TheraRadar
Data updated: May 26, 2026

ILLUCCIX (gallium ga-68 gozetotide)

Oncology Approved 2021-12-17

ILLUCCIX is indicated for the treatment of Prostate Cancer; Metastasis; Recurrence.

Source: FDA Label • TELIX
2
Indications
--
Phase 3 Trials
4
Years on Market

Details

Status
Prescription
First Approved
2021-12-17
Patent Cliff
2035

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Routes
INTRAVENOUS
Dosage Forms
POWDER

Companies

Active Ingredient: GALLIUM GA-68 GOZETOTIDE

ILLUCCIX Approval History

2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2021 to 2025 · 1 indication expansions
Dec 2025 SUPPL
Label · Labeling
Sep 2025 SUPPL
Label · Labeling
Mar 2023 SUPPL
Efficacy

What ILLUCCIX Treats

3 indications

ILLUCCIX is approved for 3 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Prostate Cancer
  • Metastasis
  • Recurrence
Source: FDA Label

ILLUCCIX 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.

What's emerging in ILLUCCIX's indications

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

Drugs Similar to ILLUCCIX

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FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

GALLIUM GA-68 GOZETOTIDE
GALLIUM GA-68 GOZETOTIDE
3 shared
IONETIX
Shared indications:
Prostate CancerMetastasisRecurrence
GOZELLIX
GALLIUM GA-68 GOZETOTIDE
3 shared
TELIX INNOVATIONS
Shared indications:
Prostate CancerMetastasisRecurrence
LOCAMETZ
GALLIUM GA-68 GOZETOTIDE
3 shared
Novartis
Shared indications:
Prostate CancerMetastasisRecurrence
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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.

ILLUCCIX FDA Label Details

Indications & Usage

FDA Label (PDF)

ILLUCCIX is indicated for the treatment of Prostate Cancer; Metastasis; Recurrence.

View full patent landscape →
1 OB patents · 1 families · 4 international docs across 1 countries

ILLUCCIX Patents & Exclusivity

Latest Patent: Jul 2035

Patents (1 active)

US11027031 Expires Jul 28, 2035
Source: FDA Orange Book

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Revenue Insights

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Patent Timeline

  • Cliff: 2035
  • 1 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

Competitive Landscape

  • 20 similar drugs
  • Same target/indication analysis
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Data Sources

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