Methyl methanesulfonate Clinical Trials

Size	Price	Qty
500mg	USD 147
1g	USD 197

Clinical Trials

Several clinical trials are currently evaluating interventions across diverse medical areas, including ulcerative colitis, palliative care, and pregnancy-related health issues. Ranging from Phase 2 and Phase 3 evaluations to non-applicable phase frameworks, these studies encompass both active recruitment and not-yet-recruiting stages. Sponsored by pharmaceutical leaders like AbbVie and Takeda alongside academic institutions such as the University of Pennsylvania, prominent studies focus on pediatric therapies for ulcerative colitis and induction efficacy in inflammatory bowel disease.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05316220	Not yet recruiting	Ulcerative Colitis (UC)	AbbVie	2024-09-15	Phase 3
NCT05806255	Not yet recruiting	Palliative Care	William Osler Health System\|Humber River Hospital\|The Ottawa Hospital\|Bruyere Research Institute\|University of Ottawa\|Ottawa Hospital Research Institute\|University of Toronto\|Queen''s University\|McMaster University	2024-07-01	Not Applicable
NCT05703373	Not yet recruiting	Pregnancy Related	University of Pennsylvania	2024-06	Not Applicable
NCT06254950	Recruiting	Ulcerative Colitis	Takeda	2024-03-29	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a DNA alkylating agent, methyl methanesulfonate covalently modifies guanine to 7-methylguanine and adenine to 3-methyladenine, leading to base mispairing and replication fork arrest during cellular DNA synthesis. This inhibition of genomic replication blocks cell proliferation and induces DNA damage-mediated cytotoxicity, supporting its utility in studying DNA repair mechanisms and therapeutic responses in clinical conditions such as ulcerative colitis.

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>).