Clinical Trials

Several clinical trials evaluate conditions associated with pulmonary pathology and diagnostic profiling, including lung transplant rejection, interstitial lung disease, and sarcoidosis. Sponsored by academic and medical institutions such as the University of Alberta, Laval University, and University Hospital Ghent, these studies carry unassigned or not applicable phase classifications and focus on biopsy molecular features and diagnostic yield evaluations. Across these records, recruitment statuses include recruiting, completed, and unknown status.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02812290 Recruiting
Lung Transplant Rejection
University of Alberta
2016-05 --
NCT02235779 Unknown status
Interstitial Lung Disease
Laval University
2014-08 Not Applicable
NCT00888212 Completed
Sarcoidosis
University Hospital Ghent
2008-06 Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

TBB (4,5,6,7-tetrabromobenzotriazole) acts as a selective, cell-permeable ATP-competitive inhibitor of protein kinase CK2, blocking CK2-mediated phosphorylation of downstream signaling substrates and impairing critical cellular survival pathways. By suppressing intracellular CK2 catalytic activity and dampening pro-inflammatory and proliferative cellular responses, TBB provides a pharmacological means to modulate aberrant signaling relevant to pulmonary inflammatory disorders, such as lung transplant rejection, interstitial lung disease, and sarcoidosis.

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>).

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