Envarsus XR

Phase 3Small molecule

UUniversity of Wisconsin, Madison

Envarsus XR is one of 7 small molecule programs targeting Kidney Pancreas Transplantation. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Kidney Pancreas TransplantationRecruiting

Renal Transplant RecipientsActive, not recruiting

Kidney BiopsyRecruiting

Kidney Pancreas TransplantationPreclinical

Recruiting

Renal Transplant RecipientsPhase 3

Active, not recruiting

Kidney BiopsyPhase 3

Recruiting

Competition

Competitive Landscape

5 competitors in Renal Transplant Recipients

#DrugCompanyPhaseTrials

Nulojix

Bristol-Myers Squibb

Approved

4 2

Prograf

VVeloxis Pharmaceuticals

Approved

14 3

Shingrix

SShenzhen Shenxin Biotechnology Co., Ltd

Phase 3

1 4

Envarsus XR

UUniversity of Wisconsin, Madison

Phase 3

1 5

Tacrolimus Pill

EEdward Geissler

Phase 3

1 6

TCD601

IITB-Med LLC

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 2/3Recruiting

Kidney Biopsy

NCT03321656

Q4 2027

PreclinicalRecruiting

Kidney Pancreas Transplantation

NCT03769298

Clinical

Trials by Indication[1]

Tacrolimus2 trials

CNS Study of Patients Switching From Tacrolimus to Envarsus

Completed·UUniversity of Colorado, Denver·Phase 4·NCT03270462·20 enrolled

Envarsus XR Compared to Immediate Release Tacrolimus

Completed·MMayo Clinic·Phase 4·NCT03979365·261 enrolled

Renal Transplant Recipients1 trial

Envarsus XR® in Adolescent Renal Transplant Recipients

Active, not recruiting·UUniversity of California, Los Angeles·Phase 4·NCT03266393·28 enrolled

Kidney Biopsy1 trial

Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile

Recruiting·RRoberto Gedaly·Phase 2/3·NCT03321656·78 enrolled

Kidney Transplant1 trial

Evaluation of Anti-rejection Drug, Tacrolimus, in African-Americans With Kidney Transplant

Active, not recruiting·TThe Methodist Hospital Research Institute·Phase 4·NCT04665310·46 enrolled

Delayed Graft Function1 trial

Envarsus in Delayed Graft Function (E-DGF)

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT03864926·100 enrolled

2 more indications

Liver Transplant1 trial

Envarsus XL Immunosuppression Following Liver Transplantation

Completed·MMethodist Healthcare·Phase 2·NCT03828058·110 enrolled

Kidney Pancreas Transplantation1 trial

Conversion From Immediate Release Tacrolimus to Envarsus XR® in Simultaneous Pancreas-Kidney Recipients: Assessment of Functional, Safety and Quality of Life Outcomes (CIRTEN SPK)

Recruiting·UUniversity of Wisconsin, Madison·Preclinical·NCT03769298·20 enrolled

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for Envarsus XR. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Envarsus XR compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Envarsus XR. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — University of Wisconsin, Madison company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: UUniversity of Wisconsin, Madison

Envarsus XR

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2027

Trials by Indication[1]

Tacrolimus2 trials

Renal Transplant Recipients1 trial

Kidney Biopsy1 trial

Kidney Transplant1 trial

Delayed Graft Function1 trial

Liver Transplant1 trial

Kidney Pancreas Transplantation1 trial

References

Drug Info

Quick Facts

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