Omiganan

Also known as: MBI 226 · CLS001

Not FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA
Randomized controlled trials 5 of 53 publications on PubMed
Registered clinical trials 18 0 active
Adverse event reports 0 0 classified as serious
  • Omiganan is not an FDA-approved drug: Drugs@FDA has no record of it.
  • PubMed lists 53 publications mentioning it, including 5 randomized controlled trials and 5 animal-only studies.
  • ClinicalTrials.gov lists 18 registered studies testing it (0 active).
  • FDA’s adverse event system (FAERS) has no reports mentioning it.

Research topics

  • Antimicrobial Cationic Peptides 34
  • Anti-Bacterial Agents 23
  • Microbial Sensitivity Tests 22
  • Bacteria 10
  • Antimicrobial Peptides 9
  • Staphylococcus aureus 8
  • Skin 7
  • Antifungal Agents 6
  • Staphylococcal Infections 6
  • Administration, Topical 5

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

No application found in Drugs@FDA, FDA's database of approved drugs.

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 53
  • Human (MeSH) 34
  • Animal only 5
  • Clinical trials 6
  • Randomized controlled trials 5
  • Systematic reviews & meta-analyses 1
  • Case reports 0
  • Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
18
Active
0
With posted results
5

Conditions studied

  • Acne Vulgaris 4
  • Rosacea 3
  • Atopic Dermatitis 2
  • Papulopustular Rosacea 2
  • Infection 2
  • Acne 2
  • Propionibacterium Acnes 2
  • Seborrheic Dermatitis 1
  • Healthy 1
  • Condylomata Acuminata (External) 1
  • Usual Type Vulval Intraepithelial Neoplasia (uVIN) 1
  • Sepsis 1
Study Status Phase Start
Omiganan Twice a Day (BID) in Patients With Facial Seborrheic Dermatitis
NCT03688971 Maruho Co., Ltd.
Unknown status Phase 2 October 22, 2018
Pharmacodynamics of Omiganan BID in Patients With Atopic Dermatitis
NCT03091426 Maruho Co., Ltd.
Completed Phase 2 March 8, 2017
Topical Challenge With Omiganan and Imiquimod in Healthy Volunteers
NCT03071679 Maruho Co., Ltd.
Completed Phase 1 February 6, 2017
Pharmacodynamics, Safety and Efficacy of Topical Omiganan in Patients With External Genital Warts
NCT02849262 Maruho Co., Ltd.
Completed Phase 2 Jul 2016
Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
NCT02547441 Maruho Co., Ltd. Results posted
Completed Phase 3 Dec 2015
Pharmacodynamics, Safety/Tolerability and Efficacy of Topical Omiganan in Patients With uVIN
NCT02596074 Maruho Co., Ltd.
Completed Phase 2 Nov 2015
A Study to Evaluate the Safety and Efficacy of Omiganan (CLS001) Topical Gel Versus Vehicle in Female Subjects With Moderate to Severe Acne Vulgaris
NCT02571998 Maruho Co., Ltd.
Completed Phase 2 Oct 2015
Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle
NCT02576860 Maruho Co., Ltd. Results posted
Completed Phase 3 Oct 2015
Study to Evaluate the Long-term Safety of a Once-Daily Omiganan Topical Gel
NCT02576847 Maruho Co., Ltd. Results posted
Completed Phase 3 Oct 2015
Pharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis
NCT02456480 Maruho Co., Ltd.
Completed Phase 2 May 2015
Show 8 more studies
Study Status Phase Start
Safety and Efficacy Study of CLS001Topical Gel Compared to Vehicle in Subjects With Inflammatory Acne Vulgaris
NCT02066545 Maruho Co., Ltd.
Completed Phase 2 Apr 2014
A 21 Day Pharmacokinetics Study in Papulopustular Rosacea
NCT02028286 Maruho Co., Ltd.
Completed Phase 1 Jan 2014
A Twelve Week Safety and Efficacy Study in Rosacea
NCT01784133 Maruho Co., Ltd.
Completed Phase 2 Mar 2013
Study of Antimicrobial Activity of Omiganan 1% Gel vs. Chlorhexidine 2% for Topical Skin Antisepsis in Healthy Adult Subjects
NCT00608959 Cadence Pharmaceuticals Results posted
Completed Phase 3 May 2008
Study of Omiganan 1% Gel in Preventing Catheter Infections/Colonization in Patients With Central Venous Catheters
NCT00231153 Cadence Pharmaceuticals Results posted
Completed Phase 3 Aug 2005
Safety and Efficacy of MBI 226 1.25% and 2.5% Topical Acne Solutions in the Treatment of Acne
NCT00211497 BioWest Therapeutics Inc
Completed Phase 2 Jan 2003
Safety and Efficacy of MBI 226 2.5% and 5.0% Topical Acne Solutions in the Treatment of Acne
NCT00211523 BioWest Therapeutics Inc
Completed Phase 2 Oct 2000
Safety and Efficacy of MBI 226 for the Prevention of Central Venous Catheter-Related Bloodstream Infections
NCT00027248 BioWest Therapeutics Inc
Completed Phase 3 Sep 2000

All 18 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

No FAERS reports mention this peptide.

Source: FDA FAERS · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.