Antimicrobial · Investigational
Iseganan (IB-367)
No lawful US pathway
01 · Overview
Iseganan is a synthetic analog of protegrin, a naturally occurring antimicrobial peptide found in porcine leukocytes, with broad-spectrum microbicidal activity against gram-positive and gram-negative bacteria as well as fungi and yeasts (PMID 16192451). It was formulated as an oral rinse or oral solution for topical use in the mouth and oropharynx.
It was developed to prevent ventilator-associated pneumonia and to reduce chemotherapy- and radiotherapy-induced oral mucositis. It has never been approved by the FDA.
02 · Research summary & key findings
In a randomized double-blind trial in 709 mechanically ventilated patients, ventilator-associated pneumonia among survivors at day 14 occurred in 16 percent of iseganan patients versus 20 percent of placebo patients, a nonsignificant difference, and the authors concluded iseganan was not effective (PMID 16192451). A phase 3 trial in 502 patients receiving stomatotoxic chemotherapy found no significant difference from placebo in peak stomatitis grade or related outcomes (PMID 15120931). A multinational phase 3 trial in 545 head-and-neck radiotherapy patients likewise found no reduction in ulcerative oral mucositis relative to placebo, although iseganan was safe (PMID 14967419).
03 · Regulatory status
Iseganan (IB-367) is in the investigational stage. While preclinical and early-phase data exist, it has not received regulatory approval for clinical use in the United States.
No lawful pathway today
Iseganan (IB-367) is not FDA-approved and does not currently have a lawful prescription or compounding pathway in the United States, so we do not sell it and will not book a consultation for it. That can change: in 2026 FDA began reviewing several peptides for compounding.
See the 3 FDA-approved compounds in Antimicrobial
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04 · Administration routes
- Oral rinse
References
- [1]A multinational, randomized phase III trial of iseganan HCl oral solution for reducing the severity of oral mucositis in patients receiving radiotherapy for head-and-neck malignancy Int J Radiat Oncol Biol Phys, 2004. PMID 14967419
- [2]A phase III, randomized, double-blind, placebo-controlled, study of iseganan for the reduction of stomatitis in patients receiving stomatotoxic chemotherapy Leuk Res, 2004. PMID 15120931
- [3]A randomized double-blind trial of iseganan in prevention of ventilator-associated pneumonia Am J Respir Crit Care Med, 2006. PMID 16192451
Primary literature
- PubMed: "Iseganan"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Iseganan"
Registered interventional and observational studies, including status and phase.
- PubChem: "Iseganan"
Chemical structure, molecular properties, and bioactivity data.
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