Overview
Polaprezinc is a chelated form of zinc and L-carnosine. It is a zinc-related medicine approved for the first time in Japan, which has been clinically used to treat gastric ulcers . It was determined that polaprezinc may be effective in pressure ulcer treatment . A study in 2013 showed that CO-administration of polaprezinc may be effective against small intestine mucosal injury associated with long-term aspirin therapy .
Background
Polaprezinc is a chelated form of zinc and L-carnosine. It is a zinc-related medicine approved for the first time in Japan, which has been clinically used to treat gastric ulcers . It was determined that polaprezinc may be effective in pressure ulcer treatment . A study in 2013 showed that CO-administration of polaprezinc may be effective against small intestine mucosal injury associated with long-term aspirin therapy .
Indication
Peptic ulcer disease, dyspepsia .
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/09/22 | Phase 1 | Completed | Jiangnan University | ||
2020/06/16 | Phase 3 | UNKNOWN | |||
2014/09/18 | Not Applicable | 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 |
|---|---|---|---|---|---|
| Polaprezinc Granules | 国药准字H20253401 | 化学药品 | 颗粒剂 | 2/20/2025 | |
| Polaprezinc Granules | 国药准字H20120091 | 化学药品 | 颗粒剂 | 9/2/2022 | |
| Polaprezinc Granules | 国药准字H20140134 | 化学药品 | 颗粒剂 | 6/14/2024 |
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 |
|---|---|---|---|---|---|
| Gut-R | 374840 | Medicine | A | 9/17/2021 | |
| Eagle Clinical GI Repair | 429298 | Medicine | A | 11/30/2023 | |
| Tri-Zinc Supreme | 409315 | Medicine | A | 5/22/2023 | |
| Skin + Gut | 464909 | Medicine | A | 10/18/2024 | |
| Gut Vitality | 482171 | Medicine | A | 3/11/2025 | |
| Zinacid | 319825 | Medicine | A | 7/8/2019 | |
| GIT Support | 462402 | Medicine | A | 9/19/2024 | |
| METAGENICS GUT INFLAMX | 382592 | Medicine | A | 1/14/2022 | |
| Bloat Clear | 455826 | Medicine | A | 7/22/2024 | |
| PeptEase | 423892 | Medicine | A | 10/4/2023 |