Overview
A nitroimidazole antitrichomonal agent effective against Trichomonas vaginalis, Entamoeba histolytica, and Giardia lamblia infections.
Indication
For the treatment of trichomoniasis caused by T. vaginalis in both female and male patients. Also for the treatment of giardiasis caused by G. duodenalis in both adults and pediatric patients older than three years of age and for the treatment of intestinal amebiasis and amebic liver abscess caused by E. histolytica in both adults and pediatric patients older than three years of age.
Associated Conditions
- Amebiasis
- Bacterial Vaginosis (BV)
- Giardiasis
- Mixed Vaginal Infections
- Nongonococcal urethritis
- Sexually Transmitted Disease (STD)
- Trichomonas Vaginalis Infection
- Trichomonas Vaginitis
- Vaginal Candidiasis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/05/20 | Not Applicable | Not yet recruiting | Shangrong Fan | ||
2020/12/03 | Phase 3 | UNKNOWN | |||
2020/02/11 | Phase 4 | UNKNOWN | Shandong University | ||
2019/10/18 | Phase 4 | Completed | |||
2019/10/10 | Phase 4 | UNKNOWN | Shandong University | ||
2018/01/26 | Not Applicable | UNKNOWN | |||
2017/05/03 | Phase 4 | UNKNOWN | Yanqing Li | ||
2016/10/24 | Phase 4 | Terminated | |||
2012/05/04 | Phase 1 | Completed | |||
2010/02/18 | Not Applicable | UNKNOWN |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Mission Pharmacal Company | 0178-8250 | ORAL | 250 mg in 1 1 | 12/27/2021 | |
| Lupin Pharmaceuticals,Inc. | 43386-551 | ORAL | 500 mg in 1 1 | 11/13/2019 | |
| RedPharm Drug, Inc. | 67296-1729 | ORAL | 500 mg in 1 1 | 1/14/2021 | |
| Rising Pharma Holdings, Inc. | 64980-427 | ORAL | 500 mg in 1 1 | 6/21/2023 | |
| RPK Pharmaceuticals, Inc. | 53002-1611 | ORAL | 500 mg in 1 1 | 12/23/2019 | |
| Novel Laboratories, Inc. | 40032-551 | ORAL | 500 mg in 1 1 | 5/25/2012 | |
| Novel Laboratories, Inc. | 40032-550 | ORAL | 250 mg in 1 1 | 5/25/2012 | |
| Rising Pharma Holdings, Inc. | 64980-426 | ORAL | 250 mg in 1 1 | 6/21/2023 | |
| Redpharm Drug, Inc. | 67296-1836 | ORAL | 500 mg in 1 1 | 2/7/2023 | |
| Mission Pharmacal Company | 0178-8500 | ORAL | 500 mg in 1 1 | 12/27/2021 |
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 |
|---|---|---|---|---|---|
| Concentrated Tinidazole Gargles | 国药准字H20010709 | 化学药品 | 漱液剂 | 5/29/2020 | |
| Concentrated Tinidazole Gargles | 国药准字H20103473 | 化学药品 | 含漱剂 | 4/8/2020 | |
| Concentrated Tinidazole Gargles | 国药准字H20123128 | 化学药品 | 洗剂 | 2/24/2022 | |
| Tinidazole Suppositories | 国药准字H20133115 | 化学药品 | 栓剂 | 7/13/2020 | |
| Tinidazole Suppositories | 国药准字H20063465 | 化学药品 | 栓剂 | 4/10/2020 | |
| Tinidazole Suppositories | 国药准字H20010063 | 化学药品 | 栓剂 | 7/13/2020 | |
| Tinidazole Suppositories | 国药准字H20084003 | 化学药品 | 栓剂 | 11/28/2022 | |
| Tinidazole Suppositories | 国药准字H20093748 | 化学药品 | 栓剂 | 9/25/2023 | |
| Tinidazole Suppositories | 国药准字H19980175 | 化学药品 | 栓剂 | 6/19/2020 | |
| Tinidazole Suppositories | 国药准字H20055248 | 化学药品 | 栓剂 | 7/7/2020 |
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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