Drotrecogin alfa

Overview

Drotrecogin alfa is activated human protein C that is synthesized by recombinant DNA technology. It is a glycoprotein of approximately 55 kilodalton molecular weight, consisting of a heavy chain and a light chain linked by a disulfide bond. Drotrecogin alfa was withdrawn from the market after a major study indicated that it was not effective in improving outcomes in patients with sepsis.

Indication

For reduction of mortality in patients with severe sepsis.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C	2016/08/31	NCT02885168	Phase 4	Completed	Central Hospital, Nancy, France
Regression Discontinuity Design to Evaluate of Drotrecogin Alpha Effectiveness	2016/07/26	NCT02843685	N/A	Completed	Boston Medical Center
Administration of Human Protein C Concentrates in Patients With Sepsis and Septic Shock.	2011/08/08	NCT01411670	Phase 2	Completed	University of Roma La Sapienza
Activated Protein C in Severe Acute Pancreatitis	2009/11/20	NCT01017107	Phase 4	Completed	Helsinki University Central Hospital
Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock	2008/01/30	NCT00604214	Phase 3	Completed	Eli Lilly and Company
An Open Label Study of Severe Sepsis in Adults	2007/12/06	NCT00568893	Phase 4	Completed	Eli Lilly and Company
The Study of Drotrecogin Alfa (Activated) in Adult Patients With Severe Sepsis at a Low Risk of Death	2007/12/06	NCT00568737	Phase 3	Completed	Eli Lilly and Company
Activated Protein C in Acute Stroke Trial	2007/09/21	NCT00533546	Phase 2	Terminated	University of Rochester
Evaluate Protein C Levels in Severe Sepsis Patients on Drotrecogin Alfa (Activated)	2006/10/11	NCT00386425	Phase 2	Completed	Eli Lilly and Company
Hemodynamic and Perfusion Response to Drotrecogin Alfa (Activated) in Patients With Septic Shock	2006/01/19	NCT00279214	Phase 4	Completed	Eli Lilly and Company

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
XIGRIS (5MG/VIAL)	eli lilly canada inc	02247129	Powder For Solution - Intravenous	5 MG / VIAL	2/20/2003
XIGRIS (20MG/VIAL)	eli lilly canada inc	02247130	Powder For Solution - Intravenous	20 MG / VIAL	3/25/2003

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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