Delving into the Latest Updates on Pexelizumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-C5 monoclonal antibody 5G1-1-SC, Monoclonal antibody 5G1.1-SC, Pexelizumab (USAN/INN)

+ [3]

Target

C5

Action

inhibitors

Mechanism

C5 inhibitors(Complement C5 inhibitors)

Therapeutic Areas

Cardiovascular DiseasesOther Diseases

Active Indication-

Inactive Indication

Acute myocardial infarctionCoronary Artery DiseaseMyocardial Infarction+ [1]

Originator Organization

Stanford University

Active Organization-

Inactive Organization

Procter & Gamble, Inc.

Stanford University

Alexion Pharmaceuticals, Inc.

License Organization

Alexion Pharmaceuticals, Inc.

Procter & Gamble Co.

Drug Highest PhaseDiscontinuedPhase 3

First Approval Date-

Regulation-

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Structure/Sequence

Sequence Code 561758592

Source: *****

During a heart bypass procedure, a substance called "complement" is activated by the body. This "complement activation" causes an inflammatory response that can lead to side affects such as chest pain, heart attacks, stroke, heart failure, or death. The purpose of this study is to find out if the study drug (pexelizumab), that blocks "complement activation," can reduce such side effects and be given safely to patients requiring the bypass procedure with the use of the heart-lung machine.

Start Date01 Jul 2004

Sponsor / Collaborator

Alexion Pharmaceuticals, Inc.

[+1]

100 Clinical Results associated with Pexelizumab

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100 Translational Medicine associated with Pexelizumab

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100 Patents (Medical) associated with Pexelizumab

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97

Literatures (Medical) associated with Pexelizumab

01 Jan 2025·Acta medica Indonesiana

Anti-inflammatory Therapy Before Reperfusion Therapy in Patients with Ischemic Vascular Disease on the Incidence of Ischemic Reperfusion Injury: An Evidence-Based Case Report.

Review

Author: Utami, Nindya P B S ; Gautama, Ade ; Antono, Dono

BACKGROUNDReperfusion serves as a mainstay therapy in almost all ischemic vascular diseases (IVD), but reperfusion may enhance cell damage after an ischemic period time. Increased ROS and inflammatory markers, decreasing organ function parameters, along with systemic inflammatory response and multi-organ damage may occur in ischemic reperfusion injury (IRI). Unfortunately, this series of events is unpredictable and sudden, causing high mortality in patients with IRI. Due to the significant role of inflammation in IRI, how is the effectiveness of anti-inflammatory agents administered before reperfusion therapy to prevent IRI? To know the efficacy of anti-inflammatory agents administered before reperfusion therapy to prevent IRI.METHODSA systematic search was conducted in databases (Pubmed, EMBASE, Scopus) and was later selected according to predetermined inclusion and exclusion criteria. Studies included later critically appraised using the CEBM Oxford questionnaire for randomized control trials and systematic review.RESULTSSeven studies were included among 1072 studies found in early searching. Six of the studies are randomized control trials, and one is a meta-analysis of randomized control trials. Methylprednisolone, pexelizumab, tirilazad mesylate, and N-acetylcysteine are known anti-inflammatory agents applicable in humans. The highest effectiveness of anti-inflammatory agents is methylprednisolone, with a relative risk reduction (RRR) of 75-85%. Besides that, pexelizumab also had an RRR of 27%, and tirilazad-mesylate had an RRR of 18%. N-acetylcysteine is not effective in preventing IRI. IL-6 levels postoperatively also decreased significantly in patients given anti-inflammatory agents before reperfusion therapy. There are no side effects of the intervention reported.CONCLUSIONAnti-inflammatory agent administration before reperfusion therapy effectively prevents IRI. The choices of anti-inflammatory agents recommended are methylprednisolone, pexelizumab, and tirilazad-mesylate. Anti-inflammatory agent administration before reperfusion therapy is recommended.

01 Jun 2022·BMJ Open

Examining anti-inflammatory therapies in the prevention of cardiovascular events: protocol for a systematic review and network meta-analysis of randomised controlled trials

Article

Author: Visintini, Sarah ; Fehlmann, Christophe A ; Wells, George A ; Boczar, Kevin Emery ; Pearson, Alexander Liam ; Bezzina, Kathryn A ; Geejo, Aishwarya ; Beanlands, Rob ; Shin, Sheojung ; Shahab, Saba

