Ardena Enables PharmaResearch’s Nanomedicine PRD‑101 to Enter Phase 1 Clinical Development

Ghent, Belgium, 10^th March 2026 – PharmaResearch, headquartered in Seongnam, South Korea, has recently received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to initiate a Phase 1 clinical trial of PRD-101, a nano-based anticancer drug candidate. The authorization marks a significant milestone in advancing PRD101 into first-in-human evaluation.

As a specialist Contract Development and Manufacturing Organization (CDMO) and bioanalytical Contract Research Organization (CRO), Ardena partnered with PharmaResearch to translate the nano-based formulation into a clinical-ready drug product and to prepare the IND submission package. The collaboration required advanced formulation and process development capabilities to ensure the product’s readiness for early-stage clinical evaluation towards safety, tolerability, and pharmacokinetics.

“Receiving FDA IND clearance is an important milestone for PRD-101 and supports our plans to initiate a Phase 1 clinical trial,” said Yujin Jung, Head of Global Strategy at PharmaResearch. “As we move PRD-101 into first-in-human evaluation, Ardena’s expertise in nanomedicine development and their disciplined execution have been instrumental.”

“We are pleased to have supported PharmaResearch in bringing PRD-101 to this stage,” said Ardena’s CEO, Jeremie Trochu. “Transitioning cutting-edge nanomedicines into the clinic demands precision, robust development strategies, and close collaboration. We look forward to continuing to work with PharmaResearch as PRD-101 progresses through its Phase 1 program.”

About PharmaResearch

PharmaResearch is a pioneering biopharmaceutical company dedicated to enhancing the quality of life for humanity through regenerative medicine. Its diverse portfolio includes medicines, medical devices, cosmetics, and supplements, all leveraging the core ingredients – DOT™ PDRN and DOT™ PN – which are protected by multiple patents. PharmaResearch is headquartered in Seongnam, South Korea, and its U.S. subsidiary located in Costa Mesa, California, United States.

About Ardena

Ardena is a specialist pharmaceutical CDMO and bioanalytical CRO supporting the development of precision medicines and other complex therapies. The company offers integrated services in nanomedicine, drug product and drug substance manufacturing, solid-state chemistry, bioanalytical services, and CMC regulatory support. Ardena’s nanomedicine capabilities cover formulation, process development, and manufacturing of advanced delivery systems including lipidic, polymeric, and metal nanoparticles.