NDAORALTABLETPriority Review
Approved
Aug 1966
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
ZYLOPRIM (allopurinol) by R-Pharm US is xanthine oxidase inhibitors [moa]. Approved for gout, hyperuricemia. First approved in 1966.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZYLOPRIM (allopurinol) is an oral xanthine oxidase inhibitor approved in 1966 for treating gout and hyperuricemia. It works by reducing uric acid production, preventing crystal formation in joints and tissues. The drug targets the root cause of gout rather than acute inflammation, making it a cornerstone of long-term urate-lowering therapy.
LOE Approaching
As an aging brand approaching loss of exclusivity with moderate competitive pressure (30%), team size is likely stable to contracting, with focus shifting toward cost-containment and generic defense strategies.
Mechanism of Action
Xanthine Oxidase Inhibitors
Pharmacologic Class:
Xanthine Oxidase Inhibitor
Indications (2)
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.