# Illuccix (kit for Ga-68 gozetotide)

Source: https://onco.cc/drugs/illuccix/  
OnCo record `illuccix` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Telix's ready-to-label kit that lets any nuclear medicine department make the gallium PSMA scan for prostate cancer.

## Summary

Illuccix was approved by the FDA in December 2021 for PET imaging of PSMA-positive lesions in men with suspected metastasis who are candidates for definitive therapy and in men with suspected recurrence based on rising PSA, and in 2025 the label was extended to selecting patients for PSMA radioligand therapy. Gozellix, a second-generation kit with longer post-labelling shelf life, was approved in 2025. Illuccix is also registered in Australia and several other markets. The kit format made PSMA PET available to centres without access to the cyclotron-produced 18F tracers.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-24
- Tags: test
- Brand: Illuccix / Gozellix
- Modality: PET imaging agent kit (PSMA, gallium-68)
- Mechanism: Kit for on-site labelling of PSMA-11 (gozetotide) with gallium-68 from a generator or cyclotron; the tracer binds PSMA on prostate cancer cells for PET imaging.
- Approvals: US 2021: PSMA PET imaging in prostate cancer (initial staging with suspected metastasis; suspected recurrence); Australia 2021: PSMA PET imaging in prostate cancer; US 2025: Gozellix kit; selection of patients for PSMA-targeted radioligand therapy

## Notes

- What a result means: PSMA-avid spots on the scan indicate prostate cancer deposits and decide between local treatment, systemic therapy or radioligand therapy.

## Sources

- PSMA-PreRP (JAMA Oncology 2021): https://doi.org/10.1001/jamaoncol.2021.3771
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d4643b31-9b4f-673f-e053-2a95a90a559d

## Connected records

- drugs: [Gallium-68 gozetotide (PSMA-11)](https://onco.cc/drugs/ga68-psma-11/), [Locametz (kit for Ga-68 gozetotide)](https://onco.cc/drugs/locametz/), [Lutetium-177 vipivotide tetraxetan](https://onco.cc/drugs/pluvicto/), [Piflufolastat F-18 / Pylarify TruVu](https://onco.cc/drugs/pylarify/)
- cancers: [Prostate cancer](https://onco.cc/cancers/prostate/)
- technologies: [PET/CT](https://onco.cc/technologies/pet-ct/), [PSMA PET](https://onco.cc/technologies/psma-pet/)
- targets: [PSMA](https://onco.cc/targets/psma/)
- companies: [Telix Pharmaceuticals](https://onco.cc/companies/telix/)
- terms: [Biochemical recurrence (BCR)](https://onco.cc/terms/biochemical-recurrence/), [Theranostics](https://onco.cc/terms/theranostics/)
- trials: [PSMA-PreRP](https://onco.cc/trials/psma-prerp/)
- key papers: [Diagnostic accuracy of 68Ga-PSMA-11 PET for pelvic nodal metastasis detection prior to radical prostatectomy and pelvic lymph node dissection: a multicenter prospective phase 3 imaging trial](https://onco.cc/key-papers/paper-psma-prerp-hope-jama-oncol-2021/)
- biomarkers: [PSMA expression by PET (PSMA-positive)](https://onco.cc/biomarkers/psma-pet-expression/)

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