Last reviewed · How we verify
switched from Prograf® to Envarsus®
Envarsus® is an extended-release formulation of tacrolimus that provides sustained immunosuppression by inhibiting calcineurin and blocking T-cell activation.
Envarsus® is an extended-release formulation of tacrolimus that provides sustained immunosuppression by inhibiting calcineurin and blocking T-cell activation. Used for Prophylaxis of organ rejection in adult patients receiving allogeneic kidney, heart, or liver transplants.
At a glance
| Generic name | switched from Prograf® to Envarsus® |
|---|---|
| Sponsor | University Hospital, Limoges |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin (protein phosphatase 2B) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Tacrolimus is a calcineurin inhibitor that prevents dephosphorylation of nuclear factor of activated T cells (NFAT), thereby suppressing T-cell proliferation and cytokine production. Envarsus® uses MeltDose® technology to provide once-daily extended-release delivery, improving bioavailability and reducing peak-to-trough fluctuations compared to immediate-release Prograf®, while maintaining equivalent immunosuppressive efficacy.
Approved indications
- Prophylaxis of organ rejection in adult patients receiving allogeneic kidney, heart, or liver transplants
Common side effects
- Tremor
- Headache
- Hypertension
- Nephrotoxicity/renal dysfunction
- Hyperglycemia/new-onset diabetes
- Infection
- Nausea
- Insomnia
Key clinical trials
- PK Assessment of Tacrolimus Exposure Before and After a Switch From Twice Daily Immediate-release (Prograf®) to Once-daily Prolonged Release Tacrolimus (Envarsus®) (PHASE4)
- Evaluation Of Switching From Twice Daily Tacrolimus To Once Daily Formulation On Cardiovascular Risk (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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- switched from Prograf® to Envarsus® CI brief — competitive landscape report
- switched from Prograf® to Envarsus® updates RSS · CI watch RSS
- University Hospital, Limoges portfolio CI