A disease-modifying treatment

The first and only approved treatment to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients 8 years of age and older with Stage 2 T1D.1

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TZIELD is a CD3-directed monoclonal antibody indicated to delay the onset of Stage 3 T1D in adults and pediatric patients aged 8 years and older with Stage 2 T1D.1
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TZIELD is a CD3-directed monoclonal antibody that binds to CD3 antigens presented on the surface of T cells.1
Pancreatic beta cell autoreactive T cell deactivation icon
The mechanism of action may involve the partial agonistic signaling and deactivation of pancreatic beta cell autoreactive T cells.1
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TZIELD can potentially delay the onset of Stage 3 T1D in your patients with Stage 2 T1D.1
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TZIELD patient selection

Appropriate patients for TZIELD are 8 years or older and have a diagnosis of Stage 2 T1D.1 Confirm Stage 2 T1D with the following criteria:
Positive for ≥2 of the following 5 pancreatic islet autoantibodies (AAbs)1:
  • Glutamic acid decarboxylase 65 autoantibody (GADA)
  • Insulinoma-associated antigen 2 autoantibody (IA-2A)
  • Insulin autoantibody (IAA)
  • Islet cell autoantibody (ICA)
  • Zinc transporter 8 autoantibody (ZnT8A)

If fewer than 2 AAbs are detected, additional screening may be appropriate for high-risk patients.2

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Dysglycemia (fluctuating glucose levels, outside normal range) without overt hyperglycemia, confirmed with3,4:
  • 2-H plasma glucose (2-H PG) 140-199 mg/dL during oral glucose tolerance test (OGTT)
  • 30-/60-/90-minute PG ≥200 mg/dL during OGTT

If an OGTT is not available, an alternative method for diagnosing dysglycemia without overt hyperglycemia may be appropriate.1

Other methods that may be appropriate are available in the ADA and ISPAD guidelines.

Ensure the clinical history of patient does not suggest type 2 diabetes. Before initiating TZIELD, review section 2.1 of the Prescribing Information.1
Learn how to identify your eligible patients in 4 steps
Identify Patients

Review the clinical results for TZIELD.



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.



  • 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.
1. TZIELD Prescribing Information. Provention Bio, Inc.2. Couper JJ, Haller MJ, Greenbaum CJ, et al. ISPAD Clinical Practice Consensus Guidelines 2018: stages of type 1 diabetes in children and adolescents. Pediatr Diabetes. 2018;19(suppl 27):20-27.3. ElSayed NA, Aleppo G, Aroda VR, et al. Standards of care in diabetes—2023. Diabetes Care. 2023;46(suppl 1):S19-S40.4. Type 1 Diabetes TrialNet. Protocol TN-10. Version June 2014. Accessed May 5, 2023. https://clinicaltrials.gov/ProvidedDocs/61/NCT01030861/Prot_000.pdf