Omiganan

Antimicrobial Peptide (cationic Peptide; Indolicidin Analogue)Rx: InvestigationalCompound: Investigational

Also known as: CLS001, MBI 226, Omiganan pentahydrochloride, Pexiganan analogue

Educational Only — Not medical advice. Consult a qualified clinician before using any peptide.

Summary

Omiganan (MBI 226 / CLS001) is a synthetic cationic antimicrobial peptide derived from bovine indolicidin. It has broad-spectrum activity against gram-positive and gram-negative bacteria as well as fungi. It has been investigated topically for prevention of catheter-related infections, treatment of rosacea, and other dermatological indications. It has not received regulatory approval to date.

Mechanism of Action

Disrupts microbial cell membrane integrity by inserting into and permeabilizing bacterial and fungal membranes, leading to loss of membrane potential and cell death; also inhibits intracellular targets including DNA synthesis in some organisms.

Routes of Administration

Topical

Goals & Uses

  • Treatment of inflammatory rosaceaDermatologyModerate
  • Broad-spectrum antimicrobial activity (gram-positive, gram-negative, fungi)Anti InfectiveModerate
  • Treatment of acne vulgarisDermatologyLow
  • Prevention of catheter-related bloodstream infectionsAnti Infective / ProphylaxisModerate

Contraindications

  • Application to open wounds or mucous membranes (outside studied indications)SafetyModerate
  • Known hypersensitivity to omiganan or related peptidesAllergyHigh

Adverse Effects

  • Local skin irritationDermatologicalCommon
  • PruritusDermatologicUncommonItching
  • Contact dermatitisDermatologicalUncommon
  • Systemic toxicitySystemicRare

Drug Interactions

  • Other topical antimicrobialsLow

Population Constraints

  • Pediatric patientsAgeRelative
  • Pregnant or lactating womenReproductiveRelative
  • Patients with compromised skin barrierDisease RelatedRelative

Regulatory Status

  • European UnionInvestigationalNo EMA approval; investigated under clinical trial frameworks.
  • United StatesInvestigationalHas undergone Phase II/III clinical trials (MBI 226 for catheter prevention; CLS001 for rosacea); no FDA approval granted.
  • United KingdomInvestigationalNo MHRA approval; status mirrors EU investigational classification.

Omiganan pentahydrochloride (MBI 226) failed to achieve primary endpoints in Phase III trials for catheter site colonization prevention. CLS001 (topical gel formulation) has been investigated in Phase II/III trials for inflammatory rosacea and acne. No FDA or EMA approval granted as of the knowledge cutoff.

Evidence & Sources

No sources recorded yet.

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