Who Is Xyzagen?
Xyzagen is a boutique, client-focused, consulting and contract research organization (CRO), providing integrated support across the full spectrum of drug development. We specialize in early drug discovery, nonclinical and clinical pharmacology and pharmacokinetics (PK), model-informed drug development, regulatory strategy, and scientific writing — including IND, NDA, 505(b)(1), and 505(b)(2) submissions.
Our mission is to help biotechs and pharmaceutical companies accelerate their programs by acting as a flexible, expert extension of their team. Whether you’re a seed-funded startup emerging from academia, a recently venture-backed biotech, or a mid- to large-sized pharmaceutical company, Xyzagen delivers the scientific and regulatory guidance you need, without requiring you to build a full in-house team.
We support innovators without deep pockets as well as drug developers with specific pharmacokinetic or regulatory needs. Our goal is to be your long-term partner in the drug development journey.
Our Story: We Understand PK & Drug Development
Xyzagen was founded as an idea and extension of what our founder had been involved with all along: bridging early discovery and clinical development with expertise in pharmacology, bioanalysis, and pharmacokinetics.
We’re not focused on high-throughput screening, AI buzzwords, or other marketing gimmicks. Our secret sauce is simply our experience and knowing how to design nonclinical and clinical pharmacology solutions that provide both regulatory rigor and the scientific knowledge needed to move programs forward to the next value inflection point.
After leaving Big Pharma, our founder built bioanalytical and pharmacokinetic capacity at two early-stage biotech companies in the Research Triangle Park (RTP) area. By integrating early bioanalysis and in vivo pharmacokinetics, these programs advanced efficiently from discovery toward clinical development. That same philosophy — strategic, science-first, and fit-for-purpose — defines how Xyzagen operates today.
Deep Expertise Across Therapeutic Areas
While nonclinical ADME/PK, bioanalysis, and clinical pharmacology/PK are broadly therapeutic agnostic, Xyzagen brings focused depth in several complex therapeutic domains, including:
- Ophthalmology
- Neurology & Pain
- Anti-Infectives
- Respiratory
- Pediatric and orphan indications
Our strongest foundations are in Ophthalmology and Neurology/Pain, two of the most complex therapeutic areas in drug development. However, our strength extends beyond these areas: our expertise in nonclinical PK/ADME and safety, clinical pharmacology, modeling and simulation, and behavioral pharmacology allows us to apply the same scientific rigor across diverse therapeutic programs.
Because PK and pharmacology principles are universal, every client benefits from our decades of experience — regardless of indication — while gaining the advantage of deep insight where the science is most challenging.
Proven Track Record
Our experience speaks for itself. Over the years, Xyzagen has achieved:
- Over 200 small molecule bioanalytical methods developed
- Over 200 nonclinical PK studies analyzed and reported
- Over 70 505(b)(1) and 505(b)(2) regulatory milestones completed including:
- 25+ Pre-IND meetings, 30+ IND submissions, and 15+ NDA submissions
- Over 75 Clinical Pharmacology/PK study analyzed and reported
- Over 50 GLP toxicokinetic (TK) studies analyzed and reported
- Over 30 bioanalytical methods developed and validated
- Over 15 end-of-phase 2 meetings
- One FDA Advisory Committee Meeting
These milestones reflect our ability to deliver high-quality, scientifically sound results across all stages of drug development.
How We Work With You
Xyzagen operates as your integrated, virtual research lab or as a third-party PK/TK analyst. We partner closely with clients at every stage, from early compound discovery and PK screening to nonclinical PK/PD studies and Phase 1–2 clinical pharmacology/PK programs.
Our goal is to provide actionable insights that support your go/no-go decisions, streamline regulatory interactions, and minimize development risk — all while maintaining the flexibility and personalized attention of a boutique firm.
Let’s Get Started
At Xyzagen, we combine deep scientific expertise, regulatory insight, and a client-focused approach to help you advance your programs efficiently.
Contact us to see how we can act as your back-office research lab or strategic partner in drug development.
