Drugs / Alfuzosin
Alfuzosin
also known as
XATRAL · SL77.0499-10 · SL770499 · alfuzosin hydrochloride · Uroxatral · Xatral XL · Alfetim Uno · Alfutral sr · +14 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | UROXATRAL | — | 2010-12-15 | fda.gov ↗ |
| Approved | US (FDA) | UROXATRAL | — | 2003-06-12 | fda.gov ↗ |
Trials 34
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02266537 | Nov 2005 → Feb 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 23 trials · 1 missed | ||||||
| Phase 2 | NCT01834729 | Mar 2013 → Sep 2017 | constipation disorder | Mayo Clinic | Completed | Missed primary |
| Phase 2 | NCT00679315 | Jun 2008 → Mar 2009 | urinary bladder disorder | Samsung Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00409357 | Nov 2004 → Aug 2005 | benign prostatic hyperplasia | Sanofi | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00688948 | Nov 2007 → Nov 2009 | multiple sclerosis, urinary bladder disorder | Nova Scotia Health Authority | Terminated | No outcome recorded Stop: Business |
| Phase 315 trials · 3 missed | ||||||
| Phase 3 | NCT00893113 | Jun 2009 → Oct 2012 | erectile dysfunction | Chesapeake Urology Research Associates | Completed | No outcome recorded |
| Phase 3 | NCT00713739 | Jan 2008 → Dec 2010 | urolithiasis | United States Naval Medical Center, San Diego | Unknown | No outcome recorded |
| Phase 3 | NCT00576823 | Dec 2007 → Jan 2009 | hydronephrosis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00549939 | Oct 2007 → Mar 2009 | urinary bladder disorder | Sanofi | Completed | Missed primary |
| Phase 3 | NCT00399464 | Nov 2006 → Oct 2007 | benign prostatic hyperplasia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00454402 | Aug 2006 → Jul 2007 | prostate disorder | Sanofi | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00629720 | Jul 2006 → Feb 2007 | urinary bladder disorder | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00467467 | Jun 2006 → Oct 2007 | — | University of Minnesota | Completed | No outcome recorded |
| Phase 3 | NCT00347061 | May 2006 → Oct 2007 | benign prostatic hyperplasia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00201630 | Sep 2005 | prostate cancer | New York Prostate Institute | Unknown | No outcome recorded |
| Phase 3 | NCT00103402 | Feb 2005 → Jan 2008 | chronic prostatitis | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | Missed primary |
| Phase 3 | NCT00453908 | May 2004 → ? | urinary tract obstruction | Sanofi | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00540891 | Feb 2003 → Oct 2004 | benign prostatic hyperplasia | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00029822 | May 2001 → Mar 2005 | benign prostatic hyperplasia, urinary tract obstruction | Sanofi | Completed | Missed primary |
| Phase 3 | NCT00290030 | May 2001 → Oct 2004 | benign prostatic hyperplasia, urinary tract obstruction | Sanofi | Completed | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT03144596 | Oct 2015 → Feb 2016 | benign prostatic hyperplasia, optic choroid disorder, pupil disorder | Kocatepe University | Completed | No outcome recorded |
| Phase 4 | NCT00451061 | Apr 2007 → ? | urinary tract obstruction | Soroka University Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT00427882 | Sep 2006 → May 2007 | benign prostatic hyperplasia | Handok Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00401661 | Jun 2006 → Dec 2007 | benign prostatic hyperplasia | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00486785 | Apr 2006 → Oct 2007 | benign prostatic hyperplasia | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00836823 | Dec 2005 → Aug 2008 | benign prostatic hyperplasia | Samsung Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00280605 | Aug 2005 → Feb 2006 | benign prostatic hyperplasia | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00542165 | Mar → Dec 2004 | benign prostatic hyperplasia | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00637715 | Oct 2003 → Dec 2004 | benign prostatic hyperplasia | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00575913 | Sep 2003 → Mar 2005 | prostate disorder | Sanofi | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT00583258 | Oct 2007 → Sep 2009 | urolithiasis | Unity Health Toronto | Withdrawn | No outcome recorded |
