On February 6, 2026 PharmaResearch Co., Ltd. (CEO: Jihoon Sohn) reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PRD-101, enabling the initiation of a Phase 1 clinical trial in the United States.
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PRD-101 is a next-generation nano anticancer drug candidate formulated using nucleotide fragments produced through PharmaResearch’s proprietary DOT (DNA Optimizing Technology). The drug leverages the company’s nucleotide-based Advanced DOT drug delivery platform, designed to enable efficient loading of therapeutics and improve pharmacokinetics.
The Phase 1 clinical trial will be conducted across up to seven clinical sites in the United States and is expected to enroll approximately 90 patients with locally advanced or metastatic solid tumors. The study is designed to evaluate the safety, tolerability, and pharmacokinetics of PRD-101.
"The FDA clearance of our IND application marks an important milestone for PRD-101. Through this Phase 1 trial, we aim to further characterize PRD-101 and continue advancing our oncology pipeline," PharmaResearch stated.
About PharmaResearch’s PRD-101
PRD-101 represents a significant advancement in cancer treatment, utilizing nucleotide fragments produced through PharmaResearch’s proprietary DNA optimizing technology (DOT) in nanoparticle anticancer formulations. Collaborative efforts between PharmaResearch and the University of California Irvine (UCI) researchers, along with support from organizations like the U.S. NCL, have propelled the development of PRD-101. PharmaResearch holds patents and exclusive licenses associated with PRD-101, marking a milestone in the company’s innovative endeavors.
Traditional anticancer drugs often face limitations due to high toxicity, which restricts patient eligibility and necessitates careful dosage management. PharmaResearch anticipates that PRD-101 will address these unmet medical needs in anticancer therapy.
(Press release, PharmaResearch, FEB 6, 2026, View Source [SID1234662532])