Naquotinib(ASP8273) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 497

Clinical Trials

Several clinical trials, primarily sponsored by Astellas Pharma entities, have evaluated the safety, pharmacokinetics, and therapeutic activity of Naquotinib (ASP8273) across Phase 1, Phase 2, and combined Phase 1/2 studies. These investigations specifically targeted patients with solid tumors and epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC), including EGFR tyrosine kinase inhibitor (TKI)-naïve populations. Across these protocols, reported recruitment statuses include completed, terminated, and withdrawn studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03082300	Terminated	Non-small Cell Lung Cancer (NSCLC)\|Epidermal Growth Factor Receptor (EGFR) Mutations	Astellas Pharma Global Development Inc.\|Astellas Pharma Inc	2017-03-24	Phase 1
NCT02674555	Withdrawn	Epidermal Growth Factor Receptor (EGFR) Mutations\|Solid Tumors	Astellas Pharma Global Development Inc.\|Astellas Pharma Inc	2016-11-15	Phase 1
NCT02500927	Terminated	EGFR-TKI-naïve Patients With NSCLC Harboring EGFR Activating Mutations	Astellas Pharma Inc	2015-06-25	Phase 2
NCT02113813	Completed	Non-Small-Cell Lung Cancer (NSCLC)\|Epidermal Growth Factor Receptor Mutations	Astellas Pharma Global Development Inc.\|Astellas Pharma Inc	2014-04-09	Phase 1
NCT02192697	Terminated	Non-small Cell Lung Cancer	Astellas Pharma Inc	2014-01-23	Phase 1\|Phase 2

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

Check the Naquotinib(ASP8273) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Naquotinib (ASP8273) selectively and irreversibly binds to mutant forms of the epidermal growth factor receptor (EGFR), potently blocking receptor autophosphorylation and downstream oncogenic signaling pathways. This molecular inhibition suppresses downstream biochemical cascades and halts cell proliferation, providing a therapeutic mechanism for treating EGFR mutation-positive non-small cell lung cancer and advanced solid tumors evaluated 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>).