16 September 2026 editorial review · Item
Teplizumab (Tzield): review notes
These notes document the scope actually reviewed, including source-access limits. They are not independent clinical certification or a guarantee that every claim was verified.
Read the item evidence page →Preventing and curing evidence review — 16 September 2026
- Disposition: corrected/updated. Current item
lastReviewed: 2026-09-16. - Claim check: Replaced stage 2-only April FDA label URL with June current US label. Verified stage 2 age 1+, jurisdiction-specific age 8+ elsewhere; added boxed viral-reactivation warning/contraindications and funding distinction. Stage 3 is separate item. PBS July rejection/NICE implementation dates are reimbursement claims, not efficacy.
- Registry NCT01030861: COMPLETED; updated 2020-08-05; enrollment 76 (ACTUAL); primary completion 2018-11 (ACTUAL); results posted.
- Registry NCT03875729: COMPLETED; updated 2024-04-24; enrollment 328 (ACTUAL); primary completion 2023-05-01 (ACTUAL); results posted.
- Registry NCT07088068: RECRUITING; updated 2026-09-14; enrollment 723 (ESTIMATED); primary completion 2028-06-06 (ESTIMATED); results not posted in retrieved record.
- Registry NCT05757713: ACTIVE_NOT_RECRUITING; updated 2026-01-30; enrollment 20 (ESTIMATED); primary completion 2026-08-27 (ESTIMATED); results not posted in retrieved record.
- Primary publication/regulatory sources checked or consulted: NEJMoa1902226; scitranslmed.abc8980; NEJMoa2308743; s40265-023-01847-y; dbi20-0054; tzield.pdf; pbac-web-outcomes-07-2026-v1.pdf; tzield-teplizumab; tzield; teplizumab-to-delay-the-onset-of-type-1-diabetes-recommended; ta1176; jama.2013.6285.
- Programme/sponsor/conference source boundary: Sanofi's Tzield approved in the US as the first disease-modifying therapy for patients recently diagnosed with stage 3 type 1 diabetes (manufacturer); Sanofi's Tzield approved in the US to delay the onset of stage 3 type 1 diabetes in young children (manufacturer); Sanofi's Teizeild approved in the EU for patients with stage 2 type 1 diabetes (manufacturer); MHRA approves teplizumab to delay progression of type 1 diabetes (regulatory).