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 diseases | D000091642 |
| hemic and lymphatic diseases | D006425 |
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 |
|---|---|---|---|---|---|
| Ultomiris | ravulizumab-cwvz | Alexion Pharmaceuticals | N-761108 RX | 2018-12-21 | 4 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ultomiris | Biologic Licensing Application | 2024-09-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| atypical hemolytic uremic syndrome | — | D065766 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ravulizumab, Ultomiris, Alexion Pharmaceuticals, Inc. | |||
| 2028-06-07 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1303 | Injection, ravulizumab-cwvz, 10 mg |
Clinical
Clinical Trials
48 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 | 1 | 4 | 11 | 1 | 7 | 23 |
| Hemoglobinuria | D006456 | — | R82.3 | 1 | 4 | 11 | 1 | 7 | 23 |
| Covid-19 | D000086382 | — | — | — | — | 2 | 1 | — | 3 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hemolysis | D006461 | — | — | — | — | 4 | — | 1 | 5 |
| Thrombotic microangiopathies | D057049 | — | M31.1 | — | — | 4 | — | — | 4 |
| Neuromyelitis optica | D009471 | EFO_0004256 | G36.0 | — | 1 | 2 | — | 2 | 4 |
| Myasthenia gravis | D009157 | EFO_0004991 | G70.0 | — | — | 2 | — | 2 | 4 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | 3 | — | — | 3 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | 2 | — | — | 3 |
| Syndrome | D013577 | — | — | — | — | 3 | — | — | 3 |
| Muscle weakness | D018908 | HP_0001324 | — | — | — | 2 | — | 1 | 3 |
| Hemolytic-uremic syndrome | D006463 | — | D59.3 | — | — | 2 | — | 1 | 3 |
| Atypical hemolytic uremic syndrome | D065766 | — | — | — | — | 2 | — | 1 | 3 |
Show 17 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lupus nephritis | D008181 | EFO_0005761 | — | — | 1 | — | — | — | 1 |
| Nephritis | D009393 | — | N05 | — | 1 | — | — | — | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | — | — | — | 1 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | — | 5 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ravulizumab |
| INN | ravulizumab |
| 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 class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1803171-55-2 |
| RxCUI | 2107301 |
| ChEMBL ID | CHEMBL3989986 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB11580 |
| UNII ID | C3VX249T6L (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
No data
Financial
Revenue by drug
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Ultomiris – Alexion Pharmaceuticals
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Ultomiris – AstraZeneca
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Ravulizumab – 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 1,110 documents
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Safety
Black-box Warning
Black-box warning for: Ultomiris
Adverse Events
Top Adverse Reactions
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5,047 adverse events reported
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