Aug. 30, 2026 — Bayer has announced the presentation of first detailed results from the Phase III REVEAL study, an investigator-initiated study by Brigham and Women’s Hospital, that evaluated the investigational positron emission tomography (PET) radiotracer iodine 124 evuzamitide (I 124 evuzamitide) for the diagnosis of cardiac amyloidosis.1
The pivotal study met its primary endpoints in the assessment of sensitivity and specificity for the diagnosis of cardiac amyloidosis based on visual scan interpretation.1 Safety data and data from secondary endpoints assessing the sensitivity and specificity in light-chain amyloidosis (AL) and, separately, in transthyretin amyloidosis (ATTR) were also presented.1 I 124 evuzamitide is an investigational compound and has not been approved by any health authority for use in any country for any indication.
These results were shared in a late-breaking oral presentation at the European Society of Cardiology Congress 2026 (ESC) in Munich, and simultaneously published in The Journal of the American Medical Association.
Why These Data Matter
“For people with cardiac amyloidosis, obtaining an accurate diagnosis can be challenging,” said REVEAL principal investigator Dr. Sharmila Dorbala, Director of Nuclear Cardiology, Brigham and Women’s Hospital, Director of Amyloidosis Research, Mass General Brigham Heart & Vascular Institute. “These challenges can lead to delays, underdiagnosis or misdiagnosis in the course of the disease.”
“Bayer is proud to present this new research on cardiac amyloidosis at ESC,” said Dr. Erin Bowman, Senior Medical Director of Molecular Imaging and Theranostics at Bayer. “The presentation of this data reflects our ongoing commitment to advancing research for patients affected by this disease.”
Key Highlights
REVEAL was a multicenter, open-label, single-arm Phase III study conducted at 18 centers in the United States, evaluating 170 adults with suspected cardiac amyloidosis.
- The Phase III REVEAL study met its primary endpoints in the assessment of sensitivity and specificity for the diagnosis of cardiac amyloidosis based on visual scan interpretation from three independent readers.
- Based on the majority read (agreement between at least two out of three readers) sensitivity was 94% (95% confidence interval [CI], 85 to 98) and specificity was 86% (95% CI, 77 to 92).
- Data from secondary efficacy endpoints, which assessed diagnostic performance in light-chain amyloidosis (AL) as well as in transthyretin amyloidosis (ATTR) based on visual scan interpretation were also presented.
- Among the 170 patients who received I 124 evuzamitide, 55 (32.4%) experienced at least one treatment-emergent adverse event (TEAE) from Day 1 to Day 30. Of these, 11 (6.5%) patients experienced a serious TEAE unrelated to I 124 evuzamitide; only one TEAE (fatigue) was considered related to I 124 evuzamitide.
- The most common TEAEs, occurring in >1% of participants, were upper respiratory tract infection (2.9%), dizziness (2.4%), nausea (1.8%), vomiting (1.8%), syncope (1.8%), hyperglycemia (1.8%) and skin laceration (1.8%).
There were no deaths or evuzamitide related TEAEs leading to discontinuation during the study period.
Iodine 124 Evuzamitide Radiotracer
Iodine 124 evuzamitide (I 124 evuzamitide) is an investigational PET radiotracer – a radioactive diagnostic imaging agent injected into the body before a PET scan to assist with visualization – being studied in patients with suspected cardiac amyloidosis. I 124 evuzamitide, also known as AT-01, is one of two investigational amyloid radiotracers that Bayer acquired from Attralus, Inc.2
I 124 evuzamitide was previously granted Breakthrough Therapy Designation by the U.S. FDA for PET imaging in patients with suspected or known cardiac amyloidosis. It was also granted Orphan Drug status for both AL and ATTR in the U.S. and the EU.3 I 124 evuzamitide is currently under investigation and has not been approved by any regulatory authority. Bayer plans to discuss these data and submission for regulatory approval with the FDA and other health authorities.
The REVEAL Study4
The REVEAL (“Research with EVuzamitide I 124 to Elucidate Cardiac AmyLoidosis”) study was an investigator-initiated Phase III clinical trial of the investigational diagnostic imaging agent I 124 evuzamitide in patients with suspected cardiac amyloidosis. Brigham and Women’s Hospital in Boston, MA, was the study sponsor.
The main purpose of the study was to evaluate the efficacy and safety of the investigational radiotracer I 124 evuzamitide for diagnosing cardiac amyloidosis in participants with suspected cardiac amyloidosis compared to clinical standard of truth diagnosis based on available clinical data. Secondary analyses assessed diagnostic performance in ATTR and AL subtypes. The imaging test used in this study was a positron emission tomography (PET) scan.
Participants received a single intravenous dose of I 124 evuzamitide, followed by cardiac and partial-body PET/CT imaging, 3-5 hours post-injection. All PET/CT images were independently read by experienced cardiac PET physicians, assessing visual presence or absence of cardiac tracer uptake, blinded to clinical data.
Cases were confirmed through an independent clinical adjudication committee, blinded to PET results, with expertise in cardiology, amyloidosis, and/or cardiac imaging. The committee established standard of truth using diagnostic data collected up to 60 days after imaging.
References
-
Data on file
-
Bayer. Bayer to expand into molecular imaging with acquisition of innovative pan-amyloid radiotracers from Attralus. Published January 12, 2026. Accessed July 24, 2026. Bayer press release
-
Bayer. Investigational PET Tracer Iodine 124 Evuzamitide from Bayer Met Primary Endpoints in Phase III Study in Patients Suspected to Have Cardiac Amyloidosis. Bayer. Published May 7, 2026. Accessed July 24, 2026. Bayer press release.
-
Clinicaltrials.gov. Research With I-124 EVuzamitide to Elucidate Cardiac AmyLoidosis (REVEAL). https://clinicaltrials.gov/study/NCT06788535
October 07, 2026 
