Details checkedStrong evidenceCheckedcompany

SENS-401 (Arazasetron) by Sensorion

Also known as: SENS-401, SENS 401, SENS-401 (R-Azasetron Besylate), R-Azasetron Besylate, Arazasetron, NOTOXIS, AUDIBLE-S

Sensorion

Primary source

Company

Sensorion

Program Type

Therapeutic

Modality

Small Molecule

Stage

Phase 2

Status

Active

Target Gene

—

Route / Mode

Oral

Confidence

94%

Status Confidence

Status confirmed

Evidence Strength

Strong evidence

Last Reviewed

2026-06-09

Geography

Europe, Australia, Canada, France

Population

adult, sudden, cisplatin-ototoxicity, cochlear-implant

Trial IDs

Mechanism

Oral R-azasetron besylate small molecule; Sensorion describes it as a 5-HT3 receptor antagonist and calcineurin inhibitor intended to protect and preserve inner-ear tissue from ototoxic and acute cochlear injury.

Indications

Hearing Loss Sensorineural Hearing Loss Sudden Sensorineural Hearing Loss Cisplatin-Induced Hearing Loss

Notes

Canonicalized the trial-generated SENS-401 (R-azasetron besylate) record into Sensorion SENS-401. Public Sensorion materials describe one clinical-stage oral small-molecule program spanning SSNHL, cisplatin-induced ototoxicity prevention, and cochlear-implant residual-hearing preservation. NOTOXIS enrollment was announced complete in March 2025 with topline results guided for end-H2 2025; no topline result source was confirmed in this pass, so the active status is retained with a current-status caveat.

Evidence & Sources

6 structured sources

company

Supports: canonicalName, aliases, company, allCompanies, mechanism, indications, route, status

IDs: SENS-401, Arazasetron, R-azasetron besylate

Open

clinicaltrials

Supports: trialIds, stage, populationTags, geography

IDs: NCT03603314

Open

clinicaltrials

Supports: aliases, trialIds, stage, populationTags, geography, notes