Prexasertib (LY2606368) Dihydrochloride Clinical Trials

Size	Price	Qty
2mg	USD 147
5mg	USD 267

Clinical Trials

Multiple clinical trials evaluate prexasertib across Phase 1, combined Phase 1/2, and Phase 2 studies for indications including ovarian, small cell lung, and breast cancers, pediatric brain tumors like medulloblastoma, and advanced solid tumors. These studies are sponsored by industry partners such as Eli Lilly and Company, academic centers including Dana-Farber Cancer Institute and Memorial Sloan Kettering Cancer Center, and government organizations like the National Cancer Institute. The overall research portfolio includes completed studies, active non-recruiting protocols, and terminated trials.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04023669	COMPLETED	Brain Tumor; Brain Tumor, Recurrent; Brain Tumor, Refractory; Brain Tumor, Pediatric; Medulloblastoma; Medulloblastoma Recurrent; Medulloblastoma, Non-WNT/Non-SHH; Medulloblastoma, Non-WNT/Non-SHH, Group 3; Medulloblastoma, Non-WNT/Non-SHH, Group 4; Brain Cancer; CNS Cancer; CNS Tumor; CNS Neoplasm	St. Jude Children's Research Hospital	2019-08-08	PHASE1
NCT02649764	COMPLETED	Chronic Myelomonocytic Leukemia; Recurrent Acute Myeloid Leukemia; Recurrent High Risk Myelodysplastic Syndrome; Refractory Acute Myeloid Leukemia; Refractory High Risk Myelodysplastic Syndrome	M.D. Anderson Cancer Center	2016-05-04	PHASE1
NCT02203513	TERMINATED	Ovarian Cancer; Breast Cancer; Prostate Cancer	National Cancer Institute (NCI)	2015-01-20	PHASE2
NCT03495323	COMPLETED	Cancer	Dana-Farber Cancer Institute	2018-05-16	PHASE1
NCT02873975	COMPLETED	Advanced Cancers	Dana-Farber Cancer Institute	2016-10-12	PHASE2
NCT03057145	COMPLETED	Solid Tumor	Geoffrey Shapiro, MD, PhD	2017-03-10	PHASE1
NCT02124148	COMPLETED	Neoplasm Metastasis; Colorectal Neoplasms; Breast Cancer	Eli Lilly and Company	2014-06-18	PHASE1
NCT02808650	COMPLETED	Childhood Solid Neoplasm; Recurrent Malignant Solid Neoplasm; Recurrent Primary Central Nervous System Neoplasm; Refractory Malignant Solid Neoplasm; Refractory Primary Central Nervous System Neoplasm	Children's Oncology Group	2017-02-27	PHASE1
NCT04095221	Active not recruiting	Desmoplastic Small Round Cell Tumor\|Rhabdomyosarcoma	Memorial Sloan Kettering Cancer Center	2019-09-17	Phase 1\|Phase 2
NCT02555644	COMPLETED	Head and Neck Neoplasms	Eli Lilly and Company	2016-02-24	PHASE1
NCT03495323	Completed	Cancer	Dana-Farber Cancer Institute\|Eli Lilly and Company	2018-05-16	Phase 1
NCT03414047	Completed	Ovarian Cancer	Eli Lilly and Company	2018-04-10	Phase 2
NCT02735980	COMPLETED	Small Cell Lung Cancer	Eli Lilly and Company	2016-05-11	PHASE2
NCT02860780	COMPLETED	Advanced Cancer; Metastatic Cancer; Colorectal Cancer; Non-small Cell Lung Cancer	Eli Lilly and Company	2016-08-10	PHASE1
NCT02778126	COMPLETED	Advanced Cancer	Eli Lilly and Company	2016-09-22	PHASE1
NCT02514603	COMPLETED	Neoplasm	Eli Lilly and Company	2015-10	PHASE1
NCT03057145	Completed	Solid Tumor	Geoffrey Shapiro MD PhD\|Eli Lilly and Company\|AstraZeneca\|Dana-Farber Cancer Institute	2017-03-10	Phase 1
NCT01115790	COMPLETED	Advanced Cancer; Squamous Cell Carcinoma; Carcinoma, Squamous Cell of Head and Neck; Lung Squamous Cell Carcinoma Stage IV; Anal Squamous Cell Carcinoma; Carcinoma, Non-Small-Cell Lung	Eli Lilly and Company	2010-02	PHASE1

(data from https://clinicaltrials.gov, updated on 2025-02-07)

Check the Prexasertib (LY2606368) Dihydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Prexasertib functions as an ATP-competitive inhibitor of checkpoint kinase 1 (CHK1), blocking its phosphorylation activity and disrupting the DNA damage repair pathway. Unresolved DNA replication stress induces premature mitotic entry and subsequent apoptosis, thereby suppressing tumor cell proliferation in clinical indications such as ovarian cancer, small cell lung cancer, and 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>).