Teizeild
Metabolic· 821 cited findings· 1 source document
Company: Sanofi →
What the regulatory reviews say
Teizeild is a drug indicated for delaying progression to Stage 3 Type 1 Diabetes (T1D). In clinical trials, the median time to progression to Stage 3 T1D for participants receiving Teizeild was 49.5 months, compared to 24.9 months for those receiving placebo. The median age of participants in the teplizumab group was 14 years, and 13 years in the placebo group. The study population was predominantly male (55.3%) and white (97.4%).
Regarding safety, 5 participants in the teplizumab group discontinued due to adverse events. The mean rate of severe hypoglycemic adverse events in the teplizumab group was 0.01 events/patient-year, compared to 0.02 events/patient-year in the control group. The ratio of Level 3 hypoglycemic events (teplizumab/placebo) was 0.29. A decrease in blood bicarbonate was observed in 19.1% of the control group. Teizeild received a positive opinion from the CHMP on 13 November 2025, following a Marketing Authorisation Application submission on 19 December 2024.
Key figures — cited to the source page
| Median time to progression to stage 3 T1D (Teizeild) | 49.5 | Sanofi — Teizeild EMA EPAR public assessment report (EMEA/H/, p.9 |
| Median time to progression to stage 3 T1D (placebo) | 24.9 | Sanofi — Teizeild EMA EPAR public assessment report (EMEA/H/, p.9 |
| Teplizumab group discontinuations due to AEs | 5 | Sanofi — Teizeild EMA EPAR public assessment report (EMEA/H/, p.118 |
| Mean rate of severe hypoglycemic adverse events (teplizumab) | 0.01 | Sanofi — Teizeild EMA EPAR public assessment report (EMEA/H/, p.140 |
| Mean rate of severe hypoglycemic adverse events (control) | 0.02 | Sanofi — Teizeild EMA EPAR public assessment report (EMEA/H/, p.140 |
| Ratio of Level 3 hypoglycemic events (teplizumab/placebo) | 0.29 | Sanofi — Teizeild EMA EPAR public assessment report (EMEA/H/, p.133 |
| CHMP positive opinion date | 13 November 2025 | Sanofi — Teizeild EMA EPAR public assessment report (EMEA/H/, p.13 |
| Marketing Authorisation Application submission date | 19 December 2024 | Sanofi — Teizeild EMA EPAR public assessment report (EMEA/H/, p.11 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.