Ningetinib Clinical Trials

Size	Price	Qty
5mg	USD 179
25mg	USD 539

Clinical Trials

Multiple clinical trials evaluate the therapeutic application of ningetinib across oncological and ophthalmological indications, encompassing Phase 1, Phase 1/2, and Phase 2 studies in advanced solid tumors, advanced non-small cell lung cancer, multiple myeloma, and age-related macular degeneration. Led by sponsors such as Sunshine Lake Pharma Co. Ltd., Santen Inc., and CARsgen Therapeutics Co. Ltd., these evaluations range from completed safety and pharmacokinetic studies to active and planned assessments of specialized therapeutic regimens.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04992858	Not yet recruiting	Advanced NSCLC	Sunshine Lake Pharma Co. Ltd.	2022-11-27	Phase 2
NCT03975907	Active not recruiting	Multiple Myeloma	CARsgen Therapeutics Co. Ltd.\|Beijing Chao Yang Hospital\|The First Affiliated Hospital of Soochow University\|Xinhua Hospital Shanghai Jiao Tong University School of Medicine\|Tianjin Medical University General Hospital\|First Affiliated Hospital of Zhejiang University\|Beijing Hospital\|Shanghai Tongji Hospital Tongji University School of Medicine\|First Affiliated Hospital of Wenzhou Medical University\|Xiangya Hospital of Central South University\|Peking University People''s Hospital\|Qilu Hospital of Shandong University\|Sun Yat-sen University\|First Affiliated Hospital Sun Yat-Sen University	2019-06-10	Phase 1\|Phase 2
NCT04577703	Completed	Advanced Solid Tumors	Sunshine Lake Pharma Co. Ltd.	2014-02-08	Phase 1
NCT02022501	Completed	Age-Related Macular Degeneration	Santen Inc.	2014-01	Phase 1\|Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ningetinib functions as a potent inhibitor of the receptor tyrosine kinases c-Met, VEGFR2, and Axl, effectively blocking autophosphorylation and downstream pro-survival signaling cascades. This molecular inhibition disrupts endothelial migration and tumor cell proliferation, offering therapeutic relevance in the treatment of advanced solid tumors and non-small cell lung cancer.

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>).