CDEK
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Eplontersen

Trade name: Wainua

BiologicalapprovedOrphan Drug FDA

Approved

Dec 21, 2023

Clinical trial activity

5 trials · 4 clinical orgs · 2 marketing orgs

Phase 1
3
Phase 2
3
Phase 3
2
Phase 4
0

Earliest trial started Dec 21, 2018 (NCT03728634)

Timeline

2010s

  1. Jan 1, 2018

    Ionis Pharmaceuticals, Inc. — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2019

    Ionis Pharmaceuticals, Inc. — Earliest Phase 3 Sponsor(trial)

2020s

  1. Jan 6, 2022

    Orphan Drug Designation

  2. Dec 21, 2023

    Ionis Pharmaceuticals, Inc. — Earliest FDA Approval

  3. Dec 21, 2023

    AstraZeneca — Marketing Organization

  4. Dec 21, 2023

    Ionis Pharmaceuticals, Inc. — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 21, 2023

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06527755Phase 1Aug 6, 2024AstraZeneca, Capital Medical University
NCT04302064Phase 1Apr 30, 2020Ionis Pharmaceuticals, Inc.
NCT04136171Phase 3Nov 30, 2019Akcea Therapeutics, Ionis Pharmaceuticals, Inc.
NCT04136184Phase 3Oct 31, 2019Akcea Therapeutics, Ionis Pharmaceuticals, Inc.
NCT03728634Phase 1/Phase 2 (Phase 2)Dec 21, 2018Ionis Pharmaceuticals, Inc.
Showing 5 of 5 trials
Page 1 / 1

Organizations

Research & Development (4)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Ionis Pharmaceuticals, Inc.For profit4432018
Akcea TherapeuticsFor profit2012019
AstraZenecaFor profit1112024
Capital Medical UniversityAcademic/Hospital1012024
4 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
AstraZenecaFor profitMKTGDec 21, 2023
Ionis Pharmaceuticals, Inc.For profitNDADec 21, 2023