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Uroxatral (ALFUZOSIN)
Alfuzosin blocks post-synaptic alpha 1-adrenoreceptors in the prostate and bladder areas to relax smooth muscle.
Uroxatral (alfuzosin) is an alpha-1B adrenergic receptor antagonist, a small molecule drug classed as an alpha-adrenergic blocker. It was originally developed by Covis Pharma SARL and is now owned by Advanz Pharma. Uroxatral is FDA-approved for the treatment of benign prostatic hyperplasia (BPH) since 2003. The drug is off-patent, with multiple generic manufacturers available. Key safety considerations include potential dizziness and orthostatic hypotension.
At a glance
| Generic name | ALFUZOSIN |
|---|---|
| Sponsor | Advanz |
| Drug class | alpha-Adrenergic Blocker |
| Target | alpha 1-adrenoreceptors |
| Modality | Small molecule |
| Therapeutic area | Urology |
| Phase | FDA-approved |
| First approval | 2003 |
Mechanism of action
Alfuzosin works by blocking specific receptors called alpha 1-adrenoreceptors that are found in the prostate and bladder regions. By doing so, it helps to relax the smooth muscles in these areas, which can improve urinary flow and reduce symptoms associated with conditions like benign prostatic hyperplasia.
Approved indications
- Benign prostatic hyperplasia
Common side effects
- Dizziness
- Upper respiratory tract infection
- Headache
- Fatigue
- Hypotension or postural hypotension
- Syncope
- Decreased diastolic blood pressure
- Decreased systolic blood pressure
- Positive orthostatic test
- Edema
- Tachycardia
- Chest pain
Drug interactions
- High Risk QT Prolonging Agents
- amiodarone
- amprenavir
- aprepitant
- clarithromycin
- diltiazem
- erythromycin
- fosamprenavir
- indinavir
- itraconazole
- lopinavir
- nefazodone
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:
- Uroxatral CI brief — competitive landscape report
- Uroxatral updates RSS · CI watch RSS
- Advanz portfolio CI