Investigational PET Tracer Iodine 124 Evuzamitide from Bayer Met Primary Endpoints in Phase III Study in Patients Suspected to Have Cardiac Amyloidosis

Key Terms

positron emission tomography medical

A positron emission tomography (PET) scan is an imaging test that uses a tiny amount of radioactive tracer injected into the body to map how organs and tissues are functioning, similar to watching traffic flow on a city map rather than just seeing roads. Investors care because PET technology and the tracers it uses are critical in developing and measuring the effectiveness of drugs, diagnosing diseases, and guiding treatment decisions, which can drive demand, regulatory scrutiny, and revenue for related healthcare companies.

pet/ct medical

A PET/CT is a combined medical imaging test that overlays two scans—PET, which shows metabolic activity like a heat map of how tissues use energy, and CT, which shows detailed body structure like a map of roads and buildings. Investors care because PET/CT scans are widely used to diagnose and monitor diseases, guide treatment decisions, and support clinical trials, affecting demand for imaging equipment, hospital services, and diagnostic-related revenue streams.

radiotracer medical

A radiotracer is a small molecule or compound tagged with a tiny amount of radioactive material that doctors use to follow biological processes inside the body, like a tracked courier showing where a disease or metabolic activity is located on medical imaging scans. Investors care because radiotracers drive the clinical usefulness, regulatory approval, and commercial demand for diagnostic tests and certain targeted therapies; their success can affect trial outcomes, reimbursement prospects, and the market value of healthcare companies.

breakthrough therapy designation regulatory

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

orphan drug status regulatory

An official label from health authorities for medicines that treat very rare diseases, given to encourage development by offering benefits such as reduced fees, tax breaks, and a period of exclusive sales. For investors it matters because these incentives lower development costs and can create a temporary monopoly-like advantage that boosts the drug’s potential revenue and valuation, much like a limited license that makes a risky project more commercially attractive.

cardiac amyloidosis medical

Cardiac amyloidosis is a condition where abnormal proteins collect in the heart muscle, making it stiff and less able to pump blood—imagine a once-springy sponge turning rigid. It matters to investors because growing diagnosis, new drugs, diagnostic tests, and device needs can create or shrink markets for biotechs, medical device makers, and healthcare providers, and regulatory approvals or trial results can quickly change company valuations and revenue forecasts.

systemic amyloid disease medical

A systemic amyloid disease is a condition in which normally soluble proteins misfold into sticky fibers that accumulate like clogging residue in multiple organs and tissues, disrupting their normal function. For investors, it matters because these diseases drive demand for diagnostics, therapies, and long development timelines and regulatory risk for companies working on treatments—similar to how a widespread mechanical failure creates market opportunity and uncertainty for makers of fixes.

phase iii medical

A Phase III trial is the late-stage clinical study that tests whether a medical treatment works and is safe in a large group of patients, often comparing it to standard care. Think of it as a final dress rehearsal or full-scale road test before regulators decide on approval; positive or negative results strongly influence a drug maker’s chance to sell the treatment, future revenue, and investment risk.

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KEY FACTS

• The Phase III REVEAL study met its primary endpoints demonstrating sensitivity and specificity of iodine 124 evuzamitide (I 124 evuzamitide) positron emission tomography computed tomography (PET/CT) for the diagnosis of cardiac amyloidosis based on visual scan interpretation¹
• I 124 evuzamitide, an investigational radiotracer for the diagnosis of cardiac amyloidosis, was previously granted Breakthrough Therapy Designation for positron emission tomography (PET) imaging in patients with suspected or known cardiac amyloidosis ²
• The compound also previously received Orphan Drug status in the U.S. and EU ³
• Cardiac amyloidosis typically takes between 2-4 years from symptom onset to diagnosis,⁴ yet there is no single, non-invasive test for the reliable detection and diagnosis of the disease
• Bayer plans to discuss the data and submission for regulatory approval with the FDA and other health authorities

