Tamnorzatinib (ONO-7475) Clinical Trials

Size	Price	Qty
5mg	USD 187
25mg	USD 570

Clinical Trials

Several clinical trials sponsored by Ono Pharmaceutical Co., Ltd. evaluate Tamnorzatinib (ONO-7475) across Phase 1 and Phase 1/2 studies, investigating its safety, tolerability, and efficacy as a monotherapy or in combination therapies. Target indications include EGFR mutation-positive non-small cell lung cancer, metastatic pancreatic cancer, acute leukemia, myelodysplastic syndromes, and advanced or metastatic solid tumors. Recruitment statuses across these studies encompass completed, active not recruiting, and terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06532331	ACTIVE_NOT_RECRUITING	Metastatic Pancreatic Cancer	Ono Pharmaceutical Co., Ltd.	2023-12-06	PHASE1
NCT06525246	COMPLETED	Stage IIIB Non-small Cell Lung Cancer; Stage IIIC Non-Small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer; Recurrent Non-Small Cell Lung Cancer; EGFR Mutation-Related Tumors	Ono Pharmaceutical Co., Ltd.	2021-08-06	PHASE1
NCT03176277	TERMINATED	Acute Leukemia; Myelodysplastic Syndromes	Ono Pharmaceutical Co., Ltd.	2017-06-26	PHASE1; PHASE2
NCT03730337	COMPLETED	Advanced or Metastatic Solid Tumors	Ono Pharmaceutical Co., Ltd.	2018-10-17	PHASE1
NCT03176277	Terminated	Acute Leukemia\|Myelodysplastic Syndromes	Ono Pharmaceutical Co. Ltd	2017-06-26	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2025-04-18)

Check the Tamnorzatinib (ONO-7475) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tamnorzatinib (ONO-7475) functions as a potent and selective inhibitor of AXL and MER tyrosine kinases, suppressing key downstream intracellular signaling pathways essential for cell survival and resistance. By blocking AXL/MER activity, it halts cellular proliferation and overcomes resistance to initial target therapies, which directly underlies its therapeutic evaluation in clinical trials for non-small cell lung cancer, advanced solid tumors, and acute leukemia.

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>).