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Teplizumab (Tzield)

Sanofi

Proven delay in a selected stage-2 population.

What it is

An anti-CD3 immune therapy given as 14 daily IV infusions for stage-2 T1D. In TN-10, 76 relatives of people with T1D were randomized; median time to stage-3 diagnosis was 48.4 months with treatment versus 24.4 with placebo. This group comparison is not a guaranteed two-year delay for each person. The US stage-2 label covers age 1+; EU, UK and Australian labels cover age 8+. Australia registered Tzield in May 2026, but PBAC did not recommend PBS listing in July. NHS England implementation follows NICE’s July guidance.

Editorial review: .

Most recent recorded citation date: 2026-09-10. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

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Approved; access variesRegulator-approvedimmunotherapydelayautoantibodymonoclonal-antibodyanti-cd3disease-modifying

Evidence behind this assessment

Key evidence notes. Study results, product eligibility and access answer different questions.

Who was studied?
Study populations and analysis groups vary. Product age limits alone do not describe who was studied.See the linked studies and their populations →
Benefit or performance
Delay of onset: Median onset delayed ~24 months in the pivotal RCT (48.4 vs 24.4 mo); extended follow-up (Sims 2021, teplizumab-stm) widened the gap to ~33 months (59.6 vs 27.1 mo) — a benefit in that trial and its follow-up.[1]
Important harms and treatment burden
Safety: The June 2026 US label carries a boxed warning for potentially life-threatening EBV/CMV reactivation and contraindicates treatment in immunocompromised patients or those with active viral infection. Blood counts, liver tests and infection monitoring accompany the infusion course.[8]
Approval and country access
Stage-2 treatment is approved from age 1 in the US and age 8 in the EU, UK and Australia. TGA registration was 21 May 2026; PBAC did not recommend PBS listing in July. NICE TA1176 was published 9 July; NHS England’s funding deadline is early October 2026. Local supply and funding determine access. The stage-2 regimen is 14 daily IV infusions.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
Follow-up and remaining uncertainty
Durability: In the 2021 TN-10 follow-up, 22/44 treated participants and 25/32 placebo participants had progressed to stage 3. Median diagnosis times differed by 32.5 months. The stage-2 label specifies one 14-day course; permanent prevention and a stage-2 repeat-course benefit are not established by these data.[2]

This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.

Editorial score: calculation and evidence

A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.

Default calculation: 78 × 30 + 50 × 20 + 45 × 20 + 45 × 15 + 58 × 15 = 5785; divide by total weight 100. Unrounded weighted result: 57.85.

Delay of onset78

Median onset delayed ~24 months in the pivotal RCT (48.4 vs 24.4 mo); extended follow-up (Sims 2021, teplizumab-stm) widened the gap to ~33 months (59.6 vs 27.1 mo) — a benefit in that trial and its follow-up.[1]

Durability50

In the 2021 TN-10 follow-up, 22/44 treated participants and 25/32 placebo participants had progressed to stage 3. Median diagnosis times differed by 32.5 months. The stage-2 label specifies one 14-day course; permanent prevention and a stage-2 repeat-course benefit are not established by these data.[2]

Safety45

The June 2026 US label carries a boxed warning for potentially life-threatening EBV/CMV reactivation and contraindicates treatment in immunocompromised patients or those with active viral infection. Blood counts, liver tests and infection monitoring accompany the infusion course.[8]

Stage breadth45

Still narrow, and the label differs by country: the US covers stage-2 delay from age 1, plus an accelerated approval for newly diagnosed stage 3 in ages 8-17, while the EU/UK label is stage 2, age 8 and older. Stage-2 use requires presymptomatic identification; US stage-3 use instead requires recent diagnosis within 8 weeks and the label’s autoantibody and C-peptide criteria.[8]

Access & cost58

Approved in the US, the EU (Teizeild), the UK, Canada, Australia (TGA), and additional countries named in the maker's June 2026 statement, and recommended for NHS funding by NICE. Australia's PBAC did not recommend PBS listing in July 2026, so TGA registration is not subsidy. Fourteen daily IV infusions and the need to identify stage-2 disease add practical access requirements; approval does not establish local supply or individual funding.[11]

Editor’s take

Editorial assessment: TN-10 established that an immune therapy can delay clinical diagnosis in a selected stage-2 population. That benefit supports finding eligible people before symptoms, but is not permanent prevention. The separate US stage-3 indication has different eligibility and dosing.

