Summary
Teplizumab has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Type 1 Diabetes would be drug repurposing rather than first-in-human development. This does not mean it is approved for Type 1 Diabetes. ClinicalTrials.gov lists 8 registered trials linking Teplizumab to Type 1 Diabetes: 3 are currently recruiting; 2 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT07088068). It plans or enrolled 723 participants. Registration activity spans 2002 to 2025. The literature layer holds 7 publications for this pair: 5 Cochrane reviews and 2 meta-analyses. Publication years run from 2023 to 2025. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Type 1 Diabetes Mellitus ranks 324 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Essentially zero for established T1DM (honeymoon phase occurs in 50-60% after diagnosis but lasts 3-12 months then ends); the disease is permanent autoimmune destruction of beta cells.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 72.5 (trials 22.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 3 recruiting, 0 active / not yet recruiting, 2 completed, 3 other |
| Linked publications | 7 (5 Cochrane reviews, 2 meta-analyses) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | other/unknown |
| Data sources | DGIdb |
| Linked via biomarker / target | CD3E |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT07088068 | A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes 2025 | recruiting | Phase 3 | 723 |
| NCT00920582 | Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus 2009 | terminated | Phase 3 | 254 |
| NCT00129259 | Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes 2005 | completed | Phase 2 | 83 |
| NCT00806572 | Treatment With hOKT3gamma1(Ala-Ala) in T1DM 2002 | terminated | Phase 2 | 10 |
| NCT01189422 | Subcutaneous Administration of Teplizumab in Adults With Type 1 Diabetes 2010 | terminated | Phase 1 | 1 |
| NCT06338553 | GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab 2024 | recruiting | Early Phase 1 | 24 |
| NCT03751007 | A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recent-onset Diagnosed Type 1 Diabetes (T1D) 2018 | completed | PHASE1, PHASE2 | 45 |
| NCT07260110 | A Longitudinal, Observational Study Comparing Real-World Experiences of Teplizumab-Treated and Untreated Participants With Stage 2 Type 1 Diabetes in the United States 2025 | recruiting | Not applicable | 550 |
Published literature
- Cochrane review Immunotherapy as a treatment for type 1 diabetes mellitus in children and young adults: A comprehensive systematic review and meta-analysisSalame G, Hakim V, Dagher C et al. · PloS one · 2025 · PMID 40215252
- Cochrane review Evaluation of teplizumab's efficacy and safety in treatment of type 1 diabetes mellitus: A systematic review and meta-analysisMa XL, Ge D, Hu XJ · World journal of diabetes · 2024 · PMID 39099823
- Cochrane review Effect of Immunotherapy on C-peptide Levels in Patients With Type I Diabetes Mellitus: A Systematic Review of Randomized Controlled TrialsRoy SS, Keshri USP, Alam MS et al. · Cureus · 2024 · PMID 38800168
- Cochrane review Safety and efficacy of teplizumab in the treatment of type 1 diabetes mellitus: An updated systematic review and meta-analysis of randomized controlled trialsGrando Alves G, Cunha L, Henkes Machado R et al. · Diabetes, obesity & metabolism · 2024 · PMID 38602411
- Meta-analysis Efficacy of teplizumab for treatment of type 1 diabetes: A meta-analysis of randomized controlled trialsHeidari E, Shafiee A, Noorian S et al. · Diabetes/metabolism research and reviews · 2024 · PMID 38757421
- Cochrane review Efficacy of anti-CD3 monoclonal antibodies in delaying the progression of recent-onset type 1 diabetes mellitus: A systematic review, meta-analyses and meta-regressionAshraf MT, Ahmed Rizvi SH, Kashif MAB et al. · Diabetes, obesity & metabolism · 2023 · PMID 37580969
- Meta-analysis Narrative Review of Anti-CD3 Antibody and Anti-CD20 Antibody: Immunotherapeutic Strategies to Treat and Prevent Type 1 DiabetesKashalikar P, Desai S, Sanap A et al. · Recent advances in inflammation & allergy drug discovery · 2023 · PMID 36415095
Mechanism and notes
Recorded mechanism or class: other/unknown.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target CD3E. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Teplizumab approved for Type 1 Diabetes?
Teplizumab has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Type 1 Diabetes would be drug repurposing rather than first-in-human development. This does not mean it is approved for Type 1 Diabetes. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Teplizumab in clinical trials for Type 1 Diabetes?
ClinicalTrials.gov lists 8 registered trials linking Teplizumab to Type 1 Diabetes: 3 are currently recruiting; 2 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT07088068). It plans or enrolled 723 participants. Registration activity spans 2002 to 2025.
What does the evidence show for Teplizumab in Type 1 Diabetes?
Teplizumab has both completed registered trials and synthesis-level publications linked to Type 1 Diabetes. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target CD3E. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.