5-Hydroxymethylcytosine Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials have investigated the epigenetic modification 5-hydroxymethylcytosine as a biomarker and therapeutic parameter in hematological malignancies—such as myelodysplastic syndromes, acute myeloid leukemia, preleukemia, and chronic myelomonocytic leukemia—along with genitourinary conditions and targeted therapy resistance. Sponsored by academic institutions, university hospitals, and research entities including the Van Andel Research Institute, Rigshospitalet Denmark, and Peking University, several clinical trials comprising mid-stage and observational protocols for hypomethylation and epigenetic profiling currently display recruiting, completed, or unknown statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04741945	Recruiting	Preleukemia\|Myelodysplastic Neoplasm\|Cytopenia\|Preleukemic Anemia	Kirsten Grønbæk\|Steno Diabetes Center Copenhagen\|Zealand University Hospital\|Van Andel Research Institute\|Herlev Hospital\|Technical University of Denmark\|Region Hovedstadens Apotek\|University of Copenhagen\|Rigshospitalet Denmark	2021-12-13	Phase 2
NCT05318989	Completed	Genitourinary Agents	Żelazna Medical Centre LLC\|Laboratory of Genetics and Human Genomics University of Gdańsk	2021-02-08	--
NCT03919539	Unknown status	Drug Resistance to Famitinib and Camrelizumab\|Biomarkers for Efficacy and Toxicity	Peking University People''s Hospital\|Peking University\|Northwestern University	2019-12-01	--
NCT03999723	Recruiting	Myelodysplastic Syndromes\|Acute Myeloid Leukemia\|Chronic Myelomonocytic Leukemia	Kirsten Grønbæk\|Van Andel Institute - Stand Up To Cancer Epigenetics Dream Team\|Karolinska University Hospital\|Skane University Hospital\|Sahlgrenska University Hospital Sweden\|University of Southern California\|Imperial College London\|University of Copenhagen\|Zealand University Hospital\|Aalborg University Hospital\|Odense University Hospital\|Technical University of Denmark\|Aarhus University Hospital\|Uppsala University Hospital\|Rigshospitalet Denmark	2019-09-11	Phase 2
NCT03526666	Completed	Myelodysplastic Syndromes\|Acute Myeloid Leukemia\|Chronic Myelomonocytic Leukemia\|MDS\|AML\|CMML	Van Andel Research Institute	2017-11-01	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a key genomic modification produced during TET-mediated active DNA demethylation, 5-hydroxymethylcytosine alters reader protein recruitment to chromatin, thereby modulating local downstream transcriptional machinery and gene expression patterns. This epigenetic regulation restores normal cellular differentiation programs, which is clinically relevant to reversing aberrant gene silencing in hematological disorders such as myelodysplastic syndromes and acute myeloid leukemia.

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>).