TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

ZEGFROVY

SUNVOZERTINIB
Approved 2025-07-02
1
Indication
--
Phase 3 Trials
1
Priority Reviews
0
Years on Market

Details

Status
Prescription
First Approved
2025-07-02
Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: SUNVOZERTINIB

ZEGFROVY Approval History

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What ZEGFROVY Treats

1 FDA approvals

Originally approved for its first indication in 2025 .

  • 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.

ZEGFROVY FDA Label Details

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ZEGFROVY Patents & Exclusivity

Latest Patent: Jan 2039
Exclusivity: Jul 2030

Patents (12 active)

US11504375 Expires Jan 28, 2039
US11896597 Expires Jan 28, 2039
US11007198 Expires Jan 28, 2039
+ 2 more patents

Exclusivity

NCE Until Jul 2030
NCE Until Jul 2030
NCE Until Jul 2030
NCE Until Jul 2030
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.