Summary
Tacrolimus Anhydrous has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Systemic Lupus Erythematosus (SLE) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Systemic Lupus Erythematosus (SLE). ClinicalTrials.gov lists 8 registered trials linking Tacrolimus Anhydrous to Systemic Lupus Erythematosus (SLE): 1 is active or not yet recruiting; 4 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01316133). The largest enrolment is 1200 participants (NCT03791827). Registration activity spans 2007 to 2025. No published literature item is linked to Tacrolimus Anhydrous and Systemic Lupus Erythematosus (SLE) 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 Systemic Lupus Erythematosus ranks 276 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: Spontaneous drug-free remission: 2-10% in some cohorts over 5 years; disease-free survival in 15-20% at 20 years; renal lupus (LN) progression to ESRD in 10-20% within 20 years on standard care.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 42.5 (trials 22.5, literature 0.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 1 active / not yet recruiting, 4 completed, 3 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 | ATRIP |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01316133 | A Study to Evaluate the Efficacy and Safety of Tacrolimus With Steroid in Korean Lupus Nephritis Patients 2011 | terminated | Phase 4 | 37 |
| NCT02630628 | Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis 2015 | completed | Phase 3 | 130 |
| NCT04082416 | Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE) 2019 | completed | Phase 3 | 335 |
| NCT07138898 | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty 2025 | not yet recruiting | Phase 2 | 80 |
| NCT00569101 | A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis 2007 | status unknown | Phase 2 | 9 |
| NCT00876616 | Assess the Efficacy and Safety of Multi-target Therapy in Lupus Nephritis 2009 | completed | Not applicable | 362 |
| NCT01056237 | Long-Term Study of Multi-target Therapy as Maintenance Treatment for Lupus Nephritis 2010 | completed | Not applicable | 206 |
| NCT03791827 | Multicenter Registry of Pediatric Lupus Nephritis in China 2018 | status unknown | Not applicable | 1,200 |
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 ATRIP. 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 Systemic Lupus Erythematosus (SLE)?
Tacrolimus Anhydrous has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Systemic Lupus Erythematosus (SLE) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Systemic Lupus Erythematosus (SLE). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Tacrolimus Anhydrous in clinical trials for Systemic Lupus Erythematosus (SLE)?
ClinicalTrials.gov lists 8 registered trials linking Tacrolimus Anhydrous to Systemic Lupus Erythematosus (SLE): 1 is active or not yet recruiting; 4 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01316133). The largest enrolment is 1200 participants (NCT03791827). Registration activity spans 2007 to 2025.
What does the evidence show for Tacrolimus Anhydrous in Systemic Lupus Erythematosus (SLE)?
Tacrolimus Anhydrous has 4 completed registered trials for Systemic Lupus Erythematosus (SLE) 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 ATRIP. 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.