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alfuzosin

Trade name: uroxatral

Small moleculeapproved

Approved

Jun 12, 2003

Alfuzosin is a quinazoline-derivative alpha-adrenergic blocking agent used to treat hypertension and benign prostatic hyperplasia. Alfuzosin is marketed in the United States by Sanofi Aventis under the brand name Uroxatral. UROXATRAL (alfuzosin HCl extended-release tablets) is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia. UROXATRAL is not indicated for the treatment of hypertension. Alfuzosin is a non-subtype specific alpha(1)-adrenergic blocking agent that exhibits selectivity for alpha(1)-adrenergic receptors in the lower urinary tract. Inhibition of these adrenoreceptors leads to the relaxation of smooth muscle in the bladder neck and prostate, resulting in the improvement in urine flow and a reduction in symptoms in benign prostate hyperplasia. Alfuzosin also inhibits the vasoconstrictor effect of circulating and locally released catecholamines (epinephrine and norepinephrine), resulting in peripheral vasodilation. — NCATS

Clinical trial activity

45 trials · 33 clinical orgs · 15 marketing orgs

Phase 1
5
Phase 2
22
Phase 3
18
Phase 4
13

Earliest trial started May 1, 2001 (NCT00290030)

Timeline

2000s

  1. Jan 1, 2001

    Earliest Phase 3 Sponsor(trial)

  2. Jun 12, 2003

    Sanofi-Synthelabo — Earliest FDA Approval

  3. Jun 12, 2003

    Sanofi-Synthelabo — NDA Organization

  4. Jun 12, 2003

    Advanz Pharma — NDA Secondary Org

  5. Jun 12, 2003

    Advanz Pharma — Marketing Organization

  6. Jan 1, 2004

    Earliest Phase 2 Sponsor(trial)

  7. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

2010s

  1. Jul 18, 2011

    Apotex — Marketing Organization

  2. Jul 18, 2011

    Mylan — Marketing Organization

  3. Jul 18, 2011

    Sun Pharmaceuticals — Marketing Organization

  4. Jul 18, 2011

    Teva — Marketing Organization

  5. Jul 18, 2011

    Torrent Pharmaceuticals Limited — Marketing Organization

  6. Jul 18, 2011

    Heritage Pharma — Marketing Organization

  7. Jul 18, 2011

    Chartwell Pharmaceuticals — Marketing Organization

  8. Jul 18, 2011

    PHARMOBEDIENT — Marketing Organization

  9. Jan 17, 2012

    Invagen Pharms — Marketing Organization

  10. Aug 10, 2012

    Atlantide Pharmaceuticals — Marketing Organization

  11. Aug 10, 2012

    Wockhardt — Marketing Organization

  12. Aug 30, 2012

    Aurobindo Pharma — Marketing Organization

  13. Jan 28, 2016

    Unichem — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJun 12, 2003

Chemistry & pharmacology

Loading structure…

SMILES

COc1cc2nc(N(C)CCCNC(=O)C3CCCO3)nc(N)c2cc1OC
Mol. weight
389.46 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • afuzosin
  • alfetim
  • alfusozine
  • alfutral sr
  • alfuzocine
  • alfuzosin
  • alfuzosin
  • alfuzosin
  • alfuzosin
  • alfuzosin
  • alfuzosin
  • alfuzosin
  • alfuzosin
  • alfuzosin
  • alfuzosin
  • alfuzosina
  • alfuzosina
  • alfuzosine
  • alfuzosine
  • alfuzosin hcl
  • alfuzosin hcl
  • alfuzosin hcl
  • alfuzosin hydrochloride
  • alfuzosin hydrochloride
  • alfuzosin hydrochloride
  • alfuzosin hydrochloride
  • alfuzosin hydrochloride
  • alfuzosin hydrochloride
  • alfuzosinum
  • alfuzosinum
  • alphuzosine
  • benestan
  • benestan
  • benestan
  • benestan ret
  • besavar xl
  • fuzatal xl
  • kelanu xl
  • (±)-n-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl)methylamino]propyl]tetrahydro-2-furamide
  • (±)-n-[3-[(4-amino-6,7-dimethoxy-2-quinazolinyl)methylamino]propyl]tetrahydro-2-furamide
  • n-(3-((4-amino-6,7-dimethoxy-2-quinazolinyl)methylamino)propyl)tetrahydro-2-furancarboxamide
  • n-[3-[(4-amino-6,7-dimethoxy-quinazolin-2-yl)- methyl-amino]propyl] tetrahydrofuran- 2-carboxamide
  • n-[3-[(4-amino-6,7-dimethoxy-quinazolin-2-yl)- methyl-amino]propyl] tetrahydrofuran- 2-carboxamide
  • sl 77
  • sl-7749910
  • sl-7749910
  • sl-77499-10
  • sl-77499-10
  • urion
  • urion s
  • urotraxal
  • uroxatral
  • uroxatral
  • uroxatral
  • uroxatral
  • vasran xl
  • xatral
  • xatral
  • xatral
  • xatral
  • xatral sr
  • xatral sr
  • zufal xl

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06316336Phase 1Jun 10, 2024Mahidol University, Pharma Nueva
NCT06228339Phase 1Mar 9, 2024Mahidol University
NCT03144596Phase 4Oct 29, 2015Afyon Kocatepe University, Kocatepe University
NCT01834729Phase 2Mar 1, 2013Mayo Clinic
NCT01418586Phase 1Aug 15, 2011Torrent Pharmaceuticals Limited
NCT01418599Phase 1Aug 15, 2011Torrent Pharmaceuticals Limited
NCT00893113Phase 3Jun 1, 2009Chesapeake Urology Research Associates, Sanofi
NCT00679315Phase 2Jun 1, 2008Handok Pharmaceuticals Co., Ltd., Sungkyunkwan University, The Korean Urological Association
NCT00687388Phase 4May 1, 2008Sungkyunkwan University, The Korean Urological Association
NCT00713739Phase 3Jan 1, 2008United States Navy
NCT00576823Phase 3Dec 1, 2007Sanofi
NCT00688948Phase 2/Phase 3 (Phase 3)Nov 1, 2007Government of Canada, Sanofi, University of Adelaide
NCT00583258N/AOct 1, 2007Sanofi, University of Toronto
NCT00549939Phase 3Oct 1, 2007Sanofi
NCT00489112Phase 4Jun 19, 2007Emek Medical Center, Technion University
NCT00451061Phase 4Apr 1, 2007Ben Gurion University, Technion University
NCT00409227Phase 2Dec 1, 2006Hebrew University, Tel Aviv University
NCT00399464Phase 3Nov 1, 2006Sanofi
NCT00388271Phase 3Oct 1, 2006Sanofi, Singapore General Hospital
NCT00427882Phase 4Sep 1, 2006Handok Pharmaceuticals Co., Ltd.
Showing 20 of 45 trials
Page 1 / 3

Organizations

Research & Development (33)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
SanofiFor profit251942001
Sungkyunkwan UniversityAcademic/Hospital3322005
Handok Pharmaceuticals Co., Ltd.For profit2122006
Mahidol UniversityAcademic/Hospital2112024
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government2212004
Technion UniversityAcademic/Hospital2012007
The Korean Urological AssociationAcademic/Hospital2022008
Torrent Pharmaceuticals LimitedFor profit2212011
Afyon Kocatepe UniversityAcademic/Hospital1012015
Ben Gurion UniversityAcademic/Hospital1112007
Boehringer IngelheimFor profit1112005
Case Western Reserve UniversityAcademic/Hospital1112005
Chesapeake Urology Research AssociatesAcademic/Hospital1112009
Emek Medical CenterAcademic/Hospital1112007
Government of CanadaGovernment1112007
Government of Hong KongGovernment1112005
Hebrew UniversityAcademic/Hospital1012006
Kocatepe UniversityAcademic/Hospital1112015
Mayo ClinicAcademic/Hospital1112013
MedtronicFor profit1012004
33 organizations
Page 1 / 2

Marketing (21)

OrganizationOrg typeRelationshipDate
Advanz PharmaFor profitNDA2Jun 12, 2003
Advanz PharmaFor profitMKTGJun 12, 2003
Advanz PharmaFor profitSYNJun 12, 2003
ApotexFor profitMKTGJul 18, 2011
Atlantide PharmaceuticalsFor profitMKTGAug 10, 2012
Aurobindo PharmaFor profitMKTGAug 30, 2012
Chartwell PharmaceuticalsFor profitMKTGJul 18, 2011
Heritage PharmaFor profitMKTGJul 18, 2011
Invagen PharmsFor profitMKTGJan 17, 2012
MylanFor profitMKTGJul 18, 2011
PHARMOBEDIENTFor profitMKTGJul 18, 2011
Sanofi-SynthelaboFor profitNDAJun 12, 2003
Sun PharmaceuticalsFor profitMKTGJul 18, 2011
Sun PharmaceuticalsFor profitSYNJul 18, 2011
TevaFor profitMKTGJul 18, 2011
Torrent Pharmaceuticals LimitedFor profitMKTGJul 18, 2011
UnichemFor profitMKTGJan 28, 2016
UnichemFor profitSYNJan 28, 2016
WockhardtFor profitMKTGAug 10, 2012
WockhardtFor profitSYNAug 10, 2012
WockhardtFor profitSYNAug 10, 2012