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Innovation of TZIELD

TZIELD is the first and only approved, disease-modifying treatment to delay the onset of stage 3 T1D (insulin-dependence) in those 8 years and older with stage 2 T1D.1,2

A young boy writing at his desk and smiling
A young boy writing at his desk and smiling

You can't control IF Stage 3 T1D will occur, but you can impact WHEN3

Patients with ≥2 islet AAbs will inevitably progress to be insulin dependent​.

Stage 2: No symptoms. Autoimmune attack. Greater than or equal to 2 AAbs means ~100% risk of insulin dependence. Stage 3: Symptomatic. Insulin dependence. Up to 62% of patients with T1D present with diabetic ketoacidosis (DKA) at diagnosis*. Progressive loss of beta-cell mass and function.
Stage 2: No symptoms. Autoimmune attack. Greater than or equal to 2 AAbs means ~100% risk of insulin dependence. Stage 3: Symptomatic. Insulin dependence. Up to 62% of patients with T1D present with diabetic ketoacidosis (DKA) at diagnosis*. Progressive loss of beta-cell mass and function.
For the first time ever, you can choose to impact an underlying autoimmune process of T1D and delay when insulin will be required.1,2
Stage 2: No symptoms. Autoimmune attack. More time in Stage 2. An autoreactive T cell, CD3, T-cell receptor, and TZIELD® (teplizumab-mzwv). Stage 3: Symptomatic. Insulin dependence. Up to 62% of patients with T1D present with DKA at diagnosis*. Progressive loss of beta-cell mass and function.
Stage 2: No symptoms. Autoimmune attack. More time in Stage 2. An autoreactive T cell, CD3, T-cell receptor, and TZIELD® (teplizumab-mzwv). Stage 3: Symptomatic. Insulin dependence. Up to 62% of patients with T1D present with DKA at diagnosis*. Progressive loss of beta-cell mass and function.

*Without screening.5

T1D progresses through 3 stages3

MECHANISM OF ACTION

TZIELD is an anti-CD3 monoclonal antibody1

  • TZIELD binds to CD3 antigens on the surface of T cells
  • The mechanism of action may involve the partial agonistic signaling and deactivation of autoreactive T cells that target pancreatic beta cells
  • TZIELD leads to an increase in the proportion of regulatory T cells and of exhausted CD8+ T cells in peripheral blood
An autoreactive T cell, CD3, T-cell receptor, and TZIELD® (teplizumab-mzwv)
An autoreactive T cell, CD3, T-cell receptor, and TZIELD® (teplizumab-mzwv)

Identifying patients’ risk via screening and monitoring to potentially impact when they progress.

A droplet with a checkmark on it
Value of proactive screening4,6-8
  • Reduces DKA risk and associated mortality
  • Allows time to prepare and build a support network​
  • Allows time for treatment considerations
An IV fluid bag
Value of TZIELD1,4,7
  • Delays the onset of Stage 3, when disease management becomes burdensome and lifestyle can become impacted
  • Offers time to seek T1D education and support
  • Provides more time for future treatments to become available

The ADA recommends that TZIELD should be discussed with selected individuals aged 8 years and older with Stage 2 T1D.9

There is currently no evidence to suggest that TZIELD will have any effect on burden of disease, outcomes, or life expectancy.

Important Safety Information Anchor

INDICATION

TZIELD is a CD3-directed monoclonal 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.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Cytokine Release Syndrome (CRS): CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration. Prior to TZIELD treatment, premedicate with antipyretics, antihistamines and/or antiemetics, and treat similarly if symptoms occur during treatment. If severe CRS develops, consider pausing dosing for 1 day to 2 days and administering the remaining doses to complete the full 14-day course on consecutive days; or discontinue treatment. Monitor liver enzymes during treatment. Discontinue TZIELD treatment in patients who develop elevated alanine aminotransferase or aspartate aminotransferase more than 5 times the upper limit of normal (ULN) or bilirubin more than 3 times ULN.
  • Serious Infections: Use of TZIELD is not recommended in patients with active serious infection or chronic infection other than localized skin infections. Monitor patients for signs and symptoms of infection during and after TZIELD administration. If serious infection develops, treat appropriately, and discontinue TZIELD.
  • Lymphopenia: Lymphopenia occurred in most TZIELD-treated patients. For most patients, lymphocyte levels began to recover after the fifth day of treatment and returned to pretreatment values within two weeks after treatment completion and without dose interruption. Monitor white blood cell counts during the treatment period. If prolonged severe lymphopenia develops (<500 cells per mcL lasting 1 week or longer), discontinue TZIELD.
  • Hypersensitivity Reactions: Acute hypersensitivity reactions including serum sickness, angioedema, urticaria, rash, vomiting and bronchospasm occurred in TZIELD-treated patients. If severe hypersensitivity reactions occur, discontinue TZIELD and treat promptly.
  • Vaccinations: The safety of immunization with live-attenuated (live) vaccines with TZIELD-treated patients has not been studied. TZIELD may interfere with immune response to vaccination and decrease vaccine efficacy. Administer all age-appropriate vaccinations prior to starting TZIELD.
    • Administer live vaccines at least 8 weeks prior to treatment. Live vaccines are not recommended during treatment, or up to 52 weeks after treatment.
    • Administer inactivated (killed) vaccines or mRNA vaccines at least 2 weeks prior to treatment. Inactivated vaccines are not recommended during treatment or 6 weeks after completion of treatment.

