Drugs / IODINE I124 EVUZAMITIDE
IODINE I124 EVUZAMITIDE
also known as
124I AT-01 · 124I-p5+14 · APi1832 · AT01 · Evuzamitide iodine i-124 · Iodine (124i) evuzamitide · p5+14
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06974877 | Sep 2025 → Jul 2031 expected | amyloidosis, cryopyrin-associated periodic syndrome | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03678259 | Oct 2018 → Oct 2021 | amyloidosis | University of Tennessee Graduate School of Medicine | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT05968846 | Dec 2022 → Aug 2023 | amyloidosis | University of Tennessee Graduate School of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT05235269 | Nov 2021 → Feb 2023 | amyloidosis | Attralus, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00788229 | Nov 2008 → Aug 2009 | dry eye syndrome | Dhp Korea Co., Ltd. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2026-08-30 | Bayer | Results Phase III REVEAL Study with Investigational PET Radiotracer Iodine 124 Evuzamitide Presented as Late-Breaker at ESC 2026 bayer.com ↗
Bayer today announced 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. |
| 2026-05-07 | Bayer | Results Investigational PET Tracer from Bayer Met Primary Endpoints in Phase III Study bayer.com ↗
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 |
| 2025-09-08 | Attralus, Inc. | Results Attralus Presents New Data on Its Pan-Amyloid Diagnostic Imaging Candidates at ASNC 2025 attralus.com ↗
124I-evuzamitide, the first pan-amyloid diagnostic imaging agent, demonstrated 100% sensitivity and specificity for the diagnosis of cardiac amyloidosis in patients suspected of or diagnosed with cardiac amyloidosis in ATTR, AL, and other rare types of systemic amyloidosis. |
| 2025-04-01 | Attralus, Inc. | Results Attralus Presents New Data on Its Pan-Amyloid Diagnostic Candidates at the 2025 American College of Cardiology (ACC) Annual Scientific Session attralus.com ↗
124I-evuzamitide (AT-01) PET/CT, the first pan-amyloid diagnostic imaging agent, demonstrated 100% sensitivity and specificity for the diagnosis of cardiac amyloidosis in patients suspected or diagnosed with cardiac amyloidosis in ATTR, AL, and other rare types of systemic amyloidosis. |
| 2024-08-05 | Attralus, Inc. | Regulatory Attralus Receives Breakthrough Therapy Designation for its Pan-Amyloid Diagnostic PET Imaging Candidate 124I-evuzamitide (AT-01) for Cardiac Amyloidosis attralus.com ↗
today announced that its investigational diagnostic imaging agent drug, 124I-evuzamitide (AT-01), has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for positron emission tomography (PET) imaging in patients with suspected or known cardiac amyloidosis. |
| 2024-05-30 | Attralus, Inc. | Results Attralus Presents New Data on Its Pan-Amyloid Therapeutic and Diagnostic Candidates at the XIX International Symposium on Amyloidosis (ISA) attralus.com ↗
AT-01 uptake in cardiac amyloid was significantly correlated with measures of cardiac structure, cardiac function, disease staging, cardiac biomarkers, and quality of life measures. |
| 2023-11-07 | Attralus, Inc. | Results Attralus Announces Publication of Two Studies Evaluating Iodine (124I) Evuzamitide (AT-01) using PET/CT in the Journal of American College of Cardiology (JACC CV Imaging) attralus.com ↗
Attralus, Inc., a clinical stage biopharmaceutical company developing transformative medicines to improve the lives of patients with systemic amyloidosis, today announced the publication of results from two Attralus-funded investigator-initiated studies of 124I-evuzamitide, the company’s investigational pan-amyloid radiotracer under development for the diagnosis and management of systemic amyloidosis. |
| 2023-10-02 | Attralus, Inc. | Results Attralus Announces Presentation of Clinical Data for 124I-Evuzamitide (AT-01), a Novel Amyloid-Specific PET Imaging Agent, at the 28th Annual Scientific Session of the American Society of Nuclear Cardiology attralus.com ↗
AT-01 demonstrated to be highly accurate, with 100% sensitivity for detection of cardiac amyloid, across three independent investigator-initiated studies. |
| 2022-09-12 | Attralus, Inc. | Results Attralus Announces New Clinical Data in ATTR CM and AL With AT-01 (Iodine (I-124) Evuzamitide), a Novel Amyloid-Specific Imaging Agent attralus.com ↗
AT-01 shows increased LV uptake and LV amyloid activity in all cardiac ATTR and AL subjects, but in none of the controls (100% accuracy) |
