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Leflunomide 20mg
Leflunomide 20mg is a Small molecule drug developed by West Virginia University. It is currently in Phase 1 development. Also known as: Arava.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Leflunomide 20mg |
|---|---|
| Also known as | Arava |
| Sponsor | West Virginia University |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Comparative Study of Leflunomide Plus Methotrexate Versus Methotrexate Monotherapy in Refractory Polyarticular Juvenile Idiopathic Arthritis Patients (PHASE4)
- Leflunomide Treatment for MEN1 Patients - the LUMEN1 Trial (NA)
- Leflunomide in Combination With Decitabine for Treatment of Relapsed or Refractory Myelodysplastic Syndromes (PHASE1, PHASE2)
- Takayasu Arteritis Clinical Trial in China (NA)
- Multicentre ObservatioNal Initiative in Treat to Target Outcomes in Psoriatic Arthritis
- New Clinical End-points in Patients With Primary Sjögren's Syndrome (PHASE2)
- Phase II Clinical Study of Leflunomide in the Treatment of MEN-1 Neuroendocrine Tumor (PHASE2)
- IL-7 and IL-7R Expression in RA Patients With Active vs. Inactive Disease Treated With DMARD or CIMZIA (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Leflunomide 20mg CI brief — competitive landscape report
- Leflunomide 20mg updates RSS · CI watch RSS
- West Virginia University portfolio CI
Frequently asked questions about Leflunomide 20mg
What is Leflunomide 20mg?
Who makes Leflunomide 20mg?
Is Leflunomide 20mg also known as anything else?
What development phase is Leflunomide 20mg in?
Related
- Manufacturer: West Virginia University — full pipeline
- Also known as: Arava
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing