AZD8421 Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

A clinical trial sponsored by AstraZeneca is currently recruiting patients to evaluate the therapeutic potential of AZD8421 in advanced malignancies. This first-in-human, open-label Phase 1/2 study is designed to assess the safety profile, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of the drug. The target population includes individuals diagnosed with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+ HER2-) advanced breast cancer or high-grade serous ovarian cancer.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06188520	RECRUITING	ER+ HER2- Advanced Breast Cancer; High-grade Serous Ovarian Cancer (HGSOC)	AstraZeneca	2023-12-05	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-06)

Check the AZD8421 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD8421 selectively binds to and inhibits Cyclin-dependent Kinase 2 (CDK2) with an IC50 of 9 nM, thereby blocking downstream retinoblastoma protein phosphorylation and arresting cell cycle progression. This anti-proliferative cellular effect suppresses tumor cell growth, offering therapeutic relevance in clinical settings such as estrogen receptor-positive, HER2-negative advanced breast cancer and high-grade serous ovarian 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>).