| 2022-09-08 | Attralus, Inc. | Results Attralus Announces Presentation of Clinical Data for AT-01 (Iodine (I-124) Evuzamitide), a Novel Amyloid-Specific Imaging Agent, at the 18th International Symposium on Amyloidosis attralus.com ↗
Using PET/CT imaging of AT-01, we have shown heterogeneous and often extensive ATTR amyloid deposits in numerous extracardiac sites, commonly the joints and spine. |
| 2022-08-08 | Attralus, Inc. | Regulatory Attralus Receives U.S. FDA Orphan Drug Designation for AT-01 (Iodine (I-124) Evuzamitide), an Investigational Diagnostic for the Management of Transthyretin Amyloidosis attralus.com ↗
Attralus, Inc., a clinical stage biopharmaceutical company developing transformative medicines to improve the lives of patients with systemic amyloidosis, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for 124I-AT-01 (iodine (I-124) evuzamitide) as a diagnostic for the management of transthyretin amyloidosis (ATTR). |
| 2022-06-14 | Attralus, Inc. | Results Positive New Data from Phase 1/2 Trial of AT-01 (Iodine I-124 Evuzamitide) Presented at 2022 Society of Nuclear Medicine & Molecular Imaging Annual Meeting attralus.com ↗
AT-01 detected patients with diverse types of systemic amyloidosis, by PET/CT imaging, with high sensitivity, notably in the heart |
| 2022-04-04 | Attralus, Inc. | Results Positive New Data from Phase 1/2 Trial of AT-01 Presented at 2022 American College of Cardiology Annual Scientific Session attralus.com ↗ |
| 2021-12-13 | Attralus, Inc. | Results Attralus Presents Positive New Data at 2021 American Society of Hematology Annual Meeting attralus.com ↗
Attralus also announced new clinical data from the University of Tennessee from its Phase 1/2 trial of 124I-AT-01,the company’s pan-amyloid binding peptide in development as a radiotracer for the diagnosis of systemic amyloidosis. |
| 2021-06-15 | Attralus, Inc. | Results Attralus Announces Presentation of Clinical Data on AT-01, a Novel Diagnostic for Systemic Amyloidosis, at the 2021 Society of Nuclear Molecular Imaging Meeting attralus.com ↗
The data demonstrated that positron emission tomography (PET) and computed tomography (CT) imaging using AT-01 enabled detection of seven types of amyloid (ATTRwt, ATTRv, AL, ALys, AGel, AApoA1, and ALect2) and identified amyloid in anatomic sites not detected clinically, including pre-symptomatic cardiac amyloid. |
| 2021-05-17 | Attralus, Inc. | Results Attralus Announces Presentation of Clinical Data on AT-01, a Novel, Potential First-in-Class Diagnostic for Systemic Amyloidosis at the 2021 American College of Cardiology Annual Meeting attralus.com ↗
AT-01 detected cardiac amyloid in AL and ATTR patients with known cardiac disease with 95% sensitivity |
| 2020-11-05 | Attralus, Inc. | Results Attralus to Present Clinical Data at Upcoming Virtual ASH 2020 attralus.com ↗
Analysis of PET images indicated retention of 124I-p5+14 (AT-01) in the heart, kidneys, liver, spleen, pancreas, bone marrow, lung, |
| 2020-09-14 | Attralus, Inc. | Results Attralus Presents Preclinical and Clinical Data at 17th International Symposium on Amyloidosis attralus.com ↗
Preliminary data show safety and efficacy of AT-01 as a pan-amyloid imaging |
All press releases naming this drug 18 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IODINE I124 EVUZAMITIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314633 ↗ |
| Known as | 124I AT-01 | “124I-AT-01 is an amyloid-reactive synthetic 45-L amino acid polypeptide radiolabeled with iodine-124, with a theoretical molecular weight of 4763.6 Da (based on amino acid sequence).” NCT06974877 ↗ |
| Known as | 124I-p5+14 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03678259 ↗ |
| Known as | APi1832 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314633 ↗ |
| Known as | AT01 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00788229 ↗ |
| Known as | Evuzamitide iodine i-124 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314633 ↗ |
| Known as | Iodine (124i) evuzamitide | ChEMBL registry synonym — accepted as the source's own label CHEMBL5314633 ↗ |
| Known as | p5+14 | “The investigational drug product (designated 124I-p5+14 Injection) is an amyloid-reactive synthetic peptide, p5+14 (also known as APi1832), radiolabeled with iodine-124 (I-124 or 124I).” NCT03678259 ↗ |
| Modality | Peptide | “a formulation of a synthetic, all natural, 45 amino acid peptide (MW = 4766.4) with a net +12 positive charge” NCT03678259 ↗ |
| Route | Other | “eye drop for 12 weeks” NCT00788229 ↗ |