Overview
Gout is a disease that occurs by the deposition of monosodium urate crystals (MSU) in body tissues, especially around joints . This disease has been well-documented in historical medical records and appears in the biographies of several prominent, historically recognized individuals . Allopurinol is a xanthine oxidase enzyme inhibitor that is considered to be one of the most effective drugs used to decrease urate levels and is frequently used in the treatment of chronic gout . It was initially approved by the FDA in 1966 and is now formulated by several manufacturers .
Background
Gout is a disease that occurs by the deposition of monosodium urate crystals (MSU) in body tissues, especially around joints . This disease has been well-documented in historical medical records and appears in the biographies of several prominent, historically recognized individuals . Allopurinol is a xanthine oxidase enzyme inhibitor that is considered to be one of the most effective drugs used to decrease urate levels and is frequently used in the treatment of chronic gout . It was initially approved by the FDA in 1966 and is now formulated by several manufacturers .
Indication
Allopurinol is indicated in : 1) the management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis, and/or nephropathy). 2) the management of patients with leukemia, lymphoma and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Treatment with allopurinol should be discontinued when the potential for overproduction of uric acid is no longer present. 3) the management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.
Associated Conditions
- Hyperuricemia
- Primary Gout
- Recurrent calcium oxalate calculi
- Secondary gout
- Calcium oxalate calculi Renal Calculi
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/24 | Phase 1 | Completed | |||
2024/02/26 | Phase 2 | ENROLLING_BY_INVITATION | |||
2023/09/28 | Phase 1 | Completed | |||
2023/07/13 | Phase 3 | Recruiting | Poznan University of Medical Sciences | ||
2023/06/05 | Phase 2 | Recruiting | |||
2023/04/25 | Phase 2 | Completed | |||
2023/04/18 | Phase 2 | Active, not recruiting | |||
2023/04/10 | Phase 2 | Recruiting | |||
2022/12/27 | Phase 2 | Active, not recruiting | |||
2022/11/01 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| NuCare Pharmaceuticals,Inc. | 68071-2926 | ORAL | 100 mg in 1 1 | 7/7/2023 | |
| Rising Pharma Holdings, Inc. | 16571-884 | ORAL | 200 mg in 1 1 | 10/2/2023 | |
| Bryant Ranch Prepack | 63629-8020 | ORAL | 100 mg in 1 1 | 11/18/2021 | |
| A-S Medication Solutions | 50090-4663 | ORAL | 300 mg in 1 1 | 10/26/2023 | |
| Bryant Ranch Prepack | 71335-0467 | ORAL | 100 mg in 1 1 | 5/26/2023 | |
| A-S Medication Solutions | 50090-3758 | ORAL | 300 mg in 1 1 | 12/12/2018 | |
| Contract Pharmacy Services-PA | 67046-022 | ORAL | 100 mg in 1 1 | 8/30/2017 | |
| REMEDYREPACK INC. | 70518-0451 | ORAL | 100 mg in 1 1 | 1/5/2024 | |
| Major Pharmaceuticals | 0904-6572 | ORAL | 300 mg in 1 1 | 9/13/2022 | |
| A-S Medication Solutions | 50090-2544 | ORAL | 100 mg in 1 1 | 1/10/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ZYLORIC TABLET 100 mg | SIN06060P | TABLET | 100 mg | 5/22/1991 | |
| ALLOPURINOL TABLET BP 100 mg | SIN06219P | TABLET | 100.00 mg | 5/24/1991 | |
| APO-ALLOPURINOL TABLET 300 mg | SIN06247P | TABLET | 300 mg | 6/13/1991 | |
| ALLOPURINOL TABLET 100 mg | SIN05804P | TABLET | 100 mg | 5/8/1991 | |
| APO-ALLOPURINOL TABLET 100 mg | SIN06248P | TABLET | 100 mg | 6/13/1991 | |
| YSP ALLOPURINOL TABLET 100 mg | SIN07051P | TABLET | 100 mg | 6/3/1992 | |
| ZYLORIC TABLET 300MG | SIN06061P | TABLET | 300mg | 5/22/1991 | |
| YSP ALLOPURINOL TABLET 300MG | SIN17004P | TABLET | 300 mg | 5/8/2024 | |
| GP-ALLOPURINOL TABLETS 300 MG | SIN17232P | TABLET | 300 mg | 5/8/2025 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Allopurinol Sustained-release Tablets | 国药准字H20041743 | 化学药品 | 片剂 | 7/23/2020 | |
| Allopurinol Tablets | 国药准字H20244620 | 化学药品 | 片剂 | 9/27/2024 | |
| Allopurinol Tablets | 国药准字H33020771 | 化学药品 | 片剂 | 4/26/2020 | |
| Allopurinol Tablets | 国药准字H20023190 | 化学药品 | 片剂 | 11/22/2019 | |
| Allopurinol Tablets | 国药准字H44021368 | 化学药品 | 片剂 | 9/12/2019 | |
| Allopurinol Tablets | 国药准字H50020455 | 化学药品 | 片剂 | 4/8/2020 | |
| Allopurinol Tablets | 国药准字H44021695 | 化学药品 | 片剂 | 8/8/2019 | |
| Allopurinol Tablets | 国药准字H34021248 | 化学药品 | 片剂 | 7/3/2020 | |
| Allopurinol Tablets | 国药准字H31020334 | 化学药品 | 片剂 | 12/4/2019 | |
| Allopurinol Tablets | 国药准字H35020661 | 化学药品 | 片剂 | 3/16/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Allopurinol-WGR allopurinol 300 mg tablet blister pack | 269646 | Medicine | A | 2/22/2017 | |
| PROGOUT VIATRIS allopurinol 100 mg tablet bottle | 269653 | Medicine | A | 2/22/2017 | |
| ALLOPURINOL SPR allopurinol 300mg tablet blister pack | 384904 | Medicine | A | 6/14/2022 | |
| PTIN-Allopurinol allopurinol 100 mg tablet blister pack | 269658 | Medicine | A | 2/22/2017 | |
| ALLOPURINOL-STR allopurinol 100mg tablet bottle | 286084 | Medicine | A | 5/3/2017 | |
| ALLOPURINOL SANDOZ allopurinol 300 mg tablet bottle | 65906 | Medicine | A | 8/31/1998 | |
| ALLOPURINOL ALPHAPHARM 300 Allopurinol 300mg tablet bottle | 17708 | Medicine | A | 9/20/1991 | |
| GTA-Allopurinol 300 mg tablet blister pack | 269660 | Medicine | A | 2/22/2017 | |
| TN-Allopurinol 100 mg tablet blister pack | 269643 | Medicine | A | 2/22/2017 | |
| ALLOPURINOL SPR allopurinol 100mg tablet bottle | 384903 | Medicine | A | 6/14/2022 |