植物薬への漢方薬の開発

 

米国FDA産業用医薬品開発ガイダンスは、植物薬として適用するための漢方薬や大麻製品などの植物性製品の扉を開きました。処方植物薬のさまざまな米国FDA規制申請における漢方薬の例を以下に示します。

これらのTCMはすべて、現在何十年もの間中国で広く使用されています。それらの安全性と有効性は、すでに多くの人々に知られており、実証されています。これらのTCMを米国の処方植物薬に開発することは、効率的な医薬品開発経路です。

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