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type1.science

Teplizumab (Tzield)

Sanofi

The first proven way to delay T1D.

An anti-CD3 immune therapy given as a single ~14-day infusion course that delays the onset of clinical (stage 3) T1D in autoantibody-positive stage-2 individuals by a median of roughly two years — the first treatment ever shown to bend the disease timeline. First approved by the FDA in 2022 and since authorised in the EU, UK, Canada, Australia, Switzerland and elsewhere.

Available nowRegulator-approvedimmunotherapydelayautoantibodymonoclonal-antibodyanti-cd3disease-modifying

The scorecard

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 real, reproducible effect.[1]

Durability50

A delay, not a halt — most still progress; one course bought a median ~2-3 years, with no established re-dosing regimen yet.[2]

Safety60

Transient lymphopenia, rash, headache and mild cytokine-release are common but self-limited; meaningful but manageable in otherwise-healthy people.[1]

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. Either way it only helps people who have already been screened and staged.[8]

Access & cost62

No longer US-only: approved in the US, the EU (as Teizeild, January 2026), the UK, Canada, Australia, Switzerland, China, Brazil, Israel and the Gulf states — and recommended for NHS funding by NICE in June 2026. Real barriers remain: a very high list price per course, delivery by ~14 daily IV infusions, and total dependence on prior autoantibody screening to find candidates.[12]

Editor’s take

Historic as proof of principle: it shows the immune attack on the body's own insulin production can be slowed in people, not just in mice. The honest framing is "delay, not stop" — and because it only works in people already found and staged, it is chained directly to the find-it-early gap. The door is open; the next question is how much further it can be pushed.

The full picture

Screening: finding T1D before it strikes

Teplizumab only matters if you can identify the right people before they get sick — and that depends on screening. Type 1 diabetes develops along a defined three-stage path. 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 is clinical disease, when insulin is needed.1 The autoantibodies are powerful predictors: in a pooled multi-cohort analysis, children who developed two or more had a ~70% risk of clinical diabetes within 10 years, with the majority progressing over the following 15 years — approaching certainty over a lifetime.2

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.3 Early detection is valuable even without treatment: people identified through screening are monitored, so when they reach stage 3 they are far less likely to arrive in diabetic ketoacidosis (DKA), a dangerous and sometimes fatal emergency.1 Detection now uses capillary or home-collected samples, lowering the burden and cost that long blocked wide screening.3

Therapy: bending the timeline

Teplizumab is an Fc-receptor-nonbinding anti-CD3 monoclonal antibody. It binds CD3 on T cells, blunting the autoreactive T-cell attack on the body's own insulin-producing cells and expanding "exhausted," less-destructive T-cell populations — buying the pancreas time.4

The pivotal evidence is the TN-10 trial (NCT01030861): 76 autoantibody-positive stage-2 relatives got a single 14-day infusion course of teplizumab or placebo. 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 0.41.4 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.5 The effect is a delay, not a cure — most participants still progressed eventually, and there is no established re-dosing schedule.

In newly diagnosed stage-3 patients, the phase-3 PROTECT trial (NCT03875729, 328 children/adolescents) showed two 12-day courses preserved C-peptide at 78 weeks, with ~95% of treated patients keeping a clinically meaningful level versus ~79% on placebo — though it did not significantly change insulin dose or HbA1c.6

Safety: the common effects are transient lymphopenia, rash, headache, and mild cytokine-release symptoms, generally self-limited — but they are not trivial when treating someone who currently feels healthy.4

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.7 The current 2026 US label extends that stage-2 delay indication to adults and children aged 1 year and older.8 It is given as a once-daily IV infusion for 14 consecutive days and carries a very high list price per course — still a major access barrier, alongside its dependence on prior screening to find candidates at all.9

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.10 The European Commission approved it on 12 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.11 As of Sanofi's June 2026 statement, the stage-2 indication is also approved in Canada, Australia, Switzerland, China, Brazil, Israel, Saudi Arabia, the UAE and Kuwait.12 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 and UK 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.1314 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. England is the first country in Europe to recommend teplizumab through a health technology appraisal, and the Scottish Medicines Consortium expects to publish its advice in early 2027.15

What's coming

Two 2026 US label changes sharpened the case for screening and early treatment. In April 2026 the FDA extended the stage-2 delay indication down to age 1, under priority review, after the PETITE-T1D study in young children — the years when T1D is hardest to manage.816 In June 2026 the FDA granted accelerated approval for newly diagnosed stage-3 disease in children aged 8-17, supported by PROTECT.12 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 still enrolling. Sanofi has said it has decided not to pursue an EU application for the stage-3 indication at this time.11 A stage-2 trial is recruiting in Japan; there is no Japanese approval yet.

