ZYLOPRIM (allopurinol)
Zyloprim (allopurinol) is indicated for the management of adults with signs and symptoms of primary or secondary gout, including acute attacks, tophi, joint destruction, and uric acid lithiasis or nephropathy. It is also indicated for adult and pediatric patients with leukemia, lymphoma, and solid tumor malignancies receiving cancer therapy that causes elevated serum and urinary uric acid levels. Additionally, it is used to manage recurrent calcium oxalate calculi in adults whose daily uric acid excretion exceeds 800 mg/day (males) or 750 mg/day (females) despite lifestyle and dietary modifications. **Limitation of Use:** Allopurinol is not recommended for the treatment of asymptomatic hyperuricemia.
How ZYLOPRIM Works
Allopurinol is a structural analogue of the purine base hypoxanthine. It reduces uric acid production by inhibiting xanthine oxidase, the enzyme responsible for the sequential conversion of hypoxanthine to xanthine and xanthine to uric acid. Allopurinol is metabolized into oxypurinol (alloxanthine), which also acts as a xanthine oxidase inhibitor. By inhibiting these biochemical reactions, the drug lowers both serum and urinary uric acid levels without disrupting the endogenous biosynthesis of purines.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1966-08-19
- Routes
- ORAL
- Dosage Forms
- TABLET
ZYLOPRIM Approval History
What ZYLOPRIM Treats
5 indicationsZYLOPRIM is approved for 5 conditions since its original approval in 1966. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Gout
- Leukemia
- Lymphoma
- Solid Tumor Malignancies
- Calcium Oxalate Calculi
ZYLOPRIM Boxed Warning
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ZYLOPRIM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ZYLOPRIM's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ZYLOPRIM treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ZYLOPRIM
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
79 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07089875 | FYU-981-CRYS-301 2024-520206-19-00 | Ph 3 | recruiting | A Study of Dotinurad Versus Allopurinol in Participants With Gout |
| NCT07089888 | FYU-981-CRYS-302 2024-520207-84-00 | Ph 3 | recruiting | A Study of Dotinurad Versus Allopurinol in Tophaceous Gout |
| NCT03150693 | A041501 NCI-2016-01981, U10CA180821 | Ph 3 | recruiting | Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia |
| NCT05536349 | 2021-0578 NCI-2022-07625 | Ph 2 | recruiting | Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT) |
| NCT03776656 ADSL | P160902J 2017-002155-28 | Ph 2 | completed | Evaluation of a Treatment With Allopurinol in Adenylosuccinate Lyase Deficiency |
| NCT05888233 RESIST | F4655-P I21RX004655-01 | Ph 2 | recruiting | Allopurinol Improves Heart Function in African Americans With Resistant Hypertension |
| NCT05818085 | ABP-671-301 | Ph 2, Ph 3 | completed | Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout |
| NCT04875702 TRUST | 2021P000517 1U01AR080985-01A1 | Ph 4 | recruiting | Treat-to-Target Serum Urate Versus Treat-to-Avoid Symptoms in Gout |
| NCT05586971 EURELIA2 | LG-GDCL010 | Ph 3 | completed | Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients |
| NCT06276556 | ABP-671-302 | Ph 2, Ph 3 | terminated | Extension Study of ABP-671 in Participants With Gout |
| NCT02953509 results posted | 5F9003 2016-003408-29 | Ph 1, Ph 2 | terminated | Trial of Magrolimab (Hu5F9-G4) in Combination With Rituximab or Rituximab + Chemotherapy in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma |
| NCT05665699 | D0120-205 | Ph 2 | active not recruiting | Phase II Study to Evaluate Efficacy and Safety of D-0120 in Combination With Allopurinol in Subjects With Gout |
| NCT06056570 | UR1-DOT-103 | Ph 1, Ph 2 | completed | Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients with Hyperuricemia |
| NCT04956432 | SHR4640-303 | Ph 3 | completed | A Multicentre, Randomized, Double-blind, Allopurinol Controlled Study to Evaluate the Efficacy and Safety of SHR4640 in Subjects With Gout |
| NCT05049863 | 202301066 | Ph 1 | terminated | Chemotherapy in Patients With Relapsed Small Cell Lung Cancer in Combination With Allopurinol and MycoPhenolate (CLAMP Trial) |
| NCT04217421 CRUCIAL | METC UMCU 18-791 2017-004596-31 | Ph 3 | recruiting | Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass |
| NCT02752633 results posted | RDCRN Protocol #6412 2013-000975-33, U54DK083908 | Ph 4 | completed | Effect of Allopurinol and Febuxostat on Urinary 2,8-Dihydroxyadenine Excretion |
| NCT02661035 | 2015LS152 | Ph 2 | completed | Allo HSCT Using RIC for Hematological Diseases |
| NCT03648996 results posted | 2012106 | Ph 2 | completed | Sex-related Differences in Arterial Stiffness in Type 2 Diabetics: Role of Uric Acid |
