NDAORALCAPSULE, EXTENDED RELEASE
Approved
Jul 2013
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
Drug data last refreshed 18h 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 to prevent organ rejection in transplant recipients. The drug works by suppressing T-cell activation and proliferation, critical for maintaining graft tolerance. It represents a formulation advancement over immediate-release tacrolimus, enabling once-daily dosing for improved patient compliance.
$0.448MPart D
PeakProduct is at peak lifecycle stage with modest Part D utilization (~591 claims in 2023), suggesting stable but narrow market penetration in transplant-specific populations, with smaller commercial team requirements.
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
ASTAGRAF XL offers career opportunities primarily in specialty pharmaceutical roles within transplant immunosuppression, a highly regulated and clinically focused niche. Success in this role requires deep clinical knowledge of transplant protocols, strong relationships with transplant centers and nephrology/hepatology practices, and expertise navigating complex reimbursement landscapes for orphan-adjacent populations.
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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.