Wainua (autoinjector)

(Eplontersen)

Phase 3RNA therapy

Wainua (autoinjector) is one of 41 small molecule programs targeting Transthyretin Amyloid Cardiomyopathy (ATTR-CM). It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Transthyretin Amyloid Cardiomyopathy (ATTR-CM)Active, not recruiting

CardiomyopathyEnrolling by invitation

Transthyretin Amyloid CardiomyopathyActive, not recruiting

PolyneuropathyActive, not recruiting

Transthyretin Amyloid Cardiomyopathy (ATTR-CM)Phase 2

Active, not recruiting

CardiomyopathyPhase 3

Enrolling by invitation

Transthyretin Amyloid CardiomyopathyPhase 3

Active, not recruiting

PolyneuropathyPhase 3

Active, not recruiting

Competition

Competitive Landscape

37 competitors in Cardiomyopathy

#DrugCompanyPhaseTrials

Bayer Aspirin

Bayer

Approved

1 2

Ozempic

Novo Nordisk

Approved

1 3

Inspra

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

2 4

Rayos

RRoxane Laboratories

Approved

2 5

Imuran

LLegacy Health System

Approved

1 6

Zocor

OOrganon and Co

Approved

1 7

Brevibloc

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Approved

1 8

Cordarone

WWyeth-Lederle Vaccines

Approved

1 9

Inpefa

LLexicon Pharmaceuticals

Approved

—10

Lipitor

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Transthyretin Amyloid Cardiomyopathy

NCT06194825

Q1 2029

Phase 2Active, not recruiting

Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

NCT07608354

Q3 2029

Phase 3Active, not recruiting

Polyneuropathy

NCT05071300

Clinical

Trials by Indication[1]

Polyneuropathy2 trials

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

Active, not recruiting· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals·Phase 3·NCT05071300·151 enrolled

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

Completed· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals·Phase 3·NCT04136184·168 enrolled

Cardiomyopathy1 trial

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

Enrolling by invitation· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals·Phase 3·NCT05667493·1,400 enrolled

Transthyretin Amyloid Cardiomyopathy1 trial

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

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06194825·64 enrolled

Tics1 trial

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

Completed· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals·Phase 1·NCT04302064·24 enrolled

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)1 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)

Completed· Ionis Pharmaceuticals logo

Ionis Pharmaceuticals·Phase 3·NCT04136171·1,438 enrolled

1 more indication

Transthyretin Amyloid Cardiomyopathy (ATTR-CM)1 trial

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)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT07608354·326 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 21, 2023

WAINUA (AUTOINJECTOR)

NDA NDA217388

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Eplontersen. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Eplontersen compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Eplontersen. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA217388). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Wainua (autoinjector). U.S. Food & Drug Administration.
[6]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: RNA therapy[2]
Highest Phase: Phase 3[1]
Company: AstraZeneca

Patent Landscape[5]

Patent Cliff

May 1, 2034

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8101743Apr 1, 2026

9127276May 1, 2034

10683499Aug 25, 2034

Wainua (autoinjector)

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q1 2029

Q3 2029

Trials by Indication[1]

Polyneuropathy2 trials

Cardiomyopathy1 trial

Transthyretin Amyloid Cardiomyopathy1 trial

Tics1 trial

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)1 trial

Transthyretin Amyloid Cardiomyopathy (ATTR-CM)1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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