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NCT05667493Phase 3ENROLLING BY INVITATION

An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

Study Summary

The purpose of this study is to evaluate the safety and tolerability of extended dosing with eplontersen in participants with ATTR-CM.

Conditions
Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
Interventions / Drugs
Eplontersen
View on ClinicalTrials.gov ↗
Sponsor
IONS
Ionis Pharmaceuticals
Antisense Therapeutics
D50/100
Study Details
Enrollment1400 participants
Primary Completion—
Lead SponsorIonis Pharmaceuticals, Inc.
Data Retrieved2026-04-11 04:17:53.139414+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Current status: ENROLLING BY INVITATION.

Enrolled: 1,400 participants
Sponsor Catalyst Profile

Ionis Pharmaceuticals (IONS) is the sponsoring company for this trial. BiotechSign currently grades this company D (50/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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