Cardura

(doxazosin)

ApprovedSmall molecule

Doxazosin is used to treat high blood pressure and to relieve urinary symptoms caused by an enlarged prostate gland, such as difficulty urinating and frequent urination.[2] Cardura is currently approved and in use across 11 indications[4].[1]

Cardura is one of 298 small molecule programs targeting Adrenal Gland Pheochromocytoma. It is currently in Approved.

Indications

Total Trials

Active Trials

297

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Adrenal Gland PheochromocytomaApproved

Drug DependenceApproved

Erectile DysfunctionApproved

Nicotine DependenceApproved

ParagangliomaApproved

Benign Prostatic HyperplasiaApproved

Angina PectorisActive, not recruiting

HypertensionCompleted

Post-Traumatic Stress DisorderSuspended

Essential HypertensionCompleted

Adrenal Gland PheochromocytomaApproved

Approved

Drug DependenceApproved

Approved

Erectile DysfunctionApproved

Approved

Nicotine DependenceApproved

Approved

ParagangliomaApproved

Approved

Benign Prostatic HyperplasiaApproved

Approved

Angina PectorisPreclinical

Active, not recruiting

HypertensionApproved

Completed

Post-Traumatic Stress DisorderApproved

Suspended

Essential HypertensionApproved

Completed

Showing 10 of 11 indications

Competition

Competitive Landscape

171 competitors in Type 2 Diabetes

#DrugCompanyPhaseTrials

Cardura

VViatris Specialty LLC

Approved

1 2

NOVOLIN R

Novo Nordisk

Preclinical

5 3

Cysteine Hydrochloride

Novartis

Preclinical

1 4

Inspra

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 5

Pravachol

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

1 6

Aurlumyn

BBTG International Inc.

Preclinical

1 7

Inderal

WWyeth-Lederle Vaccines

Preclinical

1 8

Nexium

DDexcel Pharma Technologies Ltd.

Preclinical

1 9

SGLT-2 Inhibitor

SSheffield Teaching Hospitals NHS Foundation Trust

Preclinical

2 10

Sulfonylureas

Eli Lilly

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Alcohol Use Disorder (AUD)

NCT04135846

Clinical

Trials by Indication[1]

Hypertension5 trials

Black Education and Treatment of Hypertension (BEAT HTN)

Completed·—·Phase 4·NCT00661895·99 enrolled

Optimum Treatment for Drug-Resistant Hypertension

Unknown status·UUniversity of Cambridge·Phase 4·NCT02369081·348 enrolled

Treatment of Mild Hypertension Study (TOMHS)

Completed·UUniversity of Minnesota·Phase 2·NCT00000522

Show 2 more trials

Doxazosin and Ramipril in Hypertension

Completed·KKarolinska Institutet·Phase 4·NCT02901977·71 enrolled

Genetics of Hypertension Associated Treatments (GenHAT)

Completed·DDonna Arnett, 257-5678··NCT00006294·37,939 enrolled

Cocaine Dependence2 trials

Pharmacogenetics of Doxazosin for Cocaine Dependence

Completed·—·Phase 2·NCT01145183·96 enrolled

Complementary Combination Therapy for Cocaine Dependence

Completed·—·Phase 1·NCT02538744·45 enrolled

Angina Pectoris1 trial

Effects of Intensive Long-Term Vasodilation in Hypertensive Patients With Microvascular Angina Pectoris

Terminated·UUniversity of Aarhus·N/A·NCT00424801·10 enrolled

Alcoholism1 trial

Testing Doxazosin to Treat Stress Mechanisms in Alcoholism

Completed·UUniversity of Wisconsin, Madison·Phase 2·NCT02989493·61 enrolled

Type 2 Diabetes1 trial

Nephropathy In Type 2 Diabetes and Cardio-renal Events

Completed·UUniversity of Campania Luigi Vanvitelli·Phase 4·NCT00535925·850 enrolled

17 more indications

Alcohol Use Disorders1 trial

CAP: Doxazosin in the Treatment of Co-Occurring PTSD and Alcohol Use Disorders

Completed·VVA Office of Research and Development·Phase 2·NCT02500602·144 enrolled

Essential Hypertension1 trial

Effects of Combination Therapy With Alpha-1 Blocker (Bunazosin or Doxazosin) in the Treatment of Patients With Mild to Moderate Essential Hypertension

