TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

TRUSELTIQ

INFIGRATINIB PHOSPHATE
Approved 2021-05-28
1
Indication
--
Phase 3 Trials
1
Priority Reviews
4
Years on Market

Details

Status
Discontinued
First Approved
2021-05-28
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Active Ingredient: INFIGRATINIB PHOSPHATE

TRUSELTIQ Approval History

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What TRUSELTIQ Treats

1 FDA approvals

Originally approved for its first indication in 2021 .

  • 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.

TRUSELTIQ FDA Label Details

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TRUSELTIQ Patents & Exclusivity

Latest Patent: Dec 2034
Exclusivity: May 2028

Patents (16 active)

US10278969 Expires Dec 11, 2034
US11160804 Expires Dec 11, 2034
US8552002 Expires Aug 25, 2029
US9067896 Expires Aug 6, 2028
+ 6 more patents

Exclusivity

NCE Until May 2026
ODE-353 Until May 2028
NCE Until May 2026
ODE-353 Until May 2028
NCE Until May 2026
Source: FDA Orange Book

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Data Sources

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