AYP-101 could replace Kybella? AMI Pharm’s injectable shows strong Phase 2 results for fat reduction

How did AMI Pharm’s AYP-101 perform in its phase 2 trial for reducing submental fat without surgery?

AMI Pharm, a South Korea-based pharmaceutical company specializing in novel injectables, announced that its experimental drug AYP-101 demonstrated positive outcomes in a recently completed Phase 2 clinical trial for the reduction of submental fat, commonly known as a “double chin.” The trial results, now published in the peer-reviewed journal Clinical Therapeutics, suggest AYP-101 could emerge as a next-generation alternative to existing treatments like Deoxycholic Acid (DCA).

The Phase 2 study enrolled 96 participants and focused on evaluating the safety and efficacy of two concentrations of AYP-101. The 25 mg/mL formulation administered over six sessions every two weeks delivered the most notable improvements. According to the data, 69.7% of patients in this 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) within four weeks of completing the treatment course. In contrast, only 22.58% of participants in the placebo arm achieved a similar reduction, marking the difference as statistically significant.

In addition to its efficacy, AYP-101 showed a favorable safety profile. The formulation triggered fat cell apoptosis (programmed cell death) while minimizing damage to surrounding tissues, thereby reducing the incidence of injection-site side effects often observed with DCA. These included lower levels of post-treatment swelling and paresthesia (tingling or numbness). Another differentiator was its efficiency—AYP-101 required fewer injection points compared to conventional injectable fat reducers, making it a potentially more comfortable option for patients and providers alike.

What makes AYP-101 different from Deoxycholic Acid-based therapies like Kybella?

While Deoxycholic Acid (branded as Kybella in the U.S.) is currently the leading approved injectable for submental fat reduction, its clinical usage is often associated with a high number of injection sites and considerable post-treatment inflammation. AYP-101 seeks to address these shortcomings with a more targeted apoptotic mechanism that limits off-target tissue damage.

Unlike DCA, which functions primarily by destroying fat cell membranes through lysis, AYP-101 initiates a biologically cleaner cell death pathway. According to the study authors and AMI Pharm’s internal data, this approach leads to reduced discomfort, fewer side effects, and improved patient tolerability, especially in repeat treatments.

This mechanistic advantage has been highlighted as a potential competitive differentiator as the global market for aesthetic injectables continues to expand. Cosmetic dermatologists and plastic surgeons are increasingly seeking less invasive, better-tolerated solutions that still offer clinically meaningful results. AYP-101’s pharmacological profile and patient-centric dosing regimen align well with these evolving clinical expectations.

How is AMI Pharm positioning AYP-101 in the global nonsurgical aesthetics market?

AMI Pharm is actively advancing AYP-101 as part of its broader strategy to expand into the premium injectable aesthetics segment. The company has indicated that the successful completion of the Phase 2 trial paves the way for an accelerated Phase 3 program, with enrollment already underway and primary endpoint readouts expected by the end of 2025.

In a statement attributed to Ki-Taek Lee, Chief Executive Officer of AMI Pharm, the publication of the Phase 2 results was described as a pivotal step in the firm’s R&D journey. He emphasized that AYP-101’s development is reflective of the company’s innovation-driven strategy and commitment to offering safer, science-backed cosmetic treatments. Lee also reaffirmed the company’s intent to explore international licensing and co-development opportunities to bring AYP-101 to broader markets beyond South Korea.

This forward-looking posture comes at a time when global demand for nonsurgical cosmetic enhancements—including fat reduction, skin tightening, and facial contouring—is seeing strong double-digit growth. According to industry data, the global nonsurgical fat reduction market is expected to exceed USD 2 billion by 2027, driven by increasing consumer preference for low-downtime procedures and advances in formulation technologies.

What is the institutional and expert sentiment around AYP-101’s competitive prospects?

While AMI Pharm remains a privately held entity, institutional sentiment around AYP-101 has been generally positive, especially following its peer-reviewed publication in Clinical Therapeutics. Analysts tracking the aesthetics and dermatology sector have taken note of AYP-101’s differentiated mechanism and its potential to offer an improved patient experience relative to currently marketed therapies.

Experts in the aesthetic medicine community are reportedly watching the compound’s progress closely, particularly in the context of evolving consumer expectations and increasing competition among non-invasive cosmetic solutions. With growing demand for alternatives to liposuction and surgery, treatments that deliver visible results with less pain and recovery time are viewed as increasingly commercially viable.

Furthermore, AYP-101’s potential advantage in terms of fewer injection points may appeal strongly to both clinicians and patients. Providers often face logistical challenges with high-injection treatments like DCA, including longer appointment times and patient reluctance for follow-up sessions. AYP-101’s streamlined administration could translate into greater procedural efficiency and higher patient adherence across treatment cycles.

How does this trial build on AMI Pharm’s earlier development of AYP-101?

The recent Phase 2 data builds upon earlier Phase 1 findings announced in 2024, which first demonstrated proof-of-concept for AYP-101’s fat reduction mechanism. That initial trial focused on safety, tolerability, and early pharmacodynamics, and established the groundwork for the dose optimization explored in the latest Phase 2 study.

Since then, AMI Pharm has continued to position AYP-101 not just as a single-product candidate, but as part of a broader injectable platform for localized fat reduction. The firm has hinted at pipeline expansion plans involving next-generation formulations targeting other anatomical regions such as bra fat, jowls, and axillary (underarm) bulges.

International partnerships have also been floated as part of the firm’s longer-term commercialization roadmap. While no formal agreements have been disclosed, AMI Pharm’s strategy appears geared toward both direct market entry and licensing-led monetization across North America, Europe, and Asia.

What comes next for AYP-101 and AMI Pharm’s clinical and commercial roadmap?

The next major milestone for AYP-101 will be the readout from its ongoing Phase 3 study, which aims to confirm the efficacy and safety findings from the Phase 2 trial in a larger and more diverse patient population. AMI Pharm is targeting a late 2025 completion timeline, with hopes of securing regulatory approvals in South Korea and potentially other key markets soon after.

Looking further ahead, analysts believe AYP-101 could eventually carve out a niche as a preferred nonsurgical option for patients seeking convenience, safety, and visible results. However, its commercial success will depend on not just clinical validation, but also pricing strategy, reimbursement viability, and real-world adoption by aesthetic practitioners.

The broader injectable aesthetics market remains highly competitive, with major global players already entrenched in segments like neurotoxins and fillers. However, fat-targeting injectables remain relatively underdeveloped compared to other verticals, offering AMI Pharm a potential opening—especially if it can sustain a safety and efficacy edge over existing agents like DCA.

If the Phase 3 study confirms the current data, and if international commercialization proceeds without regulatory hurdles, AYP-101 could emerge as one of the few clinically differentiated products in the aesthetic fat reduction space by 2026.