Therapeutics
Details checkedStatus confirmedHistorical/discontinuedCheckedpublication

OTO-104 (dexamethasone) by Otonomy

Also known as: OTO-104, OTO104, OTIVIDEX, sustained-release dexamethasone, dexamethasone thermosensitive gel, OTO-104 (steroid), OTO-104 3 mg, OTO-104 12 mg, dexamethasone sustained-exposure formulation

Otonomy

Primary source
Company
Otonomy
Program Type
Therapeutic
Modality
Steroid/Anti-inflammatory
Stage
Phase 3
Status
Discontinued
Target Gene
Route / Mode
Intratympanic injection
Confidence
90%
Status Confidence
Status confirmed
Evidence Strength
Needs more support
Last Reviewed
2026-06-09
Geography
United States, Europe
Population
adult, unilateral, meniere-disease, ototoxicity-risk
Trial IDs
6
Mechanism

Sustained-exposure intratympanic dexamethasone thermosensitive gel designed to maintain local steroid exposure in the inner ear for Meniere disease symptoms and other otologic indications.

Indications
Notes

Verified historical Otonomy sustained-release dexamethasone program. The early Phase 1B OTO-104 steroid trial NCT01084525 is part of the same OTO-104/OTIVIDEX program and has been merged into this canonical record. The strongest public clinical evidence is in Meniere disease, including multiple randomized Phase 3 studies that did not establish a consistent positive treatment effect; a cisplatin-ototoxicity feasibility study was terminated. Otonomy later wound down, so this should be shown as discontinued/historical rather than active.

Evidence & Sources
6 structured sources
publication
Supports: canonicalName, aliases, company, modality, mechanism, indications, stage, status...
IDs: OTO-104, NCT02612337, NCT02727442, NCT03664674
Open
publication
Supports: mechanism, route, populationTags, notes
IDs: OTO-104, NCT01412177
Open
clinicaltrials
Supports: trialIds, stage, status, indications, geography
IDs: NCT01412177, OTO-104
Open
clinicaltrials
Supports: trialIds, indications, stage, status, populationTags
IDs: NCT02997189, OTO-104
Open
company
Supports: company, stage, keyEvents
IDs: OTO-104
Open
clinicaltrials
Supports: aliases, trialIds, stage, status, route, populationTags, geography, notes
IDs: NCT01084525, OTO-104, OTO-104 (steroid) 3 mg, OTO-104 (steroid) 12 mg
Open
Key Events
Clinical Trials (6)
Data Checks
historical-discontinued-programmeniere-primary-not-hearing-primarymerged-generated-registry-fragment
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