Drug intelligence / Profile preview

leflunomide + diclofenac sodium

Development stage
Approved
Lead developer
V2 Pharma
Modality
Small Molecules
Administration
Topical
01

Overview

**Leflunomide + diclofenac sodium** is a combination drug designed for the treatment of active rheumatoid arthritis in adults and for the temporary relief of arthritis pain. Leflunomide is an immunomodulatory agent classified as a disease-modifying anti-rheumatic drug (DMARD) that inhibits pyrimidine synthesis, suppressing the proliferation of activated lymphocytes and thereby reducing inflammation. Diclofenac sodium is a non-steroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX-1 and COX-2) enzymes, reducing prostaglandin synthesis to alleviate pain and inflammation. The combination aims to address both the underlying autoimmune components (leflunomide) and provide symptomatic relief (diclofenac sodium). This combination is available as a gel kit and is not FDA-approved as of October 2025[1].

Brand names
Lefluniclo
Other names
leflunomide and diclofenac sodium gel kit
02

Targets

PTGS2 (Prostaglandin-Endoperoxide Synthase 2)DHODH (Dihydroorotate dehydrogenase (quinone), mitochondrial)PGHS-1 (Prostaglandin G/H Synthase 1)

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