AZD4547 (Fexagratinib) Clinical Trials

Size	Price	Qty
5mg	USD 147
10mg	USD 197

Clinical Trials

Numerous clinical trials spanning Phase 1 to Phase 3 have evaluated AZD4547 (fexagratinib) as monotherapy or in combination with targeted and endocrine therapies to assess safety, pharmacokinetics, and clinical response. Sponsored by pharmaceutical companies and academic institutions, these studies range from active to completed status. Research has predominantly focused on advanced solid malignancies, including recurrent FGFR1-amplified non-small cell lung cancer, gastric and oesophageal carcinomas, ER-positive breast cancer, and IDH-wildtype gliomas with FGFR-TACC fusions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05775874	UNKNOWN	Urothelial Carcinoma	Abbisko Therapeutics Co, Ltd	2022-09-30	PHASE2
NCT02664935	COMPLETED	Non-Small Cell Lung Cancer; Carcinoma, Squamous Cell; Adenocarcinoma	University of Birmingham	2015-05-13	PHASE2
NCT05086666	UNKNOWN	Urothelial Carcinoma	Abbisko Therapeutics Co, Ltd	2021-06-03	PHASE1; PHASE2
NCT02299999	ACTIVE_NOT_RECRUITING	Metastatic Breast Cancer	UNICANCER	2014-04-07	PHASE2
NCT02546661	ACTIVE_NOT_RECRUITING	Muscle Invasive Bladder Cancer	AstraZeneca	2016-12-28	PHASE1
NCT04439240	COMPLETED	Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Plasma Cell Myeloma	National Cancer Institute (NCI)	2016-05-31	PHASE2
NCT02117167	COMPLETED	Non-small Cell Lung Cancer Metastatic	UNICANCER	2014-04-23	PHASE2
NCT02824133	COMPLETED	Recurrent IDHwt Gliomas With FGFR3-TACC3 Fusion; Recurrent IDHwt Gliomas With FGFR1-TACC1 Fusion	Assistance Publique - Hôpitaux de Paris	2015-09	PHASE1; PHASE2
NCT02965378	COMPLETED	FGFR1 Gene Amplification; FGFR1 Gene Mutation; FGFR2 Gene Amplification; FGFR2 Gene Mutation; FGFR3 Gene Amplification; FGFR3 Gene Mutation; Recurrent Squamous Cell Lung Carcinoma; Stage IV Squamous Cell Lung Carcinoma AJCC v7	SWOG Cancer Research Network	2014-10	PHASE2; PHASE3
NCT01791985	COMPLETED	Breast Cancer	Imperial College London	2012-07	PHASE1; PHASE2
NCT02824133	Completed	Recurrent IDHwt Gliomas With FGFR3-TACC3 Fusion\|Recurrent IDHwt Gliomas With FGFR1-TACC1 Fusion	Assistance Publique - Hôpitaux de Paris	2015-09	Phase 1\|Phase 2
NCT01202591	COMPLETED	FGFR Inhibition, Pharmacokinetics, Biomarkers; ER+ Breast Cancer	AstraZeneca	2010-12	PHASE1; PHASE2
NCT01795768	UNKNOWN	Gastric Cancer; Oesophageal Cancer; Breast Cancer; Squamous Cell Carcinoma of the Lung	Royal Marsden NHS Foundation Trust	2012-09	PHASE2
NCT01824901	COMPLETED	Recurrent Non-small Cell Lung Cancer; Squamous Cell Lung Cancer	ECOG-ACRIN Cancer Research Group	2014-01-15	PHASE1; PHASE2
NCT00979134	TERMINATED	Cancer; Advanced Solid Malignancies	AstraZeneca	2009-10-21	PHASE1
NCT01824901	Completed	Recurrent Non-small Cell Lung Cancer\|Squamous Cell Lung Cancer	ECOG-ACRIN Cancer Research Group\|National Cancer Institute (NCI)\|Eastern Cooperative Oncology Group	2014-01-15	Phase 1\|Phase 2
NCT01457846	TERMINATED	Gastro-oesophageal Junction Cancer; Gastric Cancer	AstraZeneca	2011-11	PHASE2
NCT01213160	COMPLETED	Cancer; Advanced Solid Malignancies	AstraZeneca	2010-11	PHASE1
NCT01795768	Unknown status	Gastric Cancer\|Oesophageal Cancer\|Breast Cancer\|Squamous Cell Carcinoma of the Lung	Royal Marsden NHS Foundation Trust\|AstraZeneca	2012-09	Phase 2
NCT01213160	Completed	Cancer\|Advanced Solid Malignancies	AstraZeneca	2010-11	Phase 1

(data from https://clinicaltrials.gov, updated on 2023-03-20)

Check the AZD4547 (Fexagratinib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AZD4547 selectively binds to and inhibits fibroblast growth factor receptors 1, 2, and 3 (FGFR1/2/3), blocking receptor autophosphorylation and suppressing downstream phosphorylation of FRS2, PLC, and MAPK signaling cascades. This pathway blockade inhibits cellular proliferation and induces apoptosis in FGFR-driven tumor cells, demonstrating clinical relevance for managing FGFR-altered advanced solid malignancies including non-small cell lung, gastric, breast, and brain 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>).