Overview
Secnidazole is a second-generation 5-nitroimidazole antimicrobial agent. It is structurally related to other 5-nitroimidazoles, including Metronidazole and Tinidazole, but displays improved oral absorption and a longer terminal elimination half-life than other drugs in this class. Secnidazole is selective against many anaerobic Gram-positive and Gram-negative bacteria as well as protozoa. Once it enters bacteria and parasites, secnidazole is activated by bacterial or parasitic enzymes to form a radical anion, thereby damaging and killing the target pathogen. Secnidazole has been available in many other countries in Europe, Asia, South America, and Africa for decades. In September 2017, FDA approved secnidazole under the market name Solosec for the treatment of trichomoniasis and bacterial vaginosis.
Indication
Secnidazole is indicated for treating trichomoniasis and bacterial vaginosis in patients 12 years of age and older. In other countries, it is also available as a combination product with other antibacterial drugs, such as itraconazole.
Associated Conditions
- Bacterial Vaginosis (BV)
- Candidiasis
- Trichomonas Vaginitis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/02/15 | Phase 4 | Recruiting | |||
2021/09/05 | Phase 2 | Completed | |||
2019/05/06 | Phase 4 | Completed | |||
2019/05/02 | Phase 3 | Completed | |||
2015/05/25 | Phase 3 | Completed | Symbiomix Therapeutics | ||
2015/04/16 | Phase 3 | Completed | Symbiomix Therapeutics | ||
2014/05/28 | Phase 2 | Completed | Symbiomix Therapeutics |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Lupin Pharmaceuticals, Inc. | 27437-051 | ORAL | 2 g in 4.8 g | 7/1/2022 |
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 |
|---|---|---|---|---|---|
| Secnidazole Dispersible Tablets | 国药准字H20061012 | 化学药品 | 片剂 | 1/29/2021 | |
| Secnidazole Tablets | 国药准字H20110121 | 化学药品 | 片剂 | 8/3/2021 | |
| Secnidazole Tablets | 国药准字H20041647 | 化学药品 | 片剂 | 5/12/2020 | |
| Secnidazole Tablets | 国药准字H20103467 | 化学药品 | 片剂 | 7/5/2023 | |
| Secnidazole Tablets | 国药准字H20080706 | 化学药品 | 片剂 | 7/5/2023 | |
| Secnidazole Tablets | 国药准字H20130034 | 化学药品 | 片剂 | 1/3/2023 | |
| Secnidazole Tablets | 国药准字H20060791 | 化学药品 | 片剂 | 8/4/2021 | |
| Secnidazole Tablets | 国药准字H20070059 | 化学药品 | 片剂 | 5/12/2020 | |
| Secnidazole Tablets | 国药准字H20110122 | 化学药品 | 片剂 | 8/3/2021 | |
| Secnidazole Tablets | 国药准字H20051857 | 化学药品 | 片剂 | 4/27/2020 |
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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