TheraRadar
Data updated: May 26, 2026

IOMERVU (iomeprol)

Other Approved 2024-11-27
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Years on Market

Details

Status
Discontinued
First Approved
2024-11-27
Patent Cliff
2029

Pro Metrics

Patent cliff and revenue data

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Routes
INTRA-ARTERIAL, INTRAVENOUS
Dosage Forms
SOLUTION

Companies

BRACCO
Active Ingredient: IOMEPROL

IOMERVU Approval History

2025
2026
Original
New Indication
New Form
Label Update
26 FDA actions from 2024 to 2024
Nov 2024 ORIGINAL
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What IOMERVU Treats

1 FDA approvals

Originally approved for its first indication in 2024 .

  • Other (1)
📋

Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT01255722 X-ACT results posted ISO-44-012 Ph 4 completed Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography
🔬

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.

IOMERVU FDA Label Details

IOMERVU Patents & Exclusivity

Exclusivity: Nov 2029

Exclusivity

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Source: FDA Orange Book

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Data Sources

FDA Approval: NDA216016 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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