TheraRadar
Data updated: Nov 8, 2026

ATEBRIOZ (zilurgisertib fumarate) · MIRUM

Approved 2026-09-25
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
0
Years on Market

Details

Status
Prescription
First Approved
2026-09-25
Routes
ORAL
Dosage Forms
TABLET

Companies

MIRUM
Active Ingredient: ZILURGISERTIB FUMARATE

ATEBRIOZ Approval History

Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
Sep 2026 ORIGINAL Priority
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What ATEBRIOZ Treats

1 FDA approvals

Originally approved for its first indication in 2026 .

  • Other (1)

MIRUM's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

LIVMARLI
2021
MARALIXIBAT CHLORIDE
3 designations
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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.

ATEBRIOZ FDA Label Details

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Data Sources

FDA Approval: NDA221198 → Trials: ClinicalTrials.gov →

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