SIMULECT
LOE ApproachingmAbBLASINGLE-USEVIALPriority Review
Approved
May 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 20h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SIMULECT (basiliximab) is a chimeric monoclonal antibody that blocks the interleukin-2 receptor on T cells, preventing acute rejection in transplant recipients. It is administered as an intravenous injection and works by selectively targeting the alpha subunit of the IL-2 receptor to suppress T-cell activation. This mechanism enables it to serve as an induction agent in organ transplantation protocols.
LOE Approaching
Niche immunosuppression product with limited commercial expansion opportunities; team size likely stable to declining as exclusivity window narrows.
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 (5)
Simulect Versus ATG in Sensitized Renal Transplant Patient
Started Sep 2013
60 enrolled
Renal Transplant Rejection
Evaluate Tolerability of Myfortic®/Simulect® and Tacrolimus Without Steroids in Three Patient Populations
Started Mar 2011
2 enrolled
DiabetesImmunosuppression
Study to Evaluate the Safety of Chronic Administration of Simulect to Subjects Receiving a First Kidney Transplant
Started May 2009
5 enrolled
End Stage Renal Disease
Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans in Lung Transplant
Started May 2004
22 enrolled
COPDEmphysemaAlpha-1 Antitrypsan Deficiency
An Open-label, Prospective, Randomized, Multi-center, Phase II Comparative Trial of Thymoglobulin Versus Simulect for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients.
Started May 2000
240 enrolled
Cadaveric Donor Renal TransplantationAcute Renal Allograft RejectionInduction Therapy
Worked on SIMULECT at Novartis? Share your interview experience or compensation data (+7 days Pro)
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.