Gallium-68 FAPI-46
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.
Overview
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.
Separate 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).
- Detector ring
- FAP on fibroblasts
- 511 keV photon pair
1.Gallium-68 FAPI-46 slips into a pocket on FAP.
Trials
topTrials recruiting now
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Latest papers
topQuery for this drug: (TITLE:"Gallium-68 FAPI-46" OR ABSTRACT:"Gallium-68 FAPI-46" OR TITLE:"68Ga-FAPI-46" OR ABSTRACT:"68Ga-FAPI-46" OR TITLE:"Ga-68 FAPi-46" OR ABSTRACT:"Ga-68 FAPi-46") AND (radiopharmaceutical OR radioligand OR radionuclide OR theranostic OR "nuclear medicine" OR "molecular imaging" OR radiotracer OR scintigraphy OR cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Gallium-68 FAPI-46, not a curated reading list.
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