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teplizumab

Phase 3

Type 1 Diabetes Mellitus | Monoclonal antibody | Metabolic |Sanofi|Last Updated: Jun 8, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindNO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment1,061
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03875729Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of TeplizumabPHASE3 COMPLETED 328 — — Apr 1, 2019Apr 1, 2023Apr 23, 2024 - —
NCT07088068A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 DiabetesPHASE3 RECRUITING 723 — — Aug 6, 2025Dec 12, 2028Jun 8, 2026159 United States, Argentina +15
NCT06791291Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 DiabetesPHASE2 RECRUITING 10 — — Jul 25, 2025Mar 6, 2028Apr 13, 202611 Japan
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Study Endpoints
Primary Endpoints
For United States (US) and non-European Union (EU) countries: Glycated hemoglobin (HbA1c) change from baseline
From Baseline to Week 52
For US and non-EU countries: Total number of days without prandial insulin use
From baseline to Week 52
For EU countries: Change from baseline in mean 2 hours mixed meal tolerance test (MMTT) stimulated C-peptide concentration, calculated from Area Under the Curve (AUC) in participants 5 years and older
From baseline to Week 52
For EU countries: HbA1c change from baseline
From baseline to Week 52
For EU countries: Total number of days without prandial insulin use
From baseline to Week 52
Number of participants with Stage 3 Type 1 Diabetes based on American Diabetes Association criteria
From baseline up to Week 104
Change from baseline in area under the curve (AUC) of C-peptide
From baseline up to Week 104
Change from baseline in endogenous insulin
From baseline up to Week 104
Number of participants with TEAEs, SAEs, AEs leading to permanent study intervention- or study discontinuation; AEs of special interest; number of participants with clinically significant changes in vital signs, ECG, and/or safety laboratory test
Throughout the study, approximately 756 days

TEAE: treatment-emerged adverse event; SAE: serious adverse event; AE: adverse event

Secondary Endpoints
Change from baseline in mean 2 hours MMTT stimulated C-peptide concentration, calculated from AUC
From baseline to Week 52
Participants remaining C-peptide positive (2 hours MMTT stimulated peak C-peptide concentration ≥0.2 nmol/L)
At Week 52
Incidence of participants with HbA1c ≤6.5% and requiring ≤0.25 IU/kg/day of insulin
At Week 52
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Study Design & Arms
Treatment Arms
ArmTypeDescription
TeplizumabEXPERIMENTALParticipants will receive teplizumab in increasing doses by intravenous administration
PlaceboPLACEBO_COMPARATORParticipants will receive volume matching placebo doses to the Teplizumab arm by intravenous administration
ControlNO_INTERVENTIONParticipants will receive no treatment in the control group
Interventions
NameTypeDescription
teplizumabBIOLOGICALTreatment
PlaceboBIOLOGICALControl
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Eligibility Criteria
Age Range1 Year — 25 Years
SexALL

Inclusion Criteria: * Participants are eligible to be included in the study only if all of the following criteria apply: * Participant must be 1 to 25 years of age inclusive, at the time of signing the informed consent. * Participants diagnosed with T1D Stage 3 according to American Diabetes Associ...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaChinaCzechiaFranceGermanyIsraelItalyJapanNetherlandsPolandSpainUnited Kingdom
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Recent Changes (Last 90 Days)
LOWJun 8, 2026NCT07088068lastUpdatePostDate: changed
LOWMay 26, 2026NCT07088068primaryCompletionDate: changed
LOWMay 26, 2026NCT06791291primaryCompletionDate: changed
LOWMay 24, 2026NCT07088068studyFirstPostDate: changed
LOWMay 24, 2026NCT06791291studyFirstPostDate: changed