TheraRadar
Data updated: May 26, 2026

DOXAZOSIN MESYLATE

Cardiovascular Approved 2000-10-18

Doxazosin mesylate treats high blood pressure and helps patients manage the symptoms of benign prostatic hyperplasia (BPH). By lowering blood pressure, it helps reduce the risk of serious cardiovascular events like strokes and heart attacks. For men with BPH, this medication addresses issues such as frequent nighttime urination, weak urine flow, and incomplete bladder emptying.

Source: FDA Label • ZYDUS PHARMS

How DOXAZOSIN MESYLATE Works

This medication works by selectively blocking alpha 1 adrenergic receptors, which are found in high concentrations in the prostate and blood vessels. In the prostate and bladder neck, this blockade relaxes smooth muscle tone to reduce urethral resistance and improve urine flow. For blood pressure management, the drug decreases systemic vascular resistance to help lower overall pressure.

11
Indications
--
Phase 3 Trials
25
Years on Market

DOXAZOSIN MESYLATE Approval History

2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
336 FDA actions from 2000 to 2024
Oct 2024 SUPPL
Label · Labeling
Sep 2024 SUPPL
Label · Labeling
Jun 2024 SUPPL
Label · Labeling

What DOXAZOSIN MESYLATE Treats

2 indications

DOXAZOSIN MESYLATE is approved for 2 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Benign Prostatic Hyperplasia
  • Hypertension
Source: FDA Label

DOXAZOSIN MESYLATE Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to DOXAZOSIN MESYLATE

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CARDURA
DOXAZOSIN MESYLATE
2 shared
Viatris
ACEBUTOLOL HYDROCHLORIDE
ACEBUTOLOL HYDROCHLORIDE
1 shared
PHARMOBEDIENT
Shared indications:
ALDACTONE
SPIRONOLACTONE
1 shared
Pfizer
Shared indications:
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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

DOXAZOSIN MESYLATE FDA Label Details

Indications & Usage

FDA Label (PDF)

DOXAZOSIN MESYLATE is indicated for the treatment of Benign Prostatic Hyperplasia; Hypertension.

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CARDURA XL

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.