Summary
Tacrolimus Anhydrous has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Myasthenia Gravis (MG) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Myasthenia Gravis (MG). ClinicalTrials.gov lists 6 registered trials linking Tacrolimus Anhydrous to Myasthenia Gravis (MG): 1 is currently recruiting; 3 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT01325571). The largest enrolment is 2000 participants (NCT04101578). Registration activity spans 2006 to 2021. No published literature item is linked to Tacrolimus Anhydrous and Myasthenia Gravis (MG) 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 Myasthenia Gravis 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: Spontaneous complete stable remission (CSR) in 10-20% of patients over 10 years; generalised MG rarely resolves without treatment; ocular MG may remain limited in 50-60%.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 38.5 (trials 18.5, literature 0.0, tier 15, approved bonus 5.0) |
| Registered trials | 6 total: 1 recruiting, 0 active / not yet recruiting, 3 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 | ACHE |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00309088 | FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients 2006 | completed | Phase 3 | 80 |
| NCT00309101 | An Open Study for Steroid Resistant, Non-Thymectomized MG Patients 2006 | completed | Phase 3 | 11 |
| NCT01325571 | A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia Gravis 2011 | completed | Phase 3 | 83 |
| NCT04182984 | TheRapeutic Effect of Different immunosuppressAnts on Non-Thymoma Ocular Myasthenia Gravis: a Real-world Study 2019 | recruiting | Not applicable | 200 |
| NCT04768465 | Tacrolimus Combined With Low-dose Prednisone for Treatment of Myasthenia Gravis 2021 | status unknown | Not applicable | 160 |
| NCT04101578 | Clinical Prognosis and Progression of Myasthenia Gravis Patients 2017 | status unknown | Not applicable | 2,000 |
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 ACHE. 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 Myasthenia Gravis (MG)?
Tacrolimus Anhydrous has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Myasthenia Gravis (MG) would be drug repurposing rather than first-in-human development. This does not mean it is approved for Myasthenia Gravis (MG). Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Tacrolimus Anhydrous in clinical trials for Myasthenia Gravis (MG)?
ClinicalTrials.gov lists 6 registered trials linking Tacrolimus Anhydrous to Myasthenia Gravis (MG): 1 is currently recruiting; 3 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT01325571). The largest enrolment is 2000 participants (NCT04101578). Registration activity spans 2006 to 2021.
What does the evidence show for Tacrolimus Anhydrous in Myasthenia Gravis (MG)?
Tacrolimus Anhydrous has 3 completed registered trials for Myasthenia Gravis (MG) 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 ACHE. 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.