A Phase 3, Randomized, Double-blinded, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat.

A phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy, safety, and tolerability of CBL-514 injection for reducing abdominal subcutaneous fat.

开始日期2025-09-01

申办/合作机构

康霈生技股份有限公司

NCT06303570

/ Recruiting临床2期

A Single-Blind, Placebo-Control, Randomized Phase 2 Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With Dercum's Disease Lipomas

This is a single-blind, placebo-controlled, randomized phase 2 study to evaluate the efficacy and safety of CBL-514 injections in participants with Dercum's Disease lipomas.

开始日期2024-11-27

申办/合作机构

康霈生技股份有限公司

NCT06005441

/ Completed临床2期

A Phase 2b, Randomized, Placebo-Controlled Factorial Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection Compared With CBL-A1 and CBL-A2 for Reducing Abdominal Subcutaneous Fat

This is a randomized, placebo-controlled, Phase 2b study to evaluate the efficacy, safety, and tolerability of CBL-514 injection compared with CBL-A1 and CBL-A2 for reducing subcutaneous fat.

开始日期2023-11-10

申办/合作机构

康霈生技股份有限公司

100 项与白藜芦醇/姜黄素相关的临床结果

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100 项与白藜芦醇/姜黄素相关的专利（医药）

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项与白藜芦醇/姜黄素相关的文献（医药）

2025-05-15·Aesthetic Surgery Journal

Efficacy and Safety of CBL-514 Injection in Reducing Abdominal Subcutaneous Fat: A Randomized, Single-Blind, Placebo-Controlled Phase II Study

Article

作者: DuBois, Janet ; Ho, Wilson W S ; Ling, Yu-Fang ; Gold, Michael ; Sheu, An-Yi ; Chou, Yin-Chia ; Schlessinger, Joel ; Dayan, Steven ; Goodman, Greg J

Abstract:

Background:

A small-molecule injectable drug, CBL-514, has shown promising efficacy and safety for subcutaneous fat reduction.

Objectives:

To further evaluate the efficacy and safety of CBL-514 for abdominal subcutaneous fat reduction.

Methods:

In this single-blind, randomized, parallel-group, placebo-controlled Phase 2 trial, 76 participants were randomized (2:1) to receive up to 4 CBL-514 treatments (2 mg/cm2, maximum 600 mg/treatment) or placebo, administered subcutaneously to the abdomen every 4 weeks. Two follow-up visits were conducted at 4 and 8 weeks following final treatment. Changes in abdominal subcutaneous fat thickness and volume were measured by ultrasound. The primary endpoint was the proportion of participants with subcutaneous fat volume loss of ≥150 mL from baseline compared with placebo.

Results:

In the intention-to-treat population, a significantly higher proportion of CBL-514-treated participants achieved ≥150 mL subcutaneous fat volume reduction from baseline compared with placebo-treated participants at both follow-up visits. At 8 weeks post final treatment, 69.6% of CBL-514-treated participants lost ≥150 mL subcutaneous fat, compared with none in the placebo group (P < .001). Moreover, 60.9% of participants in the CBL-514 group further achieved the ≥200 mL subcutaneous fat loss threshold. Of the 28 participants in CBL-514 group (n = 50) who lost ≥150 mL subcutaneous fat, 42.9% (12/28 participants) achieved this target after a single treatment. The most common treatment-emergent adverse events were injection site reactions and were of mild-to-moderate severity.

Conclusions:

CBL-514 treatment significantly reduced abdominal subcutaneous fat volume with a favorable safety profile. As a noninvasive treatment, CBL-514 could be a new, promising alternative therapy for effective targeted subcutaneous fat reduction.

Level of Evidence: 2:

2022-10-13·Aesthetic surgery journal

Efficacy of a Novel Injection Lipolysis to Induce Targeted Adipocyte Apoptosis: A Randomized, Phase IIa Study of CBL-514 Injection on Abdominal Subcutaneous Fat Reduction

Article

作者: Chang, Kao-Jung ; Sheu, An-Yi ; Ling, Yu-Fang ; Goodman, Greg J ; Ho, Wilson W S

Abstract:

Background:

CBL-514 is a novel injectable drug that may be safe and efficacious for localized abdominal subcutaneous fat reduction.

