Leios Therapeutics Reports Positive End-of-Phase 2 Meeting with FDA for 10XB-101 in Submental Fat Fullness
Key Insights
Leios Therapeutics (search) reported alignment with the FDA on the Phase 3 program for 10XB-101 in moderate-to-severe submental fat fullness (search) in adults.
The FDA accepted either one adequately powered pivotal trial or two Phase 3 trials, with a Phase 3 dose up to 4%.
Leios said the program supports a potential 505(b)(2) NDA, with regional licensing deals covering South Korea and China.
Leios Therapeutics (search) said its End-of-Phase 2 meeting with the FDA produced overall alignment on the Phase 3 development program for 10XB-101, an investigational injectable for improvement in the appearance of moderate-to-severe submental fat fullness (search) in adults. The company said the meeting gave it a defined path toward a potential 505(b)(2) New Drug Application.
Under the agreement, the FDA confirmed trial design flexibility, accepting either a single adequately powered pivotal trial or two Phase 3 trials, and agreed to a Phase 3 dose of up to 4%. The agency also aligned on study design, primary and secondary efficacy endpoints, study size and total number of exposures.
10XB-101 is being developed as a minimally invasive injectable intended to reduce focal fat deposits. Its active ingredient, polidocanol, is a synthetic non-ionic detergent that induces targeted adipolysis by disrupting fat cell membranes after injection in a defined pattern, allowing destroyed cells to be absorbed. Leios has completed Phase 2 trials in the submental fat reduction indication. The company also reported 2026 regional licensing and strategic investment agreements with BNC Korea (search) and affiliates of China Medical System Holdings (search) covering South Korea and China, under which licensees assume development costs in those territories, and said two additional patent families, if granted, could provide protection through 2044 and 2047.