How many clinical trials are studying Leflunomide?

6 recruiting trials in our tracked data involve Leflunomide.

What conditions is Leflunomide being studied for?

In our tracked recruiting trials, Leflunomide is being studied in trials for Rheumatoid Arthritis, Pancreatic cancer, Advanced Pancreatic Adenocarcinoma.

Leflunomide: clinical trials recruiting now

Q: Is Leflunomide FDA-approved?

Yes. According to the FDA drug label available through openFDA, Leflunomide is an FDA-approved drug. Its FDA label carries a boxed warning.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Leflunomide appears in the FDA drug-label database. Marketed as Leflunomide.
Drug class: Antirheumatic Agent (FDA established pharmacologic class)
Boxed warning: The FDA label for Leflunomide carries a boxed warning (the FDA's most serious warning). See the full label for details.

FDA-approved use

Leflunomide Tablets, USP are indicated for the treatment of adults with active rheumatoid arthritis (RA). Leflunomide tablets are a pyrimidine synthesis inhibitor indicated for the treatment of adults with active rheumatoid arthritis. ( 1 )

FDA recalls / enforcement

Reason (FDA)	Classification	Status	Initiated
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. — Apotex Corp.	Class II (FDA: may cause temporary or reversible harm)	Terminated	2007-06-14
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications. — Apotex Corp.	Class II (FDA: may cause temporary or reversible harm)	Terminated	2007-06-14

FDA label via openFDA

Phase breakdown

Phase 1 2 Phase 2 2 Phase 3 1 Phase 4 1

Conditions being studied

Condition	Trials
Rheumatoid Arthritis · Leflunomide for Rheumatoid Arthritis	3
Pancreatic cancer	2
Advanced Pancreatic Adenocarcinoma	1
Arthritis, Rheumatoid	1
Breast cancer	1
Colorectal Cancer Recurrent	1
Colorectal cancer	1
Lung Cancer	1
Lupus	1
Melanoma	1
PTEN-Altered Advanced Solid Tumors and HER2 Negative Breast Cancer	1
Pancreas Cancer	1
Psoriasis	1
RAS Mutation	1
Ras (Kras or Nras) Gene Mutation	1

Recruiting trials involving Leflunomide

Gemcitabine and Leflunomide in Patients With Advanced Unresectable Pancreatic Cancer
NCT06454383 · Phase: Phase 1 · Ages: 18 Years and older · Sex: All (male and female) · 1 location
Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
NCT07138898 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 2 locations
Leflunomide in Patients With PTEN-Altered Advanced Solid Malignancies and HER2 Negative Breast Cancer
NCT04997993 · Phase: Phase 1 · Ages: 18 Years and older · Sex: All (male and female) · 1 location
Leflunomide or Combination of MEK Inhibitor and Hydroxychloroquine for Refractory Patients With RAS Mutations
NCT06229340 · Phase: Phase 2 · Ages: 18 Years to 85 Years · Sex: All (male and female) · 1 location
The Clinical Efficacy of Immunomodulators in RA Patients
NCT05626348 · Phase: Phase 4 · Ages: 18 Years to 80 Years · Sex: All (male and female) · 1 location
Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response
NCT03414502 · Phase: Phase 3 · Ages: 19 Years and older · Sex: All (male and female) · 1 location

Common questions

Is Leflunomide FDA-approved?

Yes, marketed as Leflunomide. Its FDA label carries a boxed warning.

How many recruiting trials involve Leflunomide?

6 recruiting trials across 15 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.