Objectives:

The aim of this study was to assess the safety and efficacy of CBL-514 in reducing abdominal subcutaneous fat volume and thickness.

Methods:

This Phase IIa, open-label, random allocation study consisted of a 6-week treatment period and follow-up at 4 and 8 weeks following the last treatment. Participants were randomly allocated to receive 1.2 mg/cm2 (180 mg), 1.6 mg/cm2 (240 mg), or 2.0 mg/cm2 (300 mg) of CBL-514 with up to 4 treatments, each comprising 60 injections into the abdominal adipose layer. Changes in abdominal subcutaneous fat were assessed by ultrasound at follow-up visits. Treatment-emergent adverse events were recorded.

Results:

Higher doses of CBL-514 (unit dose, 2.0 and 1.6 mg/cm2) significantly improved the absolute and percentage reduction in abdominal fat volume (P < 0.00001) and thickness (P < 0.0001) compared with baseline. Although the COVID-19 pandemic halted some participant recruitment and follow-ups, analysis was unaffected, even after sample size limitations.

Conclusions:

CBL-514 injection at multiple doses up to 300 mg with a unit dose of 2.0 mg/cm2 is safe, well-tolerated, and reduced abdominal fat volume and thickness by inducing adipocyte apoptosis. Although other procedures exist to treat abdominal fat, they have limitations and may cause complications. At a dose of 2.0 mg/cm2, CBL-514 safely and significantly reduced abdominal fat volume by 24.96%, making it a promising new treatment for routine, nonsurgical abdominal fat reduction in dermatologic clinics.

Level of Evidence: 4:

Medicina (Kaunas, Lithuania)

Modern and Non-Invasive Methods of Fat Removal

Article

作者: Szpila, Gabriela ; Stojko, Michał ; Żmudka, Karol ; Hawranek, Michał ; Piłat, Patrycja ; Smolarczyk, Joanna ; Moll, Martyna ; Nocoń, Jakub

Adipocytes accumulate triacylglycerols as an energy store, thereby causing an increase in the adipose tissue volume. Weight gain can be prevented through damage to the adipocyte structure or an increase in the body’s metabolic rate. Commonly used methods to disintegrate the cell membrane of adipocytes include injection lipolysis, cryolipolysis, ultrasonic lipolysis, radiofrequency lipolysis, laser lipolysis, carboxytherapy, and lipolysis using an electromagnetic field. The names of these methods suggest which substances are being used, and their main advantages are a very low invasiveness, as well as effectiveness. However, new discoveries in medicine, along with individuals’ desire to improve their appearance, have resulted in numerous studies on more ways of reducing body fat. Great potential is seen in beige adipocytes, which can be transformed, i.e., “recruited” from white adipocytes, or synthesized de novo; they also show thermogenic properties. One of the stimuli inducing the formation of beige adipocytes is cold and B3-adrenergic stimulation. Based on these findings, the researchers created, for example, cooling clothing. Additionally, curcumin and natural anthocyanins have proven to be helpful in the treatment of obesity and diabetes, by stimulating the secretion of glucagon-like peptide-1, and inducing the formation of beige adipocytes. Another study showed that the conversion of white adipose tissue is indirectly influenced by interleukin-6 secreted by the muscles, the expression of which is increased in people actively exercising. Moreover, there is potential in adenosine analogs, fenoldopam, rhubarb, the herbal extract Ephedra sinica Stapf, electroacupuncture simulation, and the drug CBL-514. Despite knowledge and experience, the ideal method for a quick and noticeable, but safe and non-invasive reduction of body fat has not been found yet. The research conducted nowadays may bring us closer to the development of a universal method, and turn out to be a breakthrough in the fight against overweight and obesity.

