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Antimicrobial · In Clinical Trials

Omiganan

No lawful US pathway

Written by Peptide Association Editorial TeamLast reviewed Editorial policy

01 · Overview

Omiganan is a synthetic cationic antimicrobial peptide derived from indolicidin, a naturally occurring peptide from bovine neutrophils. It acts by disrupting microbial membranes and has both antibacterial and antifungal activity, which is why it has been evaluated in several topical indications (PMID 37762625).

It was first developed as a gel (MBI-226) intended to prevent catheter-related bloodstream infections (PMID 14508884). It is not FDA approved for any indication.

02 · Research summary & key findings

A phase 3 trial of the gel formulation for prevention of catheter-related bloodstream infections was initiated in 2000, and no approved product followed (PMID 14508884). In phase 2 trials in human papillomavirus-induced genital lesions, topical omiganan was safe and reduced viral load in anogenital warts but did not change lesion count, size or patient-reported outcomes versus placebo (PMID 31755993). In a randomized proof-of-concept trial in mild to moderate facial seborrheic dermatitis, omiganan was safe but produced no significant clinical improvement compared with placebo, while ketoconazole did reduce disease severity (PMID 37762625).

03 · Regulatory status

Omiganan is currently undergoing clinical trials. It is not yet FDA-approved and is available only through clinical research settings or investigational protocols.

No lawful pathway today

Omiganan 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

Tell me if the status changes

One email, only if this compound's regulatory standing actually moves. Not a newsletter, not a sales sequence.

04 · Administration routes

  • Topical

References

  1. [1]MBI-226. Micrologix/Fujisawa Curr Opin Investig Drugs, 2003. PMID 14508884
  2. [2]Results of phase 2 trials exploring the safety and efficacy of omiganan in patients with human papillomavirus-induced genital lesions Br J Clin Pharmacol, 2020. PMID 31755993
  3. [3]Treatment with the Topical Antimicrobial Peptide Omiganan in Mild-to-Moderate Facial Seborrheic Dermatitis versus Ketoconazole and Placebo: Results of a Randomized Controlled Proof-of-Concept Trial Int J Mol Sci, 2023. PMID 37762625

Primary literature

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Disclaimer: This information is provided for educational and research purposes only. It is not intended as medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting any peptide therapy. The Peptide Association does not endorse or recommend any specific treatment protocol. See our editorial policy for how this content is produced and reviewed. Clinicians: join the network.