ADVERSE REACTIONS

Most common adverse reactions (>10%) were lymphopenia, rash, leukopenia, and headache.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: May cause fetal harm.
  • Lactation: A lactating woman may consider pumping and discarding breast milk during and for 20 days after TZIELD administration.

Please see full Prescribing Information, including patient selection criteria, and Medication Guide. View Important Safety Information page.

REFERENCES

  1. TZIELD Prescribing Information. Provention Bio, Inc; 2023.
  2. diaTribe Learn. FDA approves Tzield (teplizumab) to delay type 1 diabetes. Published November 17, 2022. Updated November 21, 2022. https://diatribe.org/diabetes-medications/fda-approves-tzield-teplizumab-delay-type-1-diabetes
  3. Insel RA, Dunne JL, Atkinson MA, et al. Staging presymptomatic type 1 diabetes: A scientific statement of JDRF, the Endocrine Society, and the American Diabetes Association. Diabetes Care. 2015;38(10):1964-1974.
  4. Scheiner G, Weiner S, Kruger DF, Pettus J. Screening for type 1 diabetes: Role of the diabetes care and education specialist. ADCES Pract. 2022;10(5):20-25.
  5. Beliard K, Ebekozien O, Demeterco-Berggren C, et al. Increased DKA at presentation among newly diagnosed type 1 diabetes patients with or without COVID-19: Data from a multi-site surveillance registry. J Diabetes. 2021;13(3):270-272.
  6. Elding Larsson H, Vehik K, Bell R, et al. Reduced prevalence of diabetic ketoacidosis at diagnosis of type 1 diabetes in young children participating in longitudinal follow-up. Diabetes Care. 2011;34(11):2347-2352.
  7. Edelman S. Early intervention by family physicians to delay type 1 diabetes. J Fam Pract. 2023;72(6 suppl):S19-S24.
  8. Barker JM, Goehrig SH, Barriga K, et al; DAISY study. Clinical characteristics of children diagnosed with type 1 diabetes through intensive screening and follow-up. Diabetes Care. 2004;27(6):1399-1404.
  9. American Diabetes Association Professional Practice Committee. Prevention or delay of diabetes and associated comorbidities: standards of care in diabetes—2025. Diabetes Care. 2025;(48)(Suppl 1): S50-S58.
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INDICATION

IMPORTANT SAFETY INFORMATION

INDICATION

TZIELD is a CD3-directed monoclonal 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.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Cytokine Release Syndrome (CRS): CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration. Prior to TZIELD treatment, premedicate with antipyretics, antihistamines and/or antiemetics, and treat similarly if symptoms occur during treatment. If severe CRS develops, consider pausing dosing for 1 day to 2 days and administering the remaining doses to complete the full 14-day course on consecutive days; or discontinue treatment. Monitor liver enzymes during treatment. Discontinue TZIELD treatment in patients who develop elevated alanine aminotransferase or aspartate aminotransferase more than 5 times the upper limit of normal (ULN) or bilirubin more than 3 times ULN.
  • Serious Infections: Use of TZIELD is not recommended in patients with active serious infection or chronic infection other than localized skin infections. Monitor patients for signs and symptoms of infection during and after TZIELD administration. If serious infection develops, treat appropriately, and discontinue TZIELD.
  • Lymphopenia: Lymphopenia occurred in most TZIELD-treated patients. For most patients, lymphocyte levels began to recover after the fifth day of treatment and returned to pretreatment values within two weeks after treatment completion and without dose interruption. Monitor white blood cell counts during the treatment period. If prolonged severe lymphopenia develops (<500 cells per mcL lasting 1 week or longer), discontinue TZIELD.
  • Hypersensitivity Reactions: Acute hypersensitivity reactions including serum sickness, angioedema, urticaria, rash, vomiting and bronchospasm occurred in TZIELD-treated patients. If severe hypersensitivity reactions occur, discontinue TZIELD and treat promptly.
  • Vaccinations: The safety of immunization with live-attenuated (live) vaccines with TZIELD-treated patients has not been studied. TZIELD may interfere with immune response to vaccination and decrease vaccine efficacy. Administer all age-appropriate vaccinations prior to starting TZIELD.
    • Administer live vaccines at least 8 weeks prior to treatment. Live vaccines are not recommended during treatment, or up to 52 weeks after treatment.
    • Administer inactivated (killed) vaccines or mRNA vaccines at least 2 weeks prior to treatment. Inactivated vaccines are not recommended during treatment or 6 weeks after completion of treatment.

ADVERSE REACTIONS

Most common adverse reactions (>10%) were lymphopenia, rash, leukopenia, and headache.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: May cause fetal harm.
  • Lactation: A lactating woman may consider pumping and discarding breast milk during and for 20 days after TZIELD administration.

Please see full Prescribing Information, including patient selection criteria, and Medication Guide. View Important Safety Information page.