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Envarsus Oral Product
Envarsus is a prolonged-release formulation of tacrolimus that provides sustained immunosuppression by inhibiting calcineurin and T-cell activation.
Envarsus is a prolonged-release formulation of tacrolimus that provides sustained immunosuppression by inhibiting calcineurin and T-cell activation. Used for Prophylaxis of organ rejection in adult kidney transplant recipients, Prophylaxis of organ rejection in adult heart transplant recipients, Prophylaxis of organ rejection in adult liver transplant recipients.
At a glance
| Generic name | Envarsus Oral Product |
|---|---|
| Sponsor | Imperial College Healthcare NHS Trust |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin (protein phosphatase 2B) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Transplantation |
| Phase | FDA-approved |
Mechanism of action
Tacrolimus is a calcineurin inhibitor that suppresses T-lymphocyte activation and proliferation, preventing rejection in transplant recipients. The extended-release formulation in Envarsus allows for once-daily dosing with more stable drug levels compared to immediate-release tacrolimus, improving medication adherence and reducing fluctuations in immunosuppressive coverage.
Approved indications
- Prophylaxis of organ rejection in adult kidney transplant recipients
- Prophylaxis of organ rejection in adult heart transplant recipients
- Prophylaxis of organ rejection in adult liver transplant recipients
Common side effects
- Tremor
- Headache
- Hypertension
- Nephrotoxicity
- Hyperglycemia
- Infection
- Gastrointestinal disturbances
Key clinical trials
- A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation (PHASE2)
- A Blood Stem Cell Transplant for Sickle Cell Disease (PHASE1)
- BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR) (PHASE2)
- Cyclophosphamide, Abatacept, and Tacrolimus for the Prevention of GvHD (PHASE2)
- The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients (PHASE2)
- A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration (PHASE1)
- CD40-L Blockade for Prevention of Acute Graft-Versus-Host Disease (PHASE1)
- A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy (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:
- Envarsus Oral Product CI brief — competitive landscape report
- Envarsus Oral Product updates RSS · CI watch RSS
- Imperial College Healthcare NHS Trust portfolio CI