Details checkedClinical trial listing onlyHistorical/discontinuedCheckedregistry

Brexanolone by Supernus for tinnitus

Also known as: Brexanolone, Allopregnanolone, ZULRESSO, SAGE-547, SGE-102, NCT05645432

Supernus Pharmaceuticals, Inc.

Primary source

Company

Supernus Pharmaceuticals, Inc.

Program Type

Therapeutic

Modality

Small Molecule

Stage

Phase 2

Status

Completed

Target Gene

—

Route / Mode

Intravenous infusion

Confidence

82%

Status Confidence

Status needs checking

Evidence Strength

Needs more support

Last Reviewed

2026-06-09

Geography

United States

Population

adult, tinnitus

Trial IDs

Mechanism

Intravenous neuroactive steroid and GABA-A receptor positive allosteric modulator evaluated in a small open-label Phase 2 tinnitus study.

Indications

Tinnitus

Notes

Verified as a real Supernus-sponsored Phase 2 open-label tinnitus study in adults. The study is completed and small (10 participants); no public peer-reviewed tinnitus efficacy results or active follow-on Supernus tinnitus program were confirmed in this pass, so it should be treated as a historical/completed exploratory program rather than an active pipeline asset.

Evidence & Sources

2 structured sources

clinicaltrials

Supports: canonicalName, aliases, company, programType, modality, indications, stage, status...

IDs: NCT05645432, Brexanolone, Allopregnanolone, ZULRESSO, SAGE-547

Open

regulatory

Supports: aliases, modality, mechanism, route, notes

IDs: Brexanolone, ZULRESSO

Open

Key Events

2022-12-09