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Tacrolimus and Sirolimus
Tacrolimus and sirolimus are immunosuppressive agents that inhibit T-cell activation and proliferation through different pathways to prevent organ rejection.
Tacrolimus and sirolimus are immunosuppressive agents that inhibit T-cell activation and proliferation through different pathways to prevent organ rejection. Used for Prevention of organ rejection in liver transplant recipients.
At a glance
| Generic name | Tacrolimus and Sirolimus |
|---|---|
| Also known as | Advagraf [Astellas Pharma bv), Rapamune |
| Sponsor | Foundation for Liver Research |
| Drug class | Calcineurin inhibitor and mTOR inhibitor combination |
| Target | Calcineurin (tacrolimus) and mTOR (sirolimus) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Transplantation |
| Phase | FDA-approved |
Mechanism of action
Tacrolimus binds to FK-binding protein and inhibits calcineurin, blocking T-cell receptor signaling and IL-2 production. Sirolimus binds to mTOR and inhibits cell cycle progression, synergistically reducing T-cell proliferation. Together, they provide dual immunosuppression for transplant recipients.
Approved indications
- Prevention of organ rejection in liver transplant recipients
Common side effects
- Nephrotoxicity
- Hyperglycemia
- Hypertension
- Hyperlipidemia
- Infections
- Tremor
- Headache
Key clinical trials
- Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia (PHASE2)
- A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy (PHASE3)
- A Study to Evaluate Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft-Versus-Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256) (PHASE2)
- Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS) (PHASE2)
- Allo HSCT for High Risk Hemoglobinopathies (PHASE2)
- Advancing Transplantation Outcomes in Children (PHASE2)
- HLA-Identical Sibling Renal Transplant Tolerance (NA)
- Reduced Intensity, Partially HLA Mismatched BMT to Treat Hematologic Malignancies (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tacrolimus and Sirolimus CI brief — competitive landscape report
- Tacrolimus and Sirolimus updates RSS · CI watch RSS
- Foundation for Liver Research portfolio CI