Simulect(basiliximab)
Simulect (basiliximab) is an antibody pharmaceutical. Basiliximab was first approved as Simulect on 1998-05-12. It has been approved in Europe to treat graft rejection and kidney transplantation. It is known to target interleukin-2 receptor subunit alpha.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Simulect
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| simulect | Biologic Licensing Application | 2025-01-21 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
basiliximab, Simulect, Novartis Pharmaceuticals Corporation | |||
| 2105-05-12 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J0480 | Injection, basiliximab, 20 mg |
Clinical
Clinical Trials
163 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney transplantation | D016030 | — | — | 5 | 19 | 16 | 19 | 6 | 58 |
| Liver transplantation | D016031 | EFO_0010682 | — | 1 | 2 | 6 | 4 | 1 | 13 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | 3 | 2 | 2 | 5 | 12 |
| Graft rejection | D006084 | — | — | — | — | 1 | 4 | 4 | 9 |
| Graft vs host disease | D006086 | — | D89.81 | — | 3 | 3 | 1 | 1 | 8 |
| Renal insufficiency | D051437 | — | N19 | — | 2 | 4 | 3 | — | 8 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 2 | 1 | 5 | 1 | 8 |
| Infections | D007239 | EFO_0000544 | — | — | — | 1 | 2 | 1 | 4 |
| Recurrence | D012008 | — | — | 1 | 1 | — | 1 | — | 3 |
| Delayed graft function | D051799 | — | — | — | 2 | — | 1 | — | 3 |
Show 17 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 2 | 8 | 3 | — | 4 | 15 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.9 | — | 1 | 1 | — | — | 2 |
| Ischemia | D007511 | EFO_0000556 | — | — | 1 | 1 | — | — | 2 |
| Reperfusion injury | D015427 | — | — | — | 1 | 1 | — | — | 2 |
| Organ transplantation | D016377 | — | — | — | — | 2 | — | — | 2 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | 1 | 1 | — | — | 2 |
| Induction chemotherapy | D060828 | — | — | — | 1 | 1 | — | — | 2 |
| Macular edema | D008269 | — | — | — | — | 1 | — | — | 1 |
| Retinal diseases | D012164 | — | H35.9 | — | — | 1 | — | — | 1 |
| Edema | D004487 | — | R60.9 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 2 | 2 | — | — | 1 | 5 |
| Leukemia | D007938 | — | C95 | 2 | 1 | — | — | 1 | 4 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 2 | 1 | — | — | 1 | 4 |
| Myeloid leukemia | D007951 | — | C92 | 2 | 1 | — | — | 1 | 4 |
| Hodgkin disease | D006689 | — | C81 | 1 | 2 | — | — | 1 | 4 |
| Glioblastoma | D005909 | EFO_0000515 | — | 2 | 1 | — | — | — | 3 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 1 | 1 | — | — | 1 | 3 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | 1 | — | — | 1 | 3 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | 1 | — | — | 1 | 3 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | 1 | — | — | 1 | 3 |
Show 35 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | — | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | 2 | — | — | — | — | 2 |
| T-cell lymphoma cutaneous | D016410 | — | C84.A | 1 | — | — | — | — | 1 |
| Pathologic complete response | D000095384 | — | — | 1 | — | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | 1 | — | — | — | — | 1 |
| Lymphopenia | D008231 | — | D72.810 | 1 | — | — | — | — | 1 |
| Preleukemia | D011289 | — | — | 1 | — | — | — | — | 1 |
| Syndrome | D013577 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Death | D003643 | PATO_0001422 | — | — | — | — | — | 2 | 2 |
| Immunosuppression therapy | D007165 | — | — | — | — | — | — | 2 | 2 |
| Heart disease risk factors | D000082742 | — | — | — | — | — | — | 1 | 1 |
| Bone diseases | D001847 | — | M89.9 | — | — | — | — | 1 | 1 |
| Antibody formation | D000917 | — | — | — | — | — | — | 1 | 1 |
| Carcinoma | D002277 | — | C80.0 | — | — | — | — | 1 | 1 |
| Postoperative complications | D011183 | — | — | — | — | — | — | 1 | 1 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | — | — | — | 1 | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | — | — | 1 | 1 |
| Islets of langerhans transplantation | D016381 | — | — | — | — | — | — | 1 | 1 |
Show 5 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Basiliximab |
| INN | basiliximab |
| Description | Basiliximab (chimeric mab) |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >3IU3:A,C,H|Heavy chain of Fab fragment of Basiliximab
QLQQSGTVLARPGASVKMSCKASGYSFTRYWMHWIKQRPGQGLEWIGAIYPGNSDTSYNQKFEGKAKLTAVTSASTAYME
LSSLTHEDSAVYYCSRDYGYYFDFWGQGTTLTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGA
LTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEP
>3IU3:B,D,L|Light chain of Fab fragment of Basiliximab
QIVSTQSPAIMSASPGEKVTMTCSASSSRSYMQWYQQKPGTSPKRWIYDTSKLASGVPARFSGSGSGTSYSLTISSMEAE
DAATYYCHQRSSYTFGGGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESV
TEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGE |
Identifiers
| PDB | 3IU3 |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201439 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00074 |
| UNII ID | 9927MT646M (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
IL2RA
IL2RA
Organism
Homo sapiens
Gene name
IL2RA
Gene synonyms
NCBI Gene ID
Protein name
interleukin-2 receptor subunit alpha
Protein synonyms
CD25, IL-2 receptor subunit alpha, IL-2R subunit alpha, interleukin 2 receptor, alpha, p55, TAC antigen
Uniprot ID
Mouse ortholog
Il2ra (16184)
interleukin-2 receptor subunit alpha (Q61731)
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Simulect
Adverse Events
Top Adverse Reactions
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8,347 adverse events reported
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