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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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