Saccharin 1-methylimidazole (SMI) Clinical Trials

Size	Price	Qty
10mg	USD 97

Clinical Trials

Multiple observational and interventional clinical trials, sponsored by academic institutions including Hospices Civils de Lyon and Mahidol University, are evaluating patient cohorts for post-cancer hematological follow-up and sarcopenia secondary to liver cirrhosis. Designated as Phase Not Applicable, these studies encompass recruitment statuses ranging from a not-yet-recruiting protocol measuring quadriceps muscle mass in post-cancer cohorts to a trial enrolling by invitation to evaluate pedometer-based daily step counts in cirrhotic patients.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06007794	Not yet recruiting	Cancer\|Post-cancer\|Hematology	Hospices Civils de Lyon	2024-04-01	Not Applicable
NCT06231420	Enrolling by invitation	Sarcopenia\|Cirrhosis Liver\|Daily Step Count	Mahidol University	2024-02-01	Not Applicable

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

Check the Saccharin 1-methylimidazole (SMI) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Saccharin 1-methylimidazole functions as a general-purpose activator during nucleotide synthesis by nucleophilically activating phosphoramidite intermediates, thereby promoting rapid internucleotide coupling and efficient elongation of DNA and RNA strands. By enabling high-yield assembly of functional nucleic acid constructs, it facilitates the development of therapeutic oligonucleotides relevant to biomedical research in oncology and liver 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>).