项与白藜芦醇/姜黄素相关的新闻（医药）

2025-12-29

·肽研社

Tides | 选择性诱导脂肪细胞凋亡，康霈生技的减重新药FDA提交II期临床申请

温馨提示肽研社建读者交流群啦~ 行业交流、商务合作、报告咨询请添加小编微信，后续入群哦👇 研究进展 01 Altimmune 2025-12-19，Altimmune（NASDAQ：ALT）公布其平衡型 1:1 GC/ GLP-1双受体激动肽pemvidutide在MASH患者中的 IMPACT IIb 期临床试验 48 周顶线结果。数据显示，pemvidutide在多项关键非侵入性肝纤维化指标上显著优于安慰剂，并较 24 周时点进一步改善，显示出持续的抗纤维化潜力。在 48 周时，pemvidutide 在增强型肝纤维化评分（ELF）和肝脏硬度测量（LSM）等主要非侵入性纤维化指标上，较安慰剂实现统计学显著改善，且疗效较 24 周进一步增强。1.8 mg 剂量组在 24–48 周期间体重继续下降且未出现平台期。肝脂含量、ALT、cT1 等反映肝脏炎症和健康状态的指标均显著改善。治疗耐受性良好，因不良事件导致的停药率低于安慰剂，未观察到与治疗相关的严重或重度不良事件公司同期宣布，公司已完成与 FDA 的 II 期结束（End-of-Phase 2）会议，并就 pemvidutide 在中重度肝纤维化 MASH 患者中推进注册性 III 期临床试验达成一致。FDA 亦支持在 III 期研究中引入 AIM-MASH AI Assist 工具，以提高肝组织学评估的一致性并提升开发效率。同时，基于当前 48 周数据及 FDA 反馈，公司计划于 2026 年启动 III 期临床研究。 02 Entera Bio 2025-12-22，Entera Bio（NASDAQ：ENTX）公布最新体内药代与药效学（PK/PD）验证数据，支持其口服长效甲状旁腺激素（PTH）肽类似物的进一步开发。该候选分子基于 Entera 自主 N-Tab® 口服肽递送平台，目标是开发全球首个每日一次口服片剂，用于甲状旁腺功能减退症（EB612 项目），以替代当前依赖每日注射的治疗方案。前临床研究显示，该新型 PTH 肽类似物在单次口服给药后可实现超过三天的血钙水平持续升高，并表现出显著延长的血浆半衰期；相比之下，未修饰的 PTH(1-34) 对照肽未观察到血钙升高反应。这一结果为“每日一次口服给药”提供了关键药理学依据。在研究过程中未观察到不良事件。该验证性研究在小型猪模型中完成，单次口服给药后连续监测五天 PK–PD 关系，Entera 计划在即将召开的医学会议上公布完整数据。公司此前已在 II 期临床中验证口服 PTH(1-34) 肽在甲旁减患者中的概念可行性，但当时仍需每日四次（QID）口服给药。本次长效 PTH 肽类似物的数据，标志着 EB612 项目向固定剂量、每日一次口服肽替代治疗迈出关键一步。 Entera是一家聚焦于口服肽与蛋白替代疗法的公司，其管线覆盖：1）EB612：口服 PTH 肽用于甲状旁腺功能减退症；2）EB613：口服 PTH(1-34) 肽用于骨质疏松（已完成 II 期）；3）口服双靶点 GLP-1/胰高血糖素肽（oxyntomodulin）用于肥胖与代谢综合征；4）口服 GLP-2 肽用于短肠综合征等吸收障碍疾病。 03 Lilly 2025-12-23， Lilly的替尔泊肽在CTR登记临床试验（CTR20255052），这是一项在主要不良肝脏结局发生风险增加的代谢相关脂肪性肝病成人参与者中评价多种药物的随机、对照临床试验的主研究方案（SYNERGY-Outcomes）替尔泊肽治疗代谢相关脂肪性肝病参与者的治疗特定附录（ISA1）。适应症为代谢相关脂肪性肝病。 04 Lilly 2025-12-23， Lilly的Brenipatide注射液在CTR登记临床试验（CTR20255150），这是评估Brenipatide降低成人戒烟后复吸风险的安全性和有效性研究。 05 Caliway Biopharma 2025-12-24 ，Caliway Biopharmaceuticals（康霈生技，台湾证券交易所：6919）宣布已向FDA完成递交 CBL-514 用于体重管理适应症的 II 期临床研究（CBL-0201WR）的IND申请。