A Phase 3 interventional study of Acoramidis (AG10) in Amyloidosis in Transthyretin (TTR), Amyloidosis, Familial and Amyloid Cardiomyopathy, sponsored by Eidos Therapeutics, a BridgeBio company. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Eidos Therapeutics, a BridgeBio company (part of BridgeBio) · Phase 3, Interventional, and Treatment
The AG10-504 study is an open-label extension study of acoramidis in participants with newly diagnosed transthyretin amyloid cardiomyopathy (ATTR-CM) or both ATTR-CM and transthyretin amyloid polyneuropathy (ATTR-PN).
The AG10-504 study is the extension of the Phase 3 AG10-501 study (ACT-EARLY) which was designed to investigate if the use of acoramidis as a preventative intervention in individuals who are carriers of a known pathogenic transthyretin (TTR) variant but with no clinical evidence of ATTR could prevent or delay the onset of clinically detectable ATTR and the considerable morbidity and mortality that result from this devastating, progressive, and ultimately fatal disease. Only participants who have completed the AG10-501 study (ACT-EARLY) with a diagnosis of ATTR-CM may enroll in this AG10-504 Open Label Extension (OLE) study.
The primary objective of the AG10-504 study is to evaluate the long-term safety and tolerability of acoramidis in participants with newly diagnosed ATTR-CM. The duration of this study will be up to 5 years.
Currently, acoramidis is approved for the treatment of ATTR-CM in some regions including the United States, all member states of the European Union (EU), Albania, Bosnia Herzegovina, Brazil, Iceland, Israel, Japan, Liechtenstein, Montenegro, North Macedonia, Norway, Switzerland, and the United Kingdom (UK).
82 studies on the registry are indexed under Amyloidosis, Hereditary, Transthyretin-Related; 28 are open to participants now.
This study's planned enrollment of 250 is above the median of 80 across 36 interventional studies indexed under Amyloidosis, Hereditary, Transthyretin-Related.
Browse Amyloidosis, Hereditary, Transthyretin-Related studies →Eidos Therapeutics, a BridgeBio company is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
First submitted after Eidos Therapeutics became part of BridgeBio.
Compared within Amyloidosis, Hereditary, Transthyretin-Related, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Amyloidosis, Familial. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Key Inclusion Criteria:
Participants must have completed the AG10-501 study (ACT-EARLY study) within the past 60 calendar days with a diagnosis of ATTR-CM (based on the AG10-501 protocol definition of ATTR-CM).
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive acoramidis 712 mg orally BID (which is equivalent to 800 mg acoramidis HCl BID)
Drug: Acoramidis (AG10)
TTR stabilizer administered orally twice daily (BID)
Also known as: ALXN2060
To evaluate the long-term safety and tolerability of acoramidis in participants with newly diagnosed ATTR-CM
Proportion of participants with: treatment-emergent AEs and SAEs, AEs leading to treatment discontinuation, abnormal physical examination findings of clinical relevance, abnormal vital signs of clinical relevance, abnormal ECG parameters of clinical relevance, changes in clinical safety laboratory parameters of potential concern
Time frame: The duration of study participation for the participants will be up to 5 years.
No study locations are listed for this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Acoramidis
Amyloidosis, Hereditary, Transthyretin-Related →
Eidos Therapeutics, a BridgeBio company →