Clinical Trials

Multiple clinical trials are evaluating interventions for conditions such as spontaneous bacterial peritonitis, liver cirrhosis, and acute ischemic stroke. Sponsored by institutions including the Institute of Liver and Biliary Sciences in India and the University of Edinburgh in partnership with NHS Lothian, these unassigned or phase-not-applicable studies vary in operational status, with some currently not yet recruiting while others are actively recruiting participants.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06199843 Not yet recruiting
Spontaneous Bacterial Peritonitis
Institute of Liver and Biliary Sciences India
2024-01-05 Not Applicable
NCT06041932 Not yet recruiting
Liver Cirrhosis
Institute of Liver and Biliary Sciences India
2023-11-01 Not Applicable
NCT06028802 Recruiting
Ischemic Stroke Acute
University of Edinburgh|NHS Lothian
2023-10-26 --

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

Check the Cytidine 5′-triphosphate (disodium salt) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cytidine 5′-triphosphate functions as a pyrimidine nucleoside triphosphate substrate that binds to RNA polymerases and cytidylyltransferases to drive RNA synthesis and membrane phospholipid assembly. By sustaining essential transcriptional processes and cellular lipid biosynthesis, it preserves cell survival and structural integrity, which connects to clinical research in liver cirrhosis, spontaneous bacterial peritonitis, and acute ischemic stroke.

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.