该研究将评估 CBL-514 与Zepbound®（tirzepatide）联合使用，在肥胖或超重人群中的疗效、安全性及长期体重管理潜力。 CBL-0201WR 为一项在美国多中心开展的随机、安慰剂对照 II 期临床研究，计划入组约120名肥胖（BMI＞30）或伴随合并症的超重（BMI＞27）受试者。研究将以腹部皮下脂肪体积变化（MRI 测量）和体重变化作为主要疗效终点，并通过 DEXA 系统评估体脂率、内脏脂肪及肌肉量等关键体成分指标。所有影像数据将由独立第三方CRO进行盲态分析，以确保结果的客观性与科学性。值得关注的是，该研究在设计中引入了 tirzepatide 停药后的长期随访环节，重点观察在 GLP-1/GIP 肽类药物停用后，腹部皮下脂肪、体重及体成分的变化趋势。这一设计直指当前 GLP-1 类减重治疗面临的核心挑战之一——停药后体重反弹及体成分恶化问题。 GLP-1 及 GLP-1/GIP 双受体激动肽主要通过抑制食欲实现体重下降，更多体现为脂肪细胞体积缩小，而非数量减少。停药后，脂肪细胞“记忆效应”可能导致能量快速再储存，引发体重反弹，并伴随内脏脂肪增加和代谢指标恶化。而CBL-514通过选择性诱导脂肪细胞凋亡，直接作用于脂肪组织本身；同时，既往研究还显示其可抑制脂肪生成并促进脂代谢。与以肽类激素调控食欲为主的 GLP-1/GIP 药物形成机制互补，CBL-514 有望在联合用药方案中改善脂肪组成，并提升停药后的体重维持能力。在本次 II 期研究中，受试者将在接受 8 周 tirzepatide 单药治疗后加入 CBL-514 进行联合给药，共完成 6 次联合用药，随后进入多时间点随访阶段。研究将系统评估联合方案在改善腹部皮下脂肪、体脂分布及长期体重管理方面的潜在优势，为后续临床开发和产品定位提供关键依据。支持这一策略的前期数据已在动物模型中获得验证。2025 年 12 月 14 日，Caliway 在台湾肥胖医学会第 25 届年会（TMASO 2025）上公布最新研究结果，显示 CBL-514 与 tirzepatide 联合应用可协同增强脂肪减少效果，并在 GLP-1/GIP 肽停药后维持体重与脂肪改善，该研究亦被大会列为重点报告之一。 06 云南先施药业 & 健翔生物 2025-12-25，云南先施药业的特立帕肽注射液获得CDE临床默示许可，适用于有骨折高发风险的绝经后妇女骨质疏松症的治疗。本品可显著降低绝经后妇女椎骨和非椎骨骨折风险，但对降低髋骨骨折风险的效果尚未证实。 07 中山莱博瑞辰 2025-12-25，中山莱博瑞辰的注射用RAB001获得CDE临床默示许可，适用于膝骨关节炎。 08 沃泰生物科技 2025-12-26，沃泰生物科技的冻干重组人脑利钠肽在CTR登记临床试验（CTR20255143），这是评价冻干重组人脑利钠肽治疗急性心力衰竭患者有效性和安全性的多中心、随机、双盲、安慰剂对照Ⅲ期临床研究。适应症为急性心力衰竭。注册获批 01 Novo Nordisk 2025-12-22，Novo Nordisk的司美格鲁肽注射液收到NMPA签发的注册上市证书，批准文号国药准字SJ20240020、国药准字SJ20240021、国药准字SJ20240023、国药准字SJ20240024、国药准字SJ20240022，适用于降低已确诊为心血管疾病且BMI≥27kg/m2成人患者的主要心血管不良事件（心血管死亡、非致死性心肌梗死、非致死性卒中）的风险。 02 圣雪大成制药 2025-12-23，圣雪大成制药的注射用多黏菌素E甲磺酸钠临床申请获得CDE受理（CYHL25002270）。 03 成都圣诺 2025-12-25，成都圣诺的鲑降钙素原料药（登记号：Y20250001368）在CDE进行原辅包登记备案，状态为Inactive。 04 浙江肽昇生物 2025-12-25，浙江肽昇生物的依替巴肽原料药（登记号：Y20250001300）在CDE进行原辅包登记备案，状态为Inactive。部分图文来源于网络，如有侵权，请联系删除旗舰报告专栏推荐肽研社生物医药 · 美妆个护 · 营养健康动物健康 · 绿色农业 · 生物材料专业专注 | 成就客户 | 共生成长

