Biotree's Natural Metabolic Syndrome Drug PH-100 Advances Through Clinical Trials with Global Partnership
Key Insights
Biotree Co., Ltd. (search) has successfully completed Phase 1 clinical trials in the United States and Phase 2A trials across 12 Korean university hospitals for PH-100, a natural product-based treatment for metabolic syndrome.
Phase 2A results demonstrated significant reduction in inflammatory markers (HS-CRP (search)) and positive cardiovascular effects without adverse side effects.
The drug is expected to receive conditional approval and launch as a prescription treatment in the first half of 2026, pending successful completion of ongoing Phase 2B trials.
Biotree Co., Ltd. (search), a Korean biotechnology company, has achieved significant clinical milestones with PH-100, positioning itself as the developer of the world's first natural product-based treatment for metabolic syndrome. The company has successfully completed Phase 1 clinical trials in the United States and Phase 2A trials across 12 university hospitals in Korea for this innovative therapy targeting metabolic syndrome and diabetic complications.
Clinical Trial Results Show Promise
The Phase 2A clinical trial results demonstrated encouraging efficacy signals, with PH-100 showing a significant reduction in inflammatory markers, specifically HS-CRP (search) (high-sensitivity C-reactive protein). Additionally, the treatment exhibited positive effects on cardiovascular disease parameters without causing adverse side effects, according to the trial data.
The drug is currently progressing through Phase 2B clinical trials, with conditional approval and market launch anticipated in the first half of 2026, pending successful completion of these ongoing studies. Upon approval, PH-100 will be available as a prescription-only treatment.
Novel Marine-Derived Active Ingredient
PH-100's active component is derived from Seapolynol (search), a marine polyphenol extracted from Gamtae, a type of seaweed known for its health benefits including dementia prevention, vascular health support, and anticancer effects. Biotree is the first Korean company to successfully extract this compound from Gamtae and has developed a diverse product portfolio spanning health functional foods, pharmaceuticals, daily necessities, and cosmetics.
Regulatory Achievements and Scientific Validation
Since 2008, Biotree has established itself as an industry leader in Korea, becoming the first company to obtain critical regulatory certifications including the U.S. FDA's NDI (New Dietary Ingredient) and IND (Investigational New Drug) designations, as well as the European EFSA NFI (Novel Food Ingredient) certification. The company has built a substantial intellectual property portfolio with over 50 registered patents and has published more than 130 SCI (Science Citation Index)-level papers.
Expert Leadership and Global Partnership
Dr. Eui-Shin Kim, a world-renowned oncologist and leader in nuclear medicine, serves as a senior advisor to Biotree. Dr. Kim brings extensive experience from his 32-year tenure as a professor at the University of Texas MD Anderson Cancer Center, where he gained recognition for his research on cancer diagnostic techniques utilizing genetic analysis and MRI. His achievements have earned him eleven honors as one of America's Best Doctors.
To accelerate global market penetration, Biotree has formed a strategic international business partnership with Harrison Global Holdings Inc. (search) (NASDAQ:BLMZ). The partnership encompasses establishing joint ventures or licensing agreements for local operations, joint development of new natural product drugs, sharing of branding and distribution channels, and regulatory compliance support across multiple markets including the US, Japan, China, and Asia.
Ryoshin Nakade, Co-CEO of Harrison Global Holdings, stated, "Through this partnership, we are delighted to contribute to human health by working with Biotree to complete the development of a natural metabolic syndrome treatment that has taken considerable time and investment to develop and enter the global market."