Iseganan

Summary

Iseganan (IB-367) is a synthetic protegrin-derived antimicrobial peptide developed by InNexus/Intrabiotics Pharmaceuticals for prevention of oral mucositis and ventilator-associated pneumonia. Clinical trials failed to demonstrate efficacy over placebo, and development was discontinued. It retains interest as a research prototype for membrane-disrupting antimicrobials.

Mechanism of Action

Iseganan is a synthetic analogue of porcine protegrin-1, a beta-sheet antimicrobial peptide. It disrupts bacterial and fungal cell membranes by forming ion channels and causing membrane permeabilization, leading to rapid cell death. It acts broadly against gram-positive, gram-negative bacteria, and fungi.

Routes of Administration

Goals & Uses

• Prevention of oral mucositisOncology Supportive CareLow
• Broad-spectrum antimicrobial activityAntimicrobial ResearchModerate
• Prevention of ventilator-associated pneumoniaInfectious DiseaseLow

Contraindications

• Hypersensitivity to iseganan or protegrin analoguesAllergyHigh

Adverse Effects

• Altered tasteSensoryUncommon
• Mucosal irritationLocal ReactionUncommon
• Oral discomfort/burningLocal ReactionCommon

Drug Interactions

No drug interactions recorded yet.

Population Constraints

• Pediatric patientsAgeRelative
• Pregnant or lactating womenReproductiveRelative

Regulatory Status

• European UnionUnapprovedNever received EMA marketing authorization.
• United StatesUnapprovedFailed Phase III trials; no NDA filed or approved by FDA.
• United KingdomUnapprovedNot approved by MHRA.

Iseganan did not receive regulatory approval in any jurisdiction. Phase III trials for oral mucositis in cancer patients and for ventilator-associated pneumonia were discontinued after failure to meet primary endpoints. No approved indications exist.

Evidence & Sources

No sources recorded yet.