Overview
Benign prostatic hyperplasia (BPH) refers to a benign growth or hyperplasia of the prostate and leads to lower urinary tract symptoms in men, such as urgency, frequency and changes to urine flow. The prevalence of BPH is as high as 50%-60% for males in their 60's, and this prevalence increases to 80%-90% of those over 70. Alfuzosin is an alpha-1 adrenergic blocker used in the symptomatic treatment of BPH that works by relaxing the muscles in the prostate and bladder neck. It was initially approved by the FDA in 2003 and is marketed by several pharmaceutical companies.
Background
Benign prostatic hyperplasia (BPH) refers to a benign growth or hyperplasia of the prostate and leads to lower urinary tract symptoms in men, such as urgency, frequency and changes to urine flow. The prevalence of BPH is as high as 50%-60% for males in their 60's, and this prevalence increases to 80%-90% of those over 70. Alfuzosin is an alpha-1 adrenergic blocker used in the symptomatic treatment of BPH that works by relaxing the muscles in the prostate and bladder neck. It was initially approved by the FDA in 2003 and is marketed by several pharmaceutical companies.
Indication
Alfuzosin is used to treat the signs and symptoms of benign prostatic hyperplasia (BPH).
Associated Conditions
- Benign Prostatic Hyperplasia (BPH)
Clinical Trials
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2007/10/10 | Phase 4 | Completed | |||
2007/10/08 | Phase 3 | Completed | |||
2007/06/15 | Phase 4 | Completed | |||
2007/04/30 | Phase 3 | Completed | |||
2007/03/30 | Phase 3 | Terminated | |||
2007/03/29 | Phase 3 | Terminated | |||
2007/03/22 | Phase 4 | UNKNOWN | |||
2007/01/29 | Phase 4 | Completed | |||
2006/11/20 | Phase 4 | Completed | |||
2006/11/14 | Phase 3 | Completed |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aphena Pharma Solutions - Tennessee, LLC | 43353-746 | ORAL | 10 mg in 1 1 | 7/25/2017 | |
| Unichem Pharmaceuticals (USA), Inc. | 29300-155 | ORAL | 10 mg in 1 1 | 3/25/2022 | |
| Wockhardt Limited | 55648-738 | ORAL | 10 mg in 1 1 | 7/20/2012 | |
| Bryant Ranch Prepack | 63629-9295 | ORAL | 10 mg in 1 1 | 12/18/2020 | |
| Stat Rx USA | 16590-279 | ORAL | 10 mg in 1 1 | 10/27/2009 | |
| Camber Pharmaceuticals | 31722-302 | ORAL | 10 mg in 1 1 | 1/18/2012 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-945 | ORAL | 10 mg in 1 1 | 5/22/2014 | |
| Apotex Corp. | 60505-2850 | ORAL | 10 mg in 1 1 | 9/8/2023 | |
| Sun Pharmaceutical Industries, Inc. | 47335-956 | ORAL | 10 mg in 1 1 | 1/19/2024 |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||