临床2期临床3期临床结果临床成功

2025-06-10

·PRNewswire

Caliway to Present First Preclinical Data on CBL-514 for GLP-1 Weight Rebound Management at BIO 2025

Caliway to deliver a corporate presentation on June 17 at the BIO International Convention 2025, the world's largest biotech industry event. For the first time at an international conference, Caliway will share preclinical results on CBL-514's potential new indication: combined with GLP-1 therapies to prevent post-treatment weight rebound. NEW TAIPEI CITY, June 10, 2025 /PRNewswire/ -- Caliway Biopharmaceuticals (TWSE: 6919) announced today its participation in the 2025 BIO International Convention, to be held from June 16 to 19 in Boston, U.S.A. Caliway's Vice President, April Yuan, will deliver an oral presentation on June 17, highlighting the company's latest progress in R&D and pipeline development. The presentation will cover recent updates on CBL-514, first-in-class injectable drug candidate for large-area, site-specific fat reduction, including its development across multiple indications—subcutaneous fat reduction, cellulite, and Dercum's disease. For the first time at an international conference, Caliway will also share preclinical data on a potential new indication: weight rebound management through a combination therapy with GLP-1 receptor agonists. As GLP-1 receptor agonists gain widespread use globally, post-discontinuation weight rebound has become a significant, yet unmet clinical concern. According to published studies, only 10% of patients are able to maintain weight loss after stopping GLP-1 treatment. Based on Caliway's preclinical data, co-administration of CBL-514 with GLP-1 significantly reduced post-discontinuation body weight regain and fat replenishment rate — suggesting that CBL-514 may help maintain weight loss outcomes after GLP-1 therapy. CBL-514 works by directly targeting the root cause—subcutaneous fat—through selective induction of adipocyte apoptosis. It may serve as a complementary combination therapy to GLP-1s, pairing systemic weight loss with precise body contouring. Caliway plans to submit a Phase 2 IND application to the U.S. FDA for this new indication in Q4 2025. "We believe post-weight-loss weight rebound is a promising unmet market need," said Vivian Ling, CEO of Caliway. "CBL-514 has the potential to serve as a complementary combination therapy with GLP-1 treatments — with GLP-1s driving weight reduction, and CBL-514 reshaping and maintaining outcomes through localized fat reduction, enhancing the overall treatment impact and long-term value." The BIO International Convention is the world's largest and most influential biotechnology event, attracting over 20,000 professionals and 5,000 companies from 80+ countries. It serves as a global platform for business development, innovation exchange, and investment. Caliway Presentation at BIO 2025: Date & Time: Tuesday, June 17, 2025 | 11:45 AM – 12:00 PM (EDT) Location: Room 154 | Boston Convention & Exhibition Center Speaker: April Yuan, VP, Caliway Biopharmaceuticals Session Info: About CBL-514 CBL-514, a 505(b)(1) and first-in-class small-molecule drug developed by Caliway, is the world's first injectable lipolysis drug that induces adipocyte apoptosis to reduce subcutaneous fat in targeted areas without causing any systemic side effects on the central nervous system, cardiovascular system, and respiratory system. As of May 2025, 10 clinical trials with a total of 520 subjects have been completed with all efficacy and safety endpoints met. Caliway is currently investigating multiple indications for CBL-514, including non-surgical fat reduction, moderate-to-severe cellulite, and weight rebound management through a combination therapy with GLP-1-based treatments. CBL-514D, the same active pharmaceutical ingredients (APIs) but under different formulation, is being studied for additional indications such as Dercum's disease and more. About Caliway Biopharmaceuticals Caliway Biopharmaceuticals (Caliway) is a clinical-stage biopharmaceutical company driven to breakthrough drug discovery of novel small-molecule therapeutics. Listed on the Taiwan Exchange (TWSE-6919), Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine and other diseases. For more information, please visit: Disclaimer This article and related information on this site contain forward-looking statements. The forward-looking information requires the Company to make numerous assumptions and is subject to inherent risks, uncertainties, and other factors that are beyond the control of the Company which may cause actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. The Company undertakes no obligation to timely inform, update, or revise the information on this site if circumstances should change. SOURCE Caliway Biopharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期临床申请

