Wednesday, July 8, 2026

Drug profile · INN

gallium ga-68 gozetotide

gallium ga-68 gozetotide (ILLUCCIX) is a diagnostic agent. Associated with Telix Innovations. Route of administration: intravenous. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 1
Pipeline programs 14
News articles 0
Drug details — gallium ga-68 gozetotide
US status
approved
Class
Route
INTRAVENOUS
Patents
1
Programs
14
Data quality
0.89

Quick answer

gallium ga-68 gozetotide (ILLUCCIX) is a diagnostic agent. Associated with Telix Innovations. Route of administration: intravenous. Current US regulatory status: approved.

Key facts

INN gallium ga-68 gozetotide
Brand ILLUCCIX
Mechanism Diagnostic agent
Route INTRAVENOUS
Formulation POWDER

Mechanism of action

Diagnostic agent

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. 68Ga-PSMA-11 Phase 3 · Telix Innovations · PCA
  2. 68Ga-PSMA-11 Phase 3 · Chinese Academy of · Biochemical Recurrence of Malignant Neoplasm of Prostate
  3. CAAA617B12302 Phase 3 · Novartis India · PSMA-positive metastatic castration-resistant prostate cance
  4. CAAA617C12301 Phase 3 · Novartis India · PSMA-positive metastatic hormone-sensitive prostate cancer (
  5. CAAA617D12302 Phase 3 · Novartis India · Oligometastatic prostate cancer (OMPC)
  6. Ga-68-PSMA-11 Phase 3 · Telix Innovations · Prostate Cancer
  7. UC-GTG-2301 Phase 3 · Ningbo Cancer Hospital · Novo metastatic hormone-sensitive prostate cancer (mHSPC) pa
  8. CAAA617A12202 Phase 2 · Novartis India · Progressive PSMA-Positive Metastatic Castration-Resistant Pr
  1. US 12383636

    Marking precursor with squaric acid coupling

    Expires Mon Aug 07 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is gallium ga-68 gozetotide?

gallium ga-68 gozetotide (ILLUCCIX) is a diagnostic agent. Associated with Telix Innovations. Route of administration: intravenous. Current US regulatory status: approved.

What is the brand name for gallium ga-68 gozetotide?

ILLUCCIX is a marketed brand name for gallium ga-68 gozetotide. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of gallium ga-68 gozetotide?

gallium ga-68 gozetotide has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.