DANSAN° DRIPPING PILL
FLAGSHIP
First combination TCM product in FDA-NDA process with accomplished Phase III

The clinical development of Danshen Dripping Pills includes a completed Phase III trial in stable angina pectoris, conducted according to protocols designed to meet the requirements of the U.S. Food and Drug Administration (FDA) and within a clearly defined regulatory pathway. The results of these pivotal trials indicate a clinically relevant improvement in symptoms, particularly in patients whose symptoms were not adequately controlled by standard therapy. Furthermore, the data point to a favorable safety profile, supporting the use of the preparation for long-term administration in chronic cases.

Modern pharmaceutical development
Danshen Dripping Pills are a combination medicinal formula of Traditional Chinese Medicine (TCM), whose main components consist of extracts of Salvia miltiorrhiza (Danshen) and Panax notoginseng (Notoginseng), as well as the monoterpene borneol. Salvia miltiorrhiza has been used in TCM for over 1,000 years, particularly to promote blood circulation and "blood movement," while Notoginseng is traditionally used to support hemostasis and strengthen Qi. Borneol acts as a so-called "emperor" active ingredient, improving the absorption of the herbal ingredients and enhancing their effects in the body. In TCM, Danshen-containing formulas are primarily used for cardiovascular conditions, including angina pectoris and circulatory disorders. The modern pharmaceutical development of Danshen Dripping Pills combines these traditional concepts with standardized extraction and dosage forms to ensure reproducible quality and dosage. This facilitates integration into modern therapeutic approaches, particularly in the context of chronic cardiovascular diseases.
With regard to regulatory developments, clinical trials have been conducted for Danshen Dripping Pills, adhering to international standards and aligning with requirements of the U.S. Food and Drug Administration, among others. The aim of these activities is to demonstrate efficacy and safety within the framework of evidence-based medicine and to pave the way for international approval. In particular, the conduct of controlled clinical trials and the adaptation to regulatory guidelines underscore the commitment to evaluating traditional medicines using modern pharmacological and clinical methods.

Multi-target, multi pathway

