TZIELD
TZIELD (teplizumab-mzwv) is a CD3-directed antibody indicated to delay the onset of Stage 3 type 1 diabetes. It is approved for use in adults and pediatric patients aged 8 years and older who have been diagnosed with Stage 2 type 1 diabetes. This medication provides a therapeutic intervention intended to postpone the progression to the symptomatic stage of the disease.
How TZIELD Works
Teplizumab-mzwv binds to CD3, a cell surface antigen found on T lymphocytes. This binding may involve partial agonistic signaling and the deactivation of autoreactive T lymphocytes that target pancreatic beta cells. The drug also increases the proportion of regulatory T cells and exhausted CD8+ T cells in the peripheral blood. These actions collectively work to delay the clinical onset of Stage 3 type 1 diabetes.
Details
- Status
- Prescription
- First Approved
- 2022-11-17
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TZIELD Approval History
What TZIELD Treats
1 indicationsTZIELD is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 1 Diabetes
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
TZIELD FDA Label Details
ProIndications & Usage
FDA Label (PDF)TZIELD is indicated to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and older with Stage 2 type 1 diabetes [see Dosage and Administration ] . TZIELD is a CD3-directed antibody indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D .
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.