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.
Indication
Alfuzosin is used to treat the signs and symptoms of benign prostatic hyperplasia (BPH).
Associated Conditions
- Benign Prostatic Hyperplasia (BPH)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/03/18 | Phase 1 | Not yet recruiting | Pharma Nueva | ||
2024/01/29 | Phase 1 | Not yet recruiting | International Bio service | ||
2017/05/09 | Phase 4 | Completed | Kocatepe University | ||
2016/11/30 | Not Applicable | Completed | Fondazione IRCCS Policlinico San Matteo di Pavia | ||
2014/10/17 | Phase 1 | Completed | |||
2013/04/18 | Phase 2 | Completed | |||
2009/07/17 | Not Applicable | Completed | |||
2009/05/05 | Phase 3 | Completed | Chesapeake Urology Research Associates | ||
2009/02/04 | Phase 4 | Completed | |||
2008/07/11 | Phase 3 | UNKNOWN | United States Naval Medical Center, San Diego |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aidarex Pharmaceuticals LLC | 33261-994 | ORAL | 10 mg in 1 1 | 11/14/2013 | |
| Bryant Ranch Prepack | 63629-2354 | ORAL | 10 mg in 1 1 | 3/3/2023 | |
| Concordia Pharmaceuticals Inc. | 59212-200 | ORAL | 10 mg in 1 1 | 1/31/2019 | |
| Bryant Ranch Prepack | 71335-2146 | ORAL | 10 mg in 1 1 | 4/14/2023 | |
| Northwind Pharmaceuticals, LLC | 51655-432 | ORAL | 10 mg in 1 1 | 1/23/2023 | |
| Liberty Pharmaceuticals, Inc. | 0440-5000 | ORAL | 10 mg in 1 1 | 8/9/2016 | |
| Bryant Ranch Prepack | 63629-7907 | ORAL | 10 mg in 1 1 | 5/6/2022 | |
| Northwind Pharmaceuticals, LLC | 51655-967 | ORAL | 10 mg in 1 1 | 7/5/2023 | |
| Bryant Ranch Prepack | 63629-2353 | ORAL | 10 mg in 1 1 | 2/9/2023 | |
| Rising Pharma Holdings, Inc. | 57237-114 | ORAL | 10 mg in 1 1 | 1/6/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| APO-ALFUZOSIN PROLONGED RELEASE TABLET 10mg | SIN15512P | TABLET, EXTENDED RELEASE | 10mg | 7/19/2018 | |
| Alfuzosin PH&T 10mg prolonged-release tablets | SIN13819P | TABLET, EXTENDED RELEASE | 10.000 mg | 6/21/2010 | |
| RANFUZOSIN MODIFIED RELEASE TABLETS 10MG | SIN13984P | TABLET, EXTENDED RELEASE | 10mg | 7/5/2011 | |
| XATRAL XL TABLET 10 mg | SIN11579P | TABLET | 10 mg | 7/5/2001 | |
| XATRAL SR TABLET 5 mg | SIN09546P | TABLET, EXTENDED RELEASE | 5 mg | 11/21/1997 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Alfuzosin Hydrochloride Prolonged Release Tablets | 国药准字HJ20170036 | 化学药品 | 片剂 | 4/11/2023 | |
| Alfuzosin Hydrochloride Prolonged Release Tablets | 国药准字H20064331 | 化学药品 | 片剂 | 5/20/2020 | |
| Alfuzosin Hydrochloride Prolonged Release Tablets | 国药准字HJ20170035 | 化学药品 | 片剂 | 4/11/2023 | |
| Alfuzosin Hydrochloride Tablets | 国药准字H20030066 | 化学药品 | 片剂 | 2/6/2020 | |
| Alfuzosin Hydrochloride Tablets | 国药准字H20041339 | 化学药品 | 片剂 | 3/27/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| XALTRIN PROLONGED-RELEASE TABLETS 10MG | N/A | N/A | N/A | 10/30/2021 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| XATRAL SR alfuzosin 10mg (as hydrochloride) tablet blister pack | 81900 | Medicine | A | 9/17/2002 |
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