NDAORALTABLET, EXTENDED RELEASE
Approved
Jul 2015
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
ENVARSUS XR (tacrolimus) by Veloxis Pharmaceuticals is protein, fkbp-12. Approved for kidney transplantation, liver transplantation, heart transplantation. First approved in 2015.
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ENVARSUS XR is an extended-release oral formulation of tacrolimus, a calcineurin inhibitor approved in 2015 for prevention of organ rejection in kidney transplant patients. It works by binding to FKBP-12 protein and inhibiting calcineurin phosphatase activity, which prevents T-lymphocyte activation and reduces cytokine production including IL-2, IL-6, TNF-α, and interferon-gamma. The drug is used in combination with other immunosuppressants and can be used as a conversion therapy from immediate-release tacrolimus formulations. ENVARSUS XR is the extended-release alternative in a mature immunosuppressant market dominated by generic and brand-name calcineurin inhibitors.
$0.0BPart D
2.3 years to LOEMechanism of Action
protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin (an ubiquitous mammalian intracellular enzyme) is then formed and the phosphatase activity of calcineurin inhibited. Such inhibition prevents the dephosphorylation and translocation of various factors such as…
Indications (3)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.