| — | NCT00941343 | Sep 2006 → Sep 2008 | prostate disorder | Sanofi | Completed | No outcome recorded |
| — | NCT00256399 | Nov 2005 → May 2007 | benign prostatic hyperplasia, erectile dysfunction | University Hospitals Cleveland Medical Center | Completed | No outcome recorded |
| — | NCT00563654 | Oct 2005 → Nov 2006 | benign prostatic hyperplasia, urinary tract obstruction | Hospital Authority, Hong Kong | Terminated | No outcome recorded |
| Comparator or background therapy8 trials | ||||||
| Phase 2 | NCT00409227 Comparator | Dec 2006 → Jul 2009 | nephrolithiasis, ureterolithiasis | Assaf-Harofeh Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT00336921 Comparator | Feb 2006 → Apr 2007 | urinary tract obstruction | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00388271 Comparator | Oct 2006 → Dec 2007 | urolithiasis | Singapore General Hospital | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT00064649 Comparator | Apr 2004 → Jun 2006 | benign prostatic hyperplasia | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00687388 Comparator | May 2008 → Mar 2012 | benign prostatic hyperplasia | Samsung Medical Center | Withdrawn | No outcome recorded |
| Phase 4 | NCT00696761 Comparator | May 2006 → Jul 2008 | benign prostatic hyperplasia | Asan Medical Center | Completed | No outcome recorded |
| — | NCT05094947 Background | Aug 2021 → Mar 2022 | benign prostatic hyperplasia | Moscow State University of Medicine and Dentistry | Unknown | No outcome recorded |
| — | NCT02977832 Background | Jan 2015 → Jul 2016 | benign prostatic hyperplasia | Fondazione IRCCS Policlinico San Matteo di Pavia | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2012-08-14 | Wockhardt | Regulatory WOCKHARDT TO LAUNCH GENERIC VERSION OF BPH DRUG UROXATRAL® wockhardt.com ↗
Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 10mg extended release tablets of Alfuzosin hydrochloride, which is used in treatment of Benign Prostatic Hyperplasia or enlarged prostate. |
| 2011-07-19 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma announces USFDA approval for generic Uroxatral® ER tablets Company gets 180 day marketing exclusivity on first-to-file ANDA with para IV certification sunpharma.com ↗
Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Uroxatral ® ER, alfuzosin hydrochloride extended release tablets. |
| 2009-10-01 | Wockhardt | Regulatory Wockhardt receives US FDA approval for Prostate drug Alfuzosin tablets wockhardt.com ↗ |
| 2009-05-07 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma announces USFDA tentative approval for generic Uroxatral® extended release tablets. sunpharma.com ↗
Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted its subsidiary a tentative approval for its Abbreviated New Drug Application (ANDA) for generic Uroxatral Extended Release ® tablets. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2012-08-14 | Wockhardt | WOCKHARDT TO LAUNCH GENERIC VERSION OF BPH DRUG UROXATRAL® wockhardt.com ↗ |
| 2011-07-19 | Sun Pharmaceutical Industries, Inc. | Sun Pharma announces USFDA approval for generic Uroxatral® ER tablets Company gets 180 day marketing exclusivity on first-to-file ANDA with para IV certification sunpharma.com ↗ |
| 2009-10-01 | Wockhardt | Wockhardt receives US FDA approval for Prostate drug Alfuzosin tablets wockhardt.com ↗ |
