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Solosec (SECNIDAZOLE)
Solosec works by entering susceptible microorganisms and disrupting their DNA, ultimately leading to cell death.
At a glance
| Generic name | SECNIDAZOLE |
|---|---|
| Sponsor | Evofem Inc |
| Drug class | Nitroimidazole Antimicrobial [EPC] |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2017 |
Mechanism of action
SOLOSEC is nitroimidazole antimicrobial drug [See Microbiology (12.4)].
Approved indications
- Bacterial vaginosis
- Giardiasis
- Infection by Trichomonas
Common side effects
- Vulvovaginal candidiasis
- Headache
- Nausea
- Diarrhea
- Abdominal pain
- Vulvovaginal pruritus
- Vomiting
- Dysgeusia
- Dizziness
- Hepatotoxicity
- Acute liver failure
Key clinical trials
- Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole (PHASE4)
- Suppressive Antibacterial Therapy With Once-Weekly Secnidazole Granules to Prevent Recurrent Bacterial Vaginosis; A Pilot Study (PHASE2,PHASE3)
- A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis (PHASE3)
- Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219 (PHASE3)
- Evaluate the Safety of a Single Oral Dose of Solosec™ (Secnidazole) 2g for the Treatment of Adolescent Girls With BV (PHASE4)
- A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis (PHASE2)
- A Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diverticular Sigmoïditis Among Adults (PHASE3)
- Safety and Clinical and Microbiological Efficacy of the Combination of Fluconazole and Secnidazole for the Treatment of Symptomatic Vaginal Discharge (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Solosec CI brief — competitive landscape report
- Solosec updates RSS · CI watch RSS
- Evofem Inc portfolio CI