Clinical Trials

Several clinical trials evaluate this agent across diverse indications, including ulcerative colitis, COVID-19/SARS-CoV-2 infection, and autism. Spanning Phase 2 through Phase 4 alongside non-applicable phase classifications, these studies are either actively recruiting or not yet recruiting. Sponsors encompass industry entities such as Takeda and Faes Farma S.A., as well as academic institutions including the University of Texas Southwestern Medical Center and the University of Cambridge.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06095128 Not yet recruiting
Ulcerative Colitis
Takeda
 2024-05-02 Phase 4
NCT05886816 Recruiting
SARS-CoV Infection|COVID-19
University of Texas Southwestern Medical Center
 2024-03-01 Phase 2
NCT06176560 Not yet recruiting
Colitis Ulcerative
Faes Farma S.A.
 2024-03 Phase 3
NCT06016621 Recruiting
Autism
Prof Simon Baron-Cohen|Anglia Ruskin University|Musical Universe|Rosetrees Trust|Stoneygate Trust|Autism Centre of Excellence|University of Cambridge
 2023-11-13 Not Applicable

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

MES acts as a morpholinic zwitterionic buffering agent that maintains hydrogen ion homeostasis within the pH range of 5.5 to 7.0, effectively preventing adverse pH fluctuations and subsequent cellular enzymatic disruption or protein denaturation. By maintaining stable biochemical and physiological parameters, this buffering compound preserves cell viability and cellular integrity relevant to research models of ulcerative colitis, SARS-CoV-2 infection, and neurodevelopmental conditions like autism.

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>).

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Note: Technical data last updated: Sep 1, 2026.