The full picture

Screening: finding T1D before it strikes

For teplizumab’s stage-2 indication, eligible people must be identified before clinical diagnosis. Its separate US stage-3 indication is discussed below. Type 1 diabetes is commonly described using three clinical stages. Stage 1 is two or more islet autoantibodies (against insulin, GAD, IA-2, or ZnT8) with normal blood glucose and no symptoms; stage 2 adds abnormal glucose (dysglycemia) but still no symptoms; stage 3 meets diabetes diagnostic thresholds and may be detected before symptoms during monitoring; it is not defined solely by whether insulin has started.5 The autoantibodies are powerful predictors: in a pooled multi-cohort analysis, 585 children who developed multiple autoantibodies had an estimated 69.7% risk of diabetes at 10 years and 84.2% at 15 years after seroconversion. These are cohort estimates, not a prediction of an individual’s lifetime outcome.23

Screening can be offered to relatives of people with T1D, but roughly 90% of new cases have no family history — so finding most at-risk people requires general-population testing using autoantibody (and sometimes genetic-risk) panels.5 Early detection is valuable even without treatment: people identified through screening are monitored, so when they reach stage 3 they are less likely to arrive in diabetic ketoacidosis (DKA), a dangerous and sometimes fatal emergency.5 Some screening programmes use capillary or home-collected samples; their availability and costs vary.5

Therapy: bending the timeline

Teplizumab is an Fc-receptor-nonbinding anti-CD3 monoclonal antibody. It binds CD3 on T cells. The TN-10 follow-up found that improved beta-cell function was associated with increased partially exhausted CD8 T-cell subsets; this association does not establish a complete explanation of the clinical effect.28

The pivotal evidence is the TN-10 trial (NCT01030861): 76 autoantibody-positive relatives aged 8–49 with stage-2 disease were randomized to a single 14-day course of teplizumab (44) or placebo (32). Median time to clinical (stage 3) diagnosis was 48.4 months with teplizumab versus 24.4 months with placebo — a roughly 24-month delay — with a hazard ratio of 0.41 (95% CI 0.22–0.78).1 On extended follow-up (median ~923 days), the gap widened to 59.6 vs 27.1 months, and 50% of treated participants remained diabetes-free versus 22% on placebo; treatment also improved and stabilised insulin-producing (C-peptide) function.2 At that follow-up, 22/44 treated and 25/32 placebo participants had developed stage 3. These data show delay, not permanent prevention. The stage-2 prescribing regimen is one course; the two-course US regimen applies to the separate stage-3 indication.8

In newly diagnosed stage-3 patients, the phase-3 PROTECT trial randomized 328 children aged 8–17 (217 teplizumab, 111 placebo) to two 12-day courses. At week 78, stimulated C-peptide was higher with teplizumab. The original intention-to-treat analysis found no significant difference in its key clinical secondary outcomes: insulin dose, HbA1c, time in range or clinically important hypoglycemic events.3

A 10 September 2026 per-protocol analysis examined 275 participants (180 teplizumab, 95 placebo) who met prespecified adherence and protocol criteria. It reported lower insulin dose and 6.17 percentage points more time in range at week 78 (95% CI 0.13–12.2). These selected-population secondary comparisons used nominal p values and do not replace the original randomized intention-to-treat findings.20

Safety: the June 2026 US label has a boxed warning for potentially life-threatening reactivation of Epstein-Barr virus (EBV) or cytomegalovirus (CMV). Treatment is contraindicated in immunocompromised patients or those with active viral infection. The label requires infection assessment, blood-count and liver monitoring, and monitoring for viral reactivation for at least two months after treatment. Lymphopenia, rash, gastrointestinal symptoms, cytokine-release syndrome and serious infection also matter.8

On the strength of TN-10, the FDA approved Tzield in November 2022 — the first disease-modifying therapy for T1D — to delay stage-3 onset in stage-2 patients aged 8 and older.4 The current 2026 US label extends that stage-2 delay indication to adults and children aged 1 year and older.8 Stage-2 treatment is given as a once-daily IV infusion for 14 consecutive days. Patients aged 1 to under 8 require a minimum two-hour infusion; those aged 8 and older require at least 30 minutes. Country-specific funding and access must be considered separately from the label.8

