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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09
2026
Caliway Announces Positive Phase 2 Results of CBL-514 in Dercum's Disease, Achieving Primary Endpoint with Statistically Significant and Sustained Pain Reduction
Caliway announced final statistical results from its randomized, single-blind, placebo-controlled Phase 2 clinical trial (CBL-0202DD) evaluating CBL-514 for the treatment of Dercum’s Disease (DD), a rare and debilitating disorder characterized by painful lipomas. The study successfully achieved its primary efficacy endpoint, with CBL-514 demonstrating clinically meaningful and statistically significant pain reduction in both the Full Analysis Set (FAS) and Per-Protocol (PP) populations. The results showed robust and durable efficacy, with treatment benefits consistently observed across multiple assessment time points and increasing over all treatment courses.
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08
2026
Caliway Biopharmaceuticals Highlights Global Phase 3 Progress and GLP-1 Combination Strategy at 2026 Second-Half Online Investor Conference
Caliway hosted its 2026 Second-Half Online Investor Conference, highlighting the significant momentum of its global pivotal Phase 3 program for CBL-514. The Company also detailed the strategic expansion of its GLP-1 combination program and the steady progression of its international clinical development pipeline.
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08
2026
Caliway's CBL-514 Combination Therapy Cleared by U.S. FDA for Phase 2 Trial; Pivotal Phase 3 Trial SUPREME-01 Initiates Enrollment
Caliway announced two major clinical milestones in its new drug development program. The Investigational New Drug application for CBL-0201WR, a Phase 2 clinical trial combining its first-in-class local fat-reducing new drug CBL-514 with Eli Lilly's Zepbound® (Tirzepatide), has been cleared by the U.S. FDA. In addition, the pivotal Phase 3 clinical trial SUPREME-01, evaluating large-area abdominal fat reduction, has received approval from the IRB and has officially initiated enrollment.
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08
2026
Caliway Initiates CBL-514 Clinical Development in China to Maximize Global Licensing Value in the World's Second-Largest Aesthetics Market
Caliway announced that it has submitted an IND application to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the Phase 1 clinical study (CBL-0102) of its first-in-class, large-area localized fat reduction drug candidate, CBL-514. This submission marks the formal debut of the candidate's clinical development program in China.
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07
2026
Caliway Targets First-in-Class FDA "2-Grade Improvement" Claim with Upgraded CBL-514 Phase 3 Trial Enrolling in August
Caliway announced that it has submitted trial design amendments for its first-in-class, large-volume, local fat-reducing new drug, CBL-514. The amendments for the pivotal Phase 3 clinical trial, CBL-0301 (SUPREME-01), have been filed with the U.S. FDA as an IND amendment and with Health Canada as a Clinical Trial Application (CTA) amendment, in accordance with FDA recommendations. The trial protocol is concurrently under review by central Institutional Review Boards (IRBs) in the U.S. and Canada, with the first patient expected to be enrolled in August upon IRB approval.
