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Tacrolimus and Everolimus
Tacrolimus and everolimus are immunosuppressive agents that inhibit mTOR and calcineurin pathways to prevent T-cell activation and proliferation.
Tacrolimus and everolimus are immunosuppressive agents that inhibit mTOR and calcineurin pathways to prevent T-cell activation and proliferation. Used for Prevention of organ rejection in solid organ transplantation, Prevention and treatment of graft-versus-host disease (GVHD).
At a glance
| Generic name | Tacrolimus and Everolimus |
|---|---|
| Also known as | Prograf, Advagraf, Zortress, Certican |
| Sponsor | Chang Gung Memorial Hospital |
| Drug class | Immunosuppressant (calcineurin inhibitor and mTOR inhibitor combination) |
| Target | Calcineurin (tacrolimus) and mTOR (everolimus) |
| 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. Everolimus inhibits mTOR kinase, suppressing cell proliferation and immune response. Together, they provide synergistic immunosuppression to prevent organ rejection and graft-versus-host disease.
Approved indications
- Prevention of organ rejection in solid organ transplantation
- Prevention and treatment of graft-versus-host disease (GVHD)
Common side effects
- Nephrotoxicity
- Hypertension
- Hyperglycemia
- Infections
- Neurotoxicity (tremor, headache)
- Dyslipidemia
Key clinical trials
- 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)
- REgulatory T Cell Therapy to Achieve Immunosuppression REduction (PHASE2)
- ECP-DL Cell Infusion for Induction in Living Donor Kidney (LDK) Transplants (PHASE1)
- EVR and EPO for Liver Transplant Tolerance (PHASE1)
- Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer (PHASE4)
- The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus and Leflunomide in Treatment of BK Virus Infection in Kidney Transplantation Recipient (NA)
- CERTICOEUR: A Secondary Prevention Study of Skin Cancers in Heart Transplant Patients. Everolimus Versus Calcineurin Inhibitors Multicenter Trial (PHASE3)
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 Everolimus CI brief — competitive landscape report
- Tacrolimus and Everolimus updates RSS · CI watch RSS
- Chang Gung Memorial Hospital portfolio CI