Edodekin alfa
Also known as: Edodekin-alfa, IL-13 mutein, IL-13-PE38QQR (related conjugate), recombinant human IL-13 mutein
Summary
Edodekin alfa is an investigational recombinant human IL-13 mutein (antagonist) developed primarily for the treatment of malignant glioma (glioblastoma multiforme) via intratumoral/convection-enhanced delivery. It blocks IL-13 signaling, which is implicated in tumor immune evasion and glioma cell proliferation. It has also been studied in the context of atopic dermatitis and other IL-13-driven conditions.
Mechanism of Action
Edodekin alfa is a recombinant form of interleukin-13 (IL-13) mutein that acts as an IL-13 receptor antagonist, competitively binding to IL-13 receptors (IL-13Rα1 and IL-13Rα2) without activating downstream signaling, thereby blocking the pro-inflammatory and pro-fibrotic effects of endogenous IL-13.
Routes of Administration
Goals & Uses
- Treatment of recurrent glioblastoma multiformeOncologyModerate
- Blockade of IL-13 pro-tumorigenic signalingOncology / ImmunologyModerate
- Treatment of atopic dermatitisImmunology / DermatologyLow
Contraindications
- Hypersensitivity to IL-13 mutein or excipientsAllergyHigh
- Coagulopathy or hemorrhagic diathesisHematologyHigh
- Active intracranial infectionInfectionHigh
Adverse Effects
- HeadacheNeurologicCommonPain in the head or upper neck
- Neurological deteriorationNeurologicalUncommon
- Fever / flu-like symptomsSystemicUncommon
- SeizuresNeurologicalUncommon
- Peritumoral edemaNeurologicalCommon
Drug Interactions
- CorticosteroidsLow
Population Constraints
- Pediatric patientsAgeRelative
- Pregnant womenReproductiveRelative
- Patients with poor performance statusClinicalRelative
Regulatory Status
- European UnionUnknownNo known EMA approval or marketing authorization.
- United StatesInvestigationalFDA Orphan Drug Designation granted for malignant glioma; no approved indication. Studied in phase I/II trials.
- United KingdomUnknownNo known MHRA approval or marketing authorization.
Edodekin alfa has been studied in clinical trials for recurrent glioblastoma multiforme under FDA investigational status. It has received no marketing approval in any major jurisdiction. Orphan Drug Designation was granted by the FDA for malignant glioma.
Evidence & Sources
No sources recorded yet.