01/09/2026
Enrollment is now complete in the Phase 3 BiPASS™ study evaluating Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) and Gozellix® (kit for the preparation of gallium Ga 68 gozetotide injection) for prostate cancer imaging in the pre-biopsy setting.
Telix has also positively engaged with the U.S. FDA on a New Drug Application (NDA) pathway that would support new product reimbursement and broaden patient access to ⁶⁸Ga-PSMA-PET imaging.
BiPASS is the first registrational study of ⁶⁸Ga-PSMA-PET imaging before biopsy. The study aims to evaluate whether combining MRI with Telix’s proprietary ⁶⁸Ga-PSMA-PET agents can improve diagnostic accuracy, reduce unnecessary biopsies or improve biopsy targeting compared with current standard practice.
A sincere thank you to the investigators, study teams and, most importantly, the 350 patients who participated in this important research.
Read more on our website here: https://telixpharma.com/news-views/telix-completes-enrollment-in-phase-3-bipass-study-aligns-with-fda-on-nda-pathway/
ClinicalTrials.gov ID: NCT07052214