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Data updated: May 26, 2026

HICON (sodium iodide i-131)

Oncology Approved 2003-01-24

HICON is a radioactive medication used for patients with hyperthyroidism or specific types of thyroid cancer. It helps patients with overactive thyroid glands or thyroid carcinoma by delivering targeted radiation directly to the affected tissue. This treatment is typically prescribed when a patient requires a radioactive approach to manage their thyroid condition.

Source: FDA Label • JUBILANT

How HICON Works

This drug works by entering thyroid follicular cells through the sodium-iodide symporter protein, where it reaches concentrations much higher than in the blood. Once inside, it is processed by thyroid peroxidase and incorporated into thyroglobulin. The therapeutic effect comes from beta emissions released by the I-131 isotope, which target the thyroid cells.

2
Indications
--
Phase 3 Trials
23
Years on Market

Details

Status
Prescription
First Approved
2003-01-24
Routes
ORAL
Dosage Forms
SOLUTION

Companies

Active Ingredient: SODIUM IODIDE I-131

HICON Approval History

2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
84 FDA actions from 2003 to 2021 · 1 indication expansions
Jun 2021 SUPPL
Label · Labeling
Jul 2016 SUPPL
Label · Labeling
Jun 2016 SUPPL
Label · Labeling

What HICON Treats

2 indications

HICON is approved for 2 conditions since its original approval in 2003. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hyperthyroidism
  • Thyroid Carcinoma
Source: FDA Label

HICON Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Phase 3 candidates targeting molecules with no FDA-approved drug, in indications HICON treats. First-in-class if their pivotal trials read out positive.

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Active Pipeline

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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.

HICON FDA Label Details

Indications & Usage

FDA Label (PDF)

HICON is indicated for the treatment of Hyperthyroidism; Thyroid Carcinoma.

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Data Sources

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