BLASINGLE-USEVIALPriority Review
Approved
May 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
SIMULECT (basiliximab) by Novartis is interleukin 2 receptor antagonists [moa]. Approved for interleukin-2 receptor blocking antibody [epc]. First approved in 1998.
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SIMULECT (basiliximab) is a monoclonal antibody that blocks the interleukin-2 receptor, preventing T-cell activation. It is used as an immunosuppressant in organ transplant recipients to prevent acute rejection. The drug works by binding to CD25 on activated T lymphocytes, blocking IL-2 signaling and reducing graft rejection risk.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30%), suggesting a defensive, cost-containment-focused team rather than growth-oriented expansion.
Mechanism of Action
Interleukin 2 Receptor Antagonists
Pharmacologic Class:
Interleukin-2 Receptor Blocking Antibody
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
90Y-DOTA-anti-CD25 Basiliximab, Fludarabine, Melphalan, and Total Marrow and Lymphoid Irradiation for the Treatment of High-Risk Acute Leukemia or Myelodysplastic Syndrome
Started Jul 2022
Simulect Versus ATG in Sensitized Renal Transplant Patient
Started Sep 2013
60 enrolled
Renal Transplant Rejection
Pharmacodynamics, Efficacy and Safety of Basiliximab 40 or 80 mg in Combination With Ciclosporine Microemulsion or Everolimus, in Adult Low Risk de Novo Renal Transplant Recipients (IDEALE Study)
Started Mar 2012
16 enrolled
Renal Transplantation
Evaluate Tolerability of Myfortic®/Simulect® and Tacrolimus Without Steroids in Three Patient Populations
Started Mar 2011
2 enrolled
DiabetesImmunosuppression
Safety and Efficacy of Basiliximab, Delayed Dose Tacrolimus Plus ECMPA (Enteric Coated Mycophenolic Acid) Following Liver Transplantation
Started Jan 2011
59 enrolled
Liver Transplantation
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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.