Anti-Infective Drug Development Expertise
Antibiotics, antivirals, and antifungals have transformed modern medicine. Antibiotics helped turn once-deadly infections into treatable conditions. Antivirals have enabled people living with HIV, Hepatitis, and other viral infections to maintain long, high-quality lives. Antifungals range from topical therapies for onychomycosis (toenail fungus), such as JUBLIA®, to lifesaving treatments for invasive aspergillosis in immunocompromised patients. But decades of overuse and misuse have fueled antibiotic resistance, creating one of the greatest global health challenges today. While organizations like CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) are helping drive innovation, the pace of new drug development slowed significantly in the late 20th century, and major pharmaceutical companies largely exited the antibiotic space by the early 2000s.
Guiding Anti-Infective Programs with Precision
Our expertise spans nonclinical and clinical pharmacokinetics (PK), bioanalysis, technical writing, and regulatory strategy—helping innovators navigate both established and emerging anti-infective pathways. With JUBLIA®, our team members were involved in the clinical pharmacology oversight and NDA writing of modules 2.7.1 and 2.7.2.
Our Track Record in Anti-Infective Drug Development
Ophthalmic anti-infectives
Supported the development of Azasite®, a mucoadhesive azithromycin formulation for bacterial conjunctivitis.
Dermatologic antifungals
Contributed to the development of Jublia® for onychomycosis through PK, bioanalytical support, and NDA technical writing.
Inhaled antifungals
Provided PK, tox, and bioanalytical support for the reformulation of Voriconazole for invasive pulmonary aspergillosis.
Novel antibacterials
Assisted with multiple CARB-X IND submissions targeting drug-resistant pathogens.
Model-Informed Drug Development for Anti-Infectives
At Xyzagen, we embrace a “model early, model often” philosophy. Through our First-in-Mouse® and First-in-Rat® approaches, we apply PK and efficacy data early to inform nonclinical study design, toxicology planning, and downstream clinical pharmacology strategies.
Infectious diseases have a long history with model-informed drug development (MIDD). Advances in computing power, Bayesian statistics, AI algorithms, and pathogen biology are opening new opportunities for predictive exposure–response modeling.
Benefits MIDD Can Provide Anti-Infective Development
Did You Know?
It takes a full year for a toenail to grow from nail bed to tip—why most onychomycosis trials require a 48-week primary endpoint.
Partner With Us
Whether you are developing an antibacterial, antiviral, or antifungal, Xyzagen can help integrate laboratory studies, pharmacology models, and PK/PD modeling into a cohesive development plan. We collaborate closely with clinical and medical teams to ensure continuity across studies and alignment with regulatory expectations. Explore our full suite of solutions—or contact us directly to start a conversation about how early pharmacokinetic decisions can shape the success of your anti-infective program.
