DX600 Clinical Trials

Size	Price	Qty
1mg	USD 190
5mg	USD 570

Clinical Trials

Multiple clinical trials sponsored by an academic research organization, Peking University Cancer Hospital and Institute, are evaluating DX600-based positron emission tomography probes for molecular imaging of ACE2 expression in patients with solid tumors. With recruitment statuses ranging from completed to unknown, these studies do not specify a formal clinical phase, reflecting their focus on diagnostic PET probe evaluation rather than therapeutic intervention.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04542863	UNKNOWN	Solid Tumor	Peking University Cancer Hospital & Institute	2020-09-11
NCT04422457	COMPLETED	Solid Tumor	Peking University Cancer Hospital & Institute	2020-06-13

(data from https://clinicaltrials.gov, updated on 2023-03-29)

Check the DX600 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

DX600 selectively binds to angiotensin-converting enzyme 2 (ACE2) without cross-inhibiting ACE, suppressing ACE2-mediated enzymatic hydrolysis and downstream cleavage pathways. This targeted inhibition attenuates receptor-driven signaling cascades and enzymatic turnover, providing a mechanistic basis for utilizing radiolabeled DX600 probes to visualize and quantify ACE2 expression in solid tumors.

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>).