Clinical Trials

Multiple clinical trials span Phase 3, Phase 4, and unassigned protocols to investigate conditions including hearing loss, psoriatic arthritis, hip and knee osteoarthritis, respiratory diseases, and T-cell lymphoma subtypes. Sponsoring entities range from major pharmaceutical corporations and hearing technology firms to healthcare trusts and military hospitals. Across these evaluations, recruitment statuses encompass completed, recruiting, active not recruiting, terminated, and unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03569228 TERMINATED
Hearing Loss
VA Office of Research and Development
 2019-10-28
NCT02545569 UNKNOWN
Hearing Loss, Bilateral or Unilateral
Phonak AG, Switzerland
 2020-01-06
NCT04262271 Completed
Respiratory Disease
Portsmouth Hospitals NHS Trust
 2019-08-07 --
NCT03938610 Recruiting
Knowledge Attitudes Practice
Pamela Hughes|Mike O''Callaghan Military Hospital
 2019-06-01 --
NCT03675308 Active not recruiting
Psoriatic Arthritis
AbbVie
 2019-03-25 Phase 3
NCT03671148 Active not recruiting
Psoriatic Arthritis (PsA)
AbbVie
 2019-03-07 Phase 3
NCT01746992 UNKNOWN
ALK-negative Anaplastic Large Cell Lymphoma; Peripherial T Cell Lymphoma,Not Otherwise Specified; Angioimmunoblastic T Cell Lymphoma; Enteropathy Associated T Cell Lymphoma; Hepatosplenic T Cell Lymphoma; Subcutaneous Panniculitis Like T Cell Lymphoma
Ruijin Hospital
 2012-09 PHASE4
NCT04168229 COMPLETED
Hearing Loss
Bernafon AG
 2018-07-12
NCT02709486 Completed
Osteoarthritis Hip|Osteoarthritis Knee
Pfizer|Eli Lilly and Company
 2016-03-02 Phase 3

(data from https://clinicaltrials.gov, updated on 2025-05-25)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

ITE acts as a potent endogenous agonist that directly binds the aryl hydrocarbon receptor (AhR) with a Ki of 3 nM, triggering receptor nuclear translocation and modulating transcriptional networks that control cell proliferation and immune differentiation. By driving AhR-dependent immunomodulatory and gene-regulatory responses, this compound offers potential therapeutic utility in mitigating pathological immune responses and proliferative signaling in clinical conditions such as psoriatic arthritis and T-cell lymphomas.

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.