Pittsboro, NC – July 27, 2023 – Xyzagen, Inc., a leading pharmacokinetics (PK) consultancy and contract research organization (CRO), is proud to announce its role in supporting the successful New Drug Application (NDA) approval of XDEMVY, for the treatment of Demodex blepharitis.
Xyzagen supported the nonclinical and clinical bioanalytical oversight and pharmacokinetics that contributed to the NDA approval of XDEMVY. This work included integrated PK strategy and data interpretation to support regulatory decision-making.
“We are thrilled to have contributed to the development and subsequent approval of XDEMVY, said Christopher Crean, CEO and Founder of Xyzagen. “This milestone highlights the continuing commitment to quality drug development and the value of our expertise in pharmacokinetics.
Xyzagen’s continued commitment to advancing a rigorous understanding of pharmacokinetics from bioanalytical method development through regulatory interactions reinforces its position as a trusted partner in the life sciences sector. By providing tailored support in pharmacokinetics across the drug development lifecycle, the company empowers clients to bring their transformative therapies to market efficiently and effectively.
About Xyzagen, Inc.
Xyzagen augments a client’s pharmacology and pharmacokinetics drug development team. As a leading pharmacokinetics consultancy and contract research organization with wet lab and rodent vivarium facilities, Xyzagen accelerates early-phase drug development through its proprietary First-in-Rat® and First-in-Mouse® discovery platforms. The company also supports late-stage clinical pharmacokinetics, population PK modeling, and quantitative medicine. Xyzagen’s boutique structure ensures personalized, expert collaboration with small clients during critical stages of drug development, from candidate selection to pre-NDA meetings.
Media Contact:
Christopher Crean
Founder & CEO
Xyzagen, Inc.
Phone: 919-726-2072
Email: [email protected]
