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Ultomiris(ravulizumab)
Ultomiris (ravulizumab) is an antibody pharmaceutical. Ravulizumab was first approved as Ultomiris on 2018-12-21. It is used to treat atypical hemolytic uremic syndrome in the USA. It has been approved in Europe to treat paroxysmal hemoglobinuria. It is known to target complement C5.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
hemic and lymphatic diseasesD006425
Trade Name
FDA
EMA
Ultomiris
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)
Ravulizumab
Tradename
Proper name
Company
Number
Date
Products
Ultomirisravulizumab-cwvzAlexion PharmaceuticalsN-761108 RX2018-12-21
4 products
Labels
FDA
EMA
Brand Name
Status
Last Update
ultomirisBiologic Licensing Application2020-10-19
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
atypical hemolytic uremic syndromeD065766
Agency Specific
FDA
EMA
Expiration
Code
ravulizumab, Ultomiris, Alexion Pharmaceuticals, Inc.
2028-06-07Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
L04: Immunosuppressants
L04A: Immunosuppressants
L04AA: Selective immunosuppressants
L04AA43: Ravulizumab
HCPCS
Code
Description
J1303
Injection, ravulizumab-cwvz, 10 mg
Clinical
Clinical Trials
33 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 hemoglobinuriaD006457Orphanet_447D59.12271111
Covid-19D000086382U07.1112
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Thrombotic microangiopathiesD057049M31.144
Neuromyelitis opticaD009471EFO_0004256G36.0122
Myasthenia gravisD009157EFO_0004991G70.022
Atypical hemolytic uremic syndromeD06576622
Acute kidney injuryD058186HP_0001919N1711
Respiratory distress syndromeD012128EFO_1000637J8011
PneumoniaD011014EFO_0003106J1811
Acute lung injuryD055371EFO_000461011
Viral pneumoniaD011024EFO_0007541J12.911
Amyotrophic lateral sclerosisD000690EFO_0000253G12.2111
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Iga glomerulonephritisD005922EFO_000419411
Lupus nephritisD008181EFO_000576111
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients55
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRAVULIZUMAB
INNravulizumab
Description
Ravulizumab, sold under the brand name Ultomiris, is a humanized monoclonal antibody complement inhibitor medication designed for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome. It is designed to bind to and prevent the activation of Complement component 5 (C5).
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID1803171-55-2
RxCUI2107301
ChEMBL IDCHEMBL3989986
ChEBI ID
PubChem CID
DrugBankDB11580
UNII IDC3VX249T6L (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
C5
C5
Organism
Homo sapiens
Gene name
C5
Gene synonyms
CPAMD4
NCBI Gene ID
Protein name
complement C5
Protein synonyms
anaphylatoxin C5a analog, C3 and PZP-like alpha-2-macroglobulin domain-containing protein 4, C5a anaphylatoxin, complement component 5, prepro-C5
Uniprot ID
Mouse ortholog
Hc (15139)
complement C5 (P06684)
Variants
Clinical Variant
No data
Financial
Ultomiris - Alexion Pharmaceuticals
$
£
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Ultomiris - AstraZeneca
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 675 documents
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Safety
Black-box Warning
Black-box warning for: Ultomiris
Adverse Events
Top Adverse Reactions
Mock data
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697 adverse events reported
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