Overview
Irsogladine is under investigation in clinical trial NCT02581696 (The Drug-drug Interaction and Safety of Lafutidine and Irsogladine Maleate in Healthy Adult Volunteers).
Indication
⑴用于治疗胃溃疡；⑵用于改善急性胃炎和慢性胃炎急性发作期的胃粘膜病变（糜烂、出血、充血、水肿）。
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/02/22 | Phase 4 | UNKNOWN | Lee's Pharmaceutical Limited | ||
2018/04/26 | Phase 1 | UNKNOWN | Kukje Pharma | ||
2016/05/03 | Phase 1 | Completed | |||
2015/10/21 | Phase 1 | 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 |
|---|---|---|---|---|---|
| Irsogladine Maleate Tablets | 国药准字HJ20150259 | 化学药品 | 片剂 | 8/13/2020 | |
| Irsogladine Maleate Tablets | 国药准字H20050944 | 化学药品 | 片剂 | 6/1/2020 | |
| Irsogladine Maleate Tablets | 国药准字H10980047 | 化学药品 | 片剂 | 9/23/2019 | |
| Irsogladine Maleate Tablets | 国药准字H20020374 | 化学药品 | 片剂 | 6/1/2020 | |
| Irsogladine Maleate Tablets | 国药准字H19990064 | 化学药品 | 片剂 | 9/9/2024 | |
| Irsogladine Maleate Tablets | 国药准字H10980048 | 化学药品 | 片剂 | 5/11/2024 | |
| Irsogladine Maleate Tablets | 国药准字HJ20150260 | 化学药品 | 片剂 | 8/13/2020 |
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 |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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