Soliris(eculizumab)
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
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 | 2021-01-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| atypical hemolytic uremic syndrome | — | D065766 | — |
| paroxysmal hemoglobinuria | Orphanet_447 | D006457 | D59.12 |
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
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 |
|---|---|---|---|---|---|---|---|---|---|
| Paroxysmal hemoglobinuria | D006457 | Orphanet_447 | D59.12 | — | 5 | 17 | 2 | 3 | 27 |
| Atypical hemolytic uremic syndrome | D065766 | — | 8 | — | 2 | 2 | 12 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myasthenia gravis | D009157 | EFO_0004991 | G70.0 | — | 1 | 3 | — | — | 4 |
| Neuromyelitis optica | D009471 | EFO_0004256 | G36.0 | 1 | 2 | 3 | — | — | 4 |
| Thrombotic microangiopathies | D057049 | M31.1 | — | 1 | 1 | — | 1 | 3 | |
| Guillain-barre syndrome | D020275 | EFO_0007292 | G61.0 | — | 2 | 1 | — | — | 3 |
| Delayed graft function | D051799 | — | 2 | 1 | — | — | 2 | ||
| Left ventricular dysfunction | D018487 | — | — | 1 | — | — | 1 | ||
| Shiga-toxigenic escherichia coli | D054323 | B96.21 | — | 1 | 1 | — | — | 1 | |
| Leukemia | D007938 | C95 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | U07.1 | — | 1 | — | — | 2 | 3 | |
| Membranoproliferative glomerulonephritis | D015432 | 1 | 1 | — | — | — | 2 | ||
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | 1 | 1 | — | — | — | 2 |
| Hellp syndrome | D017359 | EFO_0007297 | O14.2 | 1 | 1 | — | — | — | 2 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 2 | — | — | — | 2 |
| Anti-neutrophil cytoplasmic antibody-associated vasculitis | D056648 | I77.82 | — | 1 | — | — | — | 1 | |
| Pregnancy rate | D018873 | — | 1 | — | — | — | 1 | ||
| Sars-cov-2 | D000086402 | — | 1 | — | — | — | 1 | ||
| Multiple organ failure | D009102 | EFO_1001373 | — | 1 | — | — | — | 1 | |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 2 | — | — | — | — | 2 | ||
| End stage liver disease | D058625 | EFO_1001311 | K72.1 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Viral pneumonia | D011024 | EFO_0007541 | J12.9 | — | — | — | — | 1 | 1 |
| Coronavirus | D017934 | — | — | — | — | 1 | 1 | ||
| Protein-losing enteropathies | D011504 | HP_0002243 | — | — | — | — | 1 | 1 | |
| Hemophilia b | D002836 | D67 | — | — | — | — | 1 | 1 |
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 | 219685-50-4 |
| RxCUI | 591781 |
| ChEMBL ID | CHEMBL1201828 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB01257 |
| UNII ID | A3ULP0F556 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Soliris - Alexion Pharmaceuticals
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Soliris - AstraZeneca
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 6,194 documents
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Safety
Black-box Warning
Black-box warning for: Soliris
Adverse Events
Top Adverse Reactions
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68,684 adverse events reported
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