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Acoramidis

DRUG8 trials

Sponsors

Eidos Therapeutics, a BridgeBio company, Alexion Pharmaceuticals, Inc., Bayer

Conditions

Amyloid CardiomyopathyAmyloidosisCardiomyopathiesHealthyHeart DiseasesPolyneuropathiesTransthyretin Amyloid CardiomyopathyTransthyretin Amyloid Cardiomyopathy (ATTR-CM)

Phase 1

A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis Modified Release Formulations in Healthy Subjects
CompletedNCT04769479
Eidos Therapeutics, a BridgeBio companyAmyloidosis
Start: 2021-03-28End: 2021-09-03Updated: 2024-09-19
Study to Assess the Effect of Food on a Single Dose of Acoramidis in Healthy Adult Participants
CompletedNCT04958135
Alexion Pharmaceuticals, Inc.Healthy
Start: 2021-05-30End: 2021-08-04Updated: 2026-03-06

Phase 3

Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy
CompletedNCT03860935
Eidos Therapeutics, a BridgeBio companyAmyloid Cardiomyopathy, Amyloidosis, Cardiomyopathies +2
Start: 2019-03-19End: 2023-05-11Updated: 2024-06-27
Efficacy and Safety of Acoramidis (AG10) in Subjects with Transthyretin Amyloid Polyneurophathy (ATTRibute-PN)
WithdrawnNCT04882735
Eidos Therapeutics, a BridgeBio companyTransthyretin-Related (ATTR) Familial Amyloid Polyneuropathy
Start: 2021-09-08End: 2026-10-31Updated: 2024-09-19
Acoramidis Transthyretin Amyloidosis Prevention Trial in the Young (ACT-EARLY) Study in Asymptomatic Carriers of a Pathogenic TTR Variant
RecruitingNCT06563895
Eidos Therapeutics, a BridgeBio companyAmyloid Cardiomyopathy, Amyloidosis, Cardiomyopathies +3
Start: 2025-05-12End: 2032-12-01Target: 587Updated: 2026-08-04

Phase 4

A Study to Learn More About the Change in the Blood Levels of Transthyretin When Participants With Transthyretin Amyloidosis With Cardiomyopathy Switch From Tafamidis to Acoramidis
RecruitingNCT07298044
BayerTransthyretin Amyloid Cardiomyopathy
Start: 2026-02-13End: 2027-07-15Target: 50Updated: 2026-09-10
Real-Life Clinical Efficacy of Acoramidis in Participants With ATTR-CM and Association With Cardiac Biomarkers
RecruitingNCT07306949
Alexion Pharmaceuticals, Inc.Transthyretin-type Cardiac Amyloidosis
Start: 2025-10-01End: 2028-03-31Target: 200Updated: 2026-01-07

Unknown Phase

Study of Acoramidis in Patients With Transthyretin Amyloid Cardiomyopathy
RecruitingNCT07791160
BayerTransthyretin Amyloid Cardiomyopathy (ATTR-CM)
Start: 2026-09-07End: 2028-12-31Target: 500Updated: 2026-09-15

Related Papers

ACO-SWITCH: Rationale and Design of a Phase 4 Study Evaluating Serum Transthyretin in ATTR-CM After Switching from Tafamidis to Acoramidis
Cardiology and Therapy2026-08-20
Effect of acoramidis on risk of death and heart problem-related hospitalizations in people with transthyretin amyloid cardiomyopathy: a plain language summary
Future Cardiology2026-08-05
Rationale and Design of ACO-REAL: A Real-World Non-Interventional Study of Acoramidis in Routine Clinical Practice.
2026-07-31
Effect of Acoramidis on Heart Failure–Related Health Status
JAMA Cardiology2026-07-29
Effects of Acoramidis on Kidney Function in Transthyretin Amyloid Cardiomyopathy.
2026-07-02
Outpatient worsening heart failure in transthyretin amyloid cardiomyopathy: Findings from ATTRibute-CM.
2026-05-29
Efficacy of Acoramidis in Wild-Type and Variant Transthyretin Amyloid Cardiomyopathy: Results From ATTRibute-CM and Its Open-Label Extension.
2026-01-01
Abstract 4359483: Clinical Effects of Acoramidis Versus Placebo in the ATTRibute-CM Study: Observations from the Intention-to-Treat Population
Circulation2025-11-03
Abstract 4365761: Acoramidis Lowers NT-proBNP in a Larger Proportion of ATTRibute-CM Study Participants With Transthyretin Amyloid Cardiomyopathy Compared with Placebo, Independent of Atrial Fibrillation Status
Circulation2025-11-03
Abstract 4363872: Acoramidis Improved Clinical Outcomes, Function, Quality of Life and NT-proBNP in Patients With Transthyretin Amyloid Cardiomyopathy Regardless of Atrial Fibrillation Status at Baseline
Circulation2025-11-03
Timing of Mortality Benefit in Outcomes Trials in Transthyretin Amyloidosis.
2025-09-251 citations
A plain language review of the ATTRibute-CM study: efficacy and safety of acoramidis in transthyretin amyloid cardiomyopathy
Future Cardiology2025-09-10
Contemporary Oral Medication Use and Frequency in Patients with Transthyretin Amyloid Cardiomyopathy
American Journal of Cardiovascular Drugs2025-08-01
Early Increase in Serum Transthyretin by Acoramidis Independently Predicts Improved Survival in TTR Amyloid Cardiomyopathy.
2025-05-015 citations
Efficacy of Acoramidis on All-Cause Mortality and Cardiovascular Hospitalization in Transthyretin Amyloid Cardiomyopathy
Journal of the American College of Cardiology2025-03-0127 citations
Comparison of in-clinic assessment of 6MWT by conventional method and using wearable sensors for patients with ATTR-CM
Future Cardiology2025-01-25
Long-Term Efficacy and Safety of Acoramidis in ATTR-CM: Initial Report From the Open-Label Extension of the ATTRibute-CM Trial
Circulation2024-11-1838 citations
Efficacy and Safety of Acoramidis in Transthyretin Amyloid Cardiomyopathy
New England Journal of Medicine2024-01-10351 citations