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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Novartis Pharmaceuticals
Commercial
Trade Name
FDA
EMA
Simulect
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Basiliximab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Simulect | basiliximab | Novartis Pharmaceuticals Corporation | N-103764 RX | 1998-05-12 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| simulect | Biologic Licensing Application | 2021-02-12 |
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
94 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 | 1 | 9 | 8 | 9 | 2 | 26 | ||
| Liver transplantation | D016031 | EFO_0010682 | — | 1 | 5 | 3 | — | 9 | |
| Beta-thalassemia | D017086 | Orphanet_848 | D56.1 | — | — | — | 3 | — | 3 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 2 | 1 | 1 | — | 3 |
| Chronic renal insufficiency | D051436 | N18 | — | 1 | — | 1 | — | 2 | |
| Cytomegalovirus infections | D003586 | EFO_0001062 | B25 | — | — | — | 1 | — | 1 |
| Glomerulonephritis | D005921 | N05 | — | — | — | 1 | — | 1 | |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | 1 | — | 1 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | 1 | — | 1 |
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 | — | 6 | 2 | — | 1 | 9 |
| Reperfusion injury | D015427 | — | — | 1 | — | — | 1 | ||
| Graft rejection | D006084 | — | — | 1 | — | — | 1 | ||
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | 1 | — | — | 1 |
| Emphysema | D004646 | EFO_0000464 | J43 | — | — | 1 | — | — | 1 |
| Alpha 1-antitrypsin deficiency | D019896 | E88.01 | — | — | 1 | — | — | 1 | |
| Infections | D007239 | EFO_0000544 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | C92.0 | 2 | 1 | — | — | 1 | 4 | |
| Hodgkin disease | D006689 | C81 | 1 | 2 | — | — | 1 | 4 | |
| Non-hodgkin lymphoma | D008228 | C85.9 | 1 | 1 | — | — | 1 | 3 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 1 | 1 | — | — | 1 | 3 | |
| Graft vs host disease | D006086 | D89.81 | — | 1 | — | — | 1 | 2 | |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | 2 | — | — | — | 2 |
| Primary myelofibrosis | D055728 | D47.4 | — | 1 | — | — | 1 | 2 | |
| Multiple myeloma | D009101 | C90.0 | — | 1 | — | — | 1 | 2 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | — | 1 | — | — | 1 | 2 | |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 1 | — | — | 1 | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | — | 1 |
| Myelodysplastic syndromes | D009190 | D46 | 1 | — | — | — | — | 1 |
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 | 179045-86-4 |
| RxCUI | 196102 |
| 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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,389 documents
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Safety
Black-box Warning
Black-box warning for: Simulect
Adverse Events
Top Adverse Reactions
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3,020 adverse events reported
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