TZIELD (teplizumab-mzwv)
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.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2022-11-17
- Revenue
- $18M (Q4-2025)
- 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
TZIELD Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TZIELD's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TZIELD treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TZIELD
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07088068 βETA PRESERVE | EFC18241 2024-519494-19, U1111-1306-7316 | Ph 3 | recruiting | A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes |
| NCT06791291 KIBOU-T1D | ACT18487 U1111-1308-1324, jRCT2031240637 | Ph 2 | recruiting | Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes |
| NCT07216391 TN40A | TN40A | Ph 2 | not yet recruiting | Platform Trial to Delay Stage 3 Diabetes: Comparing Teplizumab With ATG |
| NCT05757713 PETITE-T1D | PRV-031-005 SFY18116 | Ph 4 | active not recruiting | Teplizumab in Pediatric Stage 2 Type 1 Diabetes |
| NCT03875729 PROTECT results posted | PRV-031-001 | Ph 3 | completed | Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab |
| NCT03751007 results posted | AG019-T1D-101 2017-002871-24 | Ph 1, Ph 2 | completed | A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recent-onset Diagnosed Type 1 Diabetes (T1D) |
| NCT00954915 results posted | CP-MGA031-04 | Ph 1, Ph 2 | terminated | Safety Study of the Monoclonal Antibody Teplizumab (MGA031) in Subjects With Moderate or More Severe Psoriasis |
| NCT01030861 results posted | TrialNet - tep (IND) UC4DK106993 | Ph 2 | completed | Teplizumab for Prevention of Type 1 Diabetes In Relatives "At-Risk" |
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
Indications & Usage
FDA Label (PDF)TZIELD is indicated for the treatment of Type 1 Diabetes.
Pro Intelligence Preview
Deep insights for TZIELD
Revenue Insights
- • Q4-2025: $18M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • 8 total trials
- • Stage: Stable
Competitive Landscape
- • 5 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment