Drug Profile

Gacyclidine intratympanic controlled release - Otonomy

Alternative Names: GK-11; OTO 311; OTO 313

Latest Information Update: 17 Sep 2025

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At a glance

Originator Otonomy
Class Cyclohexanes; Neuroprotectants; Piperidines; Small molecules; Thiophenes
Mechanism of Action NMDA receptor antagonists

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity No

Highest Development Phases

Discontinued Tinnitus

Most Recent Events

11 Sep 2025 DURECT Corporation has been acquired and merged into Bausch Health Companies
18 Nov 2022 Otonomy withdraws a phase III trial in Tinnitus due to the discontinuation of the development of OTO 313 (Intratympanic)
01 Aug 2022 Discontinued - Phase-II for Tinnitus in USA, Germany, Poland, United Kingdom (Intratympanic)

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