TheraRadar
Data updated: May 26, 2026

TEZRULY (terazosin hydrochloride)

Urology Approved 2024-07-29
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Years on Market

Details

Status
Discontinued
First Approved
2024-07-29
Patent Cliff
2041

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Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
SOLUTION

Companies

NOVITIUM PHARMA
Active Ingredient: TERAZOSIN HYDROCHLORIDE

TEZRULY Approval History

2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2024 to 2024
Jul 2024 ORIGINAL
New Form · Type 3 - New Dosage Form
FDA Letter Label

What TEZRULY Treats

1 FDA approvals

Originally approved for its first indication in 2024 .

  • Other (1)
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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT04760860 TZ-DLB 202101470 Ph 1, Ph 2 not yet recruiting Terazosin for Dementia With Lewy Bodies
NCT07288450 TAME-PD TAMEPD Ph 1, Ph 2 not yet recruiting Terazosin And Metabolic Engagement in Parkinson's Disease
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Active Pipeline

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Ongoing clinical trials by development phase

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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

ClinicalTrials.gov ↗ Pro

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.

TEZRULY FDA Label Details

View full patent landscape →
2 OB patents · 1 families · 4 international docs across 1 countries

TEZRULY Patents & Exclusivity

Latest Patent: Feb 2041

Patents (2 active)

US12427108 Expires Feb 1, 2041
US11224572 Expires Feb 1, 2041
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2041
  • • 4 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA218139 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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