Soliris(eculizumab)
Bekemv, Bkemv, Epysqli, Soliris (eculizumab) is an antibody pharmaceutical. Eculizumab was first approved as Soliris on 2007-03-16. It is used to treat atypical hemolytic uremic syndrome and paroxysmal hemoglobinuria in the USA. It has been approved in Europe to treat paroxysmal hemoglobinuria.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
| hemic and lymphatic diseases | D006425 |
Trade Name
FDA
EMA
Bkemv, Epysqli, Soliris
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)
Eculizumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Soliris | eculizumab | Alexion Pharmaceuticals | N-125166 RX | 2007-03-16 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| soliris | Biologic Licensing Application | 2024-09-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| paroxysmal hemoglobinuria | Orphanet_447 | D006457 | D59.12 |
| atypical hemolytic uremic syndrome | — | D065766 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
eculizumab, Soliris, Alexion Pharmaceuticals, Inc. | |||
| 2026-06-27 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1300 | Injection, eculizumab, 10 mg |
Clinical
Clinical Trials
142 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Paroxysmal hemoglobinuria | D006457 | Orphanet_447 | D59.12 | — | — | 1 | — | — | 1 |
| Hemoglobinuria | D006456 | — | R82.3 | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Eculizumab |
| INN | eculizumab |
| Description | Immunoglobulin, anti-(human complement C5 alpha-chain) (human-mouse monoclonal 5G1.1 heavy chain), disulfide with human-mouse monoclonal 5G1.1 light chain, dimer |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >5I5K:H,X|Eculizumab heavy chain (variable domain)
QVQLVQSGAEVKKPGASVKVSCKASGYIFSNYWIQWVRQAPGQGLEWMGEILPGSGSTEYTENFKDRVTMTRDTSTSTVY
MELSSLRSEDTAVYYCARYFFGSSPNWYFDVWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVT
VSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHT
>5I5K:L,Y|Eculizumab light chain (variable domain)
DIQMTQSPSSLSASVGDRVTITCGASENIYGALNWYQQKPGKAPKLLIYGATNLADGVPSRFSGSGSGTDFTLTISSLQP
EDFATYYCQNVLNTPLTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ
ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC |
Identifiers
| PDB | 5I5K |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201828 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB01257 |
| UNII ID | A3ULP0F556 (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
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Soliris – Alexion Pharmaceuticals
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Soliris – AstraZeneca
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 16,710 documents
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Safety
Black-box Warning
Black-box warning for: Soliris
Adverse Events
Top Adverse Reactions
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55,124 adverse events reported
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