SEOUL, South Korea, Aug. 11, 2025 /PRNewswire/ -- AMI Pharm, a biotechnology company focused on aesthetic and therapeutic innovations, announced today that its lead candidate, AYP-101, has entered a pivotal Phase 3 clinical trial for the treatment of submental fat, commonly referred to as a "double chin."
AYP-101 is designed to offer effective fat reduction while minimizing the pain, swelling, and social downtime associated with current injectable drugs. It represents a potential paradigm shift in the multi-billion-dollar non-surgical aesthetics market by utilizing a novel biological mechanism that fundamentally differs from existing fat-reduction approaches.
A Paradigm Shift in Fat Reduction Therapy
Currently, the only FDA-approved injectable drug for localized fat reduction is based on deoxycholic acid, which destroys fat cells through necrosis. While clinically effective, this cytolytic process causes strong inflammation, often resulting in pain, bruising, and prolonged swelling.
In contrast, AYP-101 selectively induces apoptosis, a natural and controlled form of programmed cell death that occurs without triggering inflammation. This "silent" process is intended to reduce fat gently, providing a safer, more tolerable experience for patients seeking non-surgical fat reduction.
Phase 3 Trial Underway Following Strong Early Results
AYP-101 is now being tested in a 252-participant Phase 3 trial in South Korea, scheduled for completion by late 2025. This follows promising Phase 1 and Phase 2 trials, which met all primary safety and efficacy endpoints. In Phase 2, over 70% of patients achieved at least a 1-grade improvement on the Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS) in the Per-Protocol (PP) population, with what the company described as excellent tolerability.
"AYP-101 is the result of two decades of dedicated R&D," said Ki-Taek Lee, CEO of AMI Pharm. "It's the world's first non-cytolytic injectable drug for localized fat reduction, and we believe it will lead the next wave of innovation in aesthetic medicine."
Targeting Global Expansion and Broader Indications
AMI Pharm has presented AYP-101 at global conferences such as BIO International Convention and IMCAS World Congress, and is pursuing strategic partnerships for global expansion. The company also plans to broaden its clinical focus to include cellulite, buccal (cheek) fat, and upper arm fat, reinforcing its long-term commitment to non-surgical body contouring innovation.
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