Highlighted IND Trials
A US company is currently in the process of developing a multiple-herb botanical drug product, which has been marketed as a dietary supplement in the US and other countries for several years. Real-world evidence indicates that this product is effective in enhancing the human immune system, as demonstrated in a table.
While the product's mechanism of action is not fully described, it's worth noting that the FDA botanical drug IND process does not require a detailed mechanism of action. The potential benefits of enhancing the human immune system are significant, and there are multiple possible indications for this product.
The US company has initiated the FDA botanical drug IND filing, with the first filing focusing on the most promising indication. Subsequent FDA IND filings for other potential indications will be pursued following the success of the initial filing.
A Botanical Product Enhancing the Human Immunology System
Dantonic® (T89) Capsule to Prevent and Treat Stable Angina (CAESA)
Dantonic® (T89) is a botanical drug derived from Chinese Traditional Medicine (CTM). It is composed of extracts from five herbs, including Danshen (Radix Salviae Miltiorrhizae) and Sanqi (Radix Notoginseng), along with the addition of borneol. This medication is available in capsule form and is specifically indicated for the treatment of angina pectoris, a medical condition characterized by chest pain or discomfort due to reduced blood flow to the heart muscle.
A hemp product that combines cannabis with other botanical ingredients but does not contain THC (tetrahydrocannabinol) is currently in the initial stages of the US FDA IND (Investigational New Drug) process. This product is being developed for oncological purposes, suggesting its potential use in cancer-related treatments or therapies. The absence of THC is significant, as it is the psychoactive compound in cannabis, and its exclusion indicates that the product may focus on the potential therapeutic properties of other cannabinoids or botanical components.
A Hemp Product-X for Treating Cancer
XueZhiKang (XZK) in Patients With Hyperlipidemia
Xue Zhi Kang (XZK) is a traditional Chinese medicine product formulated as an extract from fermented red yeast rice. It has successfully passed phases 1 and 2 of clinical trials conducted by the US FDA. These trials have demonstrated both the safety of XZK and its effectiveness in lowering lipid levels in patients with Hyperlipidemia, a medical condition characterized by elevated levels of lipids (fats) in the blood. This suggests that XZK may be a promising treatment option for individuals with Hyperlipidemia to manage their lipid levels safely and effectively.
CBD (Cannabidiol) is a non-psychoactive component derived from the cannabis plant, known for its various potential medicinal benefits. Some of its purported advantages include alleviating symptoms of seizure disorders, reducing inflammation, managing anxiety, and relieving nausea.
Cannabidivarin (CBDV) is a less common cannabinoid and a homolog of CBD. Although research on CBDV is in its early stages, it is gaining momentum due to its promising medicinal effects. While not as well-known as CBD, CBDV shows potential for delivering beneficial medical outcomes and is an area of interest in the field of cannabinoid research.