Berlin, Germany, August 30, 2026
Bayer announced detailed results from the Phase 3 REVEAL study evaluating investigational PET radiotracer iodine 124 evuzamitide (I 124 evuzamitide) for the diagnosis of cardiac amyloidosis. The findings were presented as a late-breaking oral presentation at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany, and were simultaneously published in The Journal of the American Medical Association. The pivotal study met its primary endpoints for sensitivity and specificity based on visual PET scan interpretation, while secondary analyses in light-chain (AL) and transthyretin (ATTR) amyloidosis also met predefined success criteria. Importantly, I 124 evuzamitide remains investigational and has not been approved by any health authority.
Phase 3 REVEAL Study Meets Diagnostic Endpoints
The multicenter, open-label, single-arm REVEAL Phase 3 study evaluated 170 adults with suspected cardiac amyloidosis across 18 centers in the United States. The primary analysis assessed the ability of I 124 evuzamitide PET imaging to correctly identify patients with cardiac amyloidosis and distinguish individuals without the condition through assessments by three independent readers. The majority interpretation, based on agreement from at least two of the three readers, demonstrated 94% sensitivity and 86% specificity, supporting the study’s predefined primary efficacy criteria. The individual reader results further demonstrated consistent diagnostic performance. Sensitivity was 94%, 94% and 90% among the three readers, while specificity was 84%, 85% and 89%, respectively. Secondary analyses also met predefined success criteria for the two major forms of cardiac amyloidosis evaluated in the study. For ATTR amyloidosis, majority-read sensitivity reached 96%, with specificity of 86%. For AL amyloidosis, majority-read sensitivity was 95%, with specificity also reaching 86%. These findings indicate the potential of the investigational PET radiotracer to support diagnosis across different amyloid subtypes.
Investigational PET Radiotracer Shows Safety Profile
The REVEAL study also evaluated the safety and tolerability of I 124 evuzamitide. Among the 170 participants who received the investigational radiotracer, 55 patients, or 32.4%, experienced at least one treatment-emergent adverse event between Day 1 and Day 30. Eleven participants, representing 6.5% of the study population, experienced a serious treatment-emergent adverse event that was considered unrelated to I 124 evuzamitide. Only one treatment-emergent adverse event, fatigue, was considered related to the investigational radiotracer. The most frequently reported adverse events occurring in more than 1% of participants included upper respiratory tract infection, dizziness, nausea, vomiting, syncope, hyperglycemia and skin laceration. The study reported no deaths and no evuzamitide-related adverse events leading to treatment discontinuation during the study period.
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Bayer Prepares Regulatory Discussions
I 124 evuzamitide, also known as AT-01, is an investigational PET radiotracer designed as a radioactive diagnostic imaging agent administered before PET imaging to help visualize amyloid deposits. Bayer acquired the radiotracer from Attralus, Inc. as part of an expansion of its molecular imaging pipeline. The investigational agent had previously received FDA Breakthrough Therapy Designation for PET imaging in patients with suspected or known cardiac amyloidosis and Orphan Drug status in the United States and European Union for AL and ATTR amyloidosis. Bayer plans to discuss the Phase 3 results and potential regulatory submissions with the FDA and other health authorities. The REVEAL findings could therefore represent an important step toward developing a non-invasive molecular imaging approach for cardiac amyloidosis, a progressive disease associated with amyloid accumulation in heart tissue. The condition can impair cardiac function and may lead to heart failure, hospitalization and premature mortality, while patients can experience prolonged diagnostic journeys involving multiple specialists and diagnostic procedures.
Source: Bayer press relese
