LOPURIN
LOE ApproachingNDAORALTABLET
Approved
Jun 1980
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
2/8 — Basic
Drug data last refreshed 4d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LOPURIN is an oral small-molecule tablet approved in 1980 for gout, hyperuricemia, and tumor lysis syndrome, with off-label use across hematologic malignancies, renal disease, and cardiovascular conditions. The drug's mechanism of action is not specified in available data, but the broad indication portfolio suggests uric acid modulation and potential immunomodulatory activity. LOPURIN is a mature NDA product currently approaching loss of exclusivity.
LOE Approaching
As a legacy product approaching loss of exclusivity with minimal current job openings, the brand team is likely small and focused on defensive positioning rather than growth initiatives.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Started Aug 2025
250 enrolled
Tophaceous Gout
A Study of Dotinurad Versus Allopurinol in Participants With Gout
Started Aug 2025
500 enrolled
Gout
Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients with Hyperuricemia
Started Oct 2023
20 enrolled
GoutHyperuricemia
Phase II Study to Evaluate Efficacy and Safety of D-0120 in Combination With Allopurinol in Subjects With Gout
Started Apr 2023
80 enrolled
Gout
Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout
Started Aug 2022
42 enrolled
GoutArthritis, GoutyHyperuricemia+1 more
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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.