Drugs / FB301
last change Jul 2026 re-read 9 days ago

FB301

Other / unclassified

Developed for
bacterial vaginosis
Investigated by
Freya Biosciences ApS · CRS Clinical Research Services Berlin GmbH · Premier Research

Trials 2

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT07453069 Jul → Oct 2026 expected — Freya Biosciences ApS Recruiting No outcome recorded
Phase 2 NCT07481955 Mar 2026 → Mar 2027 expected bacterial vaginosis Freya Biosciences ApS Not yet recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2026-04-16 Freya Biosciences ApS Results Freya Biosciences announces positive Phase 1 first-in-human data with FB301 for IVF-related embryo implantation failure freyabiosciences.com ↗
The study met all primary and secondary endpoints, demonstrating that FB301 was safe and well tolerated across all cohorts, with no serious adverse events (SAEs), severe adverse events, or discontinuations reported.

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as FB301 “The goal of this study is to evaluate how treatment with FB301 affects the balance of vaginal bacteria in women (aged 18-45) with bacterial vaginosis after pre-treatment with...” NCT07481955 ↗
2

NCT07453069 ↗

NCT07481955 ↗

Modality Other / unclassified “FB301, a Live Biotherapeutic Product (LBP) comprising consortia of Lactobacillus strains” NCT07481955 ↗
Route Other “intravaginal FB301” NCT07481955 ↗