Olix Submits Clinical Trial Application for Phase 2a US FDA Study of Non-Invasive Scar Treatment

[Asia Economy Reporter Kum Boryeong] Olix announced on the 25th that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 2a clinical trial titled "Randomized, double-blind, intra-individual comparison, placebo-controlled, proof-of-concept study to evaluate the efficacy of OLX10010 as an adjuvant therapy for recurrence suppression after scar reconstruction surgery."

The clinical trial will be conducted at five institutions within the United States. The trial duration is 24 weeks if only Groups 1 and 2 are involved, and an additional 24 weeks will be added if Group 3 is included, totaling 48 weeks.

Olix stated, "We plan to confirm the efficacy and safety of OLX10010 and proceed to the next phase of clinical trials based on these results," adding, "This confirms the potential for developing a new treatment in the hypertrophic scar treatment market, where no prescription drugs have yet been approved by the FDA."

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