Medicines (Rx)
PHN031®
Indications
Osteoporosis
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
- PHN031 can reduce osteoclast bone resorption, inhibit osteoclastic activity and bone loss.
- Effectively stimulates the proliferation of mesenchymal lineage and osteoblastic precurser cells , and the differentiation of osteoblastic cells to promote bone formation.
- It is speculated that PHN031 can compensate or resupply post-menopausal bone loss, promote the re-formation of bone cells and effectively prevent osteoporosis.
Strengths and Potential
- The plant source is indigenous to Taiwan, and the safety and quality can be highly controlled from farm to API production.
- The plant itself is edible and safe for long-term use. Genetic toxicology, single-dose toxicology and 28-day, 180-day toxicology tests have been completed, which proves its extremely high safety.
- The US FDA has approved phase II clinical trial, and a randomized double-blind, placebo-controlled , multi-center Phase IIa clinical trial (N=92) has been completed. It confirms the safety of human use and the effectiveness of preventing post- menopausal osteoporosis.
- The technology used in developing PhytoHealth PHN031 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, Chang Gung Memorial Hospital, National Taiwan University Hospital, and Mackay Memorial Hospital.
- Phase IIb clinical trials of long-term efficacy indicators surveillance and dose selection are under planning.