Our Pipeline
CSA-144, our lead Ceragenin compound, is being developed across multiple therapeutic areas with the potential to address significant unmet medical needs.
Development Status
Current clinical development progress for all CSA-144 programs.
Program Details
In-depth information about each of our development programs.
CSA-144
Topical Hydrogel
Diabetic Foot Ulcers
CSA-144 Topical Hydrogel for the treatment of diabetic foot ulcers, a chronic wound condition affecting millions of diabetic patients worldwide.
Diabetic foot ulcers affect 15-25% of diabetics during their lifetime, with limited effective treatment options and high amputation rates.
Approximately 537 million adults with diabetes globally, with 9.1-26.1 million developing foot ulcers annually.
Broad-spectrum antimicrobial activity prevents infection while promoting wound healing through biofilm disruption.
CSA-144
Topical Hydrogel
Epidermolysis Bullosa
CSA-144 for Epidermolysis Bullosa, a rare genetic skin disorder causing fragile skin that blisters easily. Orphan drug designation.
No FDA-approved treatments specifically for EB wound management. Patients face chronic wounds and high infection risk.
Estimated 500,000 people worldwide affected by various forms of EB.
Antimicrobial protection for fragile skin wounds while being non-cytotoxic to healing tissue.
CSA-144
Topical Cream
Severe Atopic Dermatitis
CSA-144 Topical Cream for severe atopic dermatitis patients with specific genetic markers indicating Ceragenin responsiveness.
Atopic dermatitis affects up to 20% of children and 3% of adults, with severe cases requiring better treatment options.
Patients with moderate-to-severe atopic dermatitis and identified genetic markers.
Reduces skin colonization by S. aureus, a key driver of AD flares and inflammation.
CSA-144
Topical Cream
Antiscarring Treatment
CSA-144 Topical Cream developed to prevent and reduce scarring following surgical procedures or traumatic wounds.
Significant scarring affects quality of life for millions of surgery and trauma patients annually.
Post-surgical patients and individuals with healing traumatic wounds.
Modulates wound healing environment to reduce excessive collagen deposition and scar formation.
CSA-144
Topical Hydrogel
Topical Antimicrobial
CSA-144 Topical Hydrogel as a broad-spectrum topical antimicrobial for various skin and wound infections.
Rising antimicrobial resistance limits treatment options for common skin infections.
Patients with bacterial, fungal, or mixed skin infections including drug-resistant strains.
Membrane-disrupting mechanism provides rapid, broad-spectrum activity without resistance development.
CSA-144
Topical Hydrogel
STI Prevention
CSA-144 Topical Hydrogel for the prevention of sexually transmitted infections through topical application.
STIs continue to rise globally with limited prevention options beyond barrier methods.
Adults seeking additional protection against common STIs.
Topical antimicrobial barrier provides protection against bacterial and viral pathogens.
CSA-144
Topical Cream
Onychomycosis
CSA-144 Topical Cream for the treatment of onychomycosis (toenail fungus), a common fungal nail infection.
Current topical treatments have low cure rates; oral antifungals carry systemic side effects.
Estimated 10% of the general population affected by onychomycosis.
Penetrates nail bed to deliver potent antifungal activity directly to the site of infection.
Development Process
Our rigorous clinical development process ensures the safety and efficacy of our Ceragenin-based therapeutics.
Discovery
Identify and validate drug candidates through laboratory research and early testing.
- Target identification
- Lead compound optimization
- In vitro efficacy studies
- Initial safety assessment
Preclinical POC
Conduct comprehensive laboratory and animal studies to establish proof of concept.
- Pharmacokinetic studies
- Toxicology assessments
- Formulation development
- IND-enabling studies
Phase 1
First-in-human trials to evaluate safety, tolerability, and pharmacokinetics.
- Safety and tolerability
- Dose escalation studies
- Pharmacokinetic profiling
- Initial efficacy signals
Phase 2
Controlled trials to assess efficacy and optimal dosing in target patient population.
- Efficacy evaluation
- Dose-response studies
- Safety monitoring
- Endpoint validation
Phase 3
Large-scale pivotal trials to confirm safety and efficacy for regulatory approval.
- Pivotal efficacy trials
- Long-term safety data
- Regulatory submissions
- Commercialization prep
Clinical development timelines vary based on indication complexity, regulatory requirements, and trial enrollment. Our experienced team works to advance programs efficiently while maintaining the highest standards of patient safety.