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Anticipated advancements in obesity, oncology, gene therapy and other areas poised to revolutionize patient care LONDON, Jan. 8, 2025 /PRNewswire/ -- Clarivate Plc (NYSE:CLVT) a leading global provider of transformative intelligence, today announced the release of the twelfth annual Drugs to Watch™ report, a trusted guide to the therapies poised to redefine the future of healthcare. This year, the highly anticipated resource highlights 11 drugs projected to achieve blockbuster status or revolutionize treatment paradigms within five years. Since its inception, Drugs to Watch has identified over 98 transformative therapies, cementing its role as an essential resource for navigating the ever-evolving pharmaceutical landscape. This year's report, powered by insights from the Clarivate Cortellis intelligence suite of products, highlights 11 therapies that have recently launched or are set to debut in 2025. These innovations, addressing critical challenges in areas such as obesity, oncology, and gene therapy, are forecast to achieve blockbuster sales by 2030 or dramatically improve patient outcomes on a global scale. The report also explores pivotal trends shaping the industry, including the surging demand for obesity treatments, the transformative potential of gene editing, and the growing impact of regulatory innovation. The report offers an in-depth analysis of the chronic disease market in Mainland China, spotlighting five therapies expected to exceed $1 billion in annual sales over the next five years or deliver transformative outcomes for patients. It also explores critical topics shaping global healthcare, including regulatory advancements, the role of radiopharmaceutical theranostics in oncology, and the growing use of real-world data (RWD) and patient-reported outcomes (PROs) to drive health equity and enhance regulatory submissions. Henry Levy, President, Life Sciences & Healthcare, Clarivate, remarked: "Innovation in the life sciences is reaching unprecedented heights, and this year's Drugs to Watch™ report once again demonstrates the industry's ability to deliver therapies that address unmet medical needs and challenge existing paradigms of care. At Clarivate, we take pride in the precision and reliability of our predictions—last year, we identified 13 molecules as Drugs to Watch, with 12 already approved and launched and one poised for launch. This track record reflects the strength of our comprehensive data and deep expertise. By continuing to provide actionable insights, we empower the sector to navigate opportunities, overcome challenges and drive progress in advancing global health." Mike Ward, Global Head of Thought Leadership, Life Sciences & Healthcare, Clarivate, stated: "2025 represents a turning point for the life sciences sector as it embraces cutting-edge technologies such as AI and machine learning to enhance drug discovery and development. This year's report captures the dynamic forces at play, including groundbreaking progress in precision oncology, the rise of radiopharmaceuticals, and the growing focus on addressing global health disparities." The 2025 Drugs to Watch™ report highlights key trends reshaping the life sciences landscape, emphasizing the transformative impact of emerging technologies and therapeutic breakthroughs. Advances in AI and machine learning are streamlining drug discovery, clinical trials, and real-world data integration, enabling precision medicine approaches. The obesity market is undergoing a revolution driven by next-generation GLP-1 therapies, while radiopharmaceutical theranostics are redefining cancer treatment with a "see it