Developing Herbal Medicine to Botanical Drugs

US FDA botanical drug Development Guidance for the Industry has opened a door for botanical products, such as herbal medicine or cannabis products to apply as botanical drugs. Examples of herbal medicines in various US FDA regulatory filing for prescription botanical drugs are listed below.

     All of those TCMs are currently widely used in China for many decades: their safety and efficacy have already been known and demonstrated on large population. Developing those TCMs to US prescription botanical drugs is a efficient drug development pathway.

Kanglaite Injection Phase I Study

The Kanglaite Injection (KLT)is a novel broad spectrum anti-cancer injection produced from traditional Chinese medicinal herbs (the Coix Seed). It was approved in China in 1995 and has become the most popular anti-cancer drug in China. In June of 2001, the Phase I study of KLT commenced at the Huntsman Cancer Institute in Salt Lake City, Utah, with the objectives of 1) To determine the maximum tolerated dose (MTD) and the safety profile of KLT in patients with refractory solid tumors; 2) To determine the pharmacokinetics of KLT in patients with refractory solid tumors; and 3) To gather preliminary efficacy data. The method of testing is open-label, sequential cohort, dose-escalation study.
Disease: Solid Tumors Refractory To Standard Therapy, Neoplasms
Intervation: Kanglaite Injection (KLT)
Phase 1
Study Type : Interventional (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)

Efficacy and Safety Study of Lipid-Lowering Effects of XueZhiKang (XZK) in Patients With Hyperlipidemia

This is a Phase 2 trial with multi-center, double-blind, randomized, placebo-controlled, parallel group study to be conducted in approximately 120 patients with hyperlipidemia in approximately 10 sites in US and China. Patients who satisfy the entry criteria at screening visit will have a 4-week Therapeutic Lifestyle Changes (TLC) diet control period during which all lipid-lowering medications will be discontinued. After the 4-week diet control period, eligible patients will be randomized to one of three treatment groups. The treatment period will last for 12-weeks. Patients will have blood samples collected at 5 time points (screening, baseline, Week 4, Week 8, and Week 12).
Disease: Hyperlipidemia
Intervention: XueZhiKang (XZK), a botanic product with multiple components | Placebo
Study Type : Interventional (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group Study of Lipid-Lowering Effects of XueZhiKang (XZK) in Patients With Hyperlipidemia

Phase III Trial of Dantonic® (T89) Capsule to Prevent and Treat Stable Angina (CAESA)

Dantonic® (T89) is a botanical drug develped from formulated TCM consists of extracts from 5 herbs including Danshen (Radix Salviae Miltiorrhizae) and Sanqi (Radix Notoginseng) with borneol in a capsule form. It had successfully passed US FDA botanical drug filing for pre-IND, pre-clinical, phase 1, and phase 2. It is currently conducting a phase III trial.
Disease Condition : Angina Pectoris
Intervention : T89 high dose; Drug | T89 Low dose | Sanqi+Bingpian | Placebo
Study Type : Interventional (Phase 3 Clinical Trial)
Actual Enrollment : 1004 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Philadelphia, USA