AMI Pharm Advances AYP-101 to Phase 3 Testing for Noninflammatory Fat Reduction

AMI Pharm has initiated a pivotal Phase 3 clinical trial of AYP-101, an investigational injectable for the treatment of submental fat. The study will evaluate the efficacy and safety of the agent, which is designed to reduce localized fat with fewer inflammatory side effects than current therapies.

The only US Food and Drug Administration (FDA)–approved injectable for submental fat reduction is deoxycholic acid, which induces adipocyte necrosis. Although effective, necrosis typically triggers inflammation, resulting in post-procedure pain, swelling, and bruising. In contrast, AYP-101 induces apoptosis—a regulated form of cell death that does not provoke an inflammatory response—potentially allowing for a more tolerable patient experience.

The multicenter, randomized Phase 3 trial will enroll 252 participants in South Korea and is expected to conclude in late 2025. According to AMI Pharm, earlier Phase 1 and Phase 2 studies met primary safety and efficacy endpoints. In the Phase 2 trial, more than 70% of participants in the per-protocol population achieved at least a 1-grade improvement on the Evaluator-Reported Submental Fat Rating Scale, with what investigators described as favorable tolerability.

“AYP-101 is 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,” AMI Pharm’s CEO Ki-Taek Lee said.

If confirmed in Phase 3, the apoptosis-based mechanism of AYP-101 could offer clinicians a new injectable option for patients seeking non-surgical submental fat reduction with potentially reduced recovery time. However, its applicability to broader aesthetic or therapeutic indications will require further study.