Omiganan pentahydrochloride is under clinical development by Cutanea Life Sciences and currently in Phase II for Seborrhea. According to GlobalData, Phase II drugs for Seborrhea have a 64% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Omiganan pentahydrochloride’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Omiganan pentahydrochloride overview

Omiganan pentahydrochloride (CLS-001) is under development for the treatment of vulvar intraepithelial neoplasia, inflammatory papules, genital warts, acne vulgaris, atopic dermatitis and seborrheic dermatitis. The drug candidate is an aqueous based gel formulation administered topically or by cutaneous route. The drug candidate is an analog of indolicidin originally purified from the cytoplasmic granules of bovine neutrophils. The drug candidate is a cationic anti-microbial peptide that targets bacterial cell membrane.

It was also under development for the treatment of catheter-related bloodstream infections (CRBSIs) and severe papulopustular rosacea.

Cutanea Life Sciences overview

Cutanea Life Sciences (Cutanea), a subsidiary of Maruho Co Ltd is a pharmaceutical company that develops technologies and therapeutic applications to treat diseases and disorders of the skin and subcutaneous tissue. The company’s product pipeline includes CLS007 for acne; CLS008 for psoriasis; CLS001 for rosacea, acne, atopic dermatitis, vulval intraepithelial neoplasia, and various forms of warts caused by human papillomavirus; and CLS003 for HPV and verruca. Its preclinical product, CLS002 is being developed for soft tissue augmentation. Cutanea is headquartered in Wayne, Pennsylvania, the US.

For a complete picture of Omiganan pentahydrochloride’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.