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Keyzilen
- Development stage
- Phase 3
- Lead developer
- Altamira Therapeutics
- Modality
- Small Molecules, Hydrogel Systems → Drug Delivery Systems
- Administration
- Intratympanic
01
Overview
Keyzilen (AM-101) is an otic gel formulation of esketamine hydrochloride, a small molecule noncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist. Developed by Auris Medical (now Altamira Therapeutics), it was specifically designed for the treatment of acute inner ear (peripheral) tinnitus. The treatment is administered via intratympanic injection into the middle ear, where it is intended to suppress the pathological overactivation of NMDA receptors in the cochlea that occurs after noise trauma or other cochlear insults. While the drug progressed through several Phase II and Phase III clinical trials (the TACTT program, including TACTT1, TACTT2, and TACTT3), it failed to consistently meet primary efficacy endpoints, leading to the discontinuation of its development for this indication.
- Brand names
- Keyzilen
- Other names
- Esketamine hydrochloride gelEsketamineAM 101AM101AM-101
02
Targets
NMDAR (Glutamate receptor ionotropic, NMDA)
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