Medicines (Rx)
PHN033®
Indications
Diabetic Nephropathy
Product Description
1. Medicine Type: Botanical new drug
2. Active pharmaceutical ingredients: Composed of active ingredients from local Taiwanese herbs which are extracted, isolated, and partially purified with patented technology.
3. Route of administration: Oral Tablet
Mechanism of Action
- PHN033 can facilitate the removal of the advanced glycation end products (AGEs) that cause vascular complications in patients with diabetes.
- PHN033 has been proven its effective prevention of liver, kidney and retina damage in diabetic animal experimental models.
- By inhibiting the formation of AGEs caused by hyperglycemia, it avoids the damage to vascular endothelial or glomerulus and prevents nephropathy caused by diabetes.
Strengths and Potential
- The plant source is indigenous to Taiwan, and the safety and quality can be highly controlled from farm(GAP) to drug production(PIC/S GMP).
- The plant itself is edible and safe for long-term use. API has completed genetic toxicology, single-dose toxicology and 28-day, 180-day toxicology tests, which proves its extremely high safety.
- The US FDA has approved the IND clinical phase II trial. A randomized double- blind, placebo-controlled, 24-week multi-center clinical trial (N=100) has been completed. It confirms the safety of human use, also the effective improvement of the renal function of diabetic nephropathy patients.
- The technology used in developing PhytoHealth PHN033 has received patent approval from the United States, the European Union, Australia, mainland China, Japan, Canada, and Taiwan.
R&D progress
- Phase II trials have been completed in Taipei Veterans General Hospital, Tri-Service General Hospital, and Taichung Veterans General Hospital.
- Clinical trials Phase IIb are under planning.