Last reviewed · How we verify
Simulect
At a glance
| Generic name | Simulect |
|---|---|
| Also known as | Basiliximab, basiliximab, Simulect IV 40 mg/day D0 and D4, and oral use Tacrolimus 0.1 mg/ kg/ day +, Myfortic 720 to 1440mg + |
| Sponsor | Astellas Pharma Inc |
| Target | Interleukin-2 receptor subunit alpha |
| Modality | Small molecule |
| Therapeutic area | Nephrology |
| Phase | FDA-approved |
Approved indications
- Renal transplant rejection
Common side effects
- Gastrointestinal disorders
- Constipation
- Nausea
- Abdominal pain
- Vomiting
- Diarrhea
- Dyspepsia
- Pain
- Peripheral edema
- Fever
- Viral infection
- Hyperkalemia
Serious adverse events
- Sepsis
- Cardiac failure
- GI hemorrhage
- Thrombosis
- Bone fracture
- Atrial fibrillation
- Hemorrhage
- Esophagitis
- Angina pectoris
- Diabetes mellitus
Key clinical trials
- Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients (PHASE2)
- Valganciclovir Prophylaxis Versus Preemptive Therapy for Cytomegalovirus in Living Donor Kidney Transplant Recipients (PHASE4)
- Examination of Immunosuppression Adjustment Impact on Kidney Function in Liver Transplant (PHASE4)
- Simulect Versus ATG in Sensitized Renal Transplant Patient (PHASE4)
- Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma (PHASE2)
- A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients (PHASE2)
- Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR (PHASE4)
- Stem Cell Transplantation for Patients With Multiple Myeloma (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Simulect CI brief — competitive landscape report
- Simulect updates RSS · CI watch RSS
- Astellas Pharma Inc portfolio CI