Our Science - Small-Molecule Drug Discovery
Caliway focuses on breakthrough medical aesthetics and inflammatory disease therapeutics through small-molecule drug discovery. Our strategy emphasizes high-potential markets—targeting unmet medical needs worth over US$10 billion, where current treatments show limited efficacy, significant side effects, or lack approved therapies—while avoiding overdeveloped or highly competitive indications.
We are driven by the mission to address fundamental patient and consumer needs by developing niche, first-in-class products with strong competitive advantages, ultimately aiming to improve treatment outcomes and enhance quality of life.
Our Focus - Aesthetics Medicine & Inflammatory Disease
CBL-514, the world’s first investigational drug for large-area localized fat reduction, is a 505(b)(1) and first-in-class small-molecule lipolysis injectable, can induce adipocyte apoptosis and lipolysis to reduce subcutaneous adiposity in treatment areas without causing any systemic side effects.
CBL-514 for Non-Surgical Fat Reduction:
CBL-514 has demonstrated significant efficacy in its second and final Phase 2b study (CBL-0205) before Phase 3. In February 2025, the study showed that over 75% of participants achieved at least a 1-grade improvement on the AFRS scale (p < 0.00005), confirming the consistency of results from the earlier CBL-0204 Phase 2b study announced in December 2024.
To date, Caliway has completed 7 CBL-514 clinical studies for localized fat reduction, covering 474 participants, with each study meeting its primary efficacy endpoints and major secondary endpoints. These consistent and reproducible results demonstrated the product’s strong efficacy and safety profile, providing a solid foundation as the company moves toward global pivotal Phase 3 studies in the second half of 2025.
CBL-514 for Rare Disease – Dercum’s Disease
CBL-514 Phase 2 study (CBL-0201DD) has demonstrated its efficacy in lipoma dimension reduction by more than 50% and significant pain improvement by 4.7 points, showing its potential in becoming the first approved treatment for Dercum’s disease. In recognition of this, CBL-514 was granted both Fast Track Designation and Orphan Drug Designation by the U.S. FDA in February 2024, followed by Orphan Drug Designation by the EMA in November 2024—becoming the only investigational drug to receive both designations for this indication.
Breakthrough Results in Cellulite Treatment
For cellulite, CBL-514 completed a two-stage Phase 2 study (CBL-0201EFP) for cellulite treatment in 2024, meeting all primary and secondary efficacy endpoints. Over 95% of participants showed aesthetic improvement as assessed by both investigators and patients, further confirming the product’s potential in aesthetic medicine.
Expanding the Pipeline
Caliway is also advancing preclinical programs targeting central obesity, hyperpigmentation, and skin aging.
Vision
To become an international leader in innovative drug development for medical aesthetics and chronic inflammatory diseases.
Mission
Dedicated to developing innovative medicines that surpass existing therapies and transform the market. We strive to unleash our full R&D potential, overcome technical barriers in drug development, and create better treatment options to improve human health and quality of life.
Global Development and Patent Strategy
In addition to initiating clinical trials of drugs and indications that require a shorter development period to accelerate product development and licensing, Caliway also targets rare disease indications to speed up the clinical trial application and reviewing process.
In terms of intellectual property, Caliway has been actively expanding its global patent portfolio in major markets to ensure robust protection. Since 2015, a total of 118 invention patent applications have been filed worldwide, with 77 patents granted to date and others under examination.
The patent protection is expected to extend through 2045, forming a strong foundation for long-term product competitiveness.
