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)
Mechanism and Biochemical Profile
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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