POSITIVE TOPLINE DATA RESULTS

Not intended for UK Media

BERLIN & WHIPPANY, N.J.--(BUSINESS WIRE)-- Bayer today announced positive topline results from the Phase III REVEAL study, an investigator-initiated study by Brigham and Women’s Hospital that evaluated the investigational PET/CT radiotracer I 124 evuzamitide.^1,5 The study met the primary endpoints of sensitivity (the ability of a test to identify individuals who have the condition) and specificity (the ability of a test to identify individuals who do not have the condition) for the diagnosis of cardiac amyloidosis based on visual scan interpretation.¹ Bayer plans to present the complete results at an upcoming scientific congress.

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.⁵ I 124 evuzamitide is an investigational compound and has not been approved by any health authority for use in any country for any indication.

The compound was previously granted Breakthrough Therapy Designation for PET imaging in patients with suspected or known cardiac amyloidosis² as well as Orphan Drug status for both light-chain amyloidosis (AL) and transthyretin amyloidosis (ATTR) in the U.S. and the EU. ³ Bayer plans to discuss the data and submission for regulatory approval with the FDA and other health authorities.

WHY THIS DATA MATTERS

“Cardiac amyloidosis is often under- or misdiagnosed,⁶ impacting patients’ ability to begin appropriate treatment earlier, when it may help prevent further organ damage,” said REVEAL principal investigator Dr. Sharmila Dorbala, Director of Nuclear Cardiology at Brigham and Women’s Hospital. “These I 124 evuzamitide data demonstrate the potential of a single test to help health care providers identify or exclude cardiac amyloidosis. Clinically, a sensitive, specific and quantitative PET tracer could help distinguish cardiac amyloidosis from other causes of heart failure, differentiate amyloid subtypes when used alongside appropriate laboratory testing, and track changes in cardiac amyloid burden over time.”

I 124 evuzamitide is one of two investigational amyloid radiotracers that Bayer acquired from Attralus, Inc. The compound is also known as AT-01. The acquisition, announced in early 2026, expanded Bayer’s radiology pipeline with complementary tracers targeting systemic amyloid disease and reinforced the company’s strategy to build a leading position in imaging for cardiovascular and other serious conditions.

“As a leader in radiology, we are committed to bringing forward options for earlier diagnosis of diseases such as cardiac amyloidosis for the benefit of patients,” said Dr. Konstanze Diefenbach, Head of Radiology Research & Development at Bayer’s Pharmaceuticals Division. “We are very excited about the positive topline results of the REVEAL study and are looking forward to sharing the data with the scientific community.”

ABOUT CARDIAC AMYLOIDOSIS

Cardiac amyloidosis is a severe, progressive disease caused by the accumulation of misfolded proteins (amyloid) in heart tissue, making it stiff and thick which can impair its ability to pump blood effectively.⁷ As the disease is underdiagnosed, current estimates state the condition impacts approximately 400,000 patients worldwide,⁸ though the number is likely greater. Without appropriate diagnosis and treatment, cardiac amyloidosis can lead to heart failure, frequent hospitalizations and early mortality.⁷

Currently, there is no single, non-invasive test that can reliably detect and diagnose cardiac amyloidosis or quantify and monitor myocardial amyloid burden. Despite increasing disease awareness by health care providers, a prolonged diagnostic journey is common,⁶ with patients often consulting several specialists and receiving multiple imaging procedures before an accurate diagnosis.

ABOUT THE REVEAL STUDY ⁵

The REVEAL (“Research with EVuzamitide I 124 to Elucidate Cardiac AmyLoidosis”) study is an investigator-initiated Phase III clinical trial of the investigational diagnostic imaging agent I 124 evuzamitide in patients with suspected cardiac amyloidosis with Brigham and Women’s Hospital in Boston, MA, as 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 care (SoC) diagnosis. Secondary analyses assessed diagnostic performance in ATTR and AL subtypes. The imaging test used in this study was a positron emission tomography computed tomography (PET/CT) scan.