| 2009-05-07 | Sun Pharmaceutical Industries, Inc. | Sun Pharma announces USFDA tentative approval for generic Uroxatral® extended release tablets. sunpharma.com ↗ |
Evidence & citations 26 cited values
Every value below carries the sentence it was read from. 43 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Alfuzosin | “Continued medication that the patient had before the enrollment of this study (tamsulosin 0.2mg, alfuzosin 10mg, doxazosin 4, 8mg, or terazosin 2-10mg daily for 8 weeks)” NCT00687388 ↗41“Alfuzosin hydrochloride was approved by the FDA for treatment of the signs and symptoms of BPH in 2003.” NCT00201630 ↗ “Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH” NCT00347061 ↗ “tamsulosin, alfuzosin, doxazosin, silodosin” NCT05094947 ↗ |
| Known as | Alfetim Uno | “10 mg Alfuzosin (Alfetim Uno®) o. d. in Patients Presenting Low-Urinary Tract Symptoms” NCT00637715 ↗ |
| Known as | Alfutral sr | ChEMBL registry synonym — accepted as the source's own label CHEMBL709 ↗ |
| Known as | Alfuzosin hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL709 ↗ |
| Known as | alfuzosin hydrochloride | “Alfuzosin hydrochloride 10 mg tablet by mouth, every 24 hours for 3 months” NCT03144596 ↗1“SL77.0499-10 (alfuzosin hydrochloride)” NCT00409357 ↗ |
| Known as | Alfuzosina | ChEMBL registry synonym — accepted as the source's own label CHEMBL709 ↗ |
| Known as | Alfuzosine | ChEMBL registry synonym — accepted as the source's own label CHEMBL709 ↗ |
| Known as | Benestan | ChEMBL registry synonym — accepted as the source's own label CHEMBL709 ↗ |
| Known as | Benestan ret | ChEMBL registry synonym — accepted as the source's own label CHEMBL709 ↗ |
| Known as | Besavar xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL709 ↗ |
| Known as | Fuzatal xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL709 ↗ |
| Known as | Kelanu xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL709 ↗ |
| Known as | NSC-760065 | ChEMBL registry synonym — accepted as the source's own label CHEMBL709 ↗ |
| Known as | SL 77 499-10 | ChEMBL registry synonym — accepted as the source's own label CHEMBL709 ↗ |
| Known as | SL77.0499-10 | “Efficacy and Safety of SL77.0499-10 (Alfuzosin) Versus Placebo and Tamsulosin in Japanese Patients With Benign Prostatic Hyperplasia” NCT00399464 ↗2“Long Term Safety of SL77.0499-10 (Alfuzosin) in Patients With BPH” NCT00347061 ↗ “SL77.0499-10 (alfuzosin hydrochloride)” NCT00409357 ↗ |
| Known as | SL770499 | “Alfuzosin (XATRAL® - SL770499)” NCT00941343 ↗ |
| Known as | Urion s | ChEMBL registry synonym — accepted as the source's own label CHEMBL709 ↗ |
| Known as | Uroxatral | “The purpose of this randomized clinical trial is to evaluate the efficacy and safety of the alpha adrenergic blocker Alfuzosin (Uroxatral) in men with relatively new onset of...” NCT00103402 ↗1“Uroxatral (alfuzosin) may not only help BPH symptoms but may also improve sexual function in males with BPH and ED.” NCT00256399 ↗ |
| Known as | Vasran xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL709 ↗ |
| Known as | XATRAL | “Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL 10mg OD), Open, 24-week Study.” NCT00401661 ↗3“Alfuzosin (XATRAL® - SL770499)” NCT00941343 ↗ “Alfuzosin (Xatral)” NCT00388271 ↗ “Alfuzosin (Xatral)” NCT00583258 ↗ |
| Known as | Xatral sr | ChEMBL registry synonym — accepted as the source's own label CHEMBL709 ↗ |
| Known as | Xatral XL | “Alfuzosin GITS (Xatral XL)” NCT00563654 ↗1“Alfuzosin(Xatral XL)” NCT00696761 ↗ |
| Known as | Zufal xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL709 ↗ |
| Action | Inhibit | “α1-selective blocking agent” NCT00696761 ↗ |
| Modality | Small molecule | — CHEMBL709 ↗ |
| Route | Oral | “with oral alfuzosin 10mg ON for 1 month” NCT00388271 ↗ |