and treat it" paradigm. Gene editing technologies are unlocking new opportunities in personalized medicine, and evolving regulatory frameworks are fostering greater emphasis on patient-reported outcomes and health equity. Together, these trends showcase the sector's resilience and its ability to navigate challenges while driving innovation to improve patient care worldwide. This year's drugs to watch exemplify the fusion of innovation and dedication to advancing patient care in an increasingly complex healthcare ecosystem. The Drugs to Watch™ 2025 list include: AWIQLI® (LAI 287; insulin icodec) developed by Novo Nordisk | Type 1 and type 2 diabetes mellitus AWIQLI®, the first once-weekly, subcutaneous insulin, has launched in Australia, Canada, the EU, Mainland China, and Japan. Its weekly dosing offers a significant advantage over daily basal insulin, potentially reducing the treatment burden for patients with type 1 or type 2 diabetes (T1DM and T2DM). CagriSema (cagrilintide + semaglutide) developed by Novo Nordisk | Obesity and type 2 diabetes mellitus CagriSema, combining cagrilintide, a long-acting amylin analog, with semaglutide, promises superior efficacy over semaglutide (OZEMPIC/WEGOVY®) and tirzepatide (MOUNJARO/ZEPBOUND®) in treating obesity and type 2 diabetes. This next-generation GLP-1 therapy leverages the benefits of GLP-1s, such as enhanced insulin secretion and appetite reduction, while incorporating amylin's effects, including slowed glucose absorption and release. If approved, CagriSema will be the first fixed-dose combination of amylin and GLP-1 receptor agonists in the obesity and T2DM markets. COBENFY™ (KarXT; xanomeline-trospium) developed by Bristol Myers Squibb | Schizophrenia and psychosis related to Alzheimer's disease Amid setbacks for emerging schizophrenia treatments, the approval of COBENFY marks a transformative milestone as the first drug in over 30 years with a novel mechanism of action for treating schizophrenia. Combining xanomeline and trospium, COBENFY selectively targets M1 and M4 receptors, rather than traditional dopamine pathways, while minimizing cholinergic side effects. While further data is needed to assess its effectiveness in Alzheimer's disease-related psychosis, COBENFY shows strong commercial potential if proven effective in treating AD-related hallucinations and delusions. EBGLYSS™ (lebrikizumab) developed by Eli Lilly and Co and Almirall | Atopic dermatitis EBGLYSS™, the third biologic targeting IL-13 for atopic dermatitis, follows DUPIXENT® (dupilumab) and ADBRY®/ADTRALZA® (tralokinumab) to market. Its less frequent dosing, more selective IL-13 inhibition, and strong efficacy and safety data position it as a likely first-line treatment for moderate-to-severe atopic dermatitis when topical corticosteroids are inadequate. Fitusiran developed by Alnylam® Pharmaceuticals Inc and Sanofi | Hemophilia A and B Fitusiran, shown to be effective in phase 3 trials for both hemophilia A and B, regardless of inhibitor status, has the potential to offer a new approach to hemophilia treatment. This small interfering RNA (siRNA) therapy works by inhibiting SerpinPC1 mRNA, reducing antithrombin levels, promoting thrombin generation, and helping to rebalance hemostasis to prevent bleeds. Leveraging Alnylam® Pharmaceuticals' ESC-GalNAc conjugate technology, fitusiran could become the first antithrombin-lowering therapy based on a double-stranded RNA molecule, pending approval. GSK-3536819 (MenABCWY) developed by GSK plc | Meningococcus GSK plc's GSK-3536819 vaccine candidate, a 5-in-1, first-generation formulation, targets the five groups of Neisseria meningitidis (A, B, C, W, and Y) responsible