AMI Pharm has announced 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 utilising a novel biological mechanism that minimises the pain and swelling commonly associated with existing treatments.
Currently, the only FDA-approved drug for localised fat reduction is based on deoxycholic acid, which destroys fat cells through necrosis—a process that induces inflammation and leads to side effects such as pain, bruising, and prolonged swelling. AYP-101 is 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.
The ongoing 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, more than 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.
“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.”
AMI Pharm is actively preparing for global commercialisation. The company is engaging international partners and showcasing its clinical data at 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.
Jim Cornall is editor of Deeptech Digest and publisher at Ayr Coastal Media. He is an award-winning writer, editor, photographer, broadcaster, designer and author. Contact Jim here.
