Respiratory Drug Development Expertise
Respiratory drug development requires a deep understanding of pulmonary physiology, drug delivery routes, and pharmacokinetics (PK) in both preclinical and clinical settings due to differences in respiration between animals and humans. Effective therapies must navigate complex barriers such as airway architecture, mucociliary clearance, and alveolar absorption, while maintaining efficacy and safety across diverse populations from healthy to disease state.
Key Therapeutic Areas
Xyzagen has experience supporting small molecule and biologic programs across multiple respiratory indications, including:
Our Track Record in Respiratory Drug Development
Our team has contributed to preclinical and clinical development programs in Cystic Fibrosis (CF), Rhinitis, and lung transplants, to name a few, by designing PK/PD studies, optimizing sample collection strategies, and supporting regulatory submissions. We leverage our expertise in lung tissue distribution, inhaled drug delivery, and translational pharmacokinetics to help clients predict human outcomes from preclinical models.
How We Support Clients in Respiratory Programs
Xyzagen provides end-to-end support for respiratory programs, including:
Preclinical PK/PD Studies
Rodent and non-rodent studies to assess tissue distribution, efficacy, and safety
Bioanalytical Support
Rodent and non-rodent studies to assess tissue distribution, efficacy, and safety
Formulation and Delivery Assessment
Rodent and non-rodent studies to assess tissue distribution, efficacy, and safety
Translational Modeling
Population PK and PK/PD modeling to guide dose selection and clinical trial design
Regulatory Support
IND and NDA submission assistance with respiratory-specific considerations
Why PK Matters in Respiratory Drug Development
Drug distribution and clearance in the lung are influenced by formulation, delivery route, and local tissue barriers. Integrating PK data early enables accurate predictions of efficacy, safety, and dosing requirements, reducing clinical risk and accelerating development timelines.
Next Steps
Talk to us about how Xyzagen can help optimize your respiratory drug development program from preclinical discovery to late-stage clinical trials. Explore our related services in pharmacology models, PK/PD studies, and bioanalytical testing—or contact our team to discuss your program.
