Manages leukemia, lymphoma, and solid tumor malignancies. Sold as Aloprim. Every FDA application for this active ingredient: 1 branded and 2 generic.
As of Nov 15, 2026, FDA lists 3 applications for Allopurinol Sodium (sold as Aloprim), first approved May 17, 1996, with 0 new uses approved and 0 published complete response letters.
| Comparison of the Effect of Allopurinol Versus Febuxostat on Serum Uric Acid in Patients With Chronic Kidney Disease Associated With HyperuricemiaHyperuricemia, Renal Insufficiency, Chronic · Nishtar Medical University | Not applicable | Active, not recruiting | Sep 30, 2026 |
| Role of Allopurinol in Prevention of Complications Related to Decompensated Cirrhosis of LiverCirrhoses, Liver, Decompensated Cirrhosis of Liver · Bangladesh Medical University | Phase 4 | Recruiting | Sep 2, 2026 |
| HMA-Venetoclax Induction in Newly Diagnosed AMLAML, AML (Acute Myeloid Leukemia) · Pakistan Blood and Marrow Transplant (PBMT) Group | Phase 2 | Not yet recruiting | Aug 5, 2026 |
| Allopurinol in DepressionDepression · Tanta University | Phase 2 / Phase 3 | Recruiting | May 7, 2026 |
| HLA-B*58:01-Guided Therapy for Gout: Effectiveness, Safety, and Cost-EffectivenessGout Initiating Urate-loweringUrate-lowering Therapy, Gout Arthritis · Haiphong University of Medicine and Pharmacy | Phase 4 | Not yet recruiting | Jan 27, 2026 |
| Orlistat and Weight Management for Uric Acid Control in Obese Gout: A RCTGout, Obesity · XueMei Guo | Not applicable | Not yet recruiting | Jan 8, 2026 |
| A Study of Dotinurad Versus Allopurinol in Tophaceous GoutTophaceous Gout · Crystalys Therapeutics | Phase 3 | Recruiting | Jul 28, 2025 |
| A Study of Dotinurad Versus Allopurinol in Participants With GoutGout · Crystalys Therapeutics | Phase 3 | Recruiting | Jul 28, 2025 |
| May 17, 1996 | AloprimNDA 20298 · New dosage form | Mylan | 7 | Marketed |
| Aug 26, 2004 | Allopurinol SodiumANDA 76870 | Hikma | 3 | Marketed |
| Jan 26, 2022 | Allopurinol SodiumANDA 212363 | Gland | 1 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA