Uroxatral

(Alfuzosin)

ApprovedSmall molecule

Alfuzosin is used to treat urinary symptoms caused by an enlarged prostate gland in men, such as difficulty urinating and frequent urination.[2] Uroxatral is currently approved and in use across 13 indications[4].[1]

Uroxatral is one of 179 small molecule programs targeting Mydriasis. It is currently in Approved.

Indications

Total Trials

Active Trials

178

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

MydriasisActive, not recruiting

Neurogenic BladderApproved

ProstatitisApproved

Erectile DysfunctionActive, not recruiting

Chronic ProstatitisActive, not recruiting

Benign Prostatic HyperplasiaActive, not recruiting

Urinary RetentionActive, not recruiting

Lower Urinary Tract SymptomActive, not recruiting

Prostate DiseaseActive, not recruiting

Multiple SclerosisActive, not recruiting

MydriasisPhase 1

Active, not recruiting

Neurogenic BladderApproved

Approved

ProstatitisApproved

Approved

Erectile DysfunctionPreclinical

Active, not recruiting

Chronic ProstatitisPhase 3

Active, not recruiting

Benign Prostatic HyperplasiaApproved

Active, not recruiting

Urinary RetentionPhase 3

Active, not recruiting

Lower Urinary Tract SymptomApproved

Active, not recruiting

Prostate DiseasePreclinical

Active, not recruiting

Multiple SclerosisPhase 2

Active, not recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

560 competitors in Multiple Sclerosis

#DrugCompanyPhaseTrials

Uroxatral

AAdvanz Pharma

Approved

1 2

Tysabri

Biogen

Preclinical

14 3

Avonex

EMD Serono

Preclinical

22 4

Campath

GGenzyme, a Sanofi Company

Preclinical

12 5

Zinbryta

Roche

Preclinical

2 6

Flomax

Sanofi

Preclinical

1 7

Pred Forte

Myfortic

Circadin

NNeurim Pharmaceuticals Ltd.

Preclinical

3 10

Lunesta

Akero Therapeutics

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Benign Prostatic Hyperplasia6 trials

The Efficacy, Onset of Effect, and Safety of Alfuzosin Once Daily in the Treatment of Lower Urinary Tract Symptoms of Benign Prostatic Hyperplasia: A Randomized, Placebo-Controlled Trial Using an Acute International Prostate Score

Completed· Sanofi logo

Sanofi·Phase 3·NCT00540891·372 enrolled

Efficacy and Safety of SL77.0499-10 (Alfuzosin) Versus Placebo and Tamsulosin in Japanese Patients With Benign Prostatic Hyperplasia

Completed· Sanofi logo

Sanofi·Phase 3·NCT00399464·1,177 enrolled

Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

Completed· Sanofi logo

Sanofi·Phase 4·NCT00401661·110 enrolled

Show 3 more trials

Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia

Completed·FFondazione IRCCS Policlinico San Matteo di Pavia·N/A·NCT02977832·30 enrolled

SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

Completed· Sanofi logo

Sanofi·Phase 4·NCT00486785·431 enrolled

Benign Prostatic Hyperplasia in Taiwan

Completed· Sanofi logo

Sanofi·N/A·NCT00941343·362 enrolled

Lower Urinary Tract Symptom3 trials

Alfuzosin XL Lower Urinary Tract Symptoms Efficacy and Sexuality Study

Completed· Sanofi logo

Sanofi·Phase 4·NCT00575913·118 enrolled

The Long Term Effects of Alfuzosin(Xatral XL) in Lower Urinary Tract Symptoms(LUTS)/BPH Patients

Completed·—·Phase 4·NCT00696761·232 enrolled

An Efficacy Study to Evaluate Alfuzosin to Treat Men With Erectile Dysfunction and Mild Lower Urinary Tract Symptoms

Completed·CChesapeake Urology Research Associates·Phase 3·NCT00893113·74 enrolled

Urinary retention2 trials

Alfuzosin for Treating Acute Urinary Retention

Completed· Sanofi logo

Sanofi·Phase 2·NCT00336921·156 enrolled

Alfuzosin Versus Placebo in Acute Urinary Retention

Terminated· Sanofi logo

Sanofi·Phase 3·NCT00453908·160 enrolled

Adolescent2 trials

Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction

Completed· Sanofi logo

Sanofi·Phase 3·NCT00549939·172 enrolled

Pharmacokinetics and Safety Study With Alfuzosin in Children and Adolescents With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology

Completed· Sanofi logo

Sanofi·Phase 3·NCT00629720·29 enrolled

Treatment2 trials

Once Daily Given Alfuzosin in the Treatment of BPH

Completed· Sanofi logo

Sanofi·Phase 4·NCT00637715·60 enrolled

Use of Alfuzosin in Stone Treatment With ESWL

Withdrawn·SSingapore General Hospital·Phase 3·NCT00388271

14 more indications

Function1 trial

Effects of Alpha-1 Antagonist, Stress and Relaxation on Anorectal Functions

Completed·MMayo Clinic·Phase 2·NCT01834729·74 enrolled

Multiple Sclerosis1 trial

Alfuzosin for Voiding Dysfunction in Multiple Sclerosis (MS)

Terminated·NNova Scotia Health Authority·Phase 2/3·NCT00688948·20 enrolled

Randomized1 trial

ALFAURUS : A DB Randomized Parallel Group Study of Alfuzosin 10mg OD vs Placebo in the Management of AUR in Patients With a 1st Episode Due to BPH

Completed· Sanofi logo

Sanofi·Phase 3·NCT00290030·800 enrolled

Chronic Prostatitis1 trial

Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 3·NCT00103402·272 enrolled

Sexual Function1 trial

Male Sexual Health Questionnaire (MSHQ) - Sexual Function Study

Completed·HHandok Inc.·Phase 4·NCT00427882·125 enrolled

Hydronephrosis1 trial

Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology

Completed· Sanofi logo

Sanofi·Phase 3·NCT00576823·25 enrolled

Efficacy1 trial

The Efficacy of Alpha-blockers for Expulsion of Distal Ureteral Stones

Unknown status·SSoroka University Medical Center·Phase 4·NCT00451061·120 enrolled

Mydriasis1 trial

Study to Assess the Influence of Three Different α-antagonists and Placebo on the Extent of Weekly Phenylephrine-induced Mydriasis at Three Different Concentrations of Phenylephrine in Healthy Male Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02266537·97 enrolled

HIE1 trial

Evaluation of Symptom-specific Goal Achievement

Completed·SSamsung Medical Center·Phase 4·NCT00836823·130 enrolled

Hypertrophy1 trial

Multicenter Prospective Study on the Changes of Sexual Function Following Treatment With Alfuzosin (Xatral XL®) in Patients With Benign Prostate Hypertrophy

Completed· Sanofi logo

Sanofi·Phase 4·NCT00542165·166 enrolled

Erectile Dysfunction1 trial

Uroxatral in Men With Benign Prostate Hypertrophy (BPH) and Erectile Dysfunction (ED)

Completed·UUniversity Hospitals Cleveland Medical Center·N/A·NCT00256399·6 enrolled

Kidney Stones1 trial

A Randomized Study of Whether Alfuzosin(Xatral) Helps in the Passage of Kidney Stones

Withdrawn·UUnity Health Toronto·N/A·NCT00583258

Clinical Trial1 trial

Clinical Trial in Males With BPH (Enlarged Prostate)

Completed· Sanofi logo

Sanofi·Phase 3·NCT00029822·1,522 enrolled

Unspecified3 trials

Alfuzosin for Medical Expulsion Therapy of Ureteral Stones

Unknown status·UUnited States Naval Medical Center, San Diego·Phase 3·NCT00713739·240 enrolled

ALF-STONE: Alfuzosin in Uretheric Stones

Terminated· Sanofi logo

Sanofi·Phase 3·NCT00454402·220 enrolled

ALF-ONE : ALFuzosin ONcE Daily

Completed· Sanofi logo

Sanofi·Phase 4·NCT00280605·200 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 12, 2003

UROXATRAL

NDA NDA021287

Sources

References

[1]
ClinicalTrials.gov — 31 trial records for Alfuzosin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Uroxatral drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Alfuzosin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Alfuzosin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021287). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Advanz Pharma company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Adrenergic Receptor Alpha-1 Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AAdvanz Pharma

Uroxatral

Status by Indication[4][1]

Competitive Landscape

Trials by Indication[1]

Benign Prostatic Hyperplasia6 trials

Lower Urinary Tract Symptom3 trials

Urinary retention2 trials

Adolescent2 trials

Treatment2 trials

Function1 trial

Multiple Sclerosis1 trial

Randomized1 trial

Chronic Prostatitis1 trial

Sexual Function1 trial

Hydronephrosis1 trial

Efficacy1 trial

Mydriasis1 trial

HIE1 trial

Hypertrophy1 trial

Erectile Dysfunction1 trial

Kidney Stones1 trial

Clinical Trial1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Related News