Data updated: May 26, 2026
StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat)
Approved 2021-06-14
1
Indication
--
Phase 3 Trials
4
Years on Market
Details
- Status
- Disc
- First Approved
- 2021-06-14
- Patent Cliff
- 2033
- Routes
- Topical
- Dosage Forms
- Cell Sheets
StrataGraft Approval History
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2021 to 2021
Jun 2021 ORIGINAL
Update · CBER biologic (Purple Book)
What StrataGraft Treats
1 FDA approvalsOriginally approved for its first indication in 2021 .
- Other (1)
Other
(1 approval)- • Approved indication (Jun 2021)
📋
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05517902 StrataSTEPS results posted | MNK15011001 | Ph 3 | completed | StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
Full development history with FDA approval milestones
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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.
StrataGraft FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.