{"id":43099,"date":"2026-02-06T07:20:00","date_gmt":"2026-02-06T07:20:00","guid":{"rendered":"http:\/\/www.prnasia.com\/story\/archive\/4882449_CN82449_0"},"modified":"2026-02-06T07:20:00","modified_gmt":"2026-02-06T07:20:00","slug":"pharmaresearch-receives-u-s-fda-clearance-to-initiate-phase-1-clinical-trial-of-nano-anticancer-drug-prd-101","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=43099","title":{"rendered":"PharmaResearch Receives U.S. FDA Clearance to Initiate Phase 1 Clinical Trial of Nano Anticancer Drug, PRD-101"},"content":{"rendered":"
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SEONGNAM, South Korea<\/span><\/span>, Feb. 6, 2026<\/span><\/span> \/PRNewswire\/ — PharmaResearch Co., Ltd. (CEO: Jihoon Sohn<\/span>) today announced 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<\/span>.<\/p>\n

\n

\"Members <\/a>
Members of the PharmaResearch PRD-101 Project Team<\/span><\/p>\n<\/p><\/div>\n

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\u2122 drug delivery platform, designed to enable efficient loading of therapeutics and improve pharmacokinetics.<\/p>\n

The Phase 1 clinical trial will be conducted across up to seven clinical sites in the United States<\/span> 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.<\/p>\n

 "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.<\/p>\n

About PharmaResearch’s PRD-101<\/b><\/p>\n

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<\/span> (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.<\/p>\n

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.<\/p>\n

About PharmaResearch<\/b><\/p>\n

PharmaResearch is a pioneering biopharmaceutical company dedicated to enhancing the quality of life through regenerative medicine. With a diverse portfolio that includes medicines, medical devices, cosmetics, and supplements, PharmaResearch focuses on leveraging its core ingredients\u2014DOT® PDRN and DOT ® PN\u2014which are protected by a suite of patents. Headquartered in Gangneung-si, Gangwon-do, South Korea<\/span>, PharmaResearch also has a subsidiary in Costa Mesa, California<\/span>.<\/p>\n

For more information about PharmaResearch, visit https:\/\/pharmaresearch.com\/en<\/a><\/p>\n

 <\/p>\n

\n<\/p><\/div>\n","protected":false},"excerpt":{"rendered":"

SEONGNAM, South Korea, Feb. 6, 2026 \/PRNewswire\/ — PharmaResearch Co., Ltd. (CEO: Jihoon Sohn) today announced 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. Members of the PharmaResearch PRD-101 Project Team PRD-101 […]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-43099","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"\nPharmaResearch Receives U.S. FDA Clearance to Initiate Phase 1 Clinical Trial of Nano Anticancer Drug, PRD-101 - My Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/transmediavictoria.net.au\/?p=43099\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"PharmaResearch Receives U.S. FDA Clearance to Initiate Phase 1 Clinical Trial of Nano Anticancer Drug, PRD-101 - My Blog\" \/>\n<meta property=\"og:description\" content=\"SEONGNAM, South Korea, Feb. 6, 2026 \/PRNewswire\/ — PharmaResearch Co., Ltd. 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