Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
124I-Evuzamitide · 1 trial · 2 indications
To evaluate the efficacy of I-124 evuzamitide for diagnosing cardiac amyloidosis based on visual scan interpretation, compared to SoC site diagnosis. We will assess: * The sensitivity of PET/MRI with 124I-evuzamitide PET/MRI for the diagnosis of cardiac amyloidosis. * The specificity of PET/MRI with 124I-evuzamitide for the diagnosis of cardiac amyloidosis.
| Arm | Type | Description |
|---|---|---|
| Patients with ATTR-CM | EXPERIMENTAL | Patients with ATTR-CM will undergo hybrid 124I-Evuzamitide PET/MRI imaging (or PET/CT) at baseline and in a subgroup, repeat imaging will be performed at an interval of 6-12 months. |
| Name | Type | Description |
|---|---|---|
| 124I-Evuzamitide | DIAGNOSTIC_TEST | Amyloid reactive protein used as imaging agent to detect systemic amyloidosis |
Inclusion Criteria: 1. Subjects will at least have one of the following conditions: systemic amyloidosis with known organ involvement, carrier of a known pathogenic mutation in the transthyretin gene, multiple myeloma, and monoclonal gammopathy of undetermined significance 2. Patient willing to con...
124I-Evuzamitide is an investigational diagnostic agent being studied for use in amyloidosis, specifically for characterizing systemic amyloidosis and transthyretin amyloidosis. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
124I-Evuzamitide is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY on the OTC market. The drug is currently in Phase 2 clinical trials for amyloidosis.
124I-Evuzamitide is currently in Phase 2 clinical development. It is an investigational agent being studied for amyloidosis and has not yet received regulatory approval. The ongoing Phase 2 trial is actively recruiting participants in the United States.
124I-Evuzamitide is being evaluated in a Phase 2 clinical trial with the identifier NCT05758493. This trial, titled 'Characterizing Iodine-124 Evuzumitide (AT-01) in Systemic Amyloidosis,' is recruiting 150 participants aged 40 years and older in the United States.
Yes, 124I-Evuzamitide is also known as AT-01. The ongoing Phase 2 clinical trial NCT05758493 refers to the drug as 'Iodine-124 Evuzumitide (AT-01)' in its title, confirming that these names refer to the same investigational agent.