References

  1. Sims EK, et al. Screening for Type 1 Diabetes in the General Population: A Status Report and Perspective. Diabetes (2022). https://doi.org/10.2337/dbi20-0054 ↩ ↩2

  2. 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 ↩

  3. Sims EK, et al. Screening for Type 1 Diabetes in the General Population: A Status Report and Perspective. Diabetes (2022). https://doi.org/10.2337/dbi20-0054 ↩ ↩2

  4. Herold KC, et al. An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes. N Engl J Med (2019). https://doi.org/10.1056/NEJMoa1902226 ↩ ↩2 ↩3

  5. Sims EK, et al. Teplizumab improves and stabilizes beta cell function in antibody-positive high-risk individuals. Sci Transl Med (2021). https://doi.org/10.1126/scitranslmed.abc8980 ↩

  6. Ramos EL, et al. Teplizumab and β-Cell Function in Newly Diagnosed Type 1 Diabetes (PROTECT). N Engl J Med (2023). https://doi.org/10.1056/NEJMoa2308743 ↩

  7. Keam SJ. Teplizumab: First Approval. Drugs (2023). https://doi.org/10.1007/s40265-023-01847-y ↩

  8. 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). https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761183s013lbl.pdf ↩ ↩2

  9. Provention prices type 1 diabetes drug Tzield at $194,000. pharmaphorum (2022). https://pharmaphorum.com/news/provention-prices-type-1-diabetes-drug-tzield-at-194000 ↩

  10. Medicines and Healthcare products Regulatory Agency. MHRA approves teplizumab to delay progression of type 1 diabetes (14 August 2025). https://www.gov.uk/government/news/mhra-approves-teplizumab-to-delay-progression-of-type-1-diabetes ↩

  11. Sanofi. Sanofi's Teizeild approved in the EU for patients with stage 2 type 1 diabetes (12 January 2026; European Commission approval, adults and children aged 8+; Sanofi states it will not progress a second EU application for the stage-3 indication at this time). https://www.sanofi.com/en/media-room/press-releases/2026/2026-01-12-06-00-00-3216525 ↩ ↩2

  12. 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). https://www.sanofi.com/en/media-room/press-releases/2026/2026-06-12-22-09-58-3311349 ↩ ↩2

  13. 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). https://www.nice.org.uk/news/articles/teplizumab-to-delay-the-onset-of-type-1-diabetes-recommended ↩

  14. 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). https://www.nice.org.uk/guidance/ta1176 ↩

  15. Diabetes UK. Teplizumab, first treatment to slow type 1 diabetes, approved for use on the NHS (2026). https://www.diabetes.org.uk/about-us/news-and-views/teplizumab-first-treatment-slow-type-1-diabetes-approved-use-nhs ↩

  16. Sanofi. Sanofi's Tzield approved in the US to delay the onset of stage 3 type 1 diabetes in young children (22 April 2026; label extension to age 1 under priority review, based on PETITE-T1D, NCT05757713, n=23). https://www.sanofi.com/en/media-room/press-releases/2026/2026-04-22-05-05-00-3278650 ↩

What's next for this

  • →NICE recommended teplizumab for NHS use in England and Wales (stage 2, age 8+) — final guidance TA1176, 9 July 2026. NHS England must make it available within 90 days of publication (by early October 2026); in Wales the clock is 60 days from the 23 June 2026 final draft · July 2026 (final guidance TA1176)
  • →Scottish Medicines Consortium advice on NHS Scotland use · expected early 2027
  • →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
  • →A stage-2 trial in Japan is recruiting; there is no Japanese approval yet · recruiting

Sources

  1. [1]An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes (TN-10 trial) · peer-reviewed · 2019-06-09 — Herold et al., N Engl J Med 2019;381:603-613. PMID 31180194. NCT01030861.
  2. [2]Teplizumab improves and stabilizes beta cell function in antibody-positive high-risk individuals (TN-10 extended follow-up) · peer-reviewed · 2021-03-03 — Sims et al., Sci Transl Med 2021;13:eabc8980. PMID 33658358.
  3. [3]Teplizumab and beta-Cell Function in Newly Diagnosed Type 1 Diabetes (PROTECT trial) · peer-reviewed · 2023-10-18 — Ramos et al., N Engl J Med 2023;389:2151-2161. PMID 37861217. NCT03875729.
  4. [4]Teplizumab: First Approval · peer-reviewed · 2023-04-01 — Keam SJ, Drugs 2023;83:439-445. PMID 36877454. Documents the Nov 2022 FDA approval.
  5. [5]Screening for Type 1 Diabetes in the General Population: A Status Report and Perspective · peer-reviewed · 2022-04-01 — Sims et al., Diabetes 2022;71:610-623. PMID 35316839. ~90% of new T1D has no family history.
  6. [6]Provention prices type 1 diabetes drug Tzield at $194,000 · news · 2022-11-21 — List price per vial and for the full 14-day course is a major access barrier.
  7. [7]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.
  8. [8]TZIELD (teplizumab-mzwv) prescribing information · regulatory · 2026-05-01 — Current FDA label: stage-2 delay indication in adults and pediatric patients 1 year and older; stage-3 new-onset indication in ages 8-17.
  9. [9]Sanofi's Tzield approved in the US to delay the onset of stage 3 type 1 diabetes in young children · manufacturer · 2026-04-22 — Label extension down to age 1, approved 22 April 2026 under priority review on the basis of PETITE-T1D (NCT05757713, n=23).
  10. [10]Sanofi's Teizeild approved in the EU for patients with stage 2 type 1 diabetes · manufacturer · 2026-01-12 — European Commission approval (12 January 2026) of Teizeild for 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.
  11. [11]MHRA approves teplizumab to delay progression of type 1 diabetes · regulatory · 2025-08-14 — UK marketing authorisation granted 14 August 2025 — the UK's first approved immunotherapy for type 1 diabetes.
  12. [12]First disease-modifying therapy for NHS use to delay the onset of type 1 diabetes recommended · regulatory · 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.
  13. [13]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 · 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).
  14. [14]Teplizumab, first treatment to slow type 1 diabetes, approved for use on the NHS · community · 2026-06-23 — England is the first country in Europe to recommend teplizumab through a health technology appraisal; the Scottish Medicines Consortium expects to publish its advice in early 2027.