Clinical Trials

Several clinical trials evaluate conditions encompassing organ and liver transplantation, inflammatory bowel disease, rheumatoid arthritis, recurrent pregnancy loss, and severe dermatological disorders such as pemphigus and Stevens-Johnson syndrome. Lacking formal phase classifications, these studies are sponsored entirely by academic medical centers and hospital networks, including Assistance Publique - Hôpitaux de Paris, Ain Shams University, and Aalborg University Hospital. Investigating targeted topics like post-transplantation vaccine responses and therapeutic resistance, their recruitment statuses span active recruiting, not yet recruiting, completed, and unknown status.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05051605 Recruiting
Liver Transplant
Ain Shams University
2021-09-15 --
NCT05040854 Recruiting
Inflammatory Bowel Diseases
Centro Hospitalar Tondela-Viseu
2021-07-01 --
NCT03861962 Not yet recruiting
Organ Transplantation
Assistance Publique - Hôpitaux de Paris
2019-05 --
NCT03506035 Unknown status
Rheumatoid Arthritis
Corporacion Parc Tauli
2018-09-01 --
NCT05284929 Unknown status
Pemphigus|Bullous Pemphigoid|Stevens-Johnson Syndrome|Toxic Epidermal Necrolyses
Sechenov University|Pirogov Russian National Research Medical University
2017-05-17 --
NCT05342948 Completed
Recurrent Pregnancy Loss
Aalborg University Hospital
2016-01-01 --

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

Check the 5,6-Dichlorobenzimidazole 1-beta-D-ribofuranoside product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

5,6-Dichlorobenzimidazole 1-beta-D-ribofuranoside acts as a nucleoside analog that binds and inhibits carboxyl-terminal domain kinases, including casein kinase II and cyclin-dependent kinases, thereby blocking CTD phosphorylation and transcriptional elongation. This inhibition triggers p53-dependent apoptosis in neoplastic cells without inducing genotoxic stress in healthy tissues, demonstrating therapeutic relevance for inflammatory and autoimmune conditions evaluated in clinical trials such as inflammatory bowel diseases, rheumatoid arthritis, and organ transplantation.

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.