NDAINJECTIONINJECTABLEPriority Review
Approved
Apr 1994
Lifecycle
LOE Approaching
Competitive Pressure
45/100
Clinical Trials
20
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 4h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROGRAF (tacrolimus) is a calcineurin inhibitor immunosuppressant administered by injection for prevention of organ rejection in transplant recipients. It works by suppressing T-cell activation and proliferation, reducing the immune response against transplanted organs. Tacrolimus is a foundational therapy in solid organ transplantation with decades of clinical validation.
LOE Approaching2.1 years to LOE
Product faces LOE within 2.1 years; commercial teams are shifting focus to lifecycle extension strategies, market consolidation, and transition planning rather than growth initiatives.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
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 Jun 2026
124 enrolled
LeukemiaMyelodysplasiaChronic Myelomonocytic Leukemia
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
Tacrolimus and Risk Factors for Glucose Metabolism Disorders in Kidney Transplant Patients
Started May 2025
120 enrolled
Kidney Transplant
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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.