SEOUL, South Korea, Sept. 1, 2025 /PRNewswire/ -- AMI Pharm's novel injectable drug, AYP-101, demonstrated promising Phase 2 trial results for reducing submental fat (SMF), commonly known as a double chin. The study results were recently published in Clinical Therapeutics, a leading journal for drug and therapy development. This publication marks a significant milestone for AYP-101 and highlights its potential as a safe and effective nonsurgical treatment option. The study evaluated the efficacy and safety of AYP-101 at two different concentrations. The results showed that the 25 mg/mL concentration, administered every two weeks for six sessions, led to statistically significant and clinically meaningful reductions in moderate to severe SMF.
Demonstrated Efficacy and Safety
The Phase 2 study enrolled 96 participants and demonstrated strong results. At four weeks after the final treatment, 69.70% of participants in the 25 mg/mL treatment group achieved at least a one-grade improvement in both the Evaluator-Reported and Subject-Reported Submental Fat Rating Scales (ER-SMFRS and SR-SMFRS). This was a statistically significant improvement compared to the 22.58% response rate in the placebo group. The trial data also highlighted AYP-101's favorable safety and tolerability profile. The drug is uniquely designed to eliminate fat through a process called apoptosis while minimizing damage to surrounding tissues. The study found that AYP-101 required fewer injection points and produced a lower incidence of post-injection swelling and paresthesia compared to what is typically reported for Deoxycholic Acid (DCA).
A Leader in the Growing Aesthetics Market
With the global demand for nonsurgical fat reduction rising, AMI Pharm is advancing AYP-101's development. According to Ki-Taek Lee, CEO of AMI Pharm, "The Phase 2 publication reaffirms our R&D strength and demonstrates AYP-101's significant potential in the localized fat reduction market". The Phase 3 study for AYP-101 is being accelerated with a goal of completion by late 2025. AMI Pharm is also actively expanding international collaborations to develop next-generation injectable drugs for localized fat reduction. This latest publication follows the positive results from AYP-101's Phase 1 study in 2024, continuing its international recognition.
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