Clinical Trials

Several clinical trials evaluate 5'-Cytidylic acid across gynecologic malignancies, renal conditions, and psychiatric disorders such as major depressive disorder and generalized anxiety disorder. Conducted by governmental, academic, and clinical groups—including the National Cancer Institute, the Gynecologic Oncology Group, Maastricht University Medical Center, and CONICET Argentina—these protocols are classified under undefined phases or designated as phase not applicable. Currently, recruitment statuses across these studies are documented as either withdrawn or not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01199250 Not yet recruiting
Lynch Syndrome|Recurrent Uterine Corpus Carcinoma|Stage I Uterine Corpus Cancer|Stage II Uterine Corpus Cancer|Stage III Uterine Corpus Cancer|Stage IV Uterine Corpus Cancer
Gynecologic Oncology Group|National Cancer Institute (NCI)|GOG Foundation
2100-01 --
NCT04598516 Withdrawn
Acute Kidney Injury (Nontraumatic)|Contrast-induced Nephropathy|Renal Insufficiency
Maastricht University Medical Center
2097-11-01 --
NCT05118594 Not yet recruiting
Major Depressive Disorder|Dysthymic Disorder|Specific Phobia|Social Anxiety Disorder|Panic Disorder|Agoraphobia|Generalized Anxiety Disorder
National Council of Scientific and Technical Research Argentina
2026-02 Not Applicable

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

Check the 5'-Cytidylic acid product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a essential pyrimidine nucleotide monomer, 5'-cytidylic acid serves as a substrate for RNA polymerases and cytidylyltransferases, driving intracellular nucleic acid transcription and phospholipid membrane biosynthesis. By replenishing essential nucleotide pools and supporting cellular structural integrity, it sustains cell viability and tissue metabolic homeostasis, providing functional relevance to clinical investigations in renal injury, uterine carcinomas, and neuropsychiatric disorders.

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.