m6A (N6-methyladenosine) Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 970

Clinical Trials

Several clinical trials sponsored by academic and medical institutions—such as the Eye & ENT Hospital of Fudan University, Beijing Tiantan Hospital, and City of Hope Medical Center—are evaluating N6-methyladenosine (m6A) modifications across conditions including cataract pathogenesis, moyamoya disease, and appendiceal adenocarcinoma. Lacking conventional phase assignments due to their observational or molecular profiling design, these studies exhibit varying recruitment statuses ranging from actively recruiting to unknown. Collectively, these investigations seek to elucidate epitranscriptomic mechanisms for enhanced disease characterization and patient risk stratification.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05682001	Recruiting	Cataract\|Pathogenesis	Eye & ENT Hospital of Fudan University\|National Natural Science Foundation of China	2022-01-01	--
NCT04696094	Unknown status	Moyamoya Disease	Beijing Tiantan Hospital	2021-01-01	--

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

Check the m6A (N6-methyladenosine) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an abundant epitranscriptomic RNA modification, N6-methyladenosine (m6A) selectively interacts with reader, writer, and eraser proteins to regulate post-transcriptional RNA processing, splicing, translation efficiency, and transcript stability. Disruption of m6A-mediated RNA methylation alters downstream cellular homeostasis and gene expression networks, underlying its pathogenic involvement in conditions currently under clinical evaluation, including cataracts, moyamoya disease, and appendiceal adenocarcinoma.

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>).