MBQ-167 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials are evaluating oral MBQ-167 monotherapy for the treatment of advanced and stage IV breast cancer. Currently recruiting, an open-label, first-in-human Phase 1 trial is investigating the drug's safety and preliminary efficacy in patients with advanced disease, sponsored by industry partner MBQ Pharma and the Congressionally Directed Medical Research Programs.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06075810	RECRUITING	Breast Cancer; Breast Neoplasm; Breast Cancer Stage IV	MBQ Pharma	2023-11-09	PHASE1
NCT06075810	Recruiting	Breast Cancer\|Breast Neoplasm\|Breast Cancer Stage IV	MBQ Pharma\|Congressionally Directed Medical Research Programs	2023-11-09	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-08-31)

Check the MBQ-167 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MBQ-167 functions as a potent dual inhibitor that binds directly to the GTPases Rac and Cdc42, thereby blocking downstream intracellular effector signaling and preventing actin cytoskeleton remodeling. By suppressing these GTPase-driven metastatic cascades, MBQ-167 inhibits cancer cell motility and invasion, which underlies its therapeutic development for advanced and stage IV breast cancer in clinical trials.

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>).