NDAORALTABLETPriority Review
Approved
Sep 1998
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
16
Data completeness
5/8 — Partial
Priority Review
ARAVA (leflunomide) by Sanofi. Approved for antirheumatic agent [epc]. First approved in 1998.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ARAVA (leflunomide) is an oral small-molecule immunomodulatory agent that inhibits dihydroorotate dehydrogenase to suppress pyrimidine synthesis and reduce inflammation. It is approved for rheumatoid arthritis, psoriatic arthritis, lupus nephritis, and investigational use in CNS tumors and prostate cancer. The active metabolite teriflunomide is responsible for essentially all in vivo activity, with a long half-life of 18-19 days enabling once-daily dosing.
$1MPart D
LOE ApproachingDeclining
ARAVA faces significant commercial headwinds with LOE approaching and minimal Part D spend ($1M in 2023), suggesting a small and contracting brand team focused on defensive positioning.
Mechanism of Action
Pharmacologic Class:
Antirheumatic Agent
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (16)
A Study of the Effectiveness of Additional Risk Minimization Measures Related to ARAVA® (Leflunomide) in Saudi Arabia
Started May 2025
3,500 enrolled
Rheumatoid ArthritisPsoriatic Arthritis
A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech Paravalvular Leak Device (PLD) in Patients With Mitral or Aortic Paravalvular Leaks
Started Feb 2025
200 enrolled
Paravalvular Leak Device (PLD)
Bioequivalence Study of Generic Leflunomide 20 mg Film-coated Tablets and Reference Product Under Fasting Conditions
Started Apr 2024
48 enrolled
Healthy Volunteer
Leflunomide Treatment for IgG4-RD
Started Jul 2018
70 enrolled
Autoimmune Disease
Laparoscopic Three-dimensional Versus Two-dimensional Sacral Colpopexy and Paravaginal Repair
Started Dec 2014
194 enrolled
Pelvic Organ ProlapseCystocele
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.