Clinical Trials

Numerous clinical trials spanning Phase I to Phase III evaluate zibotentan (ZD4054) across indications including prostate cancer, advanced solid malignancies, non-small cell lung cancer, chronic kidney disease, scleroderma, and liver cirrhosis, alongside pharmacokinetic studies in healthy volunteers. Sponsored by pharmaceutical entities such as AstraZeneca and academic institutions including University College London, these studies encompass completed, active not recruiting, and terminated statuses. Notably, several Phase II trials explore therapeutic outcomes and imaging responses in metastatic prostate cancer, scleroderma, and chronic kidney disease.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06087835 ACTIVE_NOT_RECRUITING
Chronic Kidney Disease With High Proteinuria
AstraZeneca
 2023-11-07 PHASE3
NCT06942910 ACTIVE_NOT_RECRUITING
Chronic Kidney Disease With High Proteinuria
AstraZeneca
 2025-05-07 PHASE2
NCT07404137 COMPLETED
Healthy Participants
AstraZeneca
 2026-02-16 PHASE1
NCT05516498 TERMINATED
Liver Cirrhosis
AstraZeneca
 2022-10-31 PHASE2
NCT05570305 COMPLETED
Chronic Kidney Diseases
University Medical Center Groningen
 2022-10-06 PHASE2
NCT06715670 COMPLETED
Liver Cirrhosis
AstraZeneca
 2024-12-05 PHASE1
NCT06269484 COMPLETED
Liver Cirrhosis
AstraZeneca
 2024-02-15 PHASE2
NCT04097314 COMPLETED
Microvascular Angina
NHS Greater Glasgow and Clyde
 2019-10-18 PHASE2
NCT04724837 COMPLETED
Chronic Kidney Disease
AstraZeneca
 2021-04-28 PHASE2
NCT05505162 COMPLETED
Healthy Female Participants
AstraZeneca
 2022-08-24 PHASE1
NCT05112419 COMPLETED
Hepatic Impairment; Renal Impairment
AstraZeneca
 2021-11-10 PHASE1
NCT04991571 COMPLETED
Chronic Kidney Disease
AstraZeneca
 2021-07-29 PHASE1
NCT02047708 COMPLETED
Scleroderma; Scleroderma Renal Crisis; Chronic Kidney Disease
University College, London
 2014-10 PHASE2
NCT01890135 COMPLETED
Peripheral Arterial Disease; Intermittent Claudication
University of Virginia
 2013-06 PHASE2
NCT01134497 WITHDRAWN
Metastatic Breast Cancer
Cardiff University
 PHASE2
NCT01119118 TERMINATED
Prostate Cancer
University of Wisconsin, Madison
 2010-04 PHASE2
NCT01205711 COMPLETED
Colorectal Cancer
Cardiff University
 2010-04 PHASE2
NCT01000948 TERMINATED
Prostate Cancer; Metastasis
Aarhus University Hospital
 2009-10 PHASE2
NCT00929162 TERMINATED
Patients With Advanced Ovarian Cancer Sensitive to Platinum-based Chemotherapy
AstraZeneca
 2009-06 PHASE2
NCT00617669 COMPLETED
Prostate Cancer
AstraZeneca
 2008-01 PHASE3
NCT00626548 TERMINATED
Prostate Cancer
AstraZeneca
 2008-01 PHASE3
NCT00997945 COMPLETED
Advanced Solid Malignancies
AstraZeneca
 2009-10 PHASE1
NCT01168141 UNKNOWN
Prostate Cancer; Metastasis
The Christie NHS Foundation Trust
 2009-07
NCT00554229 COMPLETED
Prostate Cancer
AstraZeneca
 2007-11 PHASE3
NCT01119118 Terminated
Prostate Cancer
University of Wisconsin Madison|AstraZeneca
 2010-04 Phase 2
NCT00745875 COMPLETED
Non Small Cell Lung Cancer; Lung Cancer
AstraZeneca
 2008-08 PHASE2
NCT01000948 Terminated
Prostate Cancer|Metastasis
Aarhus University Hospital|Rigshospitalet Denmark
 2009-10 Phase 2
NCT00997945 Completed
Advanced Solid Malignancies
AstraZeneca
 2009-10 Phase 1
NCT00090363 COMPLETED
Prostate Cancer
AstraZeneca
 2004-07 PHASE2
NCT00709553 COMPLETED
Healthy
AstraZeneca
 2008-07 PHASE1
NCT00710047 COMPLETED
Healthy Volunteers
AstraZeneca
 2008-06 PHASE1
NCT00713791 Completed
Healthy
AstraZeneca
 2008-06 Phase 1
NCT00314782 COMPLETED
Prostate Cancer
AstraZeneca
 2006-03 PHASE1
NCT00055471 COMPLETED
Prostatic Neoplasms; Metastases, Neoplasm
AstraZeneca
 2003-06 PHASE2
NCT00672581 COMPLETED
Hepatic Impairment
AstraZeneca
 2008-04 PHASE1
NCT00713791 COMPLETED
Healthy
AstraZeneca
 2008-06 PHASE1
NCT00713336 COMPLETED
Healthy
AstraZeneca
 2008-06 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-19)

Check the Zibotentan (ZD4054) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zibotentan selectively binds to the endothelin A (ETA) receptor with high affinity, effectively blocking endothelin-1-mediated downstream signaling cascades responsible for cellular proliferation and survival. By suppressing these ETA-driven pathways, the compound inhibits tumor growth and attenuates pathological vascular changes, establishing its therapeutic relevance in clinical trials for prostate cancer and chronic kidney disease.

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>).

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