Data updated: May 26, 2026
Gintuit (allogeneic cultured keratinocytes and fibroblasts in bovine collagen)
Approved 2012-03-08
1
Indication
--
Phase 3 Trials
14
Years on Market
Details
- Status
- Disc
- First Approved
- 2012-03-08
- Routes
- Topical
- Dosage Forms
- Cellular Sheet
Companies
Active Ingredient: Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen
Website: ↗
Gintuit Approval History
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2012 to 2012
Mar 2012 ORIGINAL
Update · CBER biologic (Purple Book)
What Gintuit Treats
1 FDA approvalsOriginally approved for its first indication in 2012 .
- Other (1)
Other
(1 approval)- • Approved indication (Mar 2012)
📋
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01929954 | 11-PER-005-GT | Ph 1, Ph 2 | terminated | Safety Study of Gintuit™ in Subjects Requiring Socket Grafting |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
Gintuit FDA Label Details
Track Gintuit with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.