Drug intelligence / Profile preview

FX-322

Development stage
Discontinued
Lead developer
Korro Bio
Modality
Small Molecules
Administration
Intratympanic Injection
01

Overview

**FX-322** is an investigational fixed-ratio, intratympanic small-molecule combination developed by Frequency Therapeutics for acquired sensorineural hearing loss. It combines laduviglusib, a selective glycogen synthase kinase-3 alpha and beta inhibitor that activates Wnt and beta-catenin signaling, with sodium valproate, a histone deacetylase inhibitor. The regenerative strategy was intended to activate cochlear progenitor and supporting-cell pathways to promote replacement of lost sensory hair cells. FX-322 advanced through Phase 2 studies, but Frequency discontinued the program in February 2023 after the Phase 2b FX-322-208 study in acquired sensorineural hearing loss did not meet its primary speech-perception endpoint. ([cdn.clinicaltrials.gov](https://cdn.clinicaltrials.gov/large-docs/23/NCT03616223/Prot_000.pdf))

Other names
FX322FX-322FX 322
02

Targets

HDAC (HDAC family)GSK3 (Glycogen synthase kinase 3 beta)

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