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Drug ReportsDrotrecogin alfa
Drotrecogin alfa (activated)
Xigris (drotrecogin alfa (activated)) is a protein pharmaceutical. Drotrecogin alfa (activated) was first approved as Xigris on 2002-08-22. It has been approved in Europe to treat multiple organ failure and sepsis. The pharmaceutical is active against coagulation factor VIII and coagulation factor V.
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Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
No data
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)
Drotrecogin alfa
Tradename
Proper name
Company
Number
Date
Products
Xigrisdrotrecogin alfaEli LillyN-125029 DISCN2001-11-21
2 products
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Labels
FDA
EMA
No data
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
sepsisHP_0100806D018805A41.9
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
112 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SepsisD018805HP_0100806A41.9—245819
ToxemiaD014115———22239
Septic shockD012772—A48.3—12238
Blood coagulation disordersD001778EFO_0009314D68.9———134
Hemostatic disordersD020141—————134
ShockD012769—R57.1—112—4
Hematologic neoplasmsD019337——11—1—3
HemorrhageD006470MP_0001914R58———123
Intracranial hemorrhagesD020300EFO_0000551I62———112
InfectionsD007239EFO_0000544————112
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.9243——8
Non-small-cell lung carcinomaD002289——441——7
LeukemiaD007938—C95231—15
Hemophilia aD006467EFO_0007267D66—21—25
Kidney diseasesD007674EFO_0003086N08111—25
Breast neoplasmsD001943EFO_0003869C50121——4
Precursor cell lymphoblastic leukemia-lymphomaD054198——111—13
Chronic renal insufficiencyD051436—N181—1—13
StrokeD020521EFO_0000712I63.9—21——3
Hemophilia bD002836—D67—21——3
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C8057——112
MelanomaD008545——29———9
RecurrenceD012008——13——15
Lung neoplasmsD008175HP_0100526C34.9024———5
Multiple myelomaD009101—C90.031———4
Covid-19D000086382——11——24
Colorectal neoplasmsD015179——22———3
Pancreatic neoplasmsD010190EFO_0003860C2522———3
Endometrial neoplasmsD016889EFO_0004230——3———3
GliomaD005910EFO_0000520—12———3
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
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Healthy volunteers/patients———2———13
InflammationD007249MP_0001845—1———23
FibrosisD005355——1———12
B-cell chronic lymphocytic leukemiaD015451—C91.12————2
GlioblastomaD005909EFO_0000515—1————1
MeningiomaD008579EFO_0003098D32.91————1
AstrocytomaD001254EFO_0000271—1————1
Choroid plexus neoplasmsD016545EFO_0007206—1————1
OligodendrogliomaD009837EFO_0000631—1————1
GangliogliomaD018303——1————1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Diabetes mellitusD003920HP_0000819E08-E13————22
ObesityD009765EFO_0001073E66.9————22
CandidemiaD058387EFO_1001282—————11
HypertensionD006973EFO_0000537I10————11
Portal hypertensionD006975EFO_0000666K76.6————11
Cystic fibrosisD003550EFO_0000390E84————11
Multiple sclerosisD009103EFO_0003885G35————11
Relapsing-remitting multiple sclerosisD020529EFO_0003929—————11
SclerosisD012598——————11
AppendicitisD001064EFO_0007149K37————11
Show 51 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDrotrecogin alfa (activated)
INNdrotrecogin alfa (activated)
Description
Drotrecogin alfa (activated) (Xigris, marketed by Eli Lilly and Company) is a recombinant form of human activated protein C that has anti-thrombotic, anti-inflammatory, and profibrinolytic properties. Drotrecogin alpha (activated) belongs to the class of serine proteases. Drotrecogin alfa has not been found to improve outcomes in people with severe sepsis. The manufacturer's aggressive strategies in marketing its use in severe sepsis have been criticized. On October 25, 2011, Eli Lilly & Co. withdrew Xigris from the market after a major study showed no efficacy for the treatment of sepsis.
Classification
Unknown
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL2109065
ChEBI ID—
PubChem CID—
DrugBankDB00055
UNII IDJGH8MYC891 (ChemIDplus, GSRS)
Target
Agency Approved
F8
F8
F5
F5
Organism
Homo sapiens
Gene name
F8
Gene synonyms
F8C
NCBI Gene ID
Protein name
coagulation factor VIII
Protein synonyms
AHF, Antihemophilic factor, coagulation factor VIII A1 domain, coagulation factor VIII C2 domain, coagulation factor VIII, procoagulant component, coagulation factor VIIIc, factor VIII F8B, Procoagulant component
Uniprot ID
Mouse ortholog
F8 (14069)
coagulation factor VIII (Q06194)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
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Adverse Events
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2,371 adverse events reported
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