for most invasive meningococcal disease (IMD) cases worldwide. It combines the antigenic components of GSK's licensed meningococcal vaccines, BEXSERO (MenB) and MENVEO (MenACWY), both of which have established efficacy and safety profiles. IMDELLTRA™ (tarlatamab-dlle) developed by Amgen | Small-cell lung cancer (SCLC) IMDELLTRA™ is a first-in-class immunotherapy for extensive-stage small cell lung cancer (ES-SCLC). Using Amgen's bispecific T cell engager (BiTE®) molecules, it targets CD3 on T cells and DLL3 on tumor cells, enabling T cells to attack and lyse the tumor. DLL3 is expressed on the surface of SCLC cells in more than 85% of patients but is minimally expressed on healthy cells making it an attractive target. This mechanism positions IMDELLTRA as a potential standard of care for previously treated ES-SCLC. mRESVIA (mRNA-1345) developed by Moderna Inc | RSV With its U.S. FDA approval in May 2024, mRESVIA® joined AREXVY and ABRYSVO, both featured in Drugs to Watch 2024, as respiratory syncytial virus (RSV) vaccines currently available for adults ages 60 years and older, helping further support the public health initiative to reduce the RSV-related disease burden. Even with available vaccines, RSV infections continue to be a public health concern, particularly for infants and older adults (65 years and older). SEL-212 developed by Sobi® and Cartesian Therapeutics Inc/Selecta Biosciences Inc | Gout SEL-212 is a novel, once-monthly treatment combining pegylated uricase (pegadricase; SEL-037) with ImmTOR™, an immune tolerance technology designed to inhibit the formation of anti-drug antibodies (ADAs). For this application, ImmTOR consists of SEL-110.36, an inhibitor of uricase-specific ADA. This approach may help overcome the limitations of reduced efficacy and tolerability seen with other biologic treatments, such as KRYSTEXXA® (pegloticase), in patients with chronic gout. Vepdegestrant (ARV-471) developed by Arvinas Inc and Pfizer Inc | Breast cancer A global collaboration between Arvinas Inc and Pfizer Inc, vepdegestrant may become the first PROteolysis Targeting Chimera (PROTAC®) protein degrader on the market. Designed to target and degrade the estrogen receptor (ER) protein, early studies suggest PROTAC-induced degradation is more complete than with oral selective estrogen receptor degraders (SERDs). This offers potential for overcoming endocrine resistance in breast cancer. Label expansions, including combination with IBRANCE® (palbociclib), are being explored. Zanzalintinib (XL092) developed by Exelixis Inc | Colorectal cancer, renal cell carcinoma and squamous cell carcinoma of head and neck Zanzalintinib is a third-generation oral tyrosine kinase inhibitor targeting VEGF receptors, MET, and TAM kinases involved in tumor growth and immunosuppression. Currently in phase 3 trials for non-clear-cell renal cell carcinoma (nccRCC), colorectal cancer (CRC) and squamous cell carcinoma of the head and neck (SCCHN), the company anticipates one potential zanzalintinib launch per year starting as early as 2026. Compared to CABOMETYX® (cabozantinib), zanzalintinib may offer benefits, including approval for nccRCC histology and a broader patient population. Access the Drugs to Watch 2025 report from Clarivate, here. For more Drugs to Watch updates and analyses throughout the year, visit the Drugs to Watch web page and follow Clarivate for Life Sciences & Healthcare on LinkedIn and X. Join the conversation, using #DrugstoWatch. To learn more about how Clarivate can help healthcare companies inform and shape the drug discovery, development and delivery process, visit here. Methodology for the Clarivate Drugs to Watch 2025 Report To