CDEK
← All drugs Report issue

Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen

Trade name: Gintuit

Cell therapyapproved

Approved

Mar 9, 2012

Clinical trial activity

1 trials · 2 clinical orgs · 2 marketing orgs

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

Earliest trial started Jul 1, 2013 (NCT01929954)

Timeline

2010s

  1. Mar 9, 2012

    Earliest FDA Approval

  2. Mar 15, 2012

    Organogenesis — First NDA Organization

  3. Mar 15, 2012

    Organogenesis — NDA Organization

  4. Jan 1, 2013

    Organogenesis — Earliest Phase 1 Sponsor(trial)

2020s

  1. Jun 15, 2021

    Mallinckrodt (2013) — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedMar 9, 2012

Chemistry & pharmacology

Oral

No

Parenteral

No

Topical

No

Also known as

  • allogeneic cultured keratinocytes and fibroblasts in bovine collagen
  • gintuit
  • gintuit

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT01929954Phase 1/Phase 2 (Phase 2)Jul 1, 2013Kevin G. Murphy Associates, P.A., Organogenesis
Showing 1 of 1 trials
Page 1 / 1

Organizations

Research & Development (2)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Kevin G. Murphy Associates, P.A.Academic/Hospital1012013
OrganogenesisFor profit1112013
2 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
Mallinckrodt (2013)For profitNDA2Jun 15, 2021
OrganogenesisFor profitNDAMar 15, 2012