R&D
- Aesthetics
Localized Fat Reduction, Cellulite,
Hyperpigmentation, Skin Aging
- Therapeutics
Dercum's Disease, Osteoarthritis, Central Obesity
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Discovery
Preclinical
Phase I
Phase II
Phase III
NDA/
Market
Discovery
Preclinical
Phase I
Phase II
Phase III
NDA/
Market -
Discovery
Preclinical
Phase I
Phase II
Phase III
NDA/
Market
Discovery
Preclinical
Phase I
Phase II
Phase III
NDA/
Market -
Discovery
Preclinical
Phase I
Phase II
Phase III
NDA/
Market
Discovery
Preclinical
Phase I
Phase II
Phase III
NDA/
Market
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CBL-514
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CBA-539
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CBF-520
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CBL-539, a long-acting injectable product, is designed for a more efficacious and safe treatment for refractory melasma by inhibiting melanin production. Besides, CBL-539 was evidenced that could recover skin elasticity by increasing collagen production.
Conditions/Indications： Hyperpigmentation, Skin aging
About Caliway
In Caliway, we are driven to breakthrough drug discovery of novel small-molecule therapeutics for medical aesthetics and inflammatory disease. By developing innovative drugs, we aim to provide new treatment options for the indications in which clinical needs remain unmet.
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ADVANTAGE
Well-Experimented Team of Experts
Caliway's research team comprises experts with deep knowledge and experience in drug discovery, business development, and regulatory affairs. We develop innovative new strategies with high safety to address medical conditions with no effective treatments available. -
ADVANTAGE
Target Emerging Markets
In Caliway, the diseases we are targeted on affect millions of people, often in their most productive years. We are on a mission to combine science, medicine, and advocacy with improving people's lives suffering from illnesses or life-threatening diseases. -
ADVANTAGE
Global IP Protection
We have exclusive rights to benefit from the commercial use of our products, such as producing, selling, and exporting worldwide.
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06
2026
Caliway Announces IND Submission to U.S. FDA for CBL-514 Long-Term Follow-Up Phase 3 Trial (CBL-0303)
Seamlessly Extension Twin Pivotal Phase 3 Studies to Support NDA Pathway and Target the Global Broad-Area Non-Surgical Local Fat Reduction Market
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05
2026
Caliway Announces U.S. FDA IND Clearance for CBL-0302, Its Second Global Pivotal Phase 3 Study of CBL-514; Asia-Pacific Phase 2 Study CBL-0206 Also Approved by AU HREC and Taiwan TFDA, Accelerating Global Dual-Track Strategy
The Investigational New Drug (IND) application for CBL-0302 (SUPREME-02), Caliway’s second multi-country pivotal Phase 3 study for its localized fat reduction candidate CBL-514, has successfully passed the FDA's 30-day review period.
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05
2026
Caliway Makes First ECO 2026 Oral Presentation on Preclinical Data of CBL-514 in Combination with GLP-1R-Based Weight-Loss Therapies, Attracting Strong Interest from International Experts and Global Pharmaceutical Companies for Its Systemic Metabolic Effe
CBL-514, when combined separately with two leading GLP-1R-based weight-loss therapies, semaglutide and tirzepatide, demonstrated enhanced weight loss, attenuated post-discontinuation weight regain, and greater reductions in subcutaneous and visceral fat in animal studies. The presentation also marked the first disclosure at an international congress of CBL-514’s potential to improve liver metabolic indicators.
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04
2026
Caliway’s Asia-Pacific Phase 2 Study CBL-0206 Approved by Australia’s HREC to Proceed, Officially Advancing Asia-Pacific Clinical Strategy
Caliway’s Asia-Pacific Phase 2 study of CBL-514 for reduction of abdominal subcutaneous fat, CBL-0206, has received approval from Australia’s HREC to proceed, officially advancing the Company’s Asia-Pacific clinical strategy.
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04
2026
Caliway Completes U.S. FDA IND Submission for SUPREME-02, the Second Global Pivotal Phase 3 Study of CBL-514. Advancing Dual-Track Global Phase 3 Clinical Development
Caliway has completed the U.S. FDA IND submission for SUPREME-02, the second global multi-national, multi-center pivotal Phase 3 study of CBL-514 for reduction of abdominal subcutaneous fat, progressing on schedule according to the Company’s development plan.
