Last reviewed 2026-04-22 · How we verify

APT-1011

APT-1011 is a permeation enhancer designed to improve the oral bioavailability of poorly absorbed drugs by modulating intestinal tight junctions.

APT-1011 is a permeation enhancer designed to improve the oral bioavailability of poorly absorbed drugs by modulating intestinal tight junctions. Used for Oral delivery enhancement for peptide and protein drugs in phase 3 development.

At a glance

Mechanism of action

APT-1011 works by temporarily and reversibly opening tight junctions in the intestinal epithelium, allowing larger or hydrophilic molecules to be absorbed more effectively through the paracellular pathway. This approach enables oral delivery of drugs that would otherwise require injection, potentially improving patient compliance and quality of life.

Approved indications

• Oral delivery enhancement for peptide and protein drugs in phase 3 development

Common side effects

• Gastrointestinal disturbances
• Transient intestinal permeability changes

Key clinical trials

• Expanded Access Protocol for Patients With Eosinophilic Esophagitis
• 24-Week Induction Study of APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE 3) (PHASE3)
• Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial (PHASE3)
• Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2) (PHASE3)
• Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE) (PHASE2)

Primary sources

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