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Teplizumab Can Delay Type 1 Diabetes Progression: What the U.S. Experience Shows

34 minutes ago
3 min read

A drug that can give people more time before they need insulin is making headlines in the United Kingdom—and it is already being used in the United States.


As reported by the BBC, Annette Quilter, a 42-year-old physician and mother of three, has become the first patient to receive teplizumab through routine NHS care in the UK. She began treatment at Queen Elizabeth Hospital Birmingham after screening identified stage 2 type 1 diabetes. For Quilter, the treatment offers the possibility of postponing the daily demands of insulin therapy while she prepares for the future. [1,2]


Type 1 diabetes develops when the immune system attacks the pancreas’s insulin-producing cells. Teplizumab slows that attack, helping preserve the body’s own insulin production. People with stage 2 already have early type 1 diabetes: testing shows diabetes-related autoantibodies and abnormal blood sugar, even though symptoms have not developed. Treatment aims to delay progression to stage 3, when clinical diabetes develops and insulin is generally needed. [2,3]


American patients know the medication as Tzield. The FDA first approved it in November 2022. Its current U.S. approval for delaying stage 3 includes adults and children age 1 and older with confirmed stage 2 disease. For this use, treatment consists of a daily intravenous infusion for 14 days. Eligibility requires specialized testing; a family history or an elevated A1C alone does not establish eligibility. [4,5]


How widely has it been used? In its October 30, 2026, financial report, manufacturer Sanofi said almost 1,100 patients had received Tzield/Teizeild across its markets. That is a combined figure, not a U.S.-only count. The report does not provide a separate American patient total. A 2026 study of routine clinical use documented 101 treated patients in the United States, plus nine in Israel, confirming use beyond the original clinical trials. [6,7]


The strongest evidence of effectiveness comes from the randomized TN-10 trial, which enrolled 76 people with stage 2 type 1 diabetes. According to the prescribing information, 95% of participants were from the United States. The FDA’s analysis reported these results: [4,5]


  • Participants: 44 received Tzield; 32 received placebo.

  • Median time to stage 3 diagnosis: about 50 months with Tzield, compared with 25 months with placebo.

  • Participants who developed stage 3 during follow-up: 45% with Tzield, compared with 72% with placebo.


The median follow-up was approximately 51 months. The difference in median time to diagnosis was about two years, although individual responses varied. These findings demonstrate delayed progression; they do not establish permanent prevention or a cure. [4]


Early results from routine care are also emerging. The 2026 TEPLI-REAL conference report followed 110 patients, including the 101 Americans, for a median of 14.3 months. More than 70% remained in stage 2, and 94% completed the 14-day treatment course. However, this was a small observational study without an untreated comparison group. Its findings cannot establish a national success rate or show how much of the delay was caused by treatment. Sanofi employees were among the study’s authors. [7]


U.S. access has also expanded beyond delaying stage 3. In June 2026, the FDA granted accelerated approval for certain children ages 8 through 17 who have recently been diagnosed with stage 3, to slow the decline of their remaining insulin production. That approval was based on a marker of insulin production called C-peptide; a confirmatory study is required to verify clinical benefit. Patients with stage 3 still need insulin and ongoing diabetes care. [5,8]


Treatment requires careful medical supervision. Side effects can include rash, headache and reduced white blood cell counts. Current U.S. labeling also carries a boxed warning about serious, potentially life-threatening reactivation of viruses, including Epstein-Barr virus and cytomegalovirus. Infection screening and blood-test monitoring help clinicians assess and manage those risks. [5,8]


For families, the opportunity starts with identifying type 1 diabetes early. A clinician can help determine whether autoantibody screening and specialist evaluation are appropriate. People who receive teplizumab still need monitoring for progression. For eligible patients, the potential benefit is meaningful: additional time before insulin becomes part of everyday life. [3,5]


Sources

Information checked November 12, 2026.

[2] University Hospitals Birmingham, November 5, 2026: “QEHB treats first UK patient with Teplizumab following NHS approval.”

[4] FDA: “Drug Trials Snapshots: TZIELD.” Original approval November 17, 2022.

[5] Tzield U.S. prescribing information, revised June 2026, via DailyMed.

[6] Sanofi Q3 2026 financial results, October 30, 2026, filed with the SEC.

[7] Gitelman et al., “1059-OR: TEPLI-REAL: A Real-World Retrospective Study Characterizing Individuals with Type 1 Diabetes Treated with Teplizumab and Their Metabolic Outcomes.” Diabetes 2026;75(Supplement_1):1059-OR. Conference abstract; DOI: 10.2337/db26-1059-OR. Abstract also available at ResearchGate.

 
 
 

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