Summary
Tacrolimus Anhydrous has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Rheumatoid Arthritis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Rheumatoid Arthritis. ClinicalTrials.gov lists 8 registered trials linking Tacrolimus Anhydrous to Rheumatoid Arthritis: 1 is active or not yet recruiting; 7 have completed. The most advanced is Phase 4 (NCT01511003). The largest enrolment is 210 participants (NCT00036153). Registration activity spans 2002 to 2025. No published literature item is linked to Tacrolimus Anhydrous and Rheumatoid Arthritis 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 Rheumatoid Arthritis ranks 544 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: 11% achieve drug-free remission (DFR) at median 74 months; most cohorts show 10-15% DFR ceiling.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 50.0 (trials 30.0, literature 0.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 1 active / not yet recruiting, 7 completed, 0 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 | ALOX5 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT03737708 | A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA) 2019 | completed | Phase 4 | 21 |
| NCT01850979 | Treatment of Dry Eye Using 0.03% Tacrolimus Eye Drops 2010 | completed | Phase 4 | 24 |
| NCT01746680 | Efficacy and Safety Study of Tacrobell to Treat Rheumatoid Arthritis 2012 | completed | Phase 4 | 111 |
| NCT01224418 | A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate 2008 | completed | Phase 4 | 50 |
| NCT01511003 | A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs) 2011 | completed | Phase 4 | 128 |
| NCT00319917 | A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients 2006 | completed | Phase 4 | 123 |
| NCT00036153 | Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis 2002 | completed | Phase 3 | 210 |
| NCT07138898 | Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty 2025 | not yet recruiting | Phase 2 | 80 |
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 ALOX5. 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 Rheumatoid Arthritis?
Tacrolimus Anhydrous has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Rheumatoid Arthritis would be drug repurposing rather than first-in-human development. This does not mean it is approved for Rheumatoid Arthritis. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Tacrolimus Anhydrous in clinical trials for Rheumatoid Arthritis?
ClinicalTrials.gov lists 8 registered trials linking Tacrolimus Anhydrous to Rheumatoid Arthritis: 1 is active or not yet recruiting; 7 have completed. The most advanced is Phase 4 (NCT01511003). The largest enrolment is 210 participants (NCT00036153). Registration activity spans 2002 to 2025.
What does the evidence show for Tacrolimus Anhydrous in Rheumatoid Arthritis?
Tacrolimus Anhydrous has 7 completed registered trials for Rheumatoid Arthritis 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 ALOX5. 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.