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Drug intelligence / Profile preview
OTO-313
- Development stage
- Unknown
- Lead developer
- Otonomy
- Modality
- Small Molecules
- Administration
- Intratympanic
01
Overview
OTO-313 is an investigational sustained-exposure formulation of gacyclidine, a potent and selective N-Methyl-D-Aspartate (NMDA) receptor antagonist, developed by Otonomy for the treatment of unilateral subjective tinnitus. It is administered as a single intratympanic injection to provide localized drug delivery to the inner ear. The therapeutic rationale is to reduce the over-activation of damaged auditory nerve fibers in the cochlea, thereby decreasing the severity of tinnitus symptoms. Although OTO-313 showed initial promise in a Phase 1/2 trial, Otonomy announced the discontinuation of its development in August 2022 after a Phase 2 clinical trial failed to demonstrate a significant treatment benefit over placebo.
02
Targets
NMDAR (Glutamate receptor ionotropic, NMDA)
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