AZD5153 6-hydroxy-2-naphthoic acid Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 490

Clinical Trials

A completed Phase 1 multicenter clinical trial sponsored by AstraZeneca evaluated the early-phase development of AZD5153. The investigation assessed the compound's tolerability, pharmacokinetics, and preliminary anti-tumor activity in patients with advanced malignancies, including solid tumors, lymphoma, ovarian, breast, pancreatic, and prostate cancers. These initial clinical efforts focused on establishing safety profiles and early therapeutic responses across multiple solid and hematologic cancer types.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03205176	Completed	Malignant Solid Tumors\|Lymphoma\|Ovarian Cancer\|Breast Cancer\|Pancreatic Cancer\|Prostate Cancer	AstraZeneca	2017-06-30	Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the AZD5153 6-hydroxy-2-naphthoic acid product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD5153 selectively binds to the BRD4 bromodomain with high affinity, thereby inhibiting the expression of downstream NSD3 target genes and disrupting H3K36me2-mediated epigenetic signaling required for oncogenic transcription. This blockade halts cancer cell proliferation and induces apoptosis, providing a therapeutic mechanism for suppressing tumor growth in clinical trial indications including solid tumors, lymphoma, ovarian, breast, pancreatic, and prostate 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>).