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TZIELD (TEPLIZUMAB-MZWV)
TZIELD (generic name: TEPLIZUMAB-MZWV) is a CD3-directed Antibody [EPC] drug developed by PROVENTION BIO INC. It is currently FDA-approved for Delay onset of Stage 3 type 1 diabetes.
Teplizumab-mzwv (Tzield), developed by Provention Bio Inc, is a marketed drug designed to delay the onset of Stage 3 type 1 diabetes. Its key strength lies in being the first and only approved therapy for this indication, offering a unique mechanism of action. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | TEPLIZUMAB-MZWV |
|---|---|
| Sponsor | PROVENTION BIO INC |
| Drug class | CD3-directed Antibody [EPC] |
| Target | T-cell surface glycoprotein CD3 |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
Approved indications
- Delay onset of Stage 3 type 1 diabetes
Common side effects
- Lymphopenia
- Rash
- Leukopenia
- Headache
Serious adverse events
- Serious Infections (cellulitis, gastroenteritis, pneumonia, wound infection)
- Cytokine Release Syndrome (CRS)
- Serum Sickness
Key clinical trials
- An Open-Label Study to Evaluate the Safety of Teplizumab (PRV-031) in At-Risk Relatives Who Develop Type 1 Diabetes (Phase 2)
- TEPLIzumab: QUality of Life Evaluation During Stage Transition (N/A)
- A Randomized, Double-blind, Phase 3 Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Recently Diagnosed Stage 3 Type 1 Diabetes (T (Phase 3)
- An Observational, Long-term Safety Study of TZIELD® (Teplizumab-mzwv) in Patients With Stage 2 Type 1 Diabetes (N/A)
- Optimizing Stage 2 T1DM Management: Assessing the Impact of GLP-1Ra on Metabolic Outcomes in Patients Receiving Teplizumab (EARLY/Phase 1)
- Efficacy and Safety of Teplizumab in the Treatment of Japanese Pediatric and Adult Participants Aged 8 to 34 Years With Stage 2 Type 1 Diabetes: A Multicenter, Randomized, Open-label, Controlled Study (Phase 2)
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 |
|---|---|
| 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
Frequently asked questions about TZIELD
What is TZIELD?
What is TZIELD used for?
Who makes TZIELD?
What is the generic name of TZIELD?
What drug class is TZIELD in?
What development phase is TZIELD in?
What are the side effects of TZIELD?
What does TZIELD target?
Related
- Drug class: All CD3-directed Antibody [EPC] drugs
- Target: All drugs targeting T-cell surface glycoprotein CD3
- Manufacturer: PROVENTION BIO INC — full pipeline
- Therapeutic area: All drugs in Metabolic
- Indication: Drugs for Delay onset of Stage 3 type 1 diabetes
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing