{"id":47895,"date":"2026-02-06T14:20:00","date_gmt":"2026-02-06T07:20:00","guid":{"rendered":"https:\/\/thaipropertynews.com\/feeds\/?p=47895"},"modified":"2026-02-06T14:20:00","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:\/\/thaipropertynews.com\/feeds\/?p=47895","title":{"rendered":"PharmaResearch Receives U.S. FDA Clearance to Initiate Phase 1 Clinical Trial of Nano Anticancer Drug, PRD-101"},"content":{"rendered":"\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

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<\/div>\n

PRD-101 is a next-generation nano anticancer drug candidate formulated using nucleotide fragments produced through PharmaResearch’s proprietary DOT\u00ae (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

\u00a0“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\u00ae) 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\u00ae PDRN and DOT \u00ae 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

\u00a0<\/p>\n

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

<\/p>\n\n\n\n
\"\"<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

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<\/div>\n

PRD-101 is a next-generation nano anticancer drug candidate formulated using nucleotide fragments produced through PharmaResearch’s proprietary DOT\u00ae (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

\u00a0“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\u00ae) 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\u00ae PDRN and DOT \u00ae 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

\u00a0<\/p>\n

\n<\/div>\n

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