IntroductionInflammation is emerging as an important risk factor for atherosclerotic cardiovascular disease and has been a recent target for many novel therapeutic agents. However, comparative evidence regarding efficacy of these anti-inflammatory treatment options is currently lacking.Methods and analysisThis systematic review will include randomised controlled trials evaluating the effect of anti-inflammatory agents on cardiovascular outcomes in patients with known cardiovascular disease. Studies will be retrieved from Medline, Embase, the Cochrane Central Register of Controlled Trials, as well as clinical trial registry websites, Europe PMC and conference abstract handsearching. No publication date or language restrictions will be imposed. Eligible interventions must have some component of anti-inflammatory agent. These include (but are not limited to): non-steroidal anti-inflammatory drugs (NSAIDs), colchicine, prednisone, methotrexate, canakinumab, pexelizumab, anakinra, succinobucol, losmapimod, inclacumab, atreleuton, LP-PLA2(darapladib) and sPLA2(varespladib). The primary outcomes will include major adverse cardiac events (MACE), and each individual component of MACE (myocardial infarction, stroke and cardiovascular death). Key secondary outcomes will include unstable angina, heart failure, all-cause mortality, cardiac arrest and revascularisation. Screening, inclusion, data extraction and quality assessment will be performed independently by two reviewers. Network meta-analysis based on the random effects model will be conducted to compare treatment effects both directly and indirectly. The quality of the evidence will be assessed with appropriate tools including the Grading of Recommendations, Assessment, Development and Evaluation profiler or Confidence in Network Meta-Analysis tool.Ethics and disseminationEthics approval is not required for this systematic review. The findings will be disseminated through a peer-reviewed journal.PROSPERO registration numberCRD42022303289.

01 Dec 2021·Heart

Do we need early risk stratification after ST-elevation myocardial infarction?

Communications

Author: Coffey, Sean ; Adamson, Philip D ; McLeod, Peter

Despite significant advances in the treatment of ST elevation myocardial infarction (STEMI), there remains a significant short-term and long-term increased mortality risk. Risk stratification to target those who may benefit from more intensive therapy postrevascularisation therefore remains an important goal. Risk stratification models in acute coronary syndrome (ACS) have been researched for many years, but few risk scores have been developed and validated specifically for the STEMI population. Only 27% of the cohort for the Global Registry of Acute Coronary Events (GRACE) score was derived from those undergoing percutaneous intervention (PCI), and the GRACE score performs less accurately in those undergoing PCI compared with medical therapy. Nevertheless European1 (but not American2) guidelines recommend its use for clinical risk stratification in the STEMI cohort. Risk scores derived specifically for STEMI include the Global Utilization of Streptokinase and Tissue plasminogen activator to treat Occluded arteries (GUSTO) risk score, which was developed in the era of thrombolysis, while risk scores assessing mortality in primary PCI patients include the Primary Angioplasty in Myocardial Infarction (PAMI) risk score, Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) risk score, Assessment of Pexelizumab in Acute Myocardial Infarction (APEX-AMI) score, Soroka Acute Myocardial Infarction (SAMI) score, and the Zwolle risk score. Coelho-Lima and colleagues3 examine the prognostic value of troponin specifically in the STEMI population, a group where troponin is not used to guide initial treatment. Their major findings are that admission troponin, but not troponin measured 12 hours post-reperfusion, was a significant independent predictor of both inpatient or overall mortality, with a median follow-up time of over 4 years. The authors are to be commended for this large retrospective study—in particular, the clinical …

100 Deals associated with Pexelizumab

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External Link

KEGG	Wiki	ATC	Drug Bank
D10023	Pexelizumab	-	DB04949

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute myocardial infarction	Phase 3	Switzerland	Procter & Gamble, Inc.	01 Apr 2004
Acute myocardial infarction	Phase 3	Austria	Procter & Gamble, Inc.	01 Apr 2004
Coronary Artery Disease	Phase 3	United States	Alexion Pharmaceuticals, Inc.	01 Jan 2002
Coronary Artery Disease	Phase 3	Canada	Alexion Pharmaceuticals, Inc.	01 Jan 2002
Myocardial Infarction	Phase 3	-	Stanford University	-
Myocardial Infarction	Phase 3	-	Stanford University	-
Reperfusion Injury	Phase 3	-	Stanford University	-
Reperfusion Injury	Phase 3	United States	-	-
Reperfusion Injury	Phase 3	-	Alexion Pharmaceuticals, Inc.	-
Reperfusion Injury	Phase 3	Europe	-	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00091637 (APEX-AMI, Pubmed \| Am Heart J) Manual	Phase 3	ST Elevation Myocardial Infarction	356	Pexelizumab (serum obtained before and 24 hours after administration)	pxoxzipsxa(bdkmbgikzq) = eaenudmthv oqmcgkkqzj (bwuynsssux )	Positive	01 Jul 2012
				Placebo (serum obtained before and 24 hours after administration)	imkpawcyyk(uwjjzwqcua) = fbakjbheyw lnjmguigde (evrkzhwuur ) View more
NCT00088179 (PRIMO-CABG I and II, Pubmed \| J Thorac Cardiovasc Surg) Manual	Phase 3	Cardiovascular Diseases	4,254	Pexelizumab (The PRIMO-CABG II trial)	xkecproxsa(icawvspkvb) = The PRIMO-CABG II trial did not meet its prespecified primary endpoint of death or MI at 30 days fimnmdfopx (yysyssgbue ) Not Met View more	Negative	01 Jul 2011
				Placebo (The PRIMO-CABG II trial)
NCT00091637 (Pubmed \| JAMA) Manual	Phase 3	ST Elevation Myocardial Infarction	5,745	Pexelizumab	(zyaznlizng) = ixymmmkhux rjbgrafawp (muivnxyelp ) View more	Negative	03 Jan 2007
				Placebo	(zyaznlizng) = kyzpitqnmj rjbgrafawp (muivnxyelp ) View more

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Translational Medicine

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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Pexelizumab

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Biosimilar

Regulation