Cytosine Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Several clinical trials evaluate cytosine and related therapeutic regimens across indications including acute myeloid leukemia, schizophrenia, stress management, and environmental exposures associated with infant adiposity. Spanning Phase 1/2, Phase 4, and unclassified study designs, these trials encompass recruiting, active not recruiting, completed, and unknown recruitment statuses. Sponsorship is distributed among commercial entities and major academic institutions, including Moleculin Biotech Inc., the Hospital Clinic of Barcelona, the University of Miami, and Montefiore Medical Center.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05319587	Recruiting	Leukemia Myeloid Acute	Moleculin Biotech Inc.	2022-09-29	Phase 1\|Phase 2
NCT04278027	Unknown status	Schizophrenia	Hospital Clinic of Barcelona\|National Alliance for Research on Schizophrenia and Depression\|Instituto de Salud Carlos III	2017-01-03	Not Applicable
NCT03955991	Active not recruiting	Stress	University of Miami\|Florida Department of Health	2016-07-21	Phase 4
NCT01815385	Completed	Full Term Infants\|Environmental Exposures\|Adiposity	Montefiore Medical Center\|American Diabetes Association	2013-03	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cytosine functions as an essential pyrimidine nitrogenous base that binds complementary guanine residues within nucleic acid polymers, enabling the biochemical replication and transcriptional activity necessary for cellular proliferation and functional gene expression. Perturbation or enzymatic modification of cytosine incorporation disrupts cellular DNA and RNA synthesis as well as epigenetic signaling, thereby modulating cellular viability and gene expression profiles relevant to clinical conditions such as acute myeloid leukemia, schizophrenia, and stress-related metabolic alterations.

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>).