AZD9574 (Palacaparib) Clinical Trials

Size	Price	Qty
5mg	USD 490
25mg	USD 1,470

Clinical Trials

Several clinical trials sponsored by AstraZeneca are actively recruiting participants to evaluate AZD9574 across Phase I and Phase II studies for advanced oncological indications. These evaluations assess the safety, pharmacokinetics, and preliminary efficacy of the drug in patients with advanced solid malignancies, including metastatic prostate, breast, biliary tract, ovarian, endometrial, and squamous non-small cell lung cancers. Overall, these ongoing efforts aim to establish the therapeutic potential of this selective agent across diverse solid tumor types.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07590934	RECRUITING	Metastatic Prostate Cancer	AstraZeneca	2026-06-03	PHASE1; PHASE2
NCT07181161	RECRUITING	Metastatic Prostate Cancer	AstraZeneca	2025-10-01	PHASE1; PHASE2
NCT05417594	RECRUITING	Advanced Solid Malignancies	AstraZeneca	2022-06-24	PHASE1; PHASE2
NCT05123482	RECRUITING	Breast Cancer; Biliary Tract Carcinoma; Ovarian Cancer; Endometrial Cancer; Squamous Non-Small Cell Lung Cancer	AstraZeneca	2021-10-18	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-27)

Check the AZD9574 (Palacaparib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD9574 selectively binds to and traps poly(ADP-ribose) polymerase 1 (PARP1) on single-strand DNA breaks, thereby blocking DNA repair machinery and inducing replication fork collapse that leads to lethal accumulation of double-strand DNA damage in tumor cells. This target-directed DNA trapping and high central nervous system penetration provide the mechanistic basis for its clinical investigation to inhibit tumor progression in advanced solid malignancies, including metastatic prostate, breast, and ovarian cancers.

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>).