Does the FDA approved drug Tzield delay the onset of Stage 3 Type 1 diabetes?
Tzield (teplizumab) is a medication approved by the U.S. Food and Drug Administration (FDA) to delay the onset of Stage 3 type 1 diabetes (T1D) in people who already have Stage 2 T1D. Stage 2 means the person has two or more diabetes-related autoantibodies and abnormal blood sugar levels but no symptoms yet. Stage 3 is when symptoms appear and insulin treatment is needed. Tzield is given as an intravenous infusion and works by targeting certain immune cells to slow the attack on insulin-producing beta cells in the pancreas.
What the research says
The FDA approval of Tzield was based on clinical trial results showing it can delay the onset of Stage 3 T1D. In one key study, people with Stage 2 T1D who received teplizumab had a significantly lower risk of progressing to Stage 3 compared to those who received a placebo 610. The drug is indicated for adults and children aged 8 years and older with Stage 2 T1D 610.
A 2023 phase 3 trial in children and adolescents with newly diagnosed (Stage 3) T1D found that teplizumab helped preserve beta-cell function, as measured by C-peptide levels, compared to placebo 9. This suggests the drug can slow disease progression even after diagnosis.
Real-world experiences from a 2025 survey of people who received teplizumab at Stage 2 showed that most felt grateful for the treatment and believed it would help slow the disease or make T1D easier to manage 11. However, many still expressed concern about diabetes progression 11.
What to ask your doctor
- Am I or my child a candidate for Tzield? The drug is for people with Stage 2 type 1 diabetes, which requires specific antibody and blood sugar testing.
- What are the possible side effects of Tzield? Common side effects include low white blood cell count, rash, and headache.
- How is Tzield given? It is given as an intravenous infusion over several days, typically in a clinic or hospital setting.
- How much does Tzield cost and will my insurance cover it? This is a new and expensive medication, so check coverage and any patient assistance programs.
- What should I expect after treatment? Tzield delays but does not prevent type 1 diabetes, so regular monitoring for progression to Stage 3 is still needed.
This question is drawn from common patient questions about Diabetes & Endocrinology and answered using cited medical research. We do not provide individualized advice.