2025-04-17

·PRNewswire

Caliway Selected to Present CBL-514 Phase 2 Study Results for Dercum's Disease at World Orphan Drug Congress USA 2025

CBL-514, Caliway's novel small molecule drug, was selected for data presentation at the World Orphan Drug Congress USA 2025, highlighting its promising Phase 2 study results (CBL-0201DD) for Dercum's Disease Treatment. The Phase 2 topline results met all primary and secondary endpoints, with 64.5% of painful lipomas showing ≥ 50% dimension reduction or complete clearance (per-protocol population), and pain being reduced by 4.7 points (on a 10-point scale). The program has advanced to a U.S. FDA-approved Phase 2b study (CBL-0202DD), with subject recruitment expected to be completed by Q3 2025, representing a potential breakthrough for patients with no approved treatment options. TAIPEI, April 17, 2025 /PRNewswire/ -- Caliway Biopharmaceuticals (TWSE: 6919) announced today that it has been invited to present the clinical results of its CBL-514 Phase 2 study (CBL-0201DD) in Dercum's Disease at the upcoming World Orphan Drug Congress USA 2025, to be held in Boston on April 24, 2025. CBL-514 is a novel 505(b)(1) small-molecule drug developed by Caliway. It has previously demonstrated promising results in the field of medical aesthetics. CBL-514 is also being investigated for Dercum's Disease— a rare disease characterized by the growth of painful lipomas, with no approved treatment to date. According to the CBL-0201DD Phase 2 study results, 64.5% of painful lipomas showed dimensions reduction of more than 50% or complete clearance after CBL-514 treatments, with more than half of painful lipomas achieved this outcome after only one CBL-514 treatment. The pain score was also reduced by 4.7 points (out of 10). These results support CBL-514's potential as a first-in-class treatment for Dercum's disease, offering new hope to patients by significantly reducing lipoma size and pain. The World Orphan Drug Congress USA is a leading global conference focused on rare disease and orphan drug development. Bringing together over 2,000 participants from academia, regulatory agencies, pharmaceutical and biotech companies, patient advocacy groups, and investors. The event serves as a key platform for advancing scientific innovation, regulatory policies, and access strategies in rare disease therapies. Being selected to present at the most important event for all rare disease stakeholders, not only highlights the clinical potential of CBL-514 in rare disease treatment, but also underscores Caliway's ongoing commitment to addressing unmet medical needs. The drug has entered a U.S. FDA-approved Phase 2b clinical study (CBL-0202DD), which is currently ongoing and expected to complete patient recruitment by Q3 2025. If successful, CBL-514 could become the first approved treatment for Dercum's Disease, offering a long-awaited therapeutic option for patients worldwide. CBL-514 Study Presentation Info at World Orphan Drug Congress USA: Conference: World Orphan Drug Congress USA 2025 Date & Time: April 24, 2025 (Thursday), 10:40 AM (Eastern Time) Presentation Title: Efficacy and Safety of CBL-514, a Novel Lipolytic Injectable, in the Treatment of Dercum's Disease: Phase 2 Study Results Location: Boston Convention & Exhibition Center | Theater 2 – Hall C For more details on the World Orphan Drug Congress USA 2025, please visit: the official website. About Dercum's Disease Dercum's disease is a rare disorder characterized by the development of painful lipomas primarily located on the trunk region, and the extremities close to the trunk. The pain is chronic (>3 months), symmetrical, often disabling, and resistant to traditional analgesics. The etiology of Dercum's disease remains unknown. There is no approved drug nor recommended standard treatment for Dercum's disease yet. The current treatment options, including surgical removal, liposuction, electrotherapy, and inflammation inhibitors, are symptomatic, and the efficacies are limited with numerous adverse events. The clinical need for Dercum's disease remains unmet. According to the Global Dercum's Disease Market Research Report, the global Dercum's disease treatment market size in 2022 was $11.8 billion. With a compound annual growth rate (CAGR) of 6.76%, the global market of Dercum's disease treatment in 2032 is estimated to expand to $22.7 billion. About CBL-514 CBL-514, a 505(b)(1) and first-in-class small-molecule drug developed by Caliway, is the world's first injectable lipolysis drug that induces adipocyte apoptosis to reduce subcutaneous fat in targeted areas without causing any systematic side effects on the central nervous system, cardiovascular system, and respiratory system. CBL-514 has demonstrated fewer side effects, superior efficacy, and fewer required treatments compared with existing surgical procedures and other non-invasive localized fat reduction solutions. Caliway is currently investigating multiple indications for CBL-514, including non-surgical fat reduction, moderate-to-severe cellulite and weight rebound management. A derivative compound, CBL-514D, is being developed for indications including rare diseases such as Dercum's disease and Obstructive Sleep Apnea (OSA). As of the end of November 2024, Caliway has enrolled a total of 520 subjects in clinical studies related to CBL-514. To date, 10 clinical studies have been completed with results available, and all these studies have met their primary efficacy endpoints and safety parameters. CBL-514 has demonstrated precise efficacy with a favorable safety profile across multiple indications, showing outstanding statistical significance ( p<0.00001 or p<0.0001) in both ITT and FAS populations. Caliway plans to initiate subject recruitment for two pivotal global Phase 3 studies for localized fat reduction in the second half of 2025. About Caliway Biopharmaceuticals Caliway Biopharmaceuticals (Caliway) is a clinical-stage biopharmaceutical company driven to breakthrough drug discovery of novel small-molecule therapeutics. Listed on the Taiwan Exchange (TWSE-6919), Caliway aims to become an innovative pharmaceutical leader in aesthetic medicine and other diseases. For more information, please visit: Disclaimer This article and related information on this site contain forward-looking statements. The forward-looking information requires the Company to make numerous assumptions and is subject to inherent risks, uncertainties, and other factors that are beyond the control of the Company which may cause actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. The Company undertakes no obligation to timely inform, update, or revise the information on this site if circumstances should change. SOURCE Caliway Biopharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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适应症	最高研发状态	国家/地区	公司	日期
皮下脂肪疾病	临床3期	美国	康霈生技股份有限公司	2025-09-01
皮下脂肪疾病	临床3期	加拿大	康霈生技股份有限公司	2025-09-01
脂肪团	临床2期	美国	康霈生技股份有限公司	2023-01-09
红细胞生成性原卟啉症	临床2期	美国	康霈生技股份有限公司	2023-01-09
痛性肥胖症	临床2期	美国	康霈生技股份有限公司	2022-10-03
肥胖	临床申请批准	加拿大	康霈生技股份有限公司	2025-08-12

