Clinical Trials

MTB-9655 is currently undergoing evaluation in multiple clinical trials sponsored by MetaboMed Inc. to investigate its therapeutic potential in patients with advanced solid tumors. These Phase 1, open-label studies aim to assess the preliminary safety, tolerability, and dosing of the drug, though their recruitment status is currently listed as unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04990739 UNKNOWN
Advanced Solid Tumor
MetaboMed Inc
 2021-06-30 PHASE1
NCT04990739 Unknown status
Advanced Solid Tumor
MetaboMed Inc
 2021-06-30 Phase 1

(data from https://clinicaltrials.gov, updated on 2021-12-17)

Check the MTB-9655 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MTB-9655 functions as a selective inhibitor of acetyl-coenzyme A synthetase 2 (ACSS2), binding to the enzyme to block the conversion of acetate into acetyl-CoA and thereby suppressing essential downstream lipid synthesis and metabolic energy production. This metabolic disruption impairs acetyl-CoA-dependent chromatin remodeling and cellular proliferation, which directly inhibits tumor growth and survival in patients presenting with advanced solid tumors displaying elevated ACSS2 expression.

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.