Summary
Tacrolimus Anhydrous has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Atopic Dermatitis (Eczema) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Atopic Dermatitis (Eczema). ClinicalTrials.gov lists 8 registered trials linking Tacrolimus Anhydrous to Atopic Dermatitis (Eczema): 1 is currently recruiting; 1 is active or not yet recruiting; 5 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00667160). The largest enrolment is 8071 participants (NCT00475605). Registration activity spans 2002 to 2026. No published literature item is linked to Tacrolimus Anhydrous and Atopic Dermatitis (Eczema) 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 Atopic Eczema ranks 294 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: 60-70% of childhood-onset AD achieves spontaneous remission by adolescence; adult-onset AD is more persistent; moderate-severe adult AD: <15% spontaneous clearance at 5 years.
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: 1 recruiting, 1 active / not yet recruiting, 5 completed, 1 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 | AFF1 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01782729 | An Efficacy and Safety Study of Tacrolimus Ointment in Pediatric Participants With Atopic Dermatitis 2008 | completed | Phase 4 | 30 |
| NCT00667160 | Comparison Study Between Protopic (Tacrolimus Ointment) and Elidel (Pimecrolimus Cream) in Pediatric Patients With Mild Atopic Dermatitis 2002 | completed | Phase 4 | 426 |
| NCT07437534 | Comparative Evaluation of the Safety and Effectiveness of Crisaborole Ointment (2%) Versus Tacrolimus Ointment (0.1%) for the Topical Treatment of Atopic Dermatitis 2026 | not yet recruiting | Phase 4 | 148 |
| NCT00691262 | Study to Evaluate the Response to Treatment and Safety of 0.03% Tacrolimus (FK506) Ointment Administered in Pediatric Patients With Moderate to Severe Atopic Dermatitis 2003 | completed | Phase 3 | 166 |
| NCT00523952 | Clinical Trial to Assess the Efficacy and Safety of Tacrolimus Ointment Treatment of Atopic Dermatitis in Adult Patients 2004 | completed | Phase 3 | 303 |
| NCT06241118 | A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor 2024 | recruiting | Phase 3 | 636 |
| NCT05607901 | A Comparative Clinical Trial Evaluating the Effect and Safety of Tacrolimus Versus Hydrocortisone 2022 | completed | Phase 2 | 100 |
| NCT00475605 | A Pediatric Longitudinal Evaluation to Assess the Long-Term Safety of Protopic for the Treatment of Atopic Dermatitis 2005 | terminated | Not applicable | 8,071 |
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 AFF1. 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 Atopic Dermatitis (Eczema)?
Tacrolimus Anhydrous has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Atopic Dermatitis (Eczema) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Atopic Dermatitis (Eczema). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Tacrolimus Anhydrous in clinical trials for Atopic Dermatitis (Eczema)?
ClinicalTrials.gov lists 8 registered trials linking Tacrolimus Anhydrous to Atopic Dermatitis (Eczema): 1 is currently recruiting; 1 is active or not yet recruiting; 5 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00667160). The largest enrolment is 8071 participants (NCT00475605). Registration activity spans 2002 to 2026.
What does the evidence show for Tacrolimus Anhydrous in Atopic Dermatitis (Eczema)?
Tacrolimus Anhydrous has 5 completed registered trials for Atopic Dermatitis (Eczema) 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 AFF1. 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.