AKCEA-TTR-LRx

Overview

AKCEA-TTR-LRx is under investigation in clinical trial NCT04136184 (Neuro-ttransform: A Study to Evaluate the Efficacy and Safety of Akcea-ttr-lrx in Participants With Hereditary Transthyretin-mediated Amyloid Polyneuropathy).

Background

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Assess the PK, PD, Safety and Tolerability of Eplontersen in Healthy Chinese Volunteers	2024/07/30	NCT06527755	Phase 1	Completed	AstraZeneca
EPIC-ATTR: A Study to Evaluate the Effect of Eplontersen on the Transthyretin Reduction and Long-term Safety in Chinese Subjects With Transthyretin Amyloid Cardiomyopathy	2024/01/08	NCT06194825	Phase 3	Active, not recruiting	AstraZeneca
An Extension Study to Assess Long-Term Safety of Eplontersen in Adults With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)	2022/12/28	NCT05667493	Phase 3	Recruiting	Ionis Pharmaceuticals, Inc.
A Study to Assess the Long-Term Safety and Efficacy of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Patients With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy	2021/10/08	NCT05071300	Phase 3	Active, not recruiting	Ionis Pharmaceuticals, Inc.
ION-682884 in Patients With TTR Amyloid Cardiomyopathy	2021/04/13	NCT04843020	Phase 2	Not yet recruiting	Brigham and Women's Hospital
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending and Multiple Doses of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Healthy Japanese Participants	2020/03/10	NCT04302064	Phase 1	Completed	Ionis Pharmaceuticals, Inc.
NEURO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy	2019/10/23	NCT04136184	Phase 3	Completed	Ionis Pharmaceuticals, Inc.
CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)	2019/10/23	NCT04136171	Phase 3	Active, not recruiting	Ionis Pharmaceuticals, Inc.
Evaluate the Safety and Tolerability, as Well as the Pharmacokinetic and Pharmacodynamic Profiles of Single and Multiple Doses of Eplontersen Administered Subcutaneously to Healthy Volunteers and Patients With Hereditary Transthyretin-Mediated Amyloidosis (hATTR ).	2018/11/02	NCT03728634	Phase 1	Completed	Ionis Pharmaceuticals, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
WAINUA	AstraZeneca Pharmaceuticals LP	0310-9400	SUBCUTANEOUS	45 mg in 45 mg	12/21/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

EU Approves WAINZUA (Eplontersen) for Hereditary Transthyretin-Mediated Amyloidosis with Polyneuropathy

4 months ago

The European Commission has approved WAINZUA (eplontersen), developed by Ionis Pharmaceuticals and AstraZeneca, for treating hereditary transthyretin-mediated amyloidosis with polyneuropathy (ATTRv-PN) in adult patients with stage 1 or 2 disease.

Alnylam's Vutrisiran Shows Strong Efficacy in ATTR Cardiomyopathy, Setting Stage for New Treatment Standard

4 months ago

Alnylam's RNAi drug vutrisiran demonstrated a 28% reduction in all-cause mortality and recurrent cardiovascular events in ATTR cardiomyopathy patients, with efficacy increasing to 33% in patients not taking Pfizer's tafamidis.

FDA Approves BridgeBio's Attruby, Setting Up Competition with Pfizer's Vyndamax in ATTR-CM Market

7 months ago

The FDA has approved BridgeBio Pharma's Attruby (acoramidis) for transthyretin amyloidosis cardiomyopathy (ATTR-CM), a heart condition leading to heart failure and death.

BridgeBio's Acoramidis Poised to Challenge Pfizer's Tafamidis in ATTR-CM Market