Where you can actually get it

Teplizumab is no longer a US-only drug. The MHRA approved it in the UK on 14 August 2025 — the UK's first approved immunotherapy for T1D.12 The EU marketing authorization was granted on 8 January 2026, marketed there as Teizeild, for stage-2 T1D in adults and children aged 8 and older; it is the first disease-modifying T1D therapy approved in the EU, according to the sponsor’s announcement of 12 January.1018 Australia's TGA registered Tzield on 21 May 2026 for the same stage-2, age-8-and-older population, and published its full assessment report in July.24 ARTG registration means the medicine may legally be supplied. PBAC did not recommend PBS listing in July 2026, so registration does not establish subsidised access.11 As of Sanofi's June 2026 statement, the stage-2 indication is also approved in Canada, Switzerland, China, Brazil, Israel, Saudi Arabia, the UAE and Kuwait.7 Note the labels are not identical: the US covers stage-2 delay from age 1 and adds a newly diagnosed stage-3 indication for ages 8-17, while the EU, UK and Australian labels cover stage 2 from age 8.

Approval is not the same as being able to get it, and the newest step is a funding one. On 23 June 2026 NICE recommended teplizumab for NHS use in England and Wales, in final draft guidance, confirmed in final guidance (TA1176) on 9 July 2026, for adults and children aged 8+ with stage-2 T1D.1516 NHS England has to make it available within 90 days of publication of TA1176 (i.e. by early October 2026); in Wales the clock is 60 days from 23 June 2026. NICE estimates roughly 1,100 people eligible in the first year (with about 555 expected to take it up), settling at around 820 a year. NICE described England as the first European country to recommend teplizumab through a health technology appraisal.15 Diabetes UK reported that Scottish Medicines Consortium advice was expected in early 2027; that future timetable has not been independently confirmed with SMC.17

What's coming

Two 2026 US label changes sharpened the case for screening and early treatment. The FDA extended the stage-2 indication down to age 1 on 20 April 2026; Sanofi announced the decision on 22 April and identified PETITE-T1D as supporting evidence.8919 In June 2026 the FDA granted accelerated approval for newly diagnosed stage-3 disease in children aged 8-17, supported by PROTECT.7 That one comes with an important caveat: an accelerated approval rests on a surrogate marker (preserved C-peptide) rather than proven long-term benefit, and a confirmatory trial — BETA-PRESERVE (NCT07088068) — is registered as recruiting in its 14 September 2026 update.21 The US stage-3 label requires initiation within eight weeks of diagnosis, at least one positive islet autoantibody and peak C-peptide of at least 0.2 pmol/mL. It specifies two 12-day courses, with the second normally six months after the first.8 Sanofi has said it has decided not to pursue an EU application for the stage-3 indication at this time.10 Japan’s stage-2 study jRCT2031240637 is registered as recruiting; this registry status does not establish routine treatment access.22

What's next for this

  • →NHS England implementation of NICE TA1176 for eligible stage-2 patients · Funding deadline in early October 2026
  • →Scottish Medicines Consortium advice on NHS Scotland use · Diabetes UK reported early 2027; current SMC timetable not independently confirmed
  • →FDA extended the US label down to age 1 (from age 8) following the PETITE-T1D study in young children · April 2026 (already approved)
  • →FDA granted accelerated approval for newly diagnosed stage-3 disease in children aged 8-17, supported by PROTECT · June 2026 (approved)
  • →Confirmatory BETA-PRESERVE trial for the stage-3 indication · enrolling
  • →Sanofi has decided not to pursue an EU application for the recently diagnosed stage-3 indication at this time · stated January 2026
  • →Japan’s jRCT2031240637 stage-2 study is registered as recruiting; trial participation is distinct from routine treatment access · recruiting

Sources

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    An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes (TN-10 trial) · Peer-reviewed study · 2019-06-09 — Herold et al., N Engl J Med 2019;381:603-613. PMID 31180194. NCT01030861.

    Herold KC, et al. An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes. N Engl J Med (2019).

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    Teplizumab improves and stabilizes beta cell function in antibody-positive high-risk individuals (TN-10 extended follow-up) · Peer-reviewed study · 2021-03-03 — Sims et al., Sci Transl Med 2021;13:eabc8980. PMID 33658358.

    Sims EK, et al. Teplizumab improves and stabilizes beta cell function in antibody-positive high-risk individuals. Sci Transl Med (2021).

