Clinical Trials

Multiple clinical trials are evaluating therapeutic strategies for B-cell non-Hodgkin's lymphoma, epidermolysis bullosa, severe aplastic anemia, vision disorders, and acute cerebral ischemia. Spanning Phase 1/2 safety evaluations to Phase 2/3 efficacy trials, Phase 4 post-market assessments, and behavioral interventions, these studies encompass both active and not-yet-recruiting statuses. This research landscape is sponsored by corporate entities, including Estrella Biopharma, TWi Biotechnology, and Pharmazz, as well as academic institutions like Radboud University and the 920th Hospital.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06343311 Not yet recruiting
B-Cell Non-Hodgkin''s Lymphoma (NHL)|Lymphoma Non-Hodgkins|Lymphomas Non-Hodgkin''s B-Cell|Non-Hodgkin Lymphoma|Non-Hodgkin''s Lymphoma|Large B-Cell Lymphoma|Lymphoma Non-Hodgkin''s Adult|Lymphoma|Refractory Non-Hodgkin Lymphoma|Relapsed Non-Hodgkin Lymphoma|Lymphoma Non-Hodgkin|HIV Associated Lymphoma|CNS Lymphoma|High-grade B-cell Lymphoma|Refractory B-Cell Non-Hodgkin Lymphoma
Estrella Biopharma Inc.|Eureka Therapeutics Inc.|Estrella Immunopharma Inc.
2024-05-15 Phase 1|Phase 2
NCT06073132 Recruiting
Generalized Epidermolysis Bullosa Simplex
TWi Biotechnology Inc.
2024-04 Phase 2|Phase 3
NCT06378060 Recruiting
Severe Aplastic Anemia
Hematology department of the 920th hospital
2024-03-01 Phase 2
NCT05600140 Recruiting
Vision Disorders|Vision Low
Royal Dutch Visio|Radboud University Behavioural Science Institute Nijmegen The Netherlands
2024-03-06 Not Applicable
NCT06007235 Recruiting
Epidermolysis Bullosa Dystrophica|Epidermolysis Bullosa Junctional
Organ Tissue Regeneration Repair and Replacement|Euraxi Pharma|ARANZ Medical
2024-01-29 Not Applicable
NCT05955326 Recruiting
Acute Cerebral Ischemia
Pharmazz Inc.
2024-01-08 Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ethidium bromide functions as a planar intercalating agent that inserts between adjacent DNA base pairs, deforming the helical structure and blocking downstream nucleic acid transcription and replication machinery. This persistent inhibition of DNA synthesis arrests cell cycle progression and induces cytotoxic cell death, highlighting its clinical relevance in suppressing abnormal cellular proliferation in malignancies such as B-cell non-Hodgkin's lymphoma.

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.