide 10mg tablet bottle | 251992 | Medicine | A | 12/22/2015 | |
| ATARIS 10 leflunomide 10mg tablet bottle | 164963 | Medicine | A | 3/25/2011 | |
| LUNAVA leflunomide 100mg tablet blister pack | 164968 | Medicine | A | 3/25/2011 | |
| ARAVA Leflunomide 10mg tablet bottle | 69692 | Medicine | A | 10/11/1999 | |
| LEFLUNOMIDE APOTEX leflunomide 20mg tablets blister pack | 129540 | Medicine | A | 7/14/2008 | |
| TERRY WHITE CHEMISTS LEFLUNOMIDE leflunomide 10mg tablets blister pack | 129549 | Medicine | A | 7/14/2008 | |
| LEFLUNOMIDE SANDOZ leflunomide 100mg tablet blister pack | 210919 | Medicine | A | 4/2/2014 |
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