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Arm 1 Everolimus/Reduced dose tacrolimus
Everolimus inhibits mTOR signaling to suppress immune cell proliferation, while reduced-dose tacrolimus inhibits calcineurin to prevent T-cell activation, together reducing organ rejection risk in transplant recipients.
Everolimus inhibits mTOR signaling to suppress immune cell proliferation, while reduced-dose tacrolimus inhibits calcineurin to prevent T-cell activation, together reducing organ rejection risk in transplant recipients. Used for Organ transplant rejection prophylaxis (renal transplantation).
At a glance
| Generic name | Arm 1 Everolimus/Reduced dose tacrolimus |
|---|---|
| Also known as | Zortress®, Prograf® or Hecoria® |
| Sponsor | University of Toledo Health Science Campus |
| Drug class | mTOR inhibitor + Calcineurin inhibitor combination |
| Target | mTOR; Calcineurin (PP2B) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Transplantation |
| Phase | FDA-approved |
Mechanism of action
Everolimus is an mTOR inhibitor that suppresses proliferation of T cells and B cells by blocking nutrient sensing pathways. Tacrolimus is a calcineurin inhibitor that prevents IL-2 production and T-cell activation. This combination regimen uses lower tacrolimus doses to reduce nephrotoxicity and other calcineurin-related toxicities while maintaining immunosuppressive efficacy through dual mechanism inhibition.
Approved indications
- Organ transplant rejection prophylaxis (renal transplantation)
Common side effects
- Infection
- Hyperglycemia
- Hyperlipidemia
- Anemia
- Thrombocytopenia
- Renal dysfunction
- Mouth ulcers
Key clinical trials
- REgulatory T Cell Therapy to Achieve Immunosuppression REduction (PHASE2)
- Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation (PHASE4)
- Evaluation of Calcineurin-inhibitor Reduction With Conversion at 2 Months to Everolimus/Reduced Tacrolimus in Renal Transplant Recipients Following Campath® Induction (PHASE4)
- Study in Recipients of Renal Transplant Allograft to Evaluate the Impact of Two Immunosuppressive Regimens (NA)
- Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation (PHASE4)
- Mechanisms and Treatment of Chronic Allograft Injury (CAI) Due to Calcineurin Inhibitor (CNI) Toxicity (NA)
- Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients. (PHASE3)
- Safety and Efficacy Study of Everolimus to Treat BK Virus Infection in Kidney Transplant Recipients (PHASE4)
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 |
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