In short
Furazidine is an investigational antibacterial substance being studied as a vaginal tablet for bacterial vaginosis. A single Phase 3 trial, authorised but not yet completed, is comparing furazidine 5 mg vaginal tablets with clindamycin 2% vaginal cream in 600 participants. The study measures whether furazidine is not less effective than clindamycin at clearing the infection.
Key points
- Furazidine is being tested as a 5 mg vaginal tablet for bacterial vaginosis.
- The only registered trial is a Phase 3 study with 600 participants.
- The trial compares furazidine against clindamycin 2% vaginal cream.
- The study status is Authorised, meaning it is approved to begin but not yet completed.
- The primary outcome is clinical cure rate measured 8–10 days after treatment using Amsel criteria.
- Furazidine has no marketing authorisation and remains an investigational substance.
What is furazidine?
Furazidine is a chemically synthesised antibacterial substance. In the registered trial it is formulated as a vaginal tablet containing 5 mg of the active substance. The product name in the trial record is "Furazidin, vaginal tablets, 5mg". Furazidine has no marketing authorisation in the product records, which means it is still an investigational substance and not yet approved as a medicine. The company supplying the product for the trial is ADAMED SP. Z O.O.
How does furazidine work?
The available trial record does not describe the mechanism of action of furazidine. As an antibacterial substance in the therapeutic area of bacterial infections and mycoses, it is being investigated for its ability to treat a bacterial infection of the vagina.
Which conditions is furazidine studied for?
- Bacterial vaginosis — an infection of the vagina caused by an imbalance of the normal bacteria, leading to abnormal discharge, odour and other symptoms. This is the only condition for which furazidine is being studied in the registered trial.
How is furazidine given?
Furazidine is given as a vaginal tablet. The route of administration is vaginal use, and the tablet contains 5 mg of furazidine. The trial also includes a comparison arm using Dalacin 20 mg/g vaginal cream, which contains clindamycin and is applied vaginally.
What do the clinical trials show?
There is one registered clinical trial of furazidine. It is a Phase 3, randomised, controlled study for bacterial vaginosis. The study is authorised, which means it has received approval to begin but has not yet reported results. The trial plans to enrol 600 participants. The primary objective is to demonstrate that furazidine 5 mg vaginal tablets are not less effective than clindamycin 2% vaginal cream.
What are the trials measuring?
The main outcome measure is the clinical cure rate at Visit 3, which is the test-of-cure visit on Day 8–10 after treatment. Clinical cure is defined using the Amsel criteria: resolution of abnormal vaginal discharge, a negative whiff test, and clue cells present at less than 20% of total epithelial cells on microscopic examination of a saline wet mount. In plain language, the trial checks whether the infection has cleared by looking at discharge, odour and specific cells under a microscope.
Who can take part in the trial?
The registry record does not provide detailed eligibility criteria such as age range or specific inclusion and exclusion conditions. The trial is for people with bacterial vaginosis, and the study is interventional, meaning participants receive one of the two vaginal treatments.
What side effects are known?
No side effect data for furazidine is available in the provided sources. The trial record does not list adverse events, and no supplementary sources were included.