Product Description
Leflunomide (Arava) is a drug approved to treat adult moderate to severe rheumatoid arthritis. It belongs to a class of medications called disease-modifying antirheumatic drugs (DMARDs). This class of medicines can decrease joint damage and disability caused by rheumatoid arthritis. Leflunomide is often used to treat rheumatoid arthritis alone or in combination with other DMARDs. (Sourced from: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Treatments/Leflunomide-Arava)
Mechanisms of Action: Pyrimidine Synthesis Inhibitor,TNF Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Sanofi
Company Location: PARIS I0 75008
Company CEO: Paul Hudson
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China
Active Clinical Trial Count: 2
Highest Development Phases
Phase 2: Sjogren's Syndrome
Phase 1: Arthritis, Rheumatoid
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| RepurpSS-II study | P2 |
Active, not recruiting |
Sjogren's Syndrome |
2025-05-31 |
|
| CTR20201981 | P1 |
Active, not recruiting |
Arthritis, Rheumatoid |
None |