{"entity":{"id":"illuccix","kind":"drug","name":"Illuccix (kit for Ga-68 gozetotide)","aka":[],"tldr":"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.","status":"approved","asOf":"2026-09-10","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Illuccix"}],"tags":["test"],"related":["ga68-psma-11","locametz","pylarify","f-18","ga-68"],"indications":["prostate"],"sections":[],"technologies":["psma-pet","pet-ct"],"targets":["psma"],"drugs":["pluvicto"],"companies":["telix"],"institutions":[],"pathways":[],"terms":["biochemical-recurrence","theranostics"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"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."],"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":[{"region":"US","year":2021,"indication":"PSMA PET imaging in prostate cancer (initial staging with suspected metastasis; suspected recurrence)"},{"region":"Australia","year":2021,"indication":"PSMA PET imaging in prostate cancer"},{"region":"US","year":2025,"indication":"Gozellix kit; selection of patients for PSMA-targeted radioligand therapy"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/illuccix/","neighbours":{"drug":[{"id":"ga68-psma-11","kind":"drug","name":"Gallium-68 gozetotide (PSMA-11)","route":"/drugs/ga68-psma-11/"},{"id":"locametz","kind":"drug","name":"Locametz (kit for Ga-68 gozetotide)","route":"/drugs/locametz/"},{"id":"tlx-591","kind":"drug","name":"Lutetium-177 rosopatamab tetraxetan","route":"/drugs/tlx-591/"},{"id":"pluvicto","kind":"drug","name":"Lutetium-177 vipivotide tetraxetan","route":"/drugs/pluvicto/"},{"id":"pylarify","kind":"drug","name":"Piflufolastat F-18 / Pylarify TruVu","route":"/drugs/pylarify/"}],"isotope":[{"id":"f-18","kind":"isotope","name":"Fluorine-18","route":"/isotopes/f-18/"},{"id":"ga-68","kind":"isotope","name":"Gallium-68","route":"/isotopes/ga-68/"}],"indication":[{"id":"prostate","kind":"indication","name":"Prostate cancer","route":"/indications/prostate/"}],"technology":[{"id":"cold-kit-formulation","kind":"technology","name":"Cold kit formulation","route":"/technologies/cold-kit-formulation/"},{"id":"pet-ct","kind":"technology","name":"PET/CT","route":"/technologies/pet-ct/"},{"id":"psma-pet","kind":"technology","name":"PSMA PET","route":"/technologies/psma-pet/"}],"target":[{"id":"psma","kind":"target","name":"PSMA","route":"/targets/psma/"}],"company":[{"id":"telix","kind":"company","name":"Telix Pharmaceuticals","route":"/companies/telix/"}],"term":[{"id":"biochemical-recurrence","kind":"term","name":"Biochemical recurrence (BCR)","route":"/terms/biochemical-recurrence/"},{"id":"theranostics","kind":"term","name":"Theranostics","route":"/terms/theranostics/"}],"bottleneck":[{"id":"b-reimbursement-coding","kind":"bottleneck","name":"Reimbursement and coding for radiopharmaceuticals","route":"/bottlenecks/b-reimbursement-coding/"}],"section":[{"id":"f-molecular-imaging","kind":"section","name":"Molecular imaging","route":"/fronts/f-molecular-imaging/"}],"roadmap":[{"id":"psma-theranostics-roadmap","kind":"roadmap","name":"PSMA theranostics roadmap: antigen discovery → PSMA PET → 177Lu-PSMA-617 → earlier lines and alpha","route":"/roadmaps/psma-theranostics-roadmap/"}]}}