acoramidis: 5 clinical trials tracked.
What we can confirm
5 tracked trials
What it means
What to watch
Prepared research question
What is verified about acoramidis, and what remains unknown?
Traceable citations · Unknowns marked
FDA approved ATTRUBY (acoramidis) tablets on November 22, 2024 for adults with wild-type or variant ATTR cardiomyopathy, to reduce cardiovascular death and cardiovascular-related hospitalization.
U.S. ATTRUBY tablets; NDA 216540 original approval · 2024-11-22 · FDA source
BridgeBio identifies acoramidis as the project previously called AG10 and reports an Alexion license to develop, manufacture and commercialize it and its chemical forms in Japan. Current development status outside this dated, regional statement is unknown.
Eidos/Alexion Japan license reported by BridgeBio; acoramidis project formerly AG10 · Source date unknown · SEC source
The FDA ATTRUBY label identifies acoramidis hydrochloride as the tablet’s chemical form. Project aliases and chemical-form identities retain their own source scope.
FDA 2024 original ATTRUBY label; chemical form; exact label publication date unknown · Source date unknown · FDA source
A Phase 3, Open-Label, Multicenter, Extension Study of Acoramidis in Patients With Newly Diagnosed Variant Transthyretin Amyloid Cardiomyopathy (ACT-EARLY OLE)
Primary endpoint: To evaluate the long-term safety and tolerability of acoramidis in participants with newly diagnosed ATTR-CM
An Open-Label Study to Investigate the Long-Term Effects of Acoramidis on Cardiac Function, Structure and Cardiac Amyloid Burden in Participants With Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Primary endpoint: To assess the effect of acoramidis on cardiac function improvement by CMR in participants with ATTR-CM.
A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of Acoramidis for Transthyretin Amyloidosis Prevention in the Young (ACT-EARLY Trial)
Primary endpoint: Time to development of ATTR (ATTR-CM or ATTR-PN, whichever occurs first; centrally adjudicated)
An Open-Label Extension and Safety Monitoring Study of Acoramidis (AG10) in Participants With Symptomatic Transthyretin Amyloid Cardiomyopathy Who Completed the Phase 3 ATTRibute-CM Trial (AG10-301)
Primary endpoint: Incidence of treatment-emergent Adverse Events [Safety and Tolerability]
A Phase 1, Randomized, Open-Label, 2-Period, 2-Sequence, 2-Way Crossover Study to Assess the Effect of Food on the Single Dose Pharmacokinetics of Acoramidis in Healthy Participants
Primary endpoint: Maximum Observed Plasma Concentration (Cmax) Of Acoramidis: Fed (Test) Versus Fasted (Reference) Conditions