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vutrisiran

Trade name: Amvuttra

Nucleic acidapprovedOrphan Drug FDAFast Track FDA

Approved

Jun 13, 2022

Clinical trial activity

5 trials · 1 clinical orgs · 1 marketing orgs

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

Earliest trial started May 1, 2016 (NCT02797847)

Timeline

2010s

  1. Jan 1, 2016

    Alnylam Pharmaceuticals — Earliest Phase 1 Sponsor(trial)

  2. May 25, 2018

    Orphan Drug Designation

  3. Jan 1, 2019

    Alnylam Pharmaceuticals — Earliest Phase 3 Sponsor(trial)

2020s

  1. Jun 13, 2022

    Alnylam Pharmaceuticals — Earliest FDA Approval

  2. Jun 13, 2022

    Alnylam Pharmaceuticals — Marketing Organization

  3. Jun 13, 2022

    Alnylam Pharmaceuticals — NDA Secondary Org

  4. Jun 13, 2022

    Alnylam Pharmaceuticals — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedFast trackJun 13, 2022

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • aln-ttrsc02

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07223203Phase 3Dec 31, 2025Alnylam Pharmaceuticals
NCT06679946Phase 3Nov 22, 2024Alnylam Pharmaceuticals
NCT04153149Phase 3Nov 30, 2019Alnylam Pharmaceuticals
NCT03759379Phase 3Jan 18, 2019Alnylam Pharmaceuticals
NCT02797847Phase 1May 1, 2016Alnylam Pharmaceuticals
Showing 5 of 5 trials
Page 1 / 1

Organizations

Research & Development (1)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Alnylam PharmaceuticalsFor profit5522016
1 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
Alnylam PharmaceuticalsFor profitMKTGJun 13, 2022
Alnylam PharmaceuticalsFor profitNDA2Jun 13, 2022
Alnylam PharmaceuticalsFor profitNDAJun 13, 2022