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CLS001 (Omiganan)
Omiganan is an antimicrobial peptide that disrupts bacterial cell membranes by binding to lipopolysaccharides and lipoteichoic acids, leading to bacterial cell death.
Omiganan is an antimicrobial peptide that disrupts bacterial cell membranes by binding to lipopolysaccharides and lipoteichoic acids, leading to bacterial cell death. Used for Atopic dermatitis with bacterial colonization, Impetigo and other skin and soft tissue infections.
At a glance
| Generic name | CLS001 (Omiganan) |
|---|---|
| Sponsor | Maruho Co., Ltd. |
| Drug class | Antimicrobial peptide |
| Target | Bacterial cell membrane (lipopolysaccharides and lipoteichoic acids) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Dermatology |
| Phase | Phase 3 |
Mechanism of action
Omiganan is a synthetic 12-amino acid cationic antimicrobial peptide derived from indolicidin. It exerts its bactericidal effect by interacting with negatively charged components of bacterial cell membranes, causing membrane disruption and leakage of intracellular contents. This mechanism is distinct from conventional antibiotics and may help overcome resistance mechanisms.
Approved indications
- Atopic dermatitis with bacterial colonization
- Impetigo and other skin and soft tissue infections
Common side effects
- Application site reactions (erythema, irritation)
- Pruritus
- Contact dermatitis
Key clinical trials
- Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle (PHASE3)
- Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle (PHASE3)
- Pharmacodynamics, Safety/Tolerability and Efficacy of Topical Omiganan in Patients With uVIN (PHASE2)
- Pharmacodynamics, Safety and Efficacy of Topical Omiganan in Patients With External Genital Warts (PHASE2)
- A Study to Evaluate the Safety and Efficacy of Omiganan (CLS001) Topical Gel Versus Vehicle in Female Subjects With Moderate to Severe Acne Vulgaris (PHASE2)
- Pharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis (PHASE2)
- A Twelve Week Safety and Efficacy Study in Rosacea (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CLS001 (Omiganan) CI brief — competitive landscape report
- CLS001 (Omiganan) updates RSS · CI watch RSS
- Maruho Co., Ltd. portfolio CI