Evidence memo / Immune & thymic

Omiganan

Also: MX-226 · MBI-226 · indolicidin analog

Omiganan is an antimicrobial peptide, based on a cattle peptide called indolicidin, developed as a topical gel for catheter-related infections and for inflammatory skin conditions such as rosacea, acne, and atopic dermatitis. It has been through Phase 2 and Phase 3 trials with mixed results and is not approved. The Watchlist boundary is keeping it to its specific topical research and noting the mixed trial record, separate from broad antimicrobial-peptide claims.

Controlled human dataPhase 2 / Phase 3InvestigationalSafety / regulatory watch

The verdict

Our read at a glance.

Whether omiganan's antimicrobial-peptide mechanism and its mixed skin and infection trials support its use as a treatment.

The signal
Omiganan has been tested in trials for preventing catheter-related infection and for skin conditions such as rosacea, acne, and atopic dermatitis. Results have been mixed, with some early signals but no clear, consistent approval-grade benefit, and it is not approved for any use.
The unknown
Whether omiganan can show clear, reliable benefit in a specific condition, and which skin or infection setting, if any, is the right target.
Our read
A real topical antimicrobial peptide with a mixed, inconclusive trial record, not a proven treatment. Omiganan's mechanism is genuine and it has been widely studied, but no indication has produced clear, approval-grade benefit, so it remains investigational.

The mechanism

How it works.

Omiganan is a synthetic antimicrobial peptide derived from indolicidin, a short peptide made by cattle immune cells. As a positively charged peptide it binds the negatively charged membranes of bacteria and fungi and disrupts them, killing the microbes directly, and it also appears to dampen local inflammatory signaling. It was applied as a topical gel to reduce microbes at catheter sites and to calm inflammatory skin conditions like rosacea and acne, but its trials across these uses have given mixed results and it is not approved.

Safety & regulatory boundary

The consequential part.

Omiganan is not an approved drug, and its trial results across conditions have been mixed. It was studied only as a topical product under medical supervision. Research-labeled or compounded omiganan is not an approved product, and the antimicrobial-peptide concept does not validate broad infection or skin claims.

What's next

What we're watching.

Whether any omiganan indication reaches a clear positive trial and approval, and in which condition.

Context

Why this is discussed.

Omiganan is another leading test of whether antimicrobial peptides can become approved drugs, studied across infection prevention and several skin conditions.

The evidence base

20 cited references.

Registered trials8

Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel

ClinicalTrials.gov · PHASE3 · COMPLETED · 2015-10

Omiganan Twice a Day (BID) in Patients With Facial Seborrheic Dermatitis

ClinicalTrials.gov · PHASE2 · UNKNOWN · 2018-10-22

Pharmacodynamics of Omiganan BID in Patients With Atopic Dermatitis

ClinicalTrials.gov · PHASE2 · COMPLETED · 2017-03-08

Topical Challenge With Omiganan and Imiquimod in Healthy Volunteers

ClinicalTrials.gov · PHASE1 · COMPLETED · 2017-02-06

Indexed literature (PubMed)12

From pathogenesis of acne vulgaris to anti-acne agents

Cong TX et al. · Arch Dermatol Res · 2019

MBI-226. Micrologix/Fujisawa

Isaacson RE · Curr Opin Investig Drugs · 2003

Decolonization in Prevention of Health Care-Associated Infections

Septimus EJ et al. · Clin Microbiol Rev · 2016

Rational design of stapled antimicrobial peptides

You Y et al. · Amino Acids · 2023

Keep reading

Related published memos.