Keyzilen® (AM-101)


Keyzilen® for the treatment of acute inner ear tinnitus

Auris Medical is developing Keyzilen® for the treatment of acute inner ear (peripheral) tinnitus following traumatic cochlear injury or otitis media (middle ear infection). Keyzilen® contains Esketamine hydrochloride, an N-Methyl-D-Aspartate (NMDA) receptor antagonist, formulated in a biocompatible and fully biodegradable gel. It is administered in one treatment cycle, comprising three intratympanic injections over 3 to 5 days into the middle ear. From there the drug diffuses through the so-called round window membrane into the cochlea.


How Keyzilen® works

Acoustic trauma and other insults to the inner ear may trigger increased levels of extra-cellular glutamate, which in turn cause excessive activation of cochlear NMDA receptors. This process results in damage or killing of sensory cells and is thought to be responsible for abnormal spontaneous "firing" of auditory nerves, which may be perceived as tinnitus. Under normal circumstances, the NMDA receptors are thought to play no role in fast excitatory neurotransmission, respectively normal hearing. Keyzilen® is blocking cochlear NMDA receptors to suppress the aberrant excitation of the auditory nerve that is perceived as tinnitus.


Development stage 

Keyzilen® is currently in Phase 3 clinical development.

Keyzilen Fact Sheet


* This testimonial is an individual experience, reflecting the experience of a person that participated in our TACTT2 and AMPACT1 studies. However, this is an individual experience and experiences may vary. We do not claim that this is a typical experience that all study participants achieved. This experience and testimonial is not representative of everyone who participated in our TACTT2 and AMPACT1 studies. Auris Medical is not responsible for the testimonial posted to our site. This testimonial is strictly of the view of the person providing the testimonial.