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FX-345 is a combination of two small molecules developed as a regenerative therapeutic candidate for sensorineural hearing loss (SNHL). It was designed to restore inner ear sensory hair cells by stimulating regeneration through inhibition of glycogen synthase kinase 3 (GSK3) and activation of stem cell pathways. The drug was intended to reach deeper into the cochlea than previous candidates, potentially addressing a broader range of SNHL patients. FX-345 was administered via single intratympanic injection in clinical trials. The program originated with Frequency Therapeutics and later involved Korro Bio[2][5][7]. Clinical development has been discontinued following discouraging Phase I trial results[2][9][10].
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