REVEAL is a multicenter, open-label, single-arm Phase III study conducted at 19 centers in the United States, evaluating 170 adults with suspected cardiac amyloidosis.

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. SoC diagnosis was independently adjudicated by clinical amyloidosis experts, blinded to PET results, using routine diagnostic data collected up to 60 days after imaging.

Diagnostic sensitivity and specificity of I 124 evuzamitide were determined using SoC diagnosis as the reference standard.

ABOUT MOLECULAR IMAGING

Molecular imaging allows clinicians to visualize and quantify biological processes at the molecular and cellular level in real time, enabling earlier disease detection and personalized treatment planning.⁹

ABOUT RADIOLOGY AT BAYER

Bayer’s Radiology business is a world leader among medical imaging solutions providers. The business transforms insight into technology and services with the goal of providing radiology solutions to help its customers enhance patient care. Its leading radiology portfolio features contrast agents and devices to help enable precise dose administration across modalities, equipment services, informatics and connected solution offerings.

ABOUT BAYER

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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1 Data on file.

2 Beighley, S. (2024, August 5). Attralus receives breakthrough therapy designation for its Pan-Amyloid Diagnostic Pet Imaging candidate 124i-evuzamitide (AT-01) for cardiac amyloidosis. Attralus. https://attralus.com/press-releases/attralus-receives-breakthrough-therapy-designation-for-its-pan-amyloid-diagnostic-pet-imaging-candidate-124i-evuzamitide-at-01-for-cardiac-amyloidosis

3 Beighley, S. (2022, December 19). Attralus receives FDA and Ema Orphan designation for AT-01 (iodine (I-124) evuzamitide), an investigational diagnostic for the management of Al and Attr Amyloidosis. Attralus. https://attralus.com/press-releases/attralus-receives-fda-and-ema-orphan-designation-for-at-01-iodine-i-124-evuzamitide-an-investigational-diagnostic-for-the-management-of-al-and-attr-amyloidosis

4 Rozenbaum, M. H., Large, S., Bhambri, R., Stewart, M., Whelan, J., van Doornewaard, A., Dasgupta, N., Masri, A., & Nativi-Nicolau, J. (2021). Impact of Delayed Diagnosis and Misdiagnosis for Patients with Transthyretin Amyloid Cardiomyopathy (ATTR-CM): A Targeted Literature Review. Cardiology and Therapy, 10(1), 141-159. https://doi.org/10.1007/s40119-021-00219-5.

5 Research With I-124 EVuzamitide to Elucidate Cardiac AmyLoidosis (REVEAL). Clinicaltrials.gov. (n.d.). https://clinicaltrials.gov/study/NCT06788535

6 Dang D, Fournier P, Cariou E, Huart A, Ribes D, Cintas P, Roussel M, Colombat M, Lavie-Badie Y, Carrié D, Galinier M, Lairez O. Gateway and journey of patients with cardiac amyloidosis. ESC Heart Fail. 2020 Oct;7(5):2418-2430. doi: 10.1002/ehf2.12793. Epub 2020 Jun 26. PMID: 32588554; PMCID: PMC7524246.

7 Cardiac amyloidosis: What you need to know. Cleveland Clinic. (2025, October 13). https://my.clevelandclinic.org/health/diseases/22598-cardiac-amyloidosis

8 ClinicalTrials.gov. Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy (ATTRibute-CM). Available at: https://clinicaltrials.gov/study/NCT03860935. [Accessed April 2026]

9 Fact sheet: What is nuclear medicine and molecular imaging?. SNMMI. (n.d.). https://snmmi.org/Patients/Patients/Fact-Sheets/What-is-Nuclear-Medicine-and-Molecular-Imaging.aspx

 

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Source: Bayer