Product
Eplontersen
Aliases
AKCEA-TTR-LRx, ION-682884, IONIS-TTR-LRx
Name
WAINUA
INN Name
EPLONTERSEN
FDA Approved
Yes
5 clinical trials
1 organization
3 indications
1 document
Indication
Transthyretin Amyloid CardiomyopathyClinical trial
A Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients With Hereditary Transthyretin-Mediated Amyloid PolyneuropathyStatus: Completed, Estimated PCD: 2023-04-11
Clinical trial
This Was a Phase 1/2, Double-blind, Randomized, Placebo-controlled, Dose-escalation Study Conducted at a Single Center for the Healthy Volunteer Cohorts in up to 56 Participants. It Consisted of 1 Single-dose Cohort and 3 Multiple-dose Cohorts (n = 12 Per Cohort, 10 Active:2 Placebo). The Open-label, hATTR Patient Cohort Portion of the Study Was Conducted at Multiple Centers.Status: Completed, Estimated PCD: 2020-02-20
Clinical trial
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)Status: Active (not recruiting), Estimated PCD: 2025-06-01
Clinical trial
An Open-Label, Extension Study to Assess the Long-Term Safety and Efficacy of ION-682884 in Patients With Hereditary Transthyretin-Mediated Amyloid PolyneuropathyStatus: Recruiting, Estimated PCD: 2024-07-01
Clinical trial
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)Status: Recruiting, Estimated PCD: 2025-03-15
Document
DailyMed Label: WAINUAOrganization
AstraZeneca Pharmaceuticals LP