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06005441 (CBL-0205, PRNewswire) 人工标引	临床2期	皮下脂肪疾病	173	CBL-514	醖醖構獵廠糧簾膚襯艱(艱廠衊膚鏇襯網製顧製) = 餘積夢構襯願襯觸鹹襯獵選鑰淵糧夢淵壓鹽蓋 (願鏇觸醖艱獵築獵鑰膚 ) 达到更多	积极	2025-02-10
				Placebo	醖醖構獵廠糧簾膚襯艱(艱廠衊膚鏇襯網製顧製) = 壓襯積繭鏇餘齋範選願獵選鑰淵糧夢淵壓鹽蓋 (願鏇觸醖艱獵築獵鑰膚 ) 达到更多
NCT05736107 (CBL-0204, PRNewswire) 人工标引	临床2期	腹部肥胖	107	CBL-514	選憲築鹹願糧糧製構範(鹽顧餘構構選鏇繭鑰築) = 範積鹽廠夢築簾憲糧獵鏇顧觸鏇餘餘觸夢獵窪 (鑰齋廠醖鏇憲築餘顧鬱 ) 更多	积极	2024-12-11
				Placebo	選憲築鹹願糧糧製構範(鹽顧餘構構選鏇繭鑰築) = 獵齋顧願廠範繭顧繭遞鏇顧觸鏇餘餘觸夢獵窪 (鑰齋廠醖鏇憲築餘顧鬱 ) 更多
NCT05836779 (CBL-0201EFP, PRNewswire) 人工标引	临床2期	脂肪团	23	CBL-514	淵簾製積窪糧網膚獵築(願範觸艱壓鹽窪繭範鏇) = 築觸鏇觸簾襯繭願繭憲蓋築選觸蓋積製遞範觸 (窪壓鬱糧艱衊襯顧齋遞, 1.3) 达到	积极	2024-04-25
NCT05632926 (CBL-0201EFP, PRNewswire) 人工标引	临床2期	脂肪团	12	CBL-514	衊鏇觸廠製觸簾壓夢構(繭蓋憲餘網鬱繭顧憲願) = 構醖構艱廠齋蓋窪壓鏇蓋窪獵醖選獵蓋範廠鑰 (鑰艱遞齋衊願衊構積齋, 0.9) 达到更多	积极	2024-04-25
NCT04575467 (CTgov)	临床2期	皮下脂肪疾病	25	CBL-514 (CBL-514 320 mg)	鏇選獵糧選願簾鹹鑰衊 = 網廠壓鬱願觸餘築鹽鹽蓋餘鹹鑰觸顧繭夢憲餘 (繭窪壓襯襯積糧膚餘鹽, 齋顧願獵餘齋製願糧蓋 ~ 蓋製選繭積齋觸淵衊鬱) 更多	-	2024-03-28
				CBL-514 (CBL-514 480 mg)	鏇選獵糧選願簾鹹鑰衊 = 艱鏇衊網醖衊鑰餘鹹遞蓋餘鹹鑰觸顧繭夢憲餘 (繭窪壓襯襯積糧膚餘鹽, 餘壓壓範鹽願鑰鹽簾艱 ~ 窪範夢憲齋構糧顧築網) 更多
NCT04897412 (CBL-0202, PRNewswire) 人工标引	临床2期	皮下脂肪疾病	76	CBL-514	夢鬱壓餘壓鑰繭鏇獵餘(觸鹹繭繭衊積壓餘窪壓) = 願構選願網願醖築積齋鏇積窪繭觸積構顧廠繭 (製遞鹽糧鏇膚築製廠襯 ) 更多	积极	2023-12-26
				Placebo	-
NCT04897412 (CBL-0202 , PRNewswire) 人工标引	临床2期	皮下脂肪疾病	76	CBL-514	鑰艱鏇憲夢襯構壓顧艱(願鹹獵範餘襯淵簾簾鑰) = 顧繭襯鹽鹹淵選糧醖膚醖襯衊製壓餘襯壓艱窪 (醖艱夢衊獵鹹鏇鹽網繭 ) 达到更多	积极	2023-10-02
				Placebo	鑰艱鏇憲夢襯構壓顧艱(願鹹獵範餘襯淵簾簾鑰) = 顧襯製醖遞艱壓鏇遞醖醖襯衊製壓餘襯壓艱窪 (醖艱夢衊獵鹹鏇鹽網繭 ) 达到更多
NCT05387733 (CBL-0201DD, PRNewswire 1 \| PRNewswire 2) 人工标引	临床2期	痛性肥胖症	12	CBL-514	淵衊廠餘製顧繭膚艱鬱(鹽糧積遞鬱夢壓廠鹽鹹) = in the high-dose group was reduced by 51.3% (p<0.0001) and 54.7% (p<0.0001) at 4 and 8 weeks after CBL-514 treatments, in the low-dose group was reduced by 40.0% (p=0.0002) and 34.7% (p<0.0001) at 4 and 8 weeks after CBL-514 treatments. 網願艱顧繭鹹網選淵餘 (網製壓鬱願夢築繭選網 ) 达到更多	积极	2023-09-13