Clinical Trials

Multiple clinical trials across Phase 1, Phase 3, and Phase 4 evaluate the clinical application and pharmacokinetic profile of alfuzosin in benign prostatic hyperplasia, prostatic hyperplasia accompanied by acute urinary retention, acute renal colic, and healthy volunteers. Sponsored by entities including Sanofi, Pharma Nueva, and Centre Hospitalier Universitaire de Nîmes, these studies report recruitment statuses ranging from completed to withdrawn and not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06316336 Not yet recruiting
Healthy Vollunteer
Pharma Nueva
 2024-06-10 Phase 1
NCT01685658 Withdrawn
Renal Colic|Acute Renal Colic
Centre Hospitalier Universitaire de Nīmes
 2016-09 Phase 4
NCT00637715 Completed
Benign Prostatic Hyperplasia
Sanofi
 2003-10 Phase 4
NCT00290030 Completed
Prostatic Hyperplasia|Acute Urinary Retention
Sanofi
 2001-05 Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Alfuzosin functions as a selective and competitive antagonist of α1-adrenoceptors, binding to these receptors in lower urinary tract smooth muscle to inhibit receptor-mediated intracellular calcium mobilization. This blockade induces smooth muscle relaxation in the prostate and bladder neck, thereby reducing urethral resistance and relieving symptoms in conditions such as benign prostatic hyperplasia and acute urinary retention.

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.