Completed· Eisai logo

Eisai·Phase 4·NCT00130156·93 enrolled

Cocaine Abuse1 trial

Pharmacogenetic Trial of Doxazosin for Treatment of Cocaine Abuse

Completed·VVA Office of Research and Development·Phase 2·NCT01953432·43 enrolled

PTSD1 trial

DOXAZOSIN FOR PTSD

Completed·—·Phase 1·NCT02308202·30 enrolled

Post-Traumatic Stress Disorder1 trial

Treating Nightmares in Posttraumatic Stress Disorder With Clonidine and Doxazosin

Suspended·—·Phase 2·NCT05360953·53 enrolled

Pheochromocytoma1 trial

Preoperative Alpha Blockade for Pheochromocytoma

Completed·UUniversity of California, Los Angeles·Phase 3·NCT03176693·39 enrolled

Blood Pressure Variability1 trial

The Effects of Doxazosin and Nifedipine on Blood Pressure Variability and Uric Acid in Plasma in Hypertensive Patients

Unknown status·FFirst Affiliated Hospital of Harbin Medical University·Phase 2/3·NCT02563405·30 enrolled

Methamphetamine1 trial

Pharmacological Interaction Between Doxazosin and Methylenedioxymethamphetamine (MDMA)

Completed·UUniversity Hospital, Basel, Switzerland·Phase 1·NCT01386177·16 enrolled

Benign Prostatic Hyperplasia1 trial

Effects of Chronic Use of Doxazosin in Men With Benign Prostatic Hyperplasia

Completed·SSamsung Medical Center·N/A·NCT00730418·25 enrolled

Efficacy1 trial

The Efficacy of Doxazosin for Cocaine Users

Completed·—·Phase 1·NCT00880997·35 enrolled

Cardiovascular1 trial

The Effects of Doxazosin on the Cardiovascular and Subjective Effects of Cocaine

Completed·—·Phase 1·NCT01062945·13 enrolled

Methamphetamine Dependence1 trial

DOX as a Potential Treatment for Methamphetamine Dependence

Completed·—·Phase 1·NCT02785393·11 enrolled

Heart Attack1 trial

Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 3·NCT00000542

Alcohol Dependence1 trial

Doxazosin an a1 Antagonist for Alcohol Dependence

Completed·—·Phase 1·NCT01437046·41 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

Alcohol Use Disorder (AUD)1 trial

A Focus on Alpha-1 Blockade as a Novel Pharmacological Treatment for AUD

Active, not recruiting·BBrown University·Phase 2·NCT04135846·184 enrolled

Unspecified5 trials

Alfuzosin for Medical Expulsion Therapy of Ureteral Stones

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

Phenoxybenzamine Versus Doxazosin in PCC Patients

Completed·UUniversity Medical Center Groningen·Phase 4·NCT01379898·134 enrolled

Medical Therapy of Prostatic Symptoms

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 3·NCT00021814·3,407 enrolled

Show 2 more trials

Doxazosin for Psychostimulant Dependence

Completed·UUniversity of Arkansas·Phase 1/2·NCT01371851·22 enrolled

Japan Morning Surge-1 Study

Completed·JJapan Heart Foundation·Phase 4·NCT00285519·600 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 2, 1990

CARDURA

NDA NDA019668

Feb 22, 2005

CARDURA XL

NDA NDA021269

Sources

References

[1]
ClinicalTrials.gov — 31 trial records for doxazosin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Cardura drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — doxazosin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for doxazosin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021269). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Viatris Specialty LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Adrenergic Receptor Alpha-1 Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: VViatris Specialty LLC

Cardura

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Hypertension5 trials

Cocaine Dependence2 trials

Angina Pectoris1 trial

Alcoholism1 trial

Type 2 Diabetes1 trial

Alcohol Use Disorders1 trial

Essential Hypertension1 trial

Cocaine Abuse1 trial

PTSD1 trial

Post-Traumatic Stress Disorder1 trial

Pheochromocytoma1 trial

Blood Pressure Variability1 trial

Methamphetamine1 trial

Benign Prostatic Hyperplasia1 trial

Efficacy1 trial

Cardiovascular1 trial

Methamphetamine Dependence1 trial

Heart Attack1 trial

Alcohol Dependence1 trial

Mydriasis1 trial

Alcohol Use Disorder (AUD)1 trial

Unspecified5 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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