OBI Pharma announced yesterday (22nd) that its subsidiary, OBIGEN Pharma, has received approval from Taiwan's Ministry of Health and Welfare's Food and Drug Administration (TFDA) to conduct a Phase II clinical trial on the safety of repeated dosing for its new botulinum toxin, OBI-858.

According to the announcement, OBI-858 is a novel botulinum toxin developed using a proprietary strain, designed for both cosmetic and medical applications. OBIGEN Pharma’s independently developed strain produces a unique molecular weight, which has been patented in Taiwan, Australia, New Zealand, Japan, and Russia, among other countries.

OBI Pharma stated that the Phase II clinical trial for OBI-858 is currently focused on dose selection. The recently approved trial will evaluate the safety of repeated dosing. Specifically, OBIGEN Pharma has been authorized by the TFDA to conduct a Phase II clinical trial assessing the safety of repeated doses of OBI-858 for the treatment of moderate-to-severe glabellar lines. The trial is expected to be completed by 2026.

Resource: 浩鼎新型肉毒桿菌素 報捷