Danusertib (PHA-739358) Clinical Trials

Size	Price	Qty
5mg	USD 170
50mg	USD 970

Clinical Trials

Several Phase II clinical trials have evaluated the therapeutic potential of Danusertib (PHA-739358) across hematologic malignancies and solid tumors, including leukemia, multiple myeloma, and metastatic hormone-refractory prostate cancer. Sponsored by organizations such as Nerviano Medical Sciences and the Jonsson Comprehensive Cancer Center, these studies aimed to assess efficacy across distinct patient cohorts. Recruitment statuses across these initiatives vary, encompassing completed, terminated, and unknown outcomes.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00766324	COMPLETED	Metastatic Hormone Refractory Prostate Cancer	Nerviano Medical Sciences	2007-09	PHASE2
NCT00335868	UNKNOWN	Leukemia	Jonsson Comprehensive Cancer Center	2007-03	PHASE2
NCT00872300	TERMINATED	Multiple Myeloma	Nerviano Medical Sciences	2008-10	PHASE2

(data from https://clinicaltrials.gov, updated on 2014-05-28)

Check the Danusertib (PHA-739358) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Danusertib functions as a potent small-molecule inhibitor that binds to Aurora kinases A, B, and C as well as Bcr-Abl, thereby disrupting downstream phosphorylation pathways critical for mitotic progression and oncogenic signaling. This target inhibition leads to cell cycle arrest, induction of apoptosis, and autophagy, providing the physiological basis for targeting tumor proliferation in clinical trial settings such as leukemia, multiple myeloma, and metastatic hormone-refractory prostate 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>).