Acoramidis

Generic Name: Acoramidis

Drug Type: Small Molecule

Chemical Formula: C_₁₅H_₁₇FN_₂O_₃

CAS Number: 1446711-81-4

Unique Ingredient Identifier: T12B44A1OE

Clinical Trials

Acoramidis Transthyretin Amyloidosis Prevention Trial in the Young (ACT-EARLY) Study in Asymptomatic Carriers of a Pathogenic TTR Variant

Phase 3

Recruiting

Conditions: Cardiomyopathies
Polyneuropathies
Amyloidosis
Transthyretin Amyloidosis
Amyloid Cardiomyopathy
Heart Diseases

Interventions: Drug: Acoramidis
Drug: Placebo oral tablet

First Posted Date: 2024-08-21

Last Posted Date: 2025-05-20

Lead Sponsor: Eidos Therapeutics, a BridgeBio company

Target Recruit Count: 582

Registration Number: NCT06563895

Locations: 🇪🇸
Hospital Universitario Puerta de Hierro, Majadahonda, Spain
🇺🇸
Yale University School of Medicine - Section of Cardiology, New Haven, Connecticut, United States
🇺🇸
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States

and more 19 locations

Open-Label Safety Study of Acoramidis (AG10) in Symptomatic ATTR Participants

Phase 3

Active, not recruiting

Conditions: Amyloid Cardiomyopathy, Transthyretin-Related

Interventions: Drug: Acoramidis (AG10)

First Posted Date: 2021-08-03

Last Posted Date: 2025-03-30

Lead Sponsor: Eidos Therapeutics, a BridgeBio company

Target Recruit Count: 389

Registration Number: NCT04988386

Locations: 🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States
🇺🇸
University of Colorado Hospital - Anschutz Medical Campus, Aurora, Colorado, United States
🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States

and more 69 locations

Study to Assess the Effect of Food on a Single Dose of Acoramidis in Healthy Adult Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Acoramidis

First Posted Date: 2021-07-12

Last Posted Date: 2021-09-24

Lead Sponsor: Alexion Pharmaceuticals, Inc.

Target Recruit Count: 18

Registration Number: NCT04958135

Locations: 🇺🇸
Celerion, Lincoln, Nebraska, United States

Efficacy and Safety of Acoramidis (AG10) in Subjects With Transthyretin Amyloid Polyneurophathy (ATTRibute-PN)

Phase 3

Withdrawn

Conditions: Transthyretin-Related (ATTR) Familial Amyloid Polyneuropathy

Interventions: Drug: Acoramidis

First Posted Date: 2021-05-12

Last Posted Date: 2022-02-09

Lead Sponsor: Eidos Therapeutics, a BridgeBio company

Registration Number: NCT04882735

A Single Dose Study to Evaluate the Pharmacokinetics of Acoramidis Modified Release Formulations in Healthy Subjects

Phase 1

Completed

Conditions: Amyloidosis

Interventions: Drug: acoramidis

First Posted Date: 2021-02-24

Last Posted Date: 2022-03-23

Lead Sponsor: Eidos Therapeutics, a BridgeBio company

Target Recruit Count: 14

Registration Number: NCT04769479

Locations: 🇬🇧
Quotient Sciences, Ruddington, Nottingham, United Kingdom

A Phase 3 Study of ALXN2060 in Japanese Participants With Symptomatic ATTR-CM

Phase 3

Active, not recruiting

Conditions: Symptomatic Transthyretin Amyloid Cardiomyopathy

Interventions: Drug: ALXN2060

First Posted Date: 2020-11-09

Last Posted Date: 2024-12-16

Lead Sponsor: Alexion Pharmaceuticals, Inc.

Target Recruit Count: 25

Registration Number: NCT04622046

Locations: 🇯🇵
Research Site, Suita-shi, Japan

Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Polyneurophathy

Phase 3

Withdrawn

Conditions: Transthyretin-Related (ATTR) Familial Amyloid Polyneuropathy

Interventions: Drug: AG10
Drug: Placebo

First Posted Date: 2020-06-05

Last Posted Date: 2021-06-16

Lead Sponsor: Eidos Therapeutics, a BridgeBio company

Registration Number: NCT04418024

Locations: 🇺🇸
Eidos Therapeutics, San Francisco, California, United States

Efficacy and Safety of AG10 in Subjects With Transthyretin Amyloid Cardiomyopathy

Phase 3

Completed

Conditions: Transthyretin Amyloidosis
Amyloidosis
Amyloid Cardiomyopathy
Cardiomyopathies
Heart Diseases

Interventions: Drug: Placebo Oral Tablet
Drug: acoramidis

First Posted Date: 2019-03-04

Last Posted Date: 2024-06-27

Lead Sponsor: Eidos Therapeutics, a BridgeBio company

Target Recruit Count: 632

Registration Number: NCT03860935

Locations: 🇺🇸
Piedmont Heart Institute Athens, Athens, Georgia, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
The University of Chicago Medical Center, Chicago, Illinois, United States

and more 100 locations

Open-Label Study of AG10 in Patients with Cardiomyopathy

Phase 2

Active, not recruiting

Conditions: Amyloid Cardiomyopathy

Interventions: Drug: AG10

First Posted Date: 2018-05-25

Last Posted Date: 2025-03-13

Lead Sponsor: Eidos Therapeutics, a BridgeBio company

Target Recruit Count: 55

Registration Number: NCT03536767

Locations: 🇺🇸
Yale University, New Haven, Connecticut, United States
🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States

and more 6 locations

Study of AG10 in Amyloid Cardiomyopathy

Phase 2

Completed

Conditions: Familial ATTR-CM (ATTRm-CM, or FAC)
Wild-type ATTR-CM (ATTRwt-CM)

Interventions: Drug: AG10
Drug: Placebo Oral Tablet

First Posted Date: 2018-03-08

Last Posted Date: 2022-11-16

Lead Sponsor: Eidos Therapeutics, a BridgeBio company

Target Recruit Count: 49

Registration Number: NCT03458130

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States
🇺🇸
Brigham and Women's Hospital, Boston, Massachusetts, United States

and more 10 locations

Drug Development Updates

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