TheraRadar
Data updated: Nov 8, 2026

ISOVUE READI (iopamidol) · BRACCO

Approved 2026-10-09
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2026-10-09
Routes
ORAL
Dosage Forms
SOLUTION

Companies

BRACCO
Active Ingredient: IOPAMIDOL

ISOVUE READI Approval History

Original
New Indication
New Form
Label Update
4 FDA actions from 2026 to 2026
Oct 2026 ORIGINAL
Update · Type 5 - New Formulation or New Manufacturer
FDA Letter Label

What ISOVUE READI Treats

1 FDA approvals

Originally approved for its first indication in 2026 .

  • Other (1)

BRACCO's other novel FDA approvals

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

IOMERVU
2024
IOMEPROL
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Clinical Trial Registry

9 trials
Trial Sponsor ID Phase Status Title
NCT04504331 results posted IRB-53650 BRS0113, K08CA252457 Ph 1 terminated Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer
NCT06411795 ANES-2023-31918 NCI-2024-02287, ANES-2023-31918 Ph 2 recruiting Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy
NCT03557385 ACCELERATION results posted Pro00093001 Ph 4 completed Adenosine Contrast CorrELations in Evaluating RevAscularizaTION
NCT01136876 results posted IOP-117 Ph 4 completed Kidney Damage in Patients With Moderate Fall in eGFR
NCT03384979 CA_LBW LBW_02 Ph 4 completed Optimization of Contrast Agent Dose in CT With Lean Body Weight
NCT01475097 results posted GE-012-098 Ph 4 completed Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography
NCT02040285 CTC-Prep 1 Ph 4 completed Low-dose Laxative Improves Performance and Feasibility of Computed Tomography Colonography (CTC)
NCT01376089 results posted GE-012-097 Ph 4 completed Iodixanol Versus Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic Imaging of Abdomen/Pelvis
NCT01075217 results posted IOP 119 Ph 4 completed Isovue in Peripheral Digital Subtraction Angiography (DSA)
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

ISOVUE READI FDA Label Details

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Data Sources

FDA Approval: NDA220583 → Trials: ClinicalTrials.gov →

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