Pexelizumab
Also known as: 5G1.1-scFv, Alexion anti-C5 scFv, h5G1.1-scFv
Source Pexelizumab at Peptiology
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Summary
Pexelizumab is an anti-C5 complement inhibitor developed by Alexion Pharmaceuticals that was investigated for reducing myocardial injury during cardiac surgery (CABG and PCI) and acute myocardial infarction. Despite promising phase II results, it failed to meet primary endpoints in large phase III trials (PRIMO-CABG II, APEX-AMI) and was not approved by regulatory authorities.
Mechanism of Action
Pexelizumab is a humanized single-chain antibody fragment (scFv) that selectively binds to complement component C5, preventing its cleavage into C5a and C5b. This inhibits the terminal complement pathway, blocking formation of the membrane attack complex (MAC) and reducing complement-mediated inflammation and tissue injury.
Routes of Administration
Goals & Uses
- Reduction of myocardial injury post-CABGCardioprotectionModerate
- Complement inhibition during cardiopulmonary bypassInflammatory ModulationModerate
- Reduction of infarct size in STEMI/AMIAcute Myocardial InfarctionLow
Contraindications
- Unvaccinated patients (meningococcal)Infectious DiseaseHigh
- Active Neisseria meningitidis infectionInfectious DiseaseHigh
Adverse Effects
- Increased susceptibility to encapsulated bacterial infectionsImmunologicalUncommon
- HeadacheNeurologicCommonPain in the head or upper neck
- Infusion-related reactionsHypersensitivityUncommon
Drug Interactions
- Other immunosuppressantsModerate
Population Constraints
- Pregnant womenReproductiveRelative
- Patients with complement deficienciesImmunologicalRelative
Regulatory Status
- European UnionUnapprovedEMA approval never granted; program discontinued.
- United StatesUnapprovedFDA approval never granted; development discontinued after phase III failures.
Pexelizumab was never approved by the FDA or EMA. Development was discontinued following failure in pivotal phase III trials. No current active regulatory status in any major jurisdiction.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Pexelizumab?
Pexelizumab is an anti-C5 complement inhibitor developed by Alexion Pharmaceuticals that was investigated for reducing myocardial injury during cardiac surgery (CABG and PCI) and acute myocardial infarction. Despite promising phase II results, it failed to meet primary endpoints in large phase III trials (PRIMO-CABG II, APEX-AMI) and was not approved by regulatory authorities.
What is Pexelizumab used for?
Pexelizumab is educationally associated with: Reduction of myocardial injury post-CABG, Complement inhibition during cardiopulmonary bypass, Reduction of infarct size in STEMI/AMI. Educational only — not medical advice.
How is Pexelizumab administered?
Recorded routes of administration: Intravenous.
What are the potential side effects of Pexelizumab?
Reported adverse effects include: Increased susceptibility to encapsulated bacterial infections, Headache, Infusion-related reactions. This list is not exhaustive — consult a qualified clinician.
Who should avoid Pexelizumab?
Recorded contraindications: Unvaccinated patients (meningococcal), Active Neisseria meningitidis infection. Consult a qualified clinician before use.