{"entity":{"id":"ga-68-fapi-46","kind":"drug","name":"Gallium-68 FAPI-46","aka":["68Ga-FAPI-46","Ga-68 FAPi-46"],"tldr":"An experimental PET tracer that lights up the scaffolding cells cancers build around themselves, not the cancer cells directly. It is still being tested, not yet an approved medicine.","summary":"68Ga-FAPI-46 is one of the most advanced compounds in the FAPI family under joint development by SOFIE Biosciences and GE HealthCare (global licence signed 2024). It has been studied prospectively in several hundred patients across breast, colorectal, pancreatic, head and neck, and other solid tumours. In a single-centre phase 2 trial at University Hospital Essen (NCT05160051, 155 patients scanned, reported in Lancet Oncology 2025), the tracer's positive predictive value for detecting immunohistochemically FAP-positive tumours was 90% on a per-patient basis and 92% per region, meeting the trial's pre-specified threshold.\n\nSeparate US phase 2 studies are running in resectable or borderline-resectable pancreatic ductal adenocarcinoma (NCT05262855/NCT05518903) across Mayo Clinic, UCLA, NYU Langone and BAMF Health, comparing FAPI-46 PET detection of cancer-associated fibroblasts against surgical histopathology, with phase 3 planning under way as of mid-2024. The tracer is not marketed anywhere; it is supplied under investigational new drug exemptions, and adverse events reported so far have been mild and mostly unrelated to the drug (5 of 90 adverse events in the Essen trial were judged possibly related, none serious).","status":"phase-2","asOf":"2026-09-22","links":[{"label":"Pabst et al., Lancet Oncology 2025: 68Ga-FAPI-46 PET accuracy for cancer imaging with histopathology validation (phase 2 trial)","url":"https://pubmed.ncbi.nlm.nih.gov/40774265/"},{"label":"ClinicalTrials.gov NCT05160051 (68Ga-FAPI-46 PET for imaging of FAP-expressing cancer)","url":"https://clinicaltrials.gov/study/NCT05160051"},{"label":"ClinicalTrials.gov NCT05518903 (68Ga-FAPI-46 PET/CT for localised pancreatic ductal adenocarcinoma)","url":"https://clinicaltrials.gov/study/NCT05518903"}],"tags":["FAP","stroma","investigational"],"related":["ga-68"],"indications":["pancreatic-net","nsclc"],"sections":[],"technologies":["fapi-pet","pet-ct"],"targets":["fap"],"drugs":[],"companies":["ge-healthcare"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"modality":"PET tracer","mechanism":"A quinoline-based fibroblast activation protein (FAP) inhibitor labelled with gallium-68. It binds tightly and is largely internalised by FAP-expressing cancer-associated fibroblasts in the tumour stroma, which surround the actual cancer cells in most solid epithelial tumours; the label therefore highlights the stromal reaction to a tumour rather than the tumour cells themselves.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/ga-68-fapi-46/","neighbours":{"isotope":[{"id":"ga-68","kind":"isotope","name":"Gallium-68","route":"/isotopes/ga-68/"}],"indication":[{"id":"nsclc","kind":"indication","name":"Non-small cell lung cancer","route":"/indications/nsclc/"},{"id":"pancreatic-net","kind":"indication","name":"Pancreatic neuroendocrine tumours","route":"/indications/pancreatic-net/"}],"technology":[{"id":"fapi-pet","kind":"technology","name":"FAPI PET","route":"/technologies/fapi-pet/"},{"id":"pet-ct","kind":"technology","name":"PET/CT","route":"/technologies/pet-ct/"}],"target":[{"id":"fap","kind":"target","name":"FAP","route":"/targets/fap/"}],"company":[{"id":"ge-healthcare","kind":"company","name":"GE HealthCare","route":"/companies/ge-healthcare/"}],"opportunity":[{"id":"opp-fap-pancreatic-staging","kind":"opportunity","name":"FAP imaging to stop futile pancreatic surgery","route":"/opportunities/opp-fap-pancreatic-staging/"}]}}