Imaradenant (AZD4635) Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Several Phase I and Phase II clinical trials evaluate the therapeutic potential of imaradenant (AZD4635) in novel combination regimens for advanced oncological indications, specifically metastatic castration-resistant prostate cancer and advanced non-small-cell lung carcinoma. Sponsored by pharmaceutical entities including AstraZeneca, Parexel, and MedImmune LLC, these studies range in status from completed to active, not recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04495179	Completed	Progressive Metastatic Castrate-Resistant Prostate Cancer	AstraZeneca\|Parexel	2020-08-04	Phase 2
NCT04089553	Completed	Prostate Cancer\|Metastatic Castration-Resistant Prostate Cancer (mCRPC)	AstraZeneca	2019-08-29	Phase 2
NCT03381274	Active not recruiting	Carcinoma Non-Small-Cell Lung	MedImmune LLC	2018-05-08	Phase 1\|Phase 2

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

Check the Imaradenant (AZD4635) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Imaradenant selectively binds to the human adenosine A2A receptor with high affinity, blocking adenosine-mediated cyclic AMP signaling and downstream immunosuppressive cascades. By reversing adenosine-driven immune suppression, the drug restores functional T-cell activation within the tumor microenvironment to inhibit tumor growth in clinical settings including metastatic castration-resistant prostate cancer and non-small-cell lung 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>).