Last reviewed · How we verify
ALFUZOSIN HYDROCHLORIDE
Alfuzosin blocks post-synaptic alpha 1-adrenoreceptors in the prostate and bladder areas to relax smooth muscle.
Alfuzosin Hydrochloride is a marketed drug used primarily for the treatment of Benign Prostatic Hyperplasia by blocking post-synaptic alpha 1-adrenoreceptors in the prostate and bladder areas to relax smooth muscle. Its key strength lies in its well-established mechanism of action and current market presence, supported by a key composition patent expiring in 2028. The primary risk is the potential increase in competition as the patent approaches expiration.
At a glance
| Generic name | ALFUZOSIN HYDROCHLORIDE |
|---|---|
| Target | alpha 1-adrenoreceptors |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2003 |
Mechanism of action
Alfuzosin works by blocking specific receptors called alpha 1-adrenoreceptors, which are found in the prostate and bladder. By doing so, it helps relax the smooth muscles in these areas, making it easier to urinate.
Approved indications
- Benign Prostatic Hyperplasia
Common side effects
- Dizziness
- Upper respiratory tract infection
- Headache
- Fatigue
Drug interactions
- alpha adrenergic antagonists (including alfuzosin hydrochloride extended-release tablets)
- potent CYP3A4 inhibitors (such as ketoconazole, itraconazole, or ritonavir)
- other alpha adrenergic antagonists
- antihypertensive medication and nitrates
Key clinical trials
- Alfuzosin and Mirabegron for Double-J Stent Symptoms
- Multiple Dose, Bioequivalence Study of Generic Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets Under Fed Conditions (PHASE1)
- The Bioequivalence Study of Alfuzosin 10 mg Prolong-released Tablets Under Fed Conditions (PHASE1)
- Evaluation of Symptom-specific Goal Achievement (PHASE4)
- Uroxatral in Men With Benign Prostate Hypertrophy (BPH) and Erectile Dysfunction (ED) (NA)
- Intermittent Catheterization Versus Trial Without Catheter (NA)
- The Long Term Effects of Alfuzosin(Xatral XL) in Lower Urinary Tract Symptoms(LUTS)/BPH Patients (PHASE4)
- Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ALFUZOSIN HYDROCHLORIDE CI brief — competitive landscape report
- ALFUZOSIN HYDROCHLORIDE updates RSS · CI watch RSS