AZD9496 Clinical Trials

Size	Price	Qty
2mg	USD 97
5mg	USD 167

Clinical Trials

Several completed Phase 1 clinical trials sponsored by AstraZeneca have evaluated the safety, pharmacokinetics, and pharmacodynamics of AZD9496 in patients with estrogen receptor-positive (ER+) and HER2-negative (HER2-) breast cancer. Conducted across both primary and advanced disease stages, these early-phase studies investigated dose escalation, tolerability, and formulation dynamics. Additionally, presurgical pharmacodynamic evaluations compared the biological effects of AZD9496 to established therapies such as fulvestrant in postmenopausal women.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03236974	COMPLETED	Postmenopausal Women With ER+ HER2- Primary Breast Cancer	AstraZeneca	2017-10-05	PHASE1
NCT03236974	Completed	Postmenopausal Women With ER+ HER2- Primary Breast Cancer	AstraZeneca	2017-10-05	Phase 1
NCT02248090	COMPLETED	ER+ HER2- Advanced Breast Cancer	AstraZeneca	2014-10-22	PHASE1
NCT02780713	COMPLETED	Breast Cancer	AstraZeneca	2016-06-02	PHASE1
NCT02248090	Completed	ER+ HER2- Advanced Breast Cancer	AstraZeneca	2014-10-22	Phase 1

(data from https://clinicaltrials.gov, updated on 2020-02-06)

Check the AZD9496 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD9496 is a selective, orally bioavailable estrogen receptor inhibitor that binds to estrogen receptor alpha, triggering receptor degradation and suppressing downstream estrogen-mediated transcriptional signaling. By inhibiting estrogen-driven cellular proliferation, this target degradation blocks the growth of ER-positive and ESR1-mutant tumor cells, demonstrating clinical relevance in the treatment of ER-positive HER2-negative primary and advanced breast 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>).