Drotrecogin alfa (activated)

Highest phase reached

Approved

www.ebi.ac.uk

Drug type

Protein

www.ebi.ac.uk

First approval year

2001

www.ebi.ac.uk

First approval year: 2001
www.ebi.ac.uk

Listing at source: Listed

Highest phase reached: Approved
www.ebi.ac.uk

Drug type: Protein
www.ebi.ac.uk

Drug name: Drotrecogin alfa (activated)
www.ebi.ac.uk

xigris
Xigris

activated protein c
Activated protein c
Activated protein C
Activated Protein C
BLOOD COAGULATION FACTOR XIV (HUMAN)
blood coagulation factor xiv human
drotrecogin alfa
Drotrecogin alfa
Drotrecogin alfa (activated)
DROTRECOGIN ALFA (ACTIVATED) [EMA EPAR]
drotrecogin alfa (activated) [INN]
DROTRECOGIN ALFA (ACTIVATED) [MART.]
DROTRECOGIN ALFA (ACTIVATED) [USAN]
DROTRECOGIN ALFA (ACTIVATED) [VANDF]
DROTRECOGIN ALFA (ACTIVATED), LYOPHILIZED
DROTRECOGIN ALFA [HSDB]
DROTRECOGIN ALFA [MI]
DROTRECOGIN ALFA [VANDF]
Drotrecogin alfa [WHO-DD]
drotrecogin alfa activated
Drotrecogin alfa activated
Drotrecogin alfa activated (Xigris)
drotrecogin alfa activated ema epar
drotrecogin alfa activated inn
drotrecogin alfa activated lyophilized

And 20 more, listed on the interactive page.

ATC classification codes

B01AD10

Sources for recorded values

www.ebi.ac.uk

CAS registry numbers

98530-76-8

ChEMBL ID: CHEMBL2109065
www.ebi.ac.uk

FDA ingredient codes (UNII)

JGH8MYC891

352374
353106

Status: Withdrawn
Status date: 28 Nov 2011
Authorisation date: 22 Aug 2002
Approved indications: Xigris is indicated for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care. The use of Xigris should be considered mainly in situations when therapy can be started within 24 hours after the onset of organ failure (for further information see section 5.1).
Product number: EMEA/H/C/000396
Authorisation holder: Eli Lilly Nederland B.V.
Priority medicines scheme: No
Generic: No
Biosimilar: No
Generic medicines: 0
Biosimilar medicines: 0
Advanced therapy: No
Conditional approval: No
Additional monitoring: No
Accelerated assessment: No
Exceptional circumstances: Yes

Therapeutic areas

Multiple Organ Failure
Sepsis

European medicines record

www.ema.europa.eu

Patents: 0
Designations: 1
First in class: No
Fast track: No
Breakthrough designation: No
Orphan designation: No
Priority review: Yes
Orphan exclusivity: No
Accelerated approval: No
Availability: Prescription only

Pharmacology name: drotrecogin alfa
Type: Peptide
Approval recorded by Guide to Pharmacology: Yes

Administration routes

Parenteral

Action
Inhibition
Action type
Inhibitor
Target
coagulation factor VIII
Gene symbol
F8
Protein identifier
P00451
Primary target
Yes
Action
Inhibition
Action type
Inhibitor
Target
coagulation factor V
Gene symbol
F5
Protein identifier
P12259
Primary target
Yes
Mechanism
Coagulation factor V inhibitor
Action type
Inhibitor
Target
Coagulation factor V
Protein identifier
P12259
Mechanism
Coagulation factor VIII inhibitor
Action type
Inhibitor
Target
Coagulation factor VIII
Protein identifier
P00451

Mechanism
Coagulation factor V inhibitor
Action type
Inhibitor
Target
Coagulation factor V
Mechanism
Coagulation factor VIII inhibitor
Action type
Inhibitor
Target
Coagulation factor VIII

Condition
Stroke
Highest recorded phase
2
Condition identifier
EFO:0000712
Subject identifier
D020521
Condition
Pulmonary Embolism
Highest recorded phase
2
Condition identifier
EFO:0003827
Subject identifier
D011655
Condition
Renal Insufficiency, Chronic
Highest recorded phase
2
Condition identifier
EFO:0003884
Subject identifier
D051436
Condition
Hypotension
Highest recorded phase
3
Condition identifier
EFO:0005251
Subject identifier
D007022
Condition
Shock, Septic
Highest recorded phase
3
Condition identifier
EFO:0006834
Subject identifier
D012772
Condition
Multiple Organ Failure
Highest recorded phase
4
Condition identifier
EFO:1001373
Subject identifier
D009102
Condition
Ischemic Stroke
Highest recorded phase
3
Condition identifier
HP:0002140
Subject identifier
D000083242
Condition
Thrombosis
Highest recorded phase
4
Condition identifier
HP:0004419
Subject identifier
D013927
Condition
Sepsis
Highest recorded phase
4
Condition identifier
HP:0100806
Subject identifier
D018805
Condition
Respiratory Distress Syndrome
Highest recorded phase
2
Condition identifier
MONDO:0100130
Subject identifier
D012128

