Summary
Muromonab-Cd3 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trials linking Muromonab-Cd3 to Type 1 Diabetes: 2 are active or not yet recruiting; 5 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00920582). It plans or enrolled 254 participants. Registration activity spans 2005 to 2027. No published literature item is linked to Muromonab-Cd3 and Type 1 Diabetes in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
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 | 45.5 (trials 25.5, literature 0.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 2 active / not yet recruiting, 5 completed, 1 other |
| Linked publications | 0 |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | antibody; inhibitor |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01123083 | Trial of Otelixizumab for Adolescents and Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-2 2010 | completed | Phase 3 | 179 |
| 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 |
| NCT04270942 | At-Risk for Type 1 Diabetes Extension Study (TN-10 Extension) 2020 | completed | Phase 2 | 6 |
| NCT00946257 | Subcutaneous Administration of Otelixizumab to T1DM Patients 2009 | completed | Phase 1 | 33 |
| NCT01210664 | T1DM Immunotherapy Using CD4+CD127lo/-CD25+ Polyclonal Tregs 2010 | completed | Phase 1 | 16 |
| NCT07610213 | Sequential Immune Modulation and Antigen-Specific Tolerance Induction for Disease Modification in Recent-Onset Type 1 Diabetes 2027 | not yet recruiting | Phase 1 | 60 |
| NCT04598893 | Recent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension) 2020 | active, not recruiting | Not applicable | 188 |
Published literature
No publication is linked to this pair yet.
Mechanism and notes
Recorded mechanism or class: antibody; inhibitor.
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 Muromonab-Cd3 approved for Type 1 Diabetes?
Muromonab-Cd3 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 Muromonab-Cd3 in clinical trials for Type 1 Diabetes?
ClinicalTrials.gov lists 8 registered trials linking Muromonab-Cd3 to Type 1 Diabetes: 2 are active or not yet recruiting; 5 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00920582). It plans or enrolled 254 participants. Registration activity spans 2005 to 2027.
What does the evidence show for Muromonab-Cd3 in Type 1 Diabetes?
Muromonab-Cd3 has 5 completed registered trials for Type 1 Diabetes but no linked publication, which usually means results are unpublished, pending, or not yet matched to this record. 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.