Last reviewed 2026-04-22 · How we verify

FK463

FK463 is a fungal cell wall synthesis inhibitor that disrupts β-glucan formation, leading to fungal cell death.

FK463 is a fungal cell wall synthesis inhibitor that disrupts β-glucan formation, leading to fungal cell death. Used for Invasive candidiasis, Invasive aspergillosis.

At a glance

Mechanism of action

FK463 is an echinocandin antifungal that inhibits the enzyme 1,3-β-D-glucan synthase, which is essential for fungal cell wall integrity. By blocking glucan synthesis, the drug causes weakening and rupture of the fungal cell wall, resulting in fungal cell lysis and death. This mechanism provides broad-spectrum activity against many clinically important fungal pathogens.

Approved indications

• Invasive candidiasis
• Invasive aspergillosis

Common side effects

• Elevated liver enzymes
• Infusion-related reactions
• Hypokalemia
• Headache

Key clinical trials

• A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole (PHASE3)
• Pharmacokinetic Study on Echinocandins for Patients With Septic Shock Following Secondary Peritonitis (EPI Study) (PHASE4)
• Pharmacokinetics of Micafungin in Patients of Intensive Care Units (PHASE4)
• Fluconazole Versus Micafungin in Neonates With Candidiasis (PHASE2, PHASE3)
• Antibiotic Impregnated Beads in Osteomyelitis (PHASE4)
• A Study Comparing Short-course Antifungal Therapy (SCAT) 7 Day vs Standard 14 Day Antifungal Therapy for Uncomplicated Candidemia
• A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia (PHASE4)
• Post Marketing Study to Evaluate the Efficacy and Safety of Micafungin Treatment on Invasive Aspergillosis (PHASE4)

Primary sources

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