Summary
Tacrolimus Anhydrous has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Immune Thrombocytopaenia (ITP) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Immune Thrombocytopaenia (ITP). ClinicalTrials.gov lists 2 registered trials linking Tacrolimus Anhydrous to Immune Thrombocytopaenia (ITP): 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT05471050). It plans or enrolled 120 participants. Registration activity spans 2021 to 2022. No published literature item is linked to Tacrolimus Anhydrous and Immune Thrombocytopaenia (ITP) 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 Immune Thrombocytopenia ranks 50 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: Childhood ITP: spontaneous remission in 70-80% within 6 months; Adult ITP: spontaneous remission in 20-30% at 1 year without treatment; chronic ITP (>12 months) rarely resolves spontaneously.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 24.0 (trials 4.0, literature 0.0, tier 15, approved bonus 5.0) |
| Registered trials | 2 total: 0 recruiting, 0 active / not yet recruiting, 0 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 | ADRM1 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT05471050 | The Combination of Tacrolimus and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia 2022 | status unknown | Phase 2 | 120 |
| NCT04747080 | The Combination of Tacrolimus and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia 2021 | status unknown | Phase 2 | 120 |
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 ADRM1. 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 Immune Thrombocytopaenia (ITP)?
Tacrolimus Anhydrous has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Immune Thrombocytopaenia (ITP) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Immune Thrombocytopaenia (ITP). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Tacrolimus Anhydrous in clinical trials for Immune Thrombocytopaenia (ITP)?
ClinicalTrials.gov lists 2 registered trials linking Tacrolimus Anhydrous to Immune Thrombocytopaenia (ITP): 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT05471050). It plans or enrolled 120 participants. Registration activity spans 2021 to 2022.
What does the evidence show for Tacrolimus Anhydrous in Immune Thrombocytopaenia (ITP)?
Trials of Tacrolimus Anhydrous in Immune Thrombocytopaenia (ITP) are registered but none has completed, so there is no outcome evidence from those studies yet; the record is a signal of research interest. 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 ADRM1. 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 2026-07-06. Page built 2026-10-07.