Clinical Trials

Numerous early-phase clinical trials, encompassing Phase 1, Phase 2, and combined Phase 1/2 studies, have evaluated the CXCR2 antagonist AZD5069 across respiratory inflammatory diseases and oncology indications. These investigations evaluated the compound in chronic obstructive pulmonary disease, persistent asthma, bronchiectasis, metastatic castration-resistant prostate cancer, and advanced solid tumors, including head and neck squamous cell carcinoma. Sponsored by pharmaceutical entities and research institutions, these completed and terminated studies reflect a clinical development strategy aimed at dampening pathological immune responses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03177187 TERMINATED
Metastatic Castration Resistant Prostate Cancer
Institute of Cancer Research, United Kingdom
2017-11-13 PHASE1; PHASE2
NCT02499328 COMPLETED
Advanced Solid Tumors & Metastatic Squamous Cell Carcinoma of the Head and Neck
AstraZeneca
2015-08-06 PHASE1; PHASE2
NCT02583477 COMPLETED
Metastatic Pancreatic Ductal Adenocarcinoma
AstraZeneca
2016-03-25 PHASE1; PHASE2
NCT03177187 Terminated
Metastatic Castration Resistant Prostate Cancer
Institute of Cancer Research United Kingdom|Astellas Pharma Inc|AstraZeneca|Prostate Cancer UK
2017-11-13 Phase 1|Phase 2
NCT01704495 COMPLETED
Asthma
AstraZeneca
2012-11 PHASE2
NCT01890148 COMPLETED
Asthma
AstraZeneca
2014-03 PHASE1
NCT01962935 COMPLETED
Chronic Obstructive Pulmonary Disease (COPD).
AstraZeneca
2013-11 PHASE1
NCT01989520 COMPLETED
Uncontrolled and Persistent Asthma
AstraZeneca
2014-01 PHASE1
NCT01962935 Completed
Chronic Obstructive Pulmonary Disease (COPD).
AstraZeneca
2013-11 Phase 1
NCT01735240 COMPLETED
Asthma,; Pharmacokinetics,; Cmax,; Tmax,; λz,; AUC,; Ketoconazole,; Metabolite
AstraZeneca
2012-12 PHASE1
NCT01735240 Completed
Asthma|Pharmacokinetics|Cmax|Tmax|λz|AUC|Ketoconazole|Metabolite
AstraZeneca
2012-12 Phase 1
NCT01480739 COMPLETED
Chemokine Receptor 2 (CXCR2) Antagonist
AstraZeneca
2011-12 PHASE1
NCT01255592 COMPLETED
Bronchiectasis; Lung Disease; Respiratory Diseases
AstraZeneca
2011-02 PHASE2
NCT01332903 COMPLETED
Healthy
AstraZeneca
2011-05 PHASE1
NCT01233232 COMPLETED
Scientific Terminology Chronic Obstructive Pulmonary Disease (COPD); Laymen Terminology Chronic Bronchitis and Emphysema
AstraZeneca
2010-11 PHASE2
NCT01100047 COMPLETED
Healthy
AstraZeneca
2010-05 PHASE1
NCT01083238 COMPLETED
Chronic Obstructive Pulmonary Disease
AstraZeneca
2010-02 PHASE1
NCT01051505 COMPLETED
Healthy
AstraZeneca
2010-01 PHASE1
NCT00953888 COMPLETED
Healthy
AstraZeneca
2009-07 PHASE1

(data from https://clinicaltrials.gov, updated on 2024-09-26)

Check the AZD5069 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD5069 acts as a potent small-molecule antagonist of the chemokine receptor CXCR2, potently inhibiting CXCL8 binding and suppressing downstream intracellular signaling cascades essential for neutrophil activation and migration. By disrupting CXCR2-mediated cell recruitment and proinflammatory pathways, this targeted inhibition reduces pathological tissue inflammation and alters the tumor microenvironment in clinical conditions such as chronic obstructive pulmonary disease, asthma, and metastatic 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>).

Note: Technical data last updated: Sep 1, 2026.