Clinical Trials

A clinical trial evaluating silodosin was a completed Phase 4 post-marketing study sponsored by the Recordati Group. Conducted in a European cohort, this study assessed the therapeutic effectiveness, safety, and real-world tolerability of the selective alpha-1A adrenoceptor antagonist in managing lower urinary tract symptoms associated with benign prostatic hyperplasia.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01757769 Completed
Benign Prostatic Hyperplasia
RECORDATI GROUP
 2011-05 Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Silodosin functions as a highly selective antagonist of the α1A-adrenoceptor, binding to receptors in human prostatic tissue to block G protein-coupled intracellular calcium mobilization. This inhibition relaxes smooth muscle tone in the prostate, bladder neck, and prostatic urethra, providing therapeutic relief for lower urinary tract symptoms associated with benign prostatic hyperplasia.

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>).

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Note: Technical data last updated: Sep 1, 2026.