AMI Pharm’s AYP-101 Shows Strong Phase 2 Results for Double Chin Reduction

AMI Pharm’s AYP-101 Shows Strong Phase 2 Results for Double Chin Reduction

By, Admin 2 September 2025

AMI Pharm’s novel injectable, AYP-101, has delivered promising Phase 2 results in treating submental fat (SMF)—commonly called a double chin.

The data, published in Clinical Therapeutics, underscores AYP-101’s potential as a safe, effective, nonsurgical alternative for localized fat reduction.

Phase 2 Trial Highlights

The study tested AYP-101 at two concentrations and revealed impressive results for the 25 mg/mL dose administered every two weeks across six sessions.

Key outcomes:

  • 96 participants enrolled.
  • At 4 weeks post-treatment:
    - 69.70% of patients in the 25 mg/mL group achieved ≥1-grade improvement on both ER-SMFRS and SR-SMFRS scales.
    - This compares to 22.58% in placebo, a clear and statistically significant difference.
  • Safety & tolerability:
    - AYP-101 is engineered to destroy fat via apoptosis, sparing surrounding tissue.
    - Required fewer injection points than existing options.
    - Reported lower swelling and paresthesia compared to Deoxycholic Acid (DCA).

Why It Matters for Aesthetics

The demand for nonsurgical fat reduction is surging worldwide. Unlike traditional treatments, AYP-101 offers:

  • Greater efficacy in moderate to severe SMF.
  • A better patient experience with fewer side effects.
  • A potential advancement over DCA-based injectables.

Company Outlook

Ki-Taek Lee, CEO of AMI Pharm:

“The Phase 2 data reaffirms our research capabilities and demonstrates AYP-101’s significant potential in the localized fat reduction market.”

Next steps:

  • Phase 3 trial underway, aiming for completion by end of 2025.
  • Expansion of global collaborations to develop next-gen injectables for targeted fat reduction.
  • Builds on momentum from successful Phase 1 results (2024), furthering international recognition.

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