Details checkedClinical trial listing onlyCheckedregistry

OHSU/Oricula ORC-13661 amikacin otoprotection study

Also known as: ORC-13661, ORC-13361, SOUNDS Trial, U01DC020175, NCT05730283

Investigator-led study

Primary source

Sponsor / Institution

Investigator-led study

Program Type

Therapeutic

Modality

Small Molecule

Stage

Phase 2

Status

Active

Target Gene

—

Route / Mode

Oral capsules

Confidence

83%

Status Confidence

Status needs checking

Evidence Strength

Needs more support

Last Reviewed

2026-06-09

Geography

United States

Population

adult, ototoxicity, amikacin, ntm, sensorineural

Trial IDs

Mechanism

Oral ORC-13661 small molecule evaluated in a randomized Phase 2 dose-ranging trial to prevent or mitigate IV amikacin-associated ototoxic hearing loss in adults with nontuberculous mycobacterial disease.

Indications

Hearing Loss Ototoxicity Aminoglycoside-Induced Hearing Loss

Notes

Corrected from an NCATS-owned row. ClinicalTrials.gov lists Kevin Winthrop/Oregon Health and Science University as sponsor-investigator context, NIH institutes as collaborators, and Oricula Therapeutics as an involved collaborator with an Oricula-affiliated principal investigator. Verified as an active study-level ORC-13661 otoprotection program, while avoiding an unsupported claim that Oricula is the sole trial sponsor.

Evidence & Sources

1 structured sources

clinicaltrials

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

IDs: NCT05730283, SOUNDS Trial, U01DC020175, ORC-13661

Open

Key Events

2023-02-15

ORC-13661 SOUNDS Phase 2 study first posted

2026-05-07

ClinicalTrials.gov update lists the SOUNDS trial as recruiting

Clinical Trials (1)