Irosustat (BN83495) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 417

Clinical Trials

Multiple clinical trials in Phase 1 and Phase 2 have evaluated Irosustat across hormone-dependent malignancies, including breast, endometrial, and prostate cancers. Conducted by pharmaceutical sponsors such as Ipsen alongside academic institutions like Imperial College London, these completed or terminated studies investigated preoperative biological effects, combination regimens with aromatase inhibitors, and comparative efficacy against megestrol acetate. Ultimately, these studies provided essential safety and pharmacodynamic data regarding steroid sulfatase inhibition.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01785992	COMPLETED	Locally Advanced Breast Cancer; Metastatic Breast Cancer	Imperial College London	2012-10	PHASE2
NCT01662726	TERMINATED	Breast Neoplasms	Imperial College London	2012-08	PHASE2
NCT01662726	Terminated	Breast Neoplasms	Imperial College London\|National Institute for Health Research United Kingdom\|Ipsen\|Imperial College Healthcare NHS Trust\|Guy''s and St Thomas'' NHS Foundation Trust\|University of Southern California\|QPS Netherlands B.V.	2012-08	Phase 2
NCT00910091	COMPLETED	Endometrial Cancer	Ipsen	2009-08	PHASE2
NCT01251354	TERMINATED	Endometrial Cancer	Ipsen	2010-11	PHASE2
NCT01230970	TERMINATED	Breast Cancer	Ipsen	2011-05	PHASE2
NCT00790374	COMPLETED	Prostate Cancer	Ipsen	2009-01	PHASE1
NCT01840488	COMPLETED	Breast Cancer	Ipsen	2007-04	PHASE1
NCT00910091	Completed	Endometrial Cancer	Ipsen	2009-08	Phase 2

(data from https://clinicaltrials.gov, updated on 2015-03-24)

Check the Irosustat (BN83495) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Irosustat is an orally active, nonsteroidal coumarin sulfamate that irreversibly inhibits steroid sulfatase with an IC50 of 8 nM, thereby blocking the hydrolysis of inactive steroid sulfates into active estrogens and androgen precursors. This enzymatic blockade suppresses local hormone production and inhibits cellular proliferation, offering therapeutic relevance for hormone-dependent malignancies such as breast, endometrial, and prostate 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>).