Details checkedStrong evidenceCheckedtrial

SPI-1005 by Sound Pharmaceuticals

Also known as: SPI-1005, ebselen, STOPMD-3

Sound Pharmaceuticals

Primary source

Company

Sound Pharmaceuticals

Program Type

Therapeutic

Modality

Small Molecule

Stage

Phase 3

Status

Active

Target Gene

—

Route / Mode

Oral

Confidence

90%

Status Confidence

Status confirmed

Evidence Strength

Strong evidence

Last Reviewed

2026-05-31

Geography

United States

Population

adult, noise-induced, tinnitus, cisplatin-ototoxicity

Trial IDs

Mechanism

Oral ebselen is intended to mimic glutathione peroxidase activity and reduce oxidative inner-ear injury linked to hearing loss and tinnitus.

Indications

Hearing Loss Sensorineural Hearing Loss Noise-Induced Hearing Loss Tinnitus Cisplatin-Induced Hearing Loss

Notes

One of the most persistent non-gene inner-ear drug programs; strategically relevant across Meniere's disease, noise injury, tinnitus, and ototoxicity, although no hearing-loss approval has been achieved. Generated dose-arm rows from SPI-1005 trials are treated as covered by this canonical program record, not as separate programs.

Evidence & Sources

6 structured sources

company

Supports: canonicalName, company, mechanism, indications, notes

IDs: SPI-1005

Open

company

Supports: stage, status, notes

IDs: SPI-1005, STOPMD-3

Open

clinicaltrials

Supports: trialIds, route