eplontersen
eplontersen: sourced relationships with 1 company · 5 clinical trials tracked · 1 FDA decision.
eplontersen evidence translation
What we can confirm
1 FDA record · 5 tracked trials
What it means
What to watch
Prepared research question
How could eplontersen → AZN affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence0 indications · 1 study sponsors
Related indications
No linked indication is available.
Study sponsors
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| ASTRAZENECA PLC (AZN) Reported 2023-12-21 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (5)
A Phase IIb, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate the Efficacy and Safety of Concomitant Use of Eplontersen and ALXN2220 Compared With Eplontersen and Placebo in Adult Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
Primary endpoint: Cardiopulmonary exercise test peak VO2
A Phase 3, Randomized Study, With Initial 24-week, Double-Blind and Placebo-Controlled Treatment Phase, Followed by An 80-week Open-label Extension Treatment Phase to Evaluate the Effect of Eplontersen on the Transthyretin Reduction and Long-Term Safety in Chinese Participants With Transthyretin Amyloid Cardiomyopathy (EPIC-ATTR)
Primary endpoint: Percent change of serum TTR concentration from baseline
An Open-Label Extension Study to Assess the Long-Term Safety of Eplontersen (ION-682884) in Patients With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
Primary endpoint: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
An Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy
Primary endpoint: Change From Baseline in Platelet Count
A Phase 3 Global, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
Primary endpoint: Composite Outcome of Cardiovascular (CV) Mortality and Recurrent CV Clinical Events up to Week 140
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with eplontersen?
eplontersen has dated SEC/FDA relationship records for ASTRAZENECA PLC.
How many clinical trials involve eplontersen?
BioSniper tracks 5 clinical trials involving eplontersen.
What is eplontersen's latest FDA decision?
The most recent tracked FDA decision for eplontersen is Approval for 1 INDICATIONS AND USAGE WAINUA is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. WAINUA is a transthyretin-directed antisense oligonucleotide indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. ( 1 ), dated December 21, 2023.