260518 Bichedam Completes Phase I Clinical Trial of BCD101, Demonstrating the Feasibility of Oral Puerarin Administration

Bichedam has completed its Phase I clinical trial of BCD101, a natural product-derived drug candidate. Based on the study results, the company plans to accelerate the development of a therapeutic for degenerative vascular diseases.

Bichedam Co., Ltd. (CEO Ho-Bin Moon) announced on the 18th that it has successfully completed the Phase I clinical trial of its natural product-derived drug candidate, BCD101, and has submitted both the Clinical Trial Conduct Report and the Clinical Trial Completion Report to the Ministry of Food and Drug Safety (MFDS).

The Phase I study was conducted at Chungbuk National University Hospital, with Professor Min-Gyu Park serving as the Principal Investigator (PI). The trial was designed as a randomized, double-blind, single- and multiple-ascending-dose study to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of BCD101 in healthy adult volunteers.

According to Bichedam, participant enrollment began on September 22, 2025, and the last participant completed the final follow-up visit on May 15, 2026. No serious adverse events (SAEs) were reported during the study, confirming the favorable safety and tolerability of BCD101.

BCD101 is a natural product-derived drug candidate containing puerarin as its primary pharmacologically active ingredient. Puerarin is known for its diverse pharmacological activities, including vasodilation, antioxidant effects, neuroprotection, and improvement of microcirculation.

However, puerarin has traditionally been limited by poor aqueous solubility and low membrane permeability, resulting in low oral bioavailability. Bichedam has focused on improving the oral absorption of puerarin through its proprietary multi-herbal extraction technology utilizing six medicinal herbs.

The Phase I study demonstrated that, following oral administration of BCD101, the time to maximum plasma concentration (Tmax) was 0.25 hours across all dose groups. The company also reported stable systemic exposure based on key pharmacokinetic parameters, including the maximum plasma concentration (Cmax) and the area under the plasma concentration-time curve (AUC).

Bichedam stated that these findings provide the first clinical evidence supporting the feasibility of oral administration of puerarin in humans. The results are particularly significant because they suggest the potential to develop an orally administered therapeutic, eliminating the need for injectable formulations.

Ho-Bin Moon, CEO of Bichedam, commented:

> “Our Phase I trial confirmed stable systemic exposure of puerarin following oral administration of BCD101. Based on these pharmacokinetic data, we plan to advance rapidly into a Phase II clinical trial targeting degenerative vascular diseases.”

Building on the successful completion of the Phase I study, Bichedam has initiated preparations for a Phase II clinical trial to develop BCD101 as a treatment for Nocturnal Leg Cramps (NLC) associated with peripheral microcirculatory disorders. The study will be led by Professor Ki-Yuk Jang of the Division of Cardiology, Seoul St. Mary’s Hospital, The Catholic University of Korea, who will serve as the Principal Investigator (PI).