Summary
Tacrolimus Anhydrous 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 Tacrolimus Anhydrous to Type 1 Diabetes: 2 are active or not yet recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00679042). The largest enrolment is 170 participants (NCT00533442). Registration activity spans 2000 to 2008. No published literature item is linked to Tacrolimus Anhydrous 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 | 43.5 (trials 23.5, literature 0.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 2 active / not yet recruiting, 4 completed, 2 other |
| Linked publications | 0 |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ANG |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00679042 | Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol 2007 | active, not recruiting | Phase 3 | 21 |
| NCT00464555 | Strategies to Improve Islet Survival 2006 | completed | Phase 2 | 5 |
| NCT00533442 | Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients 2000 | completed | Phase 2 | 170 |
| NCT00789308 | Safety and Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation 2008 | completed | Phase 2 | 24 |
| NCT00706420 | Islet Transplantation Alone (ITA) in Patients With Difficult to Control Type I Diabetes Mellitus Using a Glucocorticoid-free Immunosuppressive Regimen 2004 | active, not recruiting | Phase 1 | 17 |
| NCT00708604 | Islet After Kidney Transplantation (IAK) in Patients With Type 1 Diabetes 2008 | completed | Phase 1 | 3 |
| NCT01309022 | Immunosuppressive Medications for Participants in ITN005CT (NCT00014911) | no_longer_available | Not applicable | — |
| NCT00309231 | Clinical Islet Transplantation Using the Edmonton Protocol | withdrawn | Not applicable | — |
Published literature
No publication is linked to this pair yet.
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target ANG. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Tacrolimus Anhydrous approved for Type 1 Diabetes?
Tacrolimus Anhydrous 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 Tacrolimus Anhydrous in clinical trials for Type 1 Diabetes?
ClinicalTrials.gov lists 8 registered trials linking Tacrolimus Anhydrous to Type 1 Diabetes: 2 are active or not yet recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00679042). The largest enrolment is 170 participants (NCT00533442). Registration activity spans 2000 to 2008.
What does the evidence show for Tacrolimus Anhydrous in Type 1 Diabetes?
Tacrolimus Anhydrous has 4 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 Open Targets and ChEMBL, in this case via the biomarker or target ANG. 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.