AMI Pharm Advances AYP-101 to Phase 3, Paving the Way for a New Era in Fat-Reduction Injectable drugs

— Novel non-cytolytic injectable drug targets submental fat with significantly reduced pain and swelling
— Phase 3 clinical trial underway in South Korea, following strong safety and efficacy results in earlier studies
— AMI Pharm positions itself for global expansion in the multi-billion-dollar non-surgical aesthetics market

SEOUL, South Korea, Aug. 11, 2025 /PRNewswire/ -- AMI Pharm, a biotechnology company specializing in next-generation aesthetic solutions, today announced that its lead drug candidate, AYP-101, has entered a pivotal Phase 3 clinical trial for the treatment of submental fat (commonly known as a "double chin"). This innovative injectable drug is designed to dramatically improve patient comfort by utilizing a novel biological mechanism that minimizes the pain and swelling commonly associated with existing treatments.

A Paradigm Shift in Fat Reduction Therapy

Currently, the only FDA-approved drug for localized fat reduction is based on deoxycholic acid, which destroys fat cells through necrosis—a process that induces inflammation and leads to significant side effects such as pain, bruising, and prolonged swelling. In contrast, AYP-101 is uniquely engineered to eliminate fat through apoptosis, a natural and controlled form of programmed cell death that does not trigger inflammation.

This non-cytolytic mechanism offers a gentler, more tolerable alternative, potentially eliminating the need for social downtime and offering a safer, more comfortable experience for patients seeking non-surgical fat reduction.

Phase 3 Trial Underway Following Strong Early Results

The ongoing Phase 3 clinical trial involves 252 participants across multiple sites in South Korea and is expected to be completed by the end of 2025. The study builds on successful Phase 1 and 2 trials, which met all primary safety and efficacy endpoints.

In the Phase 2 trial, over 70% of patients in the AYP-101 group achieved at least a 1-grade improvement on the Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS) in the per-protocol (PP) population. The treatment also showed excellent tolerability and safety, with minimal adverse events reported.

"AYP-101 represents the culmination of two decades of dedicated research aimed at creating a safe, effective, and globally competitive solution for localized fat reduction," said Ki-Taek Lee, CEO of AMI Pharm. "By leveraging a novel mechanism of action, we are pioneering the next generation of injectable drugs in aesthetic medicine."

Targeting Global Expansion and Broader Indications

AMI Pharm is actively preparing for global commercialization. The company is engaging international partners and showcasing its clinical data at world-renowned conferences, including the BIO International Convention and the IMCAS World Congress.

While the current clinical focus is on submental fat, AMI Pharm is laying the groundwork to expand AYP-101's indications to address other high-demand aesthetic areas, including cellulite, deep buccal (cheek) fat, and upper arm fat. This broader R&D strategy highlights the company's commitment to addressing a wide spectrum of unmet needs in the aesthetic space and reinforces its ambition to become a global leader in non-surgical body contouring.