Bayer has announced positive topline results from the phase 3 REVEAL study evaluating the investigational PET/CT radiotracer I 124 evuzamitide for the diagnosis of cardiac amyloidosis. The investigator-initiated study, led by Brigham and Women’s Hospital, successfully met its primary endpoints of sensitivity and specificity based on visual scan interpretation, highlighting the compound’s potential as a non-invasive diagnostic tool for the disease.

I 124 evuzamitide is an investigational PET radiotracer designed to assist clinicians in visualising amyloid protein deposits in the heart through PET/CT imaging. Bayer stated that detailed study findings will be presented at an upcoming scientific congress, while discussions with the US Food and Drug Administration (FDA) and other regulatory authorities regarding potential approval submissions are expected to follow.

The compound has previously received Breakthrough Therapy Designation from the FDA for PET imaging in patients with suspected or known cardiac amyloidosis, along with Orphan Drug Designation in both the United States and the European Union for light-chain amyloidosis (AL) and transthyretin amyloidosis (ATTR). However, the radiotracer remains investigational and has not yet been approved for use in any country.

According to Sharmila Dorbala, cardiac amyloidosis is frequently underdiagnosed or misdiagnosed, delaying treatment and increasing the risk of organ damage. She noted that the study data suggest the imaging agent could potentially enable healthcare providers to both identify and rule out cardiac amyloidosis using a single test. The radiotracer may also help distinguish cardiac amyloidosis from other causes of heart failure, differentiate amyloid subtypes alongside laboratory testing and monitor changes in cardiac amyloid burden over time.

Bayer acquired I 124 evuzamitide, also known as AT-01, earlier in 2026 through its acquisition of imaging assets from Attralus, Inc.. The acquisition strengthened Bayer’s molecular imaging pipeline targeting systemic amyloid disease and aligned with the company’s broader strategy to expand its precision imaging portfolio in cardiovascular and other serious diseases.

Konstanze Diefenbach said the company remains committed to developing diagnostic technologies that support earlier disease detection and improved patient outcomes. She added that the positive REVEAL results reinforce Bayer’s efforts to advance molecular imaging solutions for serious conditions such as cardiac amyloidosis.

Cardiac amyloidosis is a progressive condition caused by the accumulation of misfolded amyloid proteins in heart tissue, which can impair the heart’s ability to pump blood effectively. The disease is estimated to affect around 400,000 people globally, though experts believe the true number may be significantly higher due to underdiagnosis. If left untreated, the condition can lead to heart failure, repeated hospitalisations, and early mortality.

Currently, there is no single non-invasive diagnostic test capable of reliably detecting, diagnosing and monitoring cardiac amyloidosis. Patients often undergo lengthy diagnostic journeys involving multiple specialists and imaging procedures before receiving an accurate diagnosis.

The REVEAL (Research with I 124 EVuzamitide to Elucidate Cardiac AmyLoidosis) study was a multicentre, open-label, single-arm phase III clinical trial conducted across 19 centres in the United States. The trial enrolled 170 adults with suspected cardiac amyloidosis. Participants received a single intravenous dose of I 124 evuzamitide followed by PET/CT imaging conducted three to five hours after administration. Independent cardiac PET physicians, blinded to patient clinical data, evaluated the scans, while standard-of-care diagnoses were independently adjudicated by amyloidosis experts blinded to PET findings.

The study’s primary objective was to assess the efficacy and safety of I 124 evuzamitide in diagnosing cardiac amyloidosis compared with standard clinical diagnosis. Secondary analyses examined diagnostic performance in ATTR and AL amyloidosis subtypes.

Bayer stated that molecular imaging technologies such as PET/CT play a growing role in enabling earlier disease detection and personalised treatment planning by allowing clinicians to visualise biological processes at the molecular level in real time. The company continues to invest in radiology research and innovation, with its diagnostic imaging business generating Euro 2.2 billion in sales in 2025.