Omiganan pentahydrochloride is under clinical development by Cutanea Life Sciences and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Omiganan pentahydrochloride’s likelihood of approval (LoA) and phase transition for Genital Warts (Condylomata Acuminata) took place on 20 May 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 20 May 2022 increased Omiganan pentahydrochloride’s LoA and PTSR for Seborrhea, and increased LoA and PTSR for Vulvar Cancer.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Omiganan pentahydrochloride Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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.

Quick View Omiganan pentahydrochloride LOA Data

Report Segments
  • Innovator
Drug Name
  • Omiganan pentahydrochloride
Administration Pathway
  • Cutaneous
  • Topical
Therapeutic Areas
  • Dermatology
  • Infectious Disease
  • Oncology
Key Developers
Highest Development Stage
  • Phase II

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.