CBL-514 Injection

R&D Progress

CBL-514 is a 505(b)(1) small-molecule new drug and the world’s first investigational injectable therapy specifically designed for large-area localized fat reduction. Its mechanism of action involves inducing adipocyte apoptosis and lipolysis, effectively reducing subcutaneous fat in the treated area without causing necrosis or damage to surrounding tissues. 

Administered via subcutaneous injection, CBL-514 has demonstrated a favorable safety and tolerability profile, enabling significant localized fat reduction without surgery and delivering results comparable to liposuction.

For the aesthetic indication of non-surgical fat reduction, CBL-514 has completed two Phase 2b studies (CBL-0204 and CBL-0205) and is expected to initiate subject recruitment fo two pivotal global Phase 3 studies in the second half of 2025.

• According to the results of our second and the last Phase 2b study (CBL-0205), over 75% of participants achieved at least a 1-grade improvement on the Abdominal Fat Rating Scale (AFRS) at Week 4 post-treatment (p < 0.00005). The use of AFRS also reflects Caliway’s alignment with the U.S. FDA-recommended primary endpoint for future Phase 3 studies. The outcome was consistent with results from the previous Phase 2b study (CBL-0204), demonstrating the consistency of CBL-514’s efficacy, safety, and tolerability.
• In the CBL-0204 study, nearly 60% of participants achieved at least a 1-grade improvement on the AFRS after only one CBL-514 treatment.
• Additionally, data from  CBL-0202 stage 2 phase 2 study showed that nearly 70% of participants reduced ≥ 150 mL of subcutaneous fat in the treated area, while over 60% reduced ≥ 200 mL, demonstrating surgical-level efficacy with a significantly better safety profile than liposuction.

CBL-514 remains the only investigational drug globally designed for large-area localized fat reduction. If approved, it is expected to fulfill the substantial unmet need in localized fat reduction and offer a novel non-surgical option for precise body contouring.

R&D Progress

CBL-514’s indication for treating Dercum’s disease (DD) is under investigation. In previously completed studies, CBL-514 was also observed to induce apoptosis in lipoma cells, suggesting its potential as a treatment for Dercum’s disease.

• The CBL-0201DD Phase 2 study, approved by the U.S. FDA and completed in April 2023, met all primary and secondary endpoints, and demonstrated that CBL-514 is the first and only product to show clinically meaningful and statistically significant results in painful lipomas reduction—with nearly 60% of target lipomas showing either complete clearance or >50% reduction in size, and improve pain significantly by 4.7 points on a 10-point scale  (with higher scores indicating greater pain severity).
• CBL-514 was granted both Fast Track Designation and Orphan Drug Designation by the U.S. FDA. In November 2024, it was also granted Orphan Drug Designation by the European Medicines Agency (EMA)—making it the only investigational drug globally to receive both designations for this indication. These regulatory milestones are expected to accelerate future drug approval and review processes.
• The follow-up CBL-0202DD Phase 2b study is currently ongoing in the United States, with topline results anticipated in Q3 2026.

Expanded Access Policy

Currently, CBL-514 is in clinical development stage, which means more clinical studies are required and health authorities have not yet approved the product to be an accredited treatment for Dercum’s Disease.
Caliway encourages clinicians and patients to participate in a clinical trial as the best option for patients to access investigational products. However, we understand that some individuals may not satisfy all the eligibility conditions required to enter a clinical trial, and some may have failed all treatments known to treat their conditions. These patients may receive investigational drug through another option commonly known as “Expanded Access” or “Compassionate Use”.
Generally, Caliway does not provide investigational drugs to patients until there is sufficient data on the safety and efficacy of our products to allow patients and physicians to assess the risks and benefits of using these investigational drugs outside of a clinical trial context. Therefore, after careful consideration, Caliway is not currently offering Expanded Access to CBL-514.
You can find additional information about ongoing clinical trials of CBL-514 on our website and by accessing https://clinicaltrials.gov.

Market Overview

According to the Future Market Insights report, the global cellulite treatment market size was approximately US$2.49 billion in 2018, and it is estimated to reach US$4.5 billion in 2026. According to foreign studies, about 85% of women after puberty have cellulite problems, and with the increase of age and obesity, the probability of obtaining cellulite becomes higher and higher.