drotrecogin alfa, activated

Trade name: Xigris

Recombinant proteinapprovedOrphan Drug ^FDA

Approved

Nov 21, 2001

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. — Wikipedia

Clinical trial activity

21 trials · 15 clinical orgs · 4 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Sep 1, 2002 (NCT00045760)

Timeline

1990s

Jun 23, 1992
Orphan Drug Designation

2000s

Nov 1, 2001
Eli Lilly — First NDA Organization
Nov 1, 2001
Eli Lilly — NDA Organization
Nov 21, 2001
Earliest FDA Approval
Jan 1, 2002
Eli Lilly — Earliest Phase 3 Sponsor(trial)
Jan 1, 2003
Baxalta — Earliest Phase 2 Sponsor(trial)
Mar 30, 2007
Baxalta — NDA Secondary Org
Mar 30, 2007
Takeda — NDA Secondary Org
Aug 23, 2007
Feinstein Institute for Medical Research — NDA Secondary Org

Indications

Approved for

Sepsis (approved 2001)

Studied for

Mechanism of action

Coagulation factor VINHIBITOR
F5 inhibitor
Activated protein c cleaves clotting factors to inactivate
- Coagulation factor V (F5) ↗
Coagulation factor VIIIINHIBITOR
F8 inhibitor
Activated protein c cleaves clotting factors to inactivate
- Coagulation factor VIII (F8) ↗
Vitamin K-dependent protein CEXOGENOUS PROTEIN
Vitamin K-dependent protein C exogenous protein
- Vitamin K-dependent protein C (PROC) ↗
Salivary acidic proline-rich phosphoprotein 1/2Supplementation
Salivary acidic proline-rich phosphoprotein 1/2 supplementation
- Salivary acidic proline-rich phosphoprotein 1/2 (PRH1; PRH2) ↗

Approval history

approvedNov 21, 2001

Chemistry & pharmacology

Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Parenteral
Availability: Prescription Only
Multi-specific: No

Oral

Parenteral

Yes

Topical

Sources

Also known as

activated protein c
activated protein c
autoprothrombin iia
blood coagulation factor xiv
blood coagulation factor xiv (human)
ceprotin
drotrecogin alfa
drotrecogin alfa
drotrecogin alfa
drotrecogin alfa
drotrecogin-alfa
drotrecogin alfa activated
drotrecogin alfa activated
drotrecogin alfa (activated)
drotrecogin alfa (activated)
drotrecogin alfa (activated)
drotrecogin alfa (activated)
drotrecogin alfa, activated
drotrecogin alfa (activated), lyophilized
drotrecognin alpha
human activated protein c
human protein c
human protein c
human protein c
protein c
protein c
protein c (coagulation inhibitor)
protein c concentrate
protein c concentrate human
protein c concentrate (human)
protein c concentrate (human)
protein c human
recombinant human activated protein c (rh-apc)
rhapc
xigris
xigris
xigris
xigris

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT01705808	Phase 3	Sep 1, 2012	Vita-Salute University of Milano. Italy
NCT01411670	Phase 2	Jan 1, 2011	University of Roma La Sapienza
NCT01227187	Phase 2	Oct 1, 2008	Eli Lilly, George Washington University
NCT00943267	N/A	Oct 1, 2008	University of Amsterdam
NCT00604214	Phase 3	Mar 1, 2008	Eli Lilly
NCT00625209	Phase 3	Mar 1, 2008	Government of France, St. Joseph Hospital Health Center, University of Paris, University of Versailles
NCT02885168	Phase 4	Feb 1, 2008	University of Lorraine
NCT00533546	Phase 2	Sep 1, 2007	National Heart, Lung, and Blood Institute (NHLBI), University of Rochester
NCT00386425	Phase 2	Nov 1, 2006	Eli Lilly
NCT00279214	Phase 4	Nov 1, 2005	Eli Lilly
NCT00112164	Phase 2	Jan 1, 2005	National Heart, Lung, and Blood Institute (NHLBI), University of California, San Francisco
NCT00191724	Phase 2	Sep 1, 2004	Eli Lilly
NCT00190788	Phase 3	Jun 1, 2004	Eli Lilly
NCT00157118	Phase 2/Phase 3 (Phase 3)	Aug 1, 2003	Baxalta
NCT01017107	Phase 4	Jun 1, 2003	University of Helsinki
NCT00067730	Phase 4	Mar 1, 2003	Eli Lilly
NCT00568893	Phase 4	Jan 1, 2003	Eli Lilly
NCT00049777	Phase 4	Dec 1, 2002	Eli Lilly
NCT00049764	Phase 3	Nov 1, 2002	Eli Lilly
NCT00568737	Phase 3	Nov 1, 2002	Eli Lilly

Showing 20 of 21 trials

Page 1 / 2

Organizations

Research & Development (15)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Eli Lilly	For profit	12	11	3	2002
National Heart, Lung, and Blood Institute (NHLBI)	Government	2	0	1	2005
Baxalta	For profit	1	1	1	2003
George Washington University	Academic/Hospital	1	1	1	2008
Government of France	Government	1	0	1	2008
St. Joseph Hospital Health Center	Academic/Hospital	1	0	1	2008
University of Amsterdam	Academic/Hospital	1	1	1	2008
University of California, San Francisco	Academic/Hospital	1	1	1	2005
University of Helsinki	Academic/Hospital	1	1	1	2003
University of Lorraine	Academic/Hospital	1	1	1	2008
University of Paris	Academic/Hospital	1	0	1	2008
University of Rochester	Academic/Hospital	1	1	1	2007
University of Roma La Sapienza	Academic/Hospital	1	1	1	2011
University of Versailles	Academic/Hospital	1	1	1	2008
Vita-Salute University of Milano. Italy	Academic/Hospital	1	1	1	2012

15 organizations

Page 1 / 1

Marketing (4)

Organization	Org type	Relationship	Date
Baxalta	For profit	NDA2	Mar 30, 2007
Eli Lilly	For profit	NDA	Nov 1, 2001
Feinstein Institute for Medical Research	Academic/Hospital	NDA2	Aug 23, 2007
Takeda	For profit	NDA2	Mar 30, 2007