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Tzield (TEPLIZUMAB)
Tzield works by binding to the CD3 complex on T-cells, preventing them from attacking pancreatic beta cells.
At a glance
| Generic name | TEPLIZUMAB |
|---|---|
| Sponsor | Provention Bio Inc |
| Drug class | CD3-directed Antibody [EPC] |
| Target | T-cell surface glycoprotein CD3 |
| Modality | Monoclonal antibody |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2022 |
Mechanism of action
Teplizumab-mzwv binds to CD3 (a cell surface antigen present on lymphocytes) and delays the onset of Stage type diabetes in adults and pediatric patients aged years and older with Stage type diabetes. The mechanism may involve partial agonistic signaling and deactivation of pancreatic beta cell autoreactive lymphocytes. Teplizumab-mzwv leads to an increase in the proportion of regulatory cells and of exhausted CD8+ cells in peripheral blood.
Approved indications
- Diabetes mellitus type 1
Common side effects
- Lymphopenia
- Rash
- Leukopenia
- Headache
- Neutropenia
- Increased alanine aminotransferase
- Nausea
- Diarrhea
- Nasopharyngitis
- Cytokine Release Syndrome (CRS)
- Serum sickness
- Anaphylaxis
Key clinical trials
- Long-Term Outcomes of Teplizumab in Routine Clinical Care
- Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)
- 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 (PHASE3)
- Platform Trial to Delay Stage 3 Diabetes: Comparing Teplizumab With ATG (PHASE2)
- Registry for Stage 2 Type 1 Diabetes
- Teplizumab in Pediatric Stage 2 Type 1 Diabetes (PHASE4)
- Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes (PHASE2)
- GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab (EARLY_PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tzield CI brief — competitive landscape report
- Tzield updates RSS · CI watch RSS
- Provention Bio Inc portfolio CI