VL-2397

Antifungal Peptide / Cyclic Hexapeptide (siderophore Mimic)Rx: InvestigationalCompound: Investigational

Also known as: Acremonium persicinum antifungal peptide, ASP2397, VL-2397

Educational Only — Not medical advice. Consult a qualified clinician before using any peptide.

Summary

VL-2397 (formerly ASP2397) is a novel cyclic hexapeptide antifungal agent originally isolated from the fungus Acremonium persicinum. It exhibits potent in vitro and in vivo activity against Aspergillus species, including azole-resistant strains, via a unique mechanism involving the fungal FTR1 iron permease. It has been evaluated in Phase 2 clinical trials for invasive aspergillosis in immunocompromised patients.

Mechanism of Action

Novel antifungal mechanism targeting the FTR1 iron permease transporter on the fungal cell surface; VL-2397 is a cyclic hexapeptide that mimics siderophores and is taken up by the fungal cell via iron transport machinery, disrupting iron acquisition and leading to fungal cell death. It acts selectively on Aspergillus species by exploiting their iron uptake pathway.

Routes of Administration

Intravenous

Goals & Uses

  • Treatment of invasive aspergillosisAntifungalModerate
  • Treatment of azole-resistant Aspergillus infectionsAntifungal TherapyModerate
  • Salvage therapy for refractory invasive aspergillosisAntifungal TherapyLow

Contraindications

  • Severe hepatic impairmentOrganModerateLiver function concerns
  • Known hypersensitivity to VL-2397 or any component of the formulationAllergyHigh

Adverse Effects

  • HypokalemiaElectrolyteUncommon
  • HeadacheNeurologicUncommonPain in the head or upper neck
  • NauseaGastrointestinalUncommonFeeling of sickness or urge to vomit
  • Elevated liver enzymes (transaminases)HepaticUncommon
  • Infusion-related reactionsHypersensitivityUncommon

Drug Interactions

  • Strong CYP3A4 inhibitors/inducersLow
  • Other nephrotoxic agentsModerate

Population Constraints

  • Pediatric patientsAgeRelative
  • Immunocompromised patientsImmunologicRelative
  • Pregnant womenReproductiveRelative
  • Patients with severe renal impairmentOrgan ImpairmentRelative

Regulatory Status

  • European UnionUnknownNo EMA approval or formal designation publicly confirmed as of 2024
  • United StatesInvestigationalFDA QIDP and Fast Track designation granted for invasive aspergillosis; Phase 2 clinical trials conducted; no approved indication as of 2024
  • United KingdomUnknownNo MHRA approval as of 2024

VL-2397 has received FDA Qualified Infectious Disease Product (QIDP) designation and Fast Track designation for treatment of invasive aspergillosis. It has not yet received FDA or EMA marketing approval. Developed by Valo Health (formerly licensed from Asahi Kasei).

Evidence & Sources

No sources recorded yet.

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