Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication ARAVA is indicated for the treatment of adults with active rheumatoid arthritis (RA). ARAVA is a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis. ( 1 ) FDA label
Also known as Arava
Leflunomide · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 100 mg of leflunomide |
| 2 | ACTIVE_COMPARATOR | 20 mg of leflunomide |
| Name | Type | Description |
|---|---|---|
| leflunomide | DRUG | 20 or 100 mg per os, Film coated tablet, for 3 days + matching placebo, then 20 mg once daily for 3 months |
Inclusion Criteria: * Diagnosis of active rheumatoid arthritis in the previous 6 months (according to the ACR guidelines) * Must have active disease to be initiated by DMARDs (Disease Modifying Anti-Rheumatic Drugs) Exclusion Criteria: * Patient presenting or having a history of other inflammator...
Leflunomide is a small molecule immunology drug studied for rheumatoid arthritis and systemic lupus erythematosus. It has been evaluated in a Phase 3 trial in early rheumatoid arthritis and a Phase 2 trial in SLE. It is developed by Sanofi.
Leflunomide targets DHODH, dihydroorotate dehydrogenase, and acts as an inhibitor of this enzyme. DHODH is involved in pyrimidine synthesis, and inhibiting it is the drug's mechanism of action in immunology indications such as rheumatoid arthritis and SLE.
Leflunomide is developed by Sanofi, which trades under the ticker SNY. Sanofi is the company associated with the clinical development of leflunomide in rheumatoid arthritis and systemic lupus erythematosus.
Leflunomide has been studied in Phase 3 for rheumatoid arthritis and Phase 2 for systemic lupus erythematosus. The Phase 3 rheumatoid arthritis trial is completed, and the Phase 2 SLE trial is also completed. It remains an investigational agent in these clinical programs.
Leflunomide has been evaluated in NCT00596206, a completed Phase 3 trial in early rheumatoid arthritis with 124 participants across Czechia, Italy, Portugal, Romania, and South Korea, and NCT00637819, a completed Phase 2 trial in systemic lupus erythematosus with 27 participants in Hong Kong.
Leflunomide is an investigational small molecule in clinical development for rheumatoid arthritis and systemic lupus erythematosus, with completed Phase 3 and Phase 2 trials. The available information does not indicate FDA approval for these indications.