Overview
Dotinurad is under investigation in clinical trial NCT03372200 (Febuxostat-controlled, Double-blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout).
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/19 | Phase 4 | Recruiting | |||
2023/09/28 | Phase 1 | Completed | |||
2022/03/14 | Phase 1 | Completed | |||
2021/08/16 | Phase 3 | Completed | |||
2017/12/18 | Phase 1 | Completed | Mochida Pharmaceutical Company, Ltd. | ||
2017/12/13 | Phase 3 | Completed | Mochida Pharmaceutical Company, Ltd. | ||
2017/11/22 | Phase 1 | Completed | Mochida Pharmaceutical Company, Ltd. | ||
2017/11/22 | Phase 1 | Completed | Mochida Pharmaceutical Company, Ltd. | ||
2017/10/11 | Phase 1 | Completed | Mochida Pharmaceutical Company, Ltd. | ||
2017/04/04 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Dotinurad Tablets | 国药准字HJ20240164 | 化学药品 | 片剂 | 12/6/2024 | |
| Dotinurad Tablets | 国药准字HJ20240163 | 化学药品 | 片剂 | 12/6/2024 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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