CDEK
← All drugs Report issue

acellular tissue engineered vessel

Trade name: Symvess

Cell therapyapproved

Approved

Dec 19, 2024

Clinical trial activity

7 trials · 6 clinical orgs · 1 marketing orgs

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

Earliest trial started May 24, 2016 (NCT02644941)

Timeline

2010s

  1. Jan 1, 2016

    Humacyte, Inc. — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2016

    Humacyte, Inc. — Earliest Phase 3 Sponsor(trial)

2020s

  1. Dec 19, 2024

    Humacyte, Inc. — Earliest FDA Approval

  2. Dec 19, 2024

    Humacyte, Inc. — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

  • ArteryTissue restoration

    Artery tissue restoration

Approval history

  • approvedDec 19, 2024

Chemistry & pharmacology

Oral

No

Parenteral

No

Topical

No

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05908084Phase 3Sep 7, 2023Humacyte, Inc., IQVIA
NCT03005418Phase 2/Phase 3 (Phase 3)Sep 1, 2018Atlantic Research Group, Humacyte, Inc., United States Army
NCT03183245Phase 3Sep 29, 2017California Institute for Regenerative Medicine (CIRM), CTI Clinical Trial and Consulting Services, Humacyte, Inc.
NCT02887859Phase 2Dec 20, 2016Atlantic Research Group, Humacyte, Inc.
NCT02644941Phase 3May 24, 2016California Institute for Regenerative Medicine (CIRM), CTI Clinical Trial and Consulting Services, Humacyte, Inc.
NCT07141641N/A—Humacyte, Inc.
NCT03631056N/A—Humacyte, Inc.
Showing 7 of 7 trials
Page 1 / 1

Organizations

Research & Development (6)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Humacyte, Inc.For profit7732016
Atlantic Research GroupAcademic/Hospital2022016
California Institute for Regenerative Medicine (CIRM)Academic/Hospital2012016
CTI Clinical Trial and Consulting ServicesFor profit2012016
IQVIAFor profit1012023
United States ArmyGovernment1012018
6 organizations
Page 1 / 1

Marketing (1)

OrganizationOrg typeRelationshipDate
Humacyte, Inc.For profitNDADec 19, 2024