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Details checkedStrong evidenceCheckedregulatory
Otarmeni by Regeneron
Also known as: DB-OTO, lunsotogene parvec-cwha, CHORD
Regeneron Pharmaceuticals
Company
Regeneron Pharmaceuticals
Program Type
Therapeutic
Modality
Gene Therapy
Stage
Approved
Status
Approved
Target Gene
OTOF
Route / Mode
Intracochlear infusion
Confidence
99%
Status Confidence
Status confirmed
Evidence Strength
Strong evidence
Last Reviewed
2026-05-31
Geography
United States, European Union, United Kingdom, Spain
Population
pediatric, adult, congenital, genetic, otof-dfnb9, pre-lingual, bilateral, profound
Trial IDs
1
Mechanism
Dual-AAV intracochlear gene replacement delivers functional OTOF to cochlear inner hair cells to restore otoferlin-mediated auditory signaling.
Indications
Notes
Field-defining OTOF program; transitioned from Decibel to Regeneron after the 2023 acquisition and became the first approved gene therapy for genetic hearing loss in 2026.
Evidence & Sources
3 structured sourcesregulatory
Supports: canonicalName, aliases, company, stage, status, indications, targetGene
IDs: Otarmeni, DB-OTO
company
Supports: company, allCompanies, mechanism, route, populationTags, geography
IDs: DB-OTO, Otarmeni
clinicaltrials
Supports: trialIds, route, populationTags, geography
IDs: NCT05788536
Key Events
Clinical Trials (1)
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