Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 3 evaluate ebselen for conditions including Meniere's disease, bipolar disorder, hearing loss, ototoxicity, COVID-19, and diabetes mellitus. Sponsored by pharmaceutical entities and academic institutions, these studies encompass completed, recruiting, active not recruiting, and enrolling by invitation statuses. Key research includes several clinical trials evaluating Phase 2 efficacy for bipolar disorder and severe COVID-19, alongside Phase 3 development in Meniere's disease.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06859788 ACTIVE_NOT_RECRUITING
Meniere's Disease; Ménière's Disease
Sound Pharmaceuticals, Incorporated
 2025-10-29 PHASE3
NCT06340633 RECRUITING
Hearing Loss; Cochlear Trauma
Sound Pharmaceuticals, Incorporated
 2026-12 PHASE2
NCT05117710 UNKNOWN
Depressive Disorder, Treatment-Resistant
University of Oxford
 2021-04-22 PHASE1
NCT04484025 ENROLLING_BY_INVITATION
Covid19; Corona Virus Infection; Coronavirus; Coronavirus Infection
Sound Pharmaceuticals, Incorporated
 2021-10-12 PHASE2
NCT04677972 COMPLETED
Meniere Disease; Ménière
Sound Pharmaceuticals, Incorporated
 2022-08-02 PHASE3
NCT04483973 COMPLETED
Covid19; Coronavirus; Coronavirus Infection; Corona Virus Infection
Sound Pharmaceuticals, Incorporated
 2021-08-27 PHASE2
NCT02819856 COMPLETED
Ototoxicity
Sound Pharmaceuticals, Incorporated
 2017-07-21 PHASE2
NCT03013400 COMPLETED
Bipolar Disorder; Bipolar Disorder, Manic
University of Oxford
 2017-10-01 PHASE2
NCT03013400 Completed
Bipolar Disorder|Bipolar Disorder Manic
University of Oxford|Stanley Medical Research Institute|Sound Pharmaceuticals Incorporated
 2017-10-01 Phase 2
NCT02603081 Completed
Meniere''s Disease
Sound Pharmaceuticals Incorporated
 2015-12 Phase 1|Phase 2
NCT00762671 COMPLETED
Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus
Brigham and Women's Hospital
 1999-05 PHASE2; PHASE3
NCT01452607 COMPLETED
Hearing Loss; Cancer
Sound Pharmaceuticals, Incorporated
 2006-05 PHASE1
NCT01452607 Completed
Hearing Loss|Cancer
Sound Pharmaceuticals Incorporated
 2006-05 Phase 1
NCT00762671 Completed
Type 1 Diabetes Mellitus|Type 2 Diabetes Mellitus
Brigham and Women''s Hospital
 1999-05 Phase 2|Phase 3

(data from https://clinicaltrials.gov, updated on 2026-07-13)

Check the Ebselen product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ebselen selectively binds to viral capsid assemblies to disrupt essential structural protein interactions, blocking viral uncoating and preventing downstream viral maturation within host cells. By halting capsid-mediated viral replication and associated cellular dysfunction, this mechanism underpins its therapeutic evaluation across clinical trial conditions including viral infections like COVID-19, Meniere's disease, and bipolar disorder.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.