NDAORALCAPSULE, EXTENDED RELEASE
Approved
Jul 2013
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
Drug data last refreshed 8h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ASTAGRAF XL is an extended-release oral formulation of tacrolimus, a calcineurin inhibitor immunosuppressant used primarily in organ transplant recipients to prevent rejection. The drug works by suppressing T-cell activation and proliferation, enabling long-term graft survival. Tacrolimus has a narrow therapeutic window requiring careful dose management and therapeutic drug monitoring.
$0.448MPart D
PeakProduct is at peak lifecycle stage with moderate Part D utilization, indicating stable but mature revenue with established market positioning and likely optimized commercial infrastructure.
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 (3)
Trial to Evaluate Safety and Tolerability of Tacrolimus Extended-Release (Astagraf XL) in Human Leukocyte Antigen (HLA) Sensitized Kidney Transplant Recipients
Started Sep 2017
20 enrolled
End Stage Renal Disease
Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients
Started May 2017
25 enrolled
Immunosuppression
To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients
Started Sep 2016
599 enrolled
Kidney Transplantation
Career Relevance
Working on ASTAGRAF XL positions you in a stable, mature immunosuppression franchise with deep healthcare provider relationships and specialized transplant center expertise. However, the peak lifecycle stage and high off-label/ineffectiveness reporting signal that career growth may be constrained; advancement depends on expanding into emerging indications or defending market share against generic erosion.
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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.