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Secnidazole

Generic Name
Secnidazole
Brand Names
Solosec
Drug Type
Small Molecule
Chemical Formula
C7H11N3O3
CAS Number
3366-95-8
Unique Ingredient Identifier
R3459K699K
Background

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

Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole

Phase 4
Not yet recruiting
Conditions
Trichomonas Vaginitis
Interventions
First Posted Date
2024-02-15
Last Posted Date
2024-02-15
Lead Sponsor
Tulane University
Target Recruit Count
1200
Registration Number
NCT06261840

Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study

Phase 2
Completed
Conditions
Recurrent Bacterial Vaginosis
Interventions
First Posted Date
2021-09-05
Last Posted Date
2024-02-05
Lead Sponsor
Indiana University
Target Recruit Count
24
Registration Number
NCT05033743
Locations
🇺🇸

Indiana University Hospital - Coleman Center for Women, Indianapolis, Indiana, United States

Evaluate the Safety of a Single Oral Dose of Solosec™ (Secnidazole) 2g for the Treatment of Adolescent Girls With BV

Phase 4
Completed
Conditions
Bacterial Vaginoses
Interventions
First Posted Date
2019-05-06
Last Posted Date
2020-12-19
Lead Sponsor
Lupin Research Inc
Target Recruit Count
40
Registration Number
NCT03937869
Locations
🇺🇸

Site 1007 - Investigational Research Center, Memphis, Tennessee, United States

🇺🇸

Site 1004 - Investigational Research Center, Long Beach, California, United States

🇺🇸

Site 1006 - Investigational Research Center, Frisco, Texas, United States

and more 6 locations

A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis

Phase 3
Completed
Conditions
Trichomonas Infection
Interventions
Drug: Placebo
First Posted Date
2019-05-02
Last Posted Date
2023-10-04
Lead Sponsor
Lupin Research Inc
Target Recruit Count
147
Registration Number
NCT03935217
Locations
🇺🇸

Site 1006, Virginia Beach, Virginia, United States

🇺🇸

Site 1007, Birmingham, Alabama, United States

🇺🇸

Site 1011, Charleston, South Carolina, United States

and more 8 locations

Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219

Phase 3
Completed
Conditions
Bacterial Vaginosis
Interventions
First Posted Date
2015-05-25
Last Posted Date
2021-04-13
Lead Sponsor
Symbiomix Therapeutics
Target Recruit Count
325
Registration Number
NCT02452866

A Phase 3 Study of SYM-1219 Treatment of Women and Post-Menarchal Adolescent Girls With Bacterial Vaginosis

Phase 3
Completed
Conditions
Bacterial Vaginosis
Interventions
Drug: Placebo
First Posted Date
2015-04-16
Last Posted Date
2021-10-15
Lead Sponsor
Symbiomix Therapeutics
Target Recruit Count
189
Registration Number
NCT02418845

A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis

Phase 2
Completed
Conditions
Bacterial Vaginosis
Interventions
Drug: Placebo
First Posted Date
2014-05-28
Last Posted Date
2020-11-13
Lead Sponsor
Symbiomix Therapeutics
Target Recruit Count
215
Registration Number
NCT02147899
Locations
🇺🇸

Women's Medical Research Group, LLC, Clearwater, Florida, United States

🇺🇸

Tidewater Physicians for Women, Virginia Beach, Virginia, United States

🇺🇸

Clinical Research of Philadelphia, LLC, Philadelphia, Pennsylvania, United States

and more 13 locations
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