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    Teplizumab and beta-Cell Function in Newly Diagnosed Type 1 Diabetes (PROTECT trial) · Peer-reviewed study · 2023-10-18 — Ramos et al., N Engl J Med 2023;389:2151-2161. PMID 37861217. NCT03875729.

    Ramos EL, et al. Teplizumab and β-Cell Function in Newly Diagnosed Type 1 Diabetes (PROTECT). N Engl J Med (2023).

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    Drug Trials Snapshots: TZIELD · Regulatory decision — FDA records the original approval on 17 November 2022 and the TN-10 population (44 treated, 32 placebo). This historical snapshot does not replace the current 2026 prescribing information.

    FDA. Drug Trials Snapshots: TZIELD. Original approval 17 November 2022; historical TN-10 population and results.

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    Screening for Type 1 Diabetes in the General Population: A Status Report and Perspective · Peer-reviewed study · 2022-04-01 — Sims et al., Diabetes 2022;71:610-623. PMID 35316839. ~90% of new T1D has no family history.

    Sims EK, et al. Screening for Type 1 Diabetes in the General Population: A Status Report and Perspective. Diabetes (2022).

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    Provention prices type 1 diabetes drug Tzield at $194,000 · Science journalism · 2022-11-21 — Historical reporting of the 2022 US launch list price, not a current quotation or evidence of any individual’s out-of-pocket cost.
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    Sanofi's Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes · Manufacturer · 2026-06-12 — FDA accelerated approval (12 June 2026) for recently diagnosed stage 3 T1D in ages 8-17, based on PROTECT (NCT03875729; n=328). Confirmatory trial BETA-PRESERVE (NCT07088068) enrolling. Also enumerates the ex-US stage-2 approvals.

    Sanofi. Sanofi's Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes (12 June 2026; FDA accelerated approval, ages 8-17, based on PROTECT; confirmatory BETA-PRESERVE enrolling; also enumerates the ex-US stage-2 approvals).

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    TZIELD (teplizumab-mzwv) prescribing information · Regulatory decision — June 2026 US prescribing information: stage-2 delay from age 1; accelerated stage-3 indication ages 8-17. Boxed viral-reactivation warning, contraindications and indication-specific infusion regimens. Replaces the April label, which did not yet contain the stage-3 indication.

    U.S. Food and Drug Administration. TZIELD (teplizumab-mzwv) prescribing information (2026 label; stage-2 delay indication in adults and pediatric patients 1 year and older).

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    Sanofi's Tzield approved in the US to delay the onset of stage 3 type 1 diabetes in young children · Manufacturer · 2026-04-22 — Sponsor announcement dated 22 April 2026 of the label extension down to age 1 under priority review. FDA records approval on 20 April 2026. Supporting study: PETITE-T1D (NCT05757713). Sanofi cited n=23; the live registry still lists estimated enrollment 20 and estimated primary completion 27 August 2026 (last update 30 January 2026). n=23 is the company figure, not a posted results table.

    Sanofi. Sanofi's Tzield approved in the US to delay the onset of stage 3 type 1 diabetes in young children (22 April 2026; announcement of the 20 April FDA approval; age-1 extension under priority review, based on PETITE-T1D, NCT05757713; company n=23. Registry reviewed 16 September 2026 still lists estimated n=20).

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    Sanofi's Teizeild approved in the EU for patients with stage 2 type 1 diabetes · Manufacturer · 2026-01-12 — Sponsor announcement (12 January 2026) of Teizeild approval; EMA records the authorization date as 8 January 2026. Indication: stage-2 T1D in adults and children aged 8 and older — the first T1D disease-modifying therapy approved in the EU. Sanofi states it has decided not to progress a second EU application for the recently diagnosed stage-3 indication at this time.

    Sanofi. Sanofi's Teizeild approved in the EU for patients with stage 2 type 1 diabetes (12 January 2026 announcement; EMA records authorization on 8 January; adults and children aged 8+; Sanofi states it will not progress a second EU application for the stage-3 indication at this time).

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    Recommendations made by the PBAC — July 2026 · Regulatory decision — PBAC did not recommend listing teplizumab (Tzield) to delay Stage 3 T1D in people aged 8+ with Stage 2 T1D. TGA registration is unchanged.

    Pharmaceutical Benefits Advisory Committee. July 2026 outcomes: teplizumab not recommended for PBS listing.

