LY3295668 Clinical Trials

Size	Price	Qty
5mg	USD 499
25mg	USD 1,497

Clinical Trials

Multiple clinical trials sponsored by Eli Lilly and Company and M.D. Anderson Cancer Center have evaluated Phase 1 and Phase 2 protocols of LY3295668 across indications such as small cell lung cancer, non-small cell lung carcinoma, metastatic breast cancer, neuroblastoma, and solid tumors. Early monotherapy and combination studies in small cell lung cancer and metastatic breast cancer are completed. Furthermore, trials evaluating combination therapy in lung adenocarcinoma and pediatric neuroblastoma remain active but are no longer recruiting participants.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05017025	ACTIVE_NOT_RECRUITING	Advanced Lung Non-Squamous Non-Small Cell Carcinoma; Metastatic Lung Non-Squamous Non-Small Cell Carcinoma; Stage III Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIB Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8	M.D. Anderson Cancer Center	2022-02-17	PHASE1; PHASE2
NCT04106219	ACTIVE_NOT_RECRUITING	Neuroblastoma	Eli Lilly and Company	2020-06-11	PHASE1
NCT03898791	COMPLETED	Small Cell Lung Cancer	Eli Lilly and Company	2019-07-16	PHASE1
NCT03955939	COMPLETED	Metastatic Breast Cancer	Eli Lilly and Company	2019-08-02	PHASE1
NCT03092934	COMPLETED	Neoplasms; Neoplasm Metastasis; Triple Negative Breast Neoplasms; Head and Neck Neoplasms; Breast Neoplasms; Solid Tumor, Adult; Small Cell Lung Carcinoma	Eli Lilly and Company	2017-05-29	PHASE1; PHASE2
NCT03898791	Completed	Small Cell Lung Cancer	Eli Lilly and Company	2019-07-16	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-06-22)

Check the LY3295668 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LY3295668 potently and selectively binds to Aurora A kinase with an inhibition constant of 0.8 nM, thereby blocking target phosphorylation required for proper centrosome maturation, mitotic spindle assembly, and cell cycle progression. This mechanistic blockade induces spindle abnormalities, mitotic arrest, and selective apoptosis in rapidly proliferating malignant cells, providing the biological foundation for its clinical evaluation in Aurora A-driven malignancies such as small cell lung cancer and metastatic breast 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>).