Data updated: May 26, 2026
DUZALLO (allopurinol)
Metabolic
Approved 2017-08-18
1
Indication
--
Phase 3 Trials
8
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2017-08-18
- Patent Cliff
- 2032
- Routes
- ORAL
- Dosage Forms
- TABLET
DUZALLO Approval History
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2017 to 2017
What DUZALLO Treats
1 FDA approvalsOriginally approved for its first indication in 2017 .
- Other (1)
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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
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Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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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.
DUZALLO FDA Label Details
View full patent landscape →
8 OB patents · 3 families ·
156 international docs across 39 countries
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.