SOFIE Biosciences
SOFIE Biosciences is a US radiopharmacy network running two phase 3 trials of the FAP PET tracer [18F]FAPI-74 in pancreatic and gastro-oesophageal cancer.
Overview
SOFIE Biosciences, based in Dulles, Virginia, is a US radiopharmacy network running two phase 3 trials of the FAP PET tracer 18F-FAPI-74 in pancreatic and gastro-oesophageal cancer. First patients were dosed in the FAPI-GO gastro-oesophageal trial in December 2025 and the pancreatic trial in February 2026, seven radiopharmacies have been cleared to manufacture 18F-FAPI-74 with twelve-hour shelf-life distribution planned in 2026, and the FAPI chemistry originated at Heidelberg. Nuclide links it to pancreatic, gastric and oesophageal cancer, to FAPI PET and PET, to FAP as a target, to Heidelberg University Hospital and the DKFZ, and to PET tracer manufacturing and radiopharmacy networks. Whether FAP imaging changes staging and treatment in cancers where FDG PET falls short is the question the phase 3 trials will answer. The FAPI PET technology page carries the evidence.
Scorecard
All companies- approved products +6
- modalities +2
- regions +1
- registry trials +30
The radioactive sugar used in almost every cancer PET scan, approved in the 1990s and made fresh each day by regional cyclotrons.
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