Condition identifier
EFO_0000712
Highest recorded phase
2
Condition identifier
EFO_0003884
Highest recorded phase
2
Condition identifier
EFO_0005251
Highest recorded phase
3
Condition identifier
EFO_0006834
Highest recorded phase
3
Condition identifier
EFO_1001373
Condition identifier
EFO_1001373
Highest recorded phase
4
Condition identifier
HP_0002140
Highest recorded phase
3
Condition identifier
HP_0004419
Condition identifier
HP_0004419
Highest recorded phase
4
Condition identifier
HP_0100806
Condition identifier
HP_0100806
Highest recorded phase
4
Condition identifier
MONDO_0005081
Condition identifier
MONDO_0005279
Highest recorded phase
2
Condition identifier
MONDO_0005300
Highest recorded phase
2
Condition identifier
MONDO_0006502
Highest recorded phase
2
Condition identifier
MONDO_0015796
Highest recorded phase
2
Condition identifier
MONDO_0100130
Highest recorded phase
2
Condition identifier
MONDO_1060198
Highest recorded phase
2

Event
activated partial thromboplastin time prolonged
Reports
59
Reporting signal score
257.53
Event
acute respiratory distress syndrome
Reports
8
Reporting signal score
14.3379
Event
arm amputation
Reports
2
Reporting signal score
9.1492
Event
blood fibrinogen increased
Reports
3
Reporting signal score
10.3551
Event
brain oedema
Reports
5
Reporting signal score
8.95114
Event
cardiac index decreased
Reports
2
Reporting signal score
9.58642
Event
cardio-respiratory arrest
Reports
5
Reporting signal score
7.66427
Event
cerebral haemorrhage
Reports
10
Reporting signal score
14.7283
Event
coagulopathy
Reports
12
Reporting signal score
24.9919
Event
crush syndrome
Reports
2
Reporting signal score
9.62441
Event
culture stool positive
Reports
2
Reporting signal score
8.04429
Event
dialysis
Reports
8
Reporting signal score
14.7676
Event
diarrhoea
Reports
1
Reporting signal score
16.7105
Event
disease recurrence
Reports
14
Reporting signal score
23.6904
Event
disseminated intravascular coagulation
Reports
22
Reporting signal score
63.9321
Event
dyspnoea
Reports
2
Reporting signal score
11.7429
Event
faecal occult blood positive
Reports
2
Reporting signal score
7.87867
Event
fatigue
Reports
1
Reporting signal score
18.0949
Event
fibrin d dimer increased
Reports
9
Reporting signal score
28.1545
Event
gastrointestinal haemorrhage
Reports
25
Reporting signal score
28.55
Event
general physical health deterioration
Reports
13
Reporting signal score
9.34205
Event
haematocrit decreased
Reports
28
Reporting signal score
68.0243
Event
haemodialysis
Reports
10
Reporting signal score
21.5875
Event
haemoglobin decreased
Reports
36
Reporting signal score
42.9946
Event
haemorrhage
Reports
37
Reporting signal score
58.4694

And 20 more, listed on the interactive page.

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Prodrug: No
Chirality: Single enantiomer
Inorganic: No
Natural product: No

Component
Sequence
Type
Protein
Sequence
DTEDQEDQVDPRLIDGKMTRRGDSPWQVVLLDSKKKLACGAVLIHPSWVLTAAHCMDESKKLLVRLGEYDLRRWEKWELDLDIKEVFVHPNYSKSTTDNDIALLHLAQPATLSQTIVPICLPDSGLAERELNQAGQETLVTGWGYHSSREKEAKRNRTFVLNFIKIPVVPHNECSEVMSNMVSENMLCAGILGDRQDACEGDSGGPMVASFHGTWFLVGLVSWGEGCGLLHNYGVYTKVSRYLDWIHGHIRDKEAPQKSWAP
Component
Sequence
Type
Protein
Sequence
ANSFLJJLRHSSLJRJCIJJICDFJJAKJIFQNVDDTLAFWSKHVDGDQCLVLPLEHPCASLCCGHGTCIBGIGSFSCDCRSGWEGRFCQREVSFLNCSLDNGGCTHYCLEEVGWRRCSCAPGYKLGDDLLQCHPAVKFPCGRPWKRMEKKRSHL

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Approved for (2)

Multiple organ dysfunction syndrome
Thrombotic disease

In development for (7)

Adult acute respiratory distress syndrome Phase 2
Chronic kidney disease Phase 2
Hypotensive disorder Phase 3
Ischemic stroke Phase 3
Pulmonary embolism Phase 2
Stroke disorder Phase 2
Toxic shock syndrome Phase 3

Targets (2)

F5 Coagulation factor V inhibitor
F8 Coagulation factor VIII inhibitor

Drotrecogin alfa (activated)

Development status

Names and chemistry

Brand names (2)

Other names (45)

Identifiers

RxNorm IDs (RxCUI) (2)

Regulatory information

European Union

Therapeutic areas

Other regulatory facts

Pharmacology

Drug classification

Administration routes

Mechanisms of action (4)

Open Targets mechanisms (2)

Investigated indications (10)

Open Targets indications (18)

Reported adverse events (45)

Trial references (15)

Chemical properties

Sequences (2)

Related records

Trials (293)

Approved for (2)

In development for (7)

Targets (2)