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
Leflunomide · 2 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-72
Bioequivalence based on AUC0-72
| Arm | Type | Description |
|---|---|---|
| Leflunomide | EXPERIMENTAL | Leflunomide 20 mg Tablet |
| Arava™ | ACTIVE_COMPARATOR | Arava™ 20 mg Tablet |
| Arava® | ACTIVE_COMPARATOR | Arava® 20 mg Tablet |
| Name | Type | Description |
|---|---|---|
| Leflunomide 20 mg Tablets | DRUG | 1 x 20 mg, single-dose fasting |
| ARAVA™ 20 mg Tablets | DRUG | 1 x 20 mg, single-dose fasting |
| ARAVA® 20 mg tablets | DRUG | 1 x 20 mg, single-dose non-fasting |
Inclusion Criteria: * Screening Demographics: All subjects selected for this study will be healthy men or women 18 years of age or older at the time of dosing. The weight range will not exceed ± 20% for height and body frame as per Desirable Weights for Adults - 1983 Metropolitan Height and Weight ...
Leflunomide is a small molecule drug developed by Teva Pharmaceutical Industries Limited (ticker: TEVA). It is also known as Leflunomide 20 mg Tablets. The drug is in Phase 1 clinical development, with two completed trials in healthy volunteers. Its molecular target is DHODH, and it acts as an inhibitor.
Leflunomide targets DHODH (dihydroorotate dehydrogenase). It is classified as a DHODH inhibitor. By inhibiting this enzyme, Leflunomide interferes with pyrimidine synthesis, which is important for cell proliferation. This mechanism is relevant to its development as a small molecule therapeutic.
Leflunomide is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker symbol TEVA. Teva is responsible for the clinical development of Leflunomide 20 mg Tablets.
Leflunomide is in Phase 1 clinical development. Two Phase 1 trials have been completed, and there are currently no active trials. The drug is investigational and has not been approved by the FDA for any indication.
Leflunomide has been studied in two completed Phase 1 trials: NCT00834418, titled "Leflunomide 20 mg Tablets Under Fasting Conditions," which enrolled 84 healthy volunteers, and NCT00834405, titled "Leflunomide 20 mg Tablets, Non-Fasting," which enrolled 37 healthy volunteers. Both trials were conducted in the United States.