ASP-9521 Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

A clinical trial evaluated the therapeutic potential of ASP-9521 in a Phase 1/2, multi-center, open-label study sponsored by Astellas Pharma Inc. Designed to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity in patients with castrate-resistant prostate cancer, the study's recruitment status was ultimately recorded as terminated. Overall, these data reflect early-phase clinical development by an industry sponsor targeting advanced prostate malignancy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01352208	TERMINATED	Castrate Resistant Prostate Cancer	Astellas Pharma Inc	2011-03	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2014-03-24)

Check the ASP-9521 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ASP-9521 acts as a selective inhibitor of 17beta-hydroxysteroid dehydrogenase type 5 (17β-HSD5/AKR1C3), binding to the enzyme and blocking the conversion of weak androgens into potent androgenic metabolites to suppress downstream androgen receptor activation. This disruption of intratumoral hormone biosynthesis inhibits androgen-dependent cellular proliferation, demonstrating direct therapeutic relevance for the treatment of castrate-resistant 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>).