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 | 2025-08-11 |
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
164 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 |
| Graft rejection | D006084 | — | — | — | — | 1 | 4 | 4 | 9 |
| Graft vs host disease | D006086 | — | D89.81 | — | 3 | 4 | 1 | 1 | 9 |
| Renal insufficiency | D051437 | — | N19 | — | 2 | 4 | 4 | — | 9 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 2 | 1 | 5 | 1 | 8 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | 2 | 5 | 7 |
| Psychology rejection | D012059 | — | — | — | — | 3 | 1 | — | 4 |
| Cytomegalovirus infections | D003586 | EFO_0001062 | B25 | — | — | — | 3 | — | 3 |
| Infections | D007239 | EFO_0000544 | — | — | — | 1 | 1 | 1 | 3 |
Show 16 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 | 4 | — | 4 | 16 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | 2 | 1 | — | 1 | 4 |
| Hypoglycemia | D007003 | — | E16.2 | — | 2 | 2 | — | — | 4 |
| Reperfusion injury | D015427 | — | — | — | 1 | 1 | — | — | 2 |
| Organ transplantation | D016377 | — | — | — | — | 2 | — | — | 2 |
| Leukemia | D007938 | — | C95 | — | 1 | 1 | — | 1 | 2 |
| Lymphoid leukemia | D007945 | — | C91 | — | 1 | 1 | — | 1 | 2 |
| Hepatitis c | D006526 | — | B19.2 | — | — | 2 | — | — | 2 |
| Induction chemotherapy | D060828 | — | — | — | 1 | 1 | — | — | 2 |
| Macular edema | D008269 | — | — | — | — | 1 | — | — | 1 |
Show 6 more
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 |
| 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 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | 2 | — | — | — | 2 |
| Primary myelofibrosis | D055728 | — | D47.4 | — | 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 |
Show 26 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 2 | — | — | — | 1 | 3 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | — | — | — | — | 2 |
| Gliosarcoma | D018316 | — | — | 2 | — | — | — | — | 2 |
| Recurrence | D012008 | — | — | 1 | — | — | — | — | 1 |
| T-cell lymphoma | D016399 | — | — | 1 | — | — | — | — | 1 |
| T-cell lymphoma cutaneous | D016410 | — | C84.A | 1 | — | — | — | — | 1 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | 1 | — | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | 1 | — | — | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | — | 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 6 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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8,473 adverse events reported
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