| NCT04327024 AMETHYST results posted | D5496C00005 2019-004862-16 | Ph 2 | completed | Study of Verinurad in Heart Failure With Preserved Ejection Fraction |
| NCT04532918 results posted | D5495C00013 | Ph 1 | completed | Pharmacokinetics of Verinurad and Allopurinol in Combination With Cyclosporine and Rifampicin in Healthy Volunteers |
| NCT03990363 SAPPHIRE results posted | D5495C00002 | Ph 2 | completed | A Study of Verinurad and Allopurinol in Patients With Chronic Kidney Disease and Hyperuricaemia |
| NCT04256629 results posted | D5495C00012 | Ph 1 | completed | A Study to Assess the Effect of Verinurad on the Electric Activity of the Heart |
| NCT02122718 XILO-FIST | GN12MT494 TSA BHF 2013/01 | Ph 4 | completed | XILO-FIST, the Effect of Allopurinol on the Brain Heart and Blood Pressure After Stroke |
| NCT04983160 | PI12/01866 | Ph 2 | completed | Crossover Clinical Trial, Randomized, Double Blind, Placebo Controlled Trial |
| NCT03865407 results posted | HM20014698 | Ph 2 | terminated | Uric Acid Reduction as a Novel Treatment for Pediatric Chronic Kidney Disease |
| NCT02038179 results posted | F130408004 P50AR060772 | Ph 2, Ph 3 | completed | Center of Research Translation (CORT) Project 2 |
| NCT02017171 results posted | DK101108 UC4DK101108-01 | Ph 3 | completed | A Multicenter Clinical Trial of Allopurinol to Prevent Kidney Function Loss in Type 1 Diabetes |
| NCT01637623 CVD/OSA results posted | 2012-0026 U01HL105365, A561000 | Ph 2 | completed | Study of Cardiovascular Disease and Obstructive Sleep Apnea |
| NCT02956278 results posted | 14-14550 R01DK103729 | Ph 4 | completed | The Effects of BCRP Q141K on Allopurinol Pharmacokinetics and Dynamics |
| NCT01200485 results posted | 2010-0284 NCI-2012-01889 | Ph 2 | completed | Rasburicase in Patients at High Risk for Tumor Lysis Syndrome (TLS) During Cycle-2 |
| NCT00899431 results posted | 2007-0871 NCI-2012-01620 | Ph 2 | terminated | Nonmyeloablative Stem Cell Transplantation for Chronic Lymphocytic Leukemia (CLL) |
| NCT00732251 results posted | IRB13414 | Ph 4 | terminated | Allopurinol Maintenance Study for Bipolar Disorder |
| NCT02078219 results posted | D5491C00001 RDEA3170-203 | Ph 2 | completed | Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia |
| NCT02237339 ALLAY | 2012CV15 2014-002083-33 | Ph 4 | completed | Does Allopurinol Reduce Thickening of the Left Ventricle of the Heart in Patient With Treated Hypertension? |
| NCT02600780 ZEST | DUHS-GTZ-MD-001-13 | Ph 4 | completed | Zurig (Febuxostat) 40mg Efficacy and Safety Trial |
| NCT03836599 | D5495C00006 | Ph 1 | completed | A Study to Assess the Safety and Pharmacokinetics of Verinurad and Allopurinol in Asian and Chinese Subjects |
| NCT02129764 PUSH-PATH-2 | PUSH-PATH 2 | Ph 2, Ph 3 | completed | Prednisone for Heart Failure Patients With Hyperuricemia |
| NCT03680573 | 2017-0842 | Ph 1 | completed | The Effect of Antioxidants on Skin Blood Flow-BH4 |
| NCT03680638 | 2016-0268 | Ph 1 | completed | The Effect of Antioxidants on Skin Blood Flow During Local Heating |
| NCT02829177 MIKAL | 3004 | Ph 4 | completed | Microalbuminuria and Allopurinol in Type 1 Diabetes |
| NCT00819585 results posted | CACZ885H2251 EudraCT : 2008-005876-28 | Ph 2 | completed | A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study) |
| NCT01101035 CARES results posted | TMX-67_301 U1111-1114-4194 | Ph 3 | completed | Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities (CARES) |
| NCT01550107 | GEO006 | Ph 4 | completed | Allopurinol in Functional Impairment (ALFIE) Trial: 'Improving Muscle Strength' |
| NCT01564277 results posted | I 197711 NCI-2011-03231, I 197711 | Ph 2 | terminated | Rasburicase and Allopurinol in Treating Patients With Hematologic Malignancies |
| NCT01464359 results posted | MT2011-15 | Ph 2 | terminated | T-Cell Depleted Double UCB for Refractory AML |
| NCT00652899 results posted | 2007LS138 UMN-MT2007-19R, UMN-WCC-53 | Ph 2 | terminated | Allogeneic Natural Killer Cells in Patients With Recurrent Ovarian Cancer, Fallopian Tube, and Primary Peritoneal Cancer |
| NCT00288158 | DK71223 (completed) R21DK071223 | Ph 2 | completed | Primary Prevention of Hypertension in Obese Adolescents |
| NCT01459796 UPSURGE results posted | IL1T-GA-1101 | Ph 3 | terminated | Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares |
| NCT01320722 MODERATE results posted | 2010-P-002049 1R01HL105440 | Ph 3 | completed | Study of Vitamin D and Uric Acid Lowering on Kidney and Blood Vessel Function |
Showing 50 of 79 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ZYLOPRIM FDA Label Details
Indications & Usage
FDA Label (PDF)ZYLOPRIM is indicated for the treatment of Gout; Leukemia; Lymphoma; Solid Tumor Malignancies; Calcium Oxalate Calculi.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment