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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 diseasesD000091642
hemic and lymphatic diseasesD006425
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
SoliriseculizumabAlexion PharmaceuticalsN-125166 RX2007-03-16
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
solirisBiologic Licensing Application2021-01-29
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
atypical hemolytic uremic syndromeD065766
paroxysmal hemoglobinuriaOrphanet_447D006457D59.12
Agency Specific
FDA
EMA
Expiration
Code
eculizumab, Soliris, Alexion Pharmaceuticals, Inc.
2026-06-27Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
L04: Immunosuppressants
L04A: Immunosuppressants
L04AA: Selective immunosuppressants
L04AA25: Eculizumab
HCPCS
Code
Description
J1300
Injection, eculizumab, 10 mg
Clinical
Clinical Trials
94 clinical trials
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Mock data
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Paroxysmal hemoglobinuriaD006457Orphanet_447D59.125172327
Atypical hemolytic uremic syndromeD06576682212
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myasthenia gravisD009157EFO_0004991G70.0134
Neuromyelitis opticaD009471EFO_0004256G36.01234
Thrombotic microangiopathiesD057049M31.11113
Guillain-barre syndromeD020275EFO_0007292G61.0213
Delayed graft functionD051799212
Left ventricular dysfunctionD01848711
Shiga-toxigenic escherichia coliD054323B96.21111
LeukemiaD007938C9511
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Covid-19D000086382U07.1123
Membranoproliferative glomerulonephritisD015432112
Pre-eclampsiaD011225EFO_0000668O14112
Hellp syndromeD017359EFO_0007297O14.2112
Chronic kidney failureD007676EFO_0003884N18.622
Anti-neutrophil cytoplasmic antibody-associated vasculitisD056648I77.8211
Pregnancy rateD01887311
Sars-cov-2D00008640211
Multiple organ failureD009102EFO_100137311
Diabetes mellitusD003920EFO_0000400E08-E1311
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients22
End stage liver diseaseD058625EFO_1001311K72.111
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Viral pneumoniaD011024EFO_0007541J12.911
CoronavirusD01793411
Protein-losing enteropathiesD011504HP_000224311
Hemophilia bD002836D6711
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameECULIZUMAB
INNeculizumab
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 classmonoclonal antibodies
Image (chem structure or protein)ECULIZUMAB
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
PDB5I5K
CAS-ID219685-50-4
RxCUI591781
ChEMBL IDCHEMBL1201828
ChEBI ID
PubChem CID
DrugBankDB01257
UNII IDA3ULP0F556 (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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Tabular view
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
Mock data
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68,684 adverse events reported
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