evuzamitide (I 124 evuzamitide) - (REVEAL)

August 30, 2026: Bayer reported detailed Phase III REVEAL results for investigational PET radiotracer iodine 124 evuzamitide (AT-01) in 170 adults with suspected cardiac amyloidosis, presented as a late-breaking oral at ESC Congress 2026 in Munich and simultaneously published in JAMA.

The multicenter, open-label, single-arm study met its primary endpoints for visual PET scan diagnosis of cardiac amyloidosis. By majority read, sensitivity was 94% (95% CI 85-98) and specificity was 86% (95% CI 77-92). Individual reader sensitivity ranged 90%-94% and specificity 84%-89%.

Secondary analyses showed diagnostic performance in amyloidosis subtypes: for ATTR, majority-read sensitivity was 96% (95% CI 87-100) and specificity 86% (95% CI 77-92); for AL, sensitivity was 95% (95% CI 76-100) and specificity 86% (95% CI 77-92).

Safety: 55/170 patients (32.4%) had at least one TEAE through Day 30; 11 patients (6.5%) had serious TEAEs unrelated to the tracer. Only one related TEAE (fatigue) was reported. No deaths or tracer-related discontinuations occurred.

I 124 evuzamitide remains unapproved. Bayer said it plans to discuss these data and regulatory submission with the FDA and other health authorities.