Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BNT331 · 1 trial · 1 indication
In participants who have received at least one dose of BNT331 or placebo. For each dose level cohort of BNT331 and for the combined placebo group.
In participants who have received at least one dose of BNT331 or placebo. For each dose level cohort of BNT331 and for the combined placebo group.
In participants who have received at least one dose of BNT331 or placebo. For each dose level cohort of BNT331 and for the combined placebo group.
In participants who have received at least one dose of BNT331 or placebo. For each dose level cohort of BNT331 and for the combined placebo group.
| Arm | Type | Description |
|---|---|---|
| BNT331 - Part A | EXPERIMENTAL | Single ascending dose levels |
| Placebo - Part A | PLACEBO_COMPARATOR | Single dose |
| BNT331 - Part B Dose 1 | EXPERIMENTAL | Fixed dose for 5 consecutive days |
| BNT331 - Part B Dose 2 | EXPERIMENTAL | Fixed dose for 5 consecutive days |
| Placebo - Part B | PLACEBO_COMPARATOR | Multiple dose |
| Name | Type | Description |
|---|---|---|
| BNT331 | DRUG | Vaginal insert |
| Placebo | OTHER | Vaginal insert |
Inclusion Criteria (applicable to all participants unless otherwise specified): * Have given written informed consent by signing and dating the informed consent form (ICF) before initiation of any study-specific procedures. * Participant reported assigned female sex at birth, at least 18 years of a...
BNT331 is an investigational small molecule being developed for the treatment of bacterial vaginosis, a common vaginal infection. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
BNT331 is being developed by BioNTech SE, a biotechnology company traded on the NASDAQ under the ticker symbol BNTX. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
BNT331 is in Phase 1 clinical development. A first-in-human trial has been completed, which evaluated single ascending doses in healthy women and multiple ascending doses in women diagnosed with bacterial vaginosis.
BNT331 has one completed Phase 1 clinical trial registered as NCT06469164. This trial enrolled 102 female participants in the United States and was a randomized, double-blind, placebo-controlled study assessing safety.
No alternative names for BNT331 have been reported. It is identified solely by its code name BNT331 in clinical trial registries and scientific literature.