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Drug

Teplizumab

Approved · FDA / EMA
Emerging researchLate-stage development

Also known as Tzield.

RxNorm2621880UNIIS4M959U2IJ
2
Research papers
5
Active clinical trials
5
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Randomized, Double-blind, Phase 3 Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Recently Diagnosed Stage 3 Type 1 Diabetes (T1D)

Clinical trial2026-07-09Results expected Q2 2028 · ClinicalTrials.gov

Efficacy and Safety of Teplizumab in the Treatment of Japanese Pediatric and Adult Participants Aged 1 to 34 Years With Stage 2 Type 1 Diabetes: A Multicenter, Randomized, Open-label, Controlled Study.

Clinical trial2026-07-01Results expected Q1 2028 · ClinicalTrials.gov

FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 Diabetes

Regulatory2026-06-15Regulatory news · FDA Press Releases

Sanofi, once on FDA course for speedy approval, gains late expansion for Tzield

Industry2026-06-15Manufacturing · Fierce Pharma

Indication expansion: TEPLIZUMAB-MZWV (BLA761183)

Regulatory2026-06-12FDA

Supplemental approval: TEPLIZUMAB-MZWV (BLA761183)

Regulatory2026-06-12FDA

MATIN-2: Sequential Immune Modulation and Antigen-Specific Tolerance Induction for Disease Modification in Recent-Onset Type 1 Diabetes - A Mechanistic Framework and Phase I/II Protocol Proposal

Clinical trial2026-05-27Results expected Q4 2029 · ClinicalTrials.gov

Adaptive Platform Trial to Delay Progression From Stage 2 to Stage 3 Type 1 Diabetes: Comparing Teplizumab With Low-dose Anti-Thymocyte Globulin (ATG) Protocol TN-40A

Clinical trial2026-05-22Results expected Q4 2029 · ClinicalTrials.gov

Indication expansion: TEPLIZUMAB-MZWV (BLA761183)

Regulatory2026-04-20FDA

Approval: Teizeild (EMA)

Regulatory2026-01-08EMA

Teplizumab and β-Cell Function in Newly Diagnosed Type 1 Diabetes.

Research2023-10-18The New England journal of medicine

An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes.

Research2019-06-09The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Teplizumab
Aliases & brands
Tzield
RxNorm CUI
2621880
UNII
S4M959U2IJ
Regulatory jurisdictions
emafda

Regulatory timeline

5 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2026-01-08 → 2026-06-12)
Earliest approval
2022-11-17
Latest approval
2026-06-12
Authorities
FDA · EMA
Total events
5
fdaU.S. Food and Drug Administration· 4 events
2026-06-12Indication expansionMulti-authority
Indication expansion: TEPLIZUMAB-MZWV (BLA761183)
Evidence ↗
2026-06-12Supplemental approvalMulti-authority
Supplemental approval: TEPLIZUMAB-MZWV (BLA761183)
Evidence ↗
2026-04-20Indication expansionMulti-authority
Indication expansion: TEPLIZUMAB-MZWV (BLA761183)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2026-01-08ApprovalMulti-authority
Approval: Teizeild (EMA)

Indication: Teizeild is indicated to delay the onset of stage 3 type 1 diabetes (T1D) in adult and paediatric patients 8 years of age and older with stage 2 T1D.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

10 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
10
registered trials across all phases
LATEST COMPLETION 2023
5
Active studies
4
Recruiting
4
Late-stage (III+)
4
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 10
Phase 11Phase 1 / 22Phase 23Phase 2 / 31Phase 32Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Single Arm, Open-label Study to Assess the Safety and Pharmacokinetics of a 14-day Regimen of Teplizumab in Pediatric Stage 2 Type 1 Diabetes (Participants <8 Years of Age With at Least Two Autoantibodies and Dysglycemia)

Active, not recruitingPH IVSanofin=202026

A Randomized, Double-blind, Phase 3 Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Recently Diagnosed Stage 3 Type 1 Diabetes (T1D)

RecruitingPH IIISanofin=7232028

Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized Fc Receptor (FcR) Non-Binding Anti-cluster of Differentiation 3 (CD3) Monoclonal Antibody, in Children and Adolescents With Newly Diagnosed Type 1 Diabetes

CompletedPH IIIProvention Bio, Inc.n=3282023

A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of MGA031, a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

CompletedPH II/IIIMacroGenicsn=5542011

Recent completions

Trials that read out recently, adding to the completed evidence base.

Phase 3 Randomized Double-Blind Multinational Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab, a Humanized Fc Receptor (FcR) Non-Binding Anti-cluster of Differentiation 3 (CD3) Monoclonal Antibody, in Children and Adolescents With Newly Diagnosed Type 1 Diabetes

CompletedPH IIIProvention Bio, Inc.n=3282023

A Prospective, Multi-center, Phase 1b/2a Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Association With Teplizumab in Patients With Clinical Recent-onset Type 1 Diabetes Mellitus (T1D)

CompletedPH I/IIPrecigen Actobio T1D, LLCn=452021

AntiCD3 Mab (Teplizumab) For Prevention of Diabetes In Relatives At-Risk for Type 1 Diabetes Mellitus

CompletedPH IINational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)n=762019

A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of MGA031, a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

CompletedPH II/IIIMacroGenicsn=5542011

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20192023
Most influential

An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes.

The New England journal of medicine · 2019 · 849 cites

Teplizumab and β-Cell Function in Newly Diagnosed Type 1 Diabetes.

The New England journal of medicine · 2023 · 189 cites
Recent papers

Teplizumab and β-Cell Function in Newly Diagnosed Type 1 Diabetes.

The New England journal of medicine · 2023 · 189 cites

An Anti-CD3 Antibody, Teplizumab, in Relatives at Risk for Type 1 Diabetes.

The New England journal of medicine · 2019 · 849 cites
Major research themes2
Antibodies, Monoclonal, Humanized1Diabetes Mellitus, Type 11
Journals, researchers & institutions
Top journals
  • The New England journal of medicine2
Leading researchers
  • Gitelman SE2
  • Herold KC2
  • Bluestone JA1
  • Bundy BN1
  • Chatenoud L1
  • Dayan CM1
  • DiMeglio LA1
  • Dufort MJ1
Leading institutions
free-text, unnormalised
  • W.T.); Cardiff University1
  • Yale University1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.