TheraRadar
Data updated: May 26, 2026

GIAZO (balsalazide disodium)

Immunology Approved 2012-02-03
1
Indication
--
Phase 3 Trials
14
Years on Market

Details

Status
Discontinued
First Approved
2012-02-03
Patent Cliff
2031

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Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: BALSALAZIDE DISODIUM

GIAZO Approval History

2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2012 to 2021
Nov 2021 SUPPL
Label · Labeling
Oct 2020 SUPPL
Label · Labeling
Jan 2020 SUPPL
Label · Labeling

What GIAZO Treats

1 FDA approvals

Originally approved for its first indication in 2012 .

  • Other (1)
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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

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.

GIAZO FDA Label Details

View full patent landscape →
4 OB patents · 2 families · 23 international docs across 9 countries

GIAZO Patents & Exclusivity

Latest Patent: Jun 2031

Patents (4 active)

US8497256 Expires Jun 23, 2031
US7452872 Expires Aug 24, 2026
US7625884 Expires Aug 24, 2026
US9192616 Expires Aug 2, 2026
Source: FDA Orange Book

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Revenue Insights

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Patent Timeline

  • Cliff: 2031
  • 4 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

Competitive Landscape

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  • Same target/indication analysis
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Data Sources

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