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Fudan EH002 OTOF gene therapy study

Also known as: EH002 administration, EH002, DFNB9 congenital deafness gene therapy, NCT06722170

Institution-led study

Primary source

Sponsor / Institution

Institution-led study

Program Type

Therapeutic

Modality

Gene Therapy

Stage

Interventional/NA

Status

Active

Target Gene

OTOF

Route / Mode

Intracochlear injection

Confidence

84%

Status Confidence

Status needs checking

Evidence Strength

Needs more support

Last Reviewed

2026-06-09

Geography

China

Population

genetic, pediatric, congenital, pre-lingual, sensorineural, profound

Trial IDs

Mechanism

Recruiting investigator-led study evaluating intracochlear EH002 gene therapy for congenital deafness caused by OTOF mutations, with dose-escalation cohorts and safety, tolerability, and preliminary efficacy endpoints.

Indications

Hearing Loss Sensorineural Hearing Loss Genetic Hearing Loss OTOF-Related Hearing Loss

Notes

Verified as a real active OTOF/DFNB9 gene therapy study, but normalized as institution-led because the registry lead sponsor/responsible party is Yilai Shu/Eye & ENT Hospital of Fudan University, not a disclosed commercial company. No company ownership or product sponsor was verified in this pass.

Evidence & Sources

1 structured sources

clinicaltrials

Supports: canonicalName, aliases, allCompanies, isIndustrySponsored, stage, status, route, indications...

IDs: NCT06722170

Open

Key Events

2024-11-22

EH002 OTOF gene therapy study started

2025-07-25

ClinicalTrials.gov posted latest recruiting update reviewed in this pass

Clinical Trials (1)