NDAORALTABLET, EXTENDED RELEASE
Approved
Jul 2015
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
6/8 — Strong
ENVARSUS XR (tacrolimus) by Veloxis Pharmaceuticals is protein, fkbp-12. First approved in 2015.
Drug data last refreshed 8h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ENVARSUS XR is an extended-release oral formulation of tacrolimus, a calcineurin inhibitor used for immunosuppression in organ transplant recipients. It works by binding FKBP-12 and inhibiting calcineurin phosphatase activity, preventing T-cell activation and cytokine production. The extended-release formulation provides improved dosing convenience and potentially better bioavailability compared to immediate-release tacrolimus.
$0.013BPart D
LOE ApproachingStable
1.9 years to LOEProduct approaching loss of exclusivity (2028) with modest Part D presence; brand team focus shifting toward lifecycle extension and managed decline strategies.
Mechanism 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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations
Started May 2026
300 enrolled
Pulmonary Arterial HypertensionPulmonary Arterial Hypertension (PAH)Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)+2 more
Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients
Started Mar 2026
92 enrolled
Kidney Transplant RecipientsOld Age
A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
Started Mar 2026
526 enrolled
Kidney Transplant Rejection
Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis in Myeloablative Allogeneic Peripheral Blood Stem Cell Transplantation
Started Jan 2026
124 enrolled
LeukemiaMyelodysplasiaChronic Myelomonocytic Leukemia
EFFICACY AND TOLERANCE OF AN EYELID BALM IN COMBINATION WITH TACROLIMUS 0.1% IN PATIENTS WITH EYELID ATOPIC DERMATITIS
Started Nov 2025
33 enrolled
Atopic Dermatitis (AD)
Worked on ENVARSUS XR at Veloxis Pharmaceuticals? Share your interview experience or compensation data (+7 days Pro)
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.