OTO-311

OTO-311 is an investigational, single-dose, sustained-exposure intratympanic formulation of the potent and selective N-methyl-D-aspartate (NMDA) receptor antagonist gacyclidine, developed by Otonomy for the treatment of tinnitus.[1][5][8][9][11] Using a poloxamer (P407)-based delivery system to achieve prolonged inner-ear exposure from a single middle-ear injection, OTO-311 is designed to block cochlear NMDA receptors implicated in tinnitus generation while minimizing systemic exposure and central nervous system side effects.[1][8][9] Otonomy completed a Phase 1 clinical safety trial in healthy volunteers showing that OTO-311 was well tolerated, but the program has not advanced to later-stage efficacy trials and Otonomy has subsequently focused its tinnitus efforts on the related intratympanic gacyclidine product OTO-313.[8][9][10]

Other names

poloxamer-based sustained-exposure intratympanic gacyclidine formulationP407-based formulation of gacyclidineP-407-based formulation of gacyclidineP 407-based formulation of gacyclidine