Clinical Trials

Several clinical trials are currently actively recruiting to investigate conditions including breast cancer, cervical cancer, atrial fibrillation, job stress, and autoimmune neurological disorders such as neuromyelitis optica spectrum disorder. Sponsored by academic institutions and health organizations including Johns Hopkins University, Northwestern University, and Brigham and Women's Hospital, these studies feature unassigned phase designations or are classified as not applicable. Overall, the research focuses on behavioral interventions, diagnostic evaluations, and biomarker analyses across these specified health conditions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06026280 Recruiting
Job Stress|Distress Emotional
Inspiration at Work|Northwestern University
2023-08-07 Not Applicable
NCT05364138 Recruiting
Breast Cancer|Benign Breast Disease|Cervix Cancer
Brigham and Women''s Hospital|Partners in Health|Rwanda Biomedical Centre|Johns Hopkins University
2023-07-31 --
NCT05862038 Recruiting
Atrial Fibrillation
Ana Jordan|University Hospital Dubrava
2023-02-10 --
NCT05414890 Recruiting
NMO Spectrum Disorder|NMDA-R Encephalitis|Diagnostic Self Evaluation|Immune System Diseases|Nervous System Diseases|Autoimmune Diseases of the Nervous System|Autoimmune Diseases
Beijing Tiantan Hospital|Tianjin Medical University General Hospital
2022-06-30 --

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

Check the CBA (TRPM4-IN-5) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CBA acts as a selective inhibitor of the transient receptor potential melastatin member 4 (TRPM4) cation channel, blocking monovalent ion flux and perturbing membrane depolarization along with intracellular calcium dynamics. This targeted suppression of TRPM4-mediated conductance impairs cell proliferation and alters physiological excitation, which is directly relevant to clinical trial conditions such as breast cancer oncogenesis and cardiac arrhythmias like atrial fibrillation.

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.