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    MHRA approves teplizumab to delay progression of type 1 diabetes · Regulatory decision · 2025-08-14 — UK marketing authorisation granted 14 August 2025 — the UK's first approved immunotherapy for type 1 diabetes.

    Medicines and Healthcare products Regulatory Agency. MHRA approves teplizumab to delay progression of type 1 diabetes (14 August 2025).

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    Tzield (teplizumab) — Australian prescription medicine decision summary · Regulatory decision · 2026-06-04 — TGA registration decision dated 21 May 2026: stage-2 T1D delay in adults and children aged 8 and older. ARTG registration permits supply; it is not the same as Pharmaceutical Benefits Scheme subsidy.
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    First disease-modifying therapy for NHS use to delay the onset of type 1 diabetes recommended · Regulatory decision · 2026-06-23 — NICE final draft guidance (23 June 2026) recommending teplizumab for stage-2 T1D in adults and children aged 8+. England within 90 days of publication of the final guidance; Wales within 60 days of 23 June 2026. ~1,100 people eligible in year 1 (~555 expected to take it up), settling at ~820/year.

    National Institute for Health and Care Excellence. First disease-modifying therapy for NHS use to delay the onset of type 1 diabetes recommended (final draft guidance, 23 June 2026).

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    Teplizumab for delaying the onset of stage 3 type 1 diabetes in people 8 years and over with stage 2 type 1 diabetes (NICE TA1176) · Regulatory decision · 2026-07-09 — NICE final technology appraisal guidance TA1176, published 9 July 2026 — confirming the June 2026 final draft recommendation. NHS England must make it available within 90 days of publication (i.e. by early October 2026).

    National Institute for Health and Care Excellence. Teplizumab for delaying the onset of stage 3 type 1 diabetes in people 8 years and over with stage 2 type 1 diabetes (final technology appraisal guidance TA1176, published 9 July 2026).

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    Teplizumab, first treatment to slow type 1 diabetes, approved for use on the NHS · Open-source community · 2026-06-23 — England is the first country in Europe to recommend teplizumab through a health technology appraisal; Diabetes UK reports that the Scottish Medicines Consortium expects advice in early 2027; this is not an independently confirmed SMC timetable.

    Diabetes UK. Teplizumab, first treatment to slow type 1 diabetes, approved for use on the NHS (2026).

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    EMA. Teizeild EPAR. EU authorization 8 January 2026.

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    FDA. Orphan Drug Designations and Approvals: teplizumab-mzwv. Records April extension approval on 20 April 2026 and stage-3 approval on 12 June 2026.

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    Preserving beta cell function in children and adolescents with newly diagnosed stage 3 type 1 diabetes: per-protocol population analysis from the PROTECT randomised trial · Peer-reviewed study · 2026-09-10 — Herold et al.; 275 per-protocol participants, not a new randomized trial. Clinical secondary comparisons are nominal and do not replace the original intention-to-treat analysis.

    Herold KC, et al. Preserving beta cell function in children and adolescents with newly diagnosed stage 3 type 1 diabetes: per-protocol population analysis from the PROTECT randomised trial. Diabetologia (10 September 2026).

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    BETA-PRESERVE — NCT07088068 · Trial registry — Registry update posted 14 September 2026 lists recruiting; site availability requires confirmation.

    ClinicalTrials.gov. BETA-PRESERVE, NCT07088068. Update posted 14 September 2026.

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    Efficacy and safety of teplizumab in Japanese participants with Stage 2 type 1 diabetes · Trial registry — jRCT2031240637; NIPH registry lists recruiting. Registry status is not a Japanese marketing-authorization decision.

    NIPH Clinical Trials Search. Efficacy and safety of teplizumab in Japanese participants with Stage 2 type 1 diabetes, jRCT2031240637.

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    Ziegler AG, et al. Seroconversion to multiple islet autoantibodies and risk of progression to diabetes in children. JAMA (2013). https://doi.org/10.1001/jama.2013.6285

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    Therapeutic Goods Administration. Tzield (teplizumab) — Australian prescription medicine decision summary (registration decision 21 May 2026; published 4 June 2026) and Australian Public Assessment Report (published 23 July 2026). https://www.tga.gov.au/resources/auspmd/tzield-teplizumab and https://www.tga.gov.au/resources/auspar/tzield