Hydroxyflutamide (Hydroxyniphtholide) Clinical Trials

Size	Price	Qty
5mg	USD 79

Clinical Trials

Multiple completed Phase II clinical trials have evaluated intraprostatic depot formulations of hydroxyflutamide, such as Liproca Depot, in patients with prostate cancer. Sponsored by Lidds AB in collaboration with Uppsala University and CMX Research, these fully recruited studies assessed safety, tolerability, dose-finding, and local antitumor efficacy. Together, these clinical investigations demonstrate the potential of controlled-release hydroxyflutamide as a localized therapeutic intervention.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03348527	Completed	Prostate Cancer	Lidds AB\|CMX Research	2017-05-12	Phase 2
NCT02341404	Completed	Prostate Cancer	Lidds AB\|Uppsala University	2012-05	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Hydroxyflutamide functions as an androgen receptor antagonist with an IC50 of 0.7 μM, competitively binding to the receptor to prevent androgen-mediated gene transcription and downstream biochemical signaling. This receptor blockade disrupts androgen-dependent survival pathways and suppresses tumor cell proliferation, thereby demonstrating therapeutic relevance against 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>).