identify this year's Drugs to Watch, Clarivate drew from the expertise of over 160 analysts covering hundreds of diseases, drugs and markets, along with 11 integrated data sets that span the R&D and commercialization lifecycle, including: Cortellis Competitive Intelligence™, Disease Landscape & Forecast, Epidemiology Intelligence, BioWorld™, Cortellis Regulatory Intelligence™, Drug Timeline & Success Rates, Cortellis Clinical Trials Intelligence™, Cortellis Deals Intelligence™, Access & Reimbursement payer studies, Clarivate Real-World Data and Analytics, Web of Science™, Derwent Innovation™, and other industry sources including biopharma company press releases, filings and peer-reviewed publications. Candidate drugs in phase 2 or phase 3 trials, at pre-registration or registration stage, or already launched in 2024 were selected for analysis, including both novel treatments and already-marketed drugs pursuing new indications that could be particularly impactful. Drugs launched prior to 2024 were excluded. The dataset was filtered for drugs that had total forecast sales of $1 billion or more by 2030. Clarivate experts and analysts evaluated each drug in its individual context, based on factors such as expected approval or launch dates, competitive landscape, regulatory status, trial results, market dynamics and other key factors, and added novel drugs that, while likely to fall short of blockbuster status, are poised to be therapeutic game-changers. Please note that Clarivate analysts generated the data shown in this report prior to December 31, 2024. The Drugs to Watch 2025 Report and the treatments referenced in this release are based on Clarivate's current expectations per existing data, but actual results derived from the drugs named in the report and here may differ significantly. Clarivate is committed to comprehensively supporting customers across the entire drug, device and medical technology lifecycles to advance human health. By combining patient journey data, therapeutic area expertise, artificial intelligence and analytics in ways that unlock hidden insights, data-driven decisions and accelerating innovation, Clarivate's end-to-end research intelligence is designed to enable customers to make informed evidence-based decisions. About Clarivate Clarivate™ is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare. 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▎药明康德内容团队编辑 手部红斑、丘疹、水疱、糜烂、渗出等，伴或不伴有瘙痒等症状的手部湿疹皮炎样改变，临床称为手部湿疹或手部皮炎，终生患病率约为15%。多达2/3的手部湿疹会演变为慢性病，即持续3个月以上或在12个月内复发2次及以上。 近期，《柳叶刀》（The Lancet）发表一项关于手部湿疹的综述，阐述了手部湿疹的主要影响因素、临床症状和诊断以及当前相关治疗措施的进展，以期为临床管理慢性手部湿疹提供参考。 截图来源：The Lancet 特应性皮炎和皮肤干燥是导致手部湿疹的主要影响因素 手部湿疹常见于成人，平均发病年龄在20岁左右。特应性皮炎和皮肤干燥是导致手部湿疹的主要影响因素。特应性皮炎、暴露于刺激物（如摩擦）和接触过敏原（如某些香料、橡胶添加剂等）是导致手部湿疹的主要外在因素，而有些职业可能需要长期接触某些刺激物（如理发师、美容师等），也会增加手部湿疹的发生风险。 ▲手部湿疹通常由内源性因素和刺激性或接触过敏原等因素共同导致（图片来源：参考文献[1]） 手部湿疹的症状和临床诊断 手部湿疹通常表现为手掌发红、水肿和浸润、水疱、糜烂、鳞屑、角化过度和裂纹。手部湿疹急性期以渗出、水疱和结痂为主，而慢性期以浸润和鳞屑为主，主要症状为皮肤瘙痒和疼痛。值得注意的是，高达30%的慢性手部湿疹患者同时存在足部湿疹。如下图所示，图A为角化过度-裂隙型手部湿疹，表现为红斑斑块伴鳞屑，可覆盖整个手掌，有裂隙或皲裂；图B为复发水疱型手部湿疹，表现为手掌、手指掌侧和外侧出现瘙痒、复发性、对称性、深层、1~2 mm的充满液体的水疱，水疱迅速破裂，数周后消退。水疱周围通常很少或没有红斑。 ▲手部湿疹的不同表现（图片来源：参考文献[1]） 手部湿疹的诊断需考虑到病史、临床特征，同时排除其他诊断。询问患者病史时应详细了解发病时间、病程（发作-复发性或持续性）、有无潜在刺激物及特应性皮炎病史等。慢性手部湿疹，特别是疑似有接触性过敏时，可采用斑贴试验。若斑贴试验结果为阳性，表明患者接触了致敏性物质，需结合患者病史、暴露情况和临床病程来评估。皮肤点刺、抓挠试验或测量过敏原特异性IgE浓度对诊断手部湿疹通常价值不大，但在某些特殊情况可能是有用的，如疑似患者患有罕见接触性荨麻疹综合征，对植物或动物来源的乳胶或蛋白质过敏，在持续或重复暴露的情况，可能会引起手部湿疹。几种皮肤病症状表现类似手部湿疹，临床需注意加以鉴别，如银屑病、手掌角化病、掌跎脓疱病、皮肤癣菌感染等。 目前已有各种工具可用于测量手部湿疹严重程度，但由于多数评估工具并未得到有效验证，因此临床实际使用的频率并不高，相对常用的临床评估工具有：手部湿疹严重程度指数（HECSI）、皮肤病生活质量指数。 手部湿疹的治疗和管理 慢性手部湿疹的管理核心在于做好患者教育，识别和避免接触外源性触发饮食，改善症状，实现长期疾病控制。临床可选择的治疗方式较多，如使用润肤剂持续修复表皮屏障、外用糖皮质激素、钙调磷酸酶抑制剂等治疗，以及额外的光疗或全身治疗等。 外用治疗 尽管相关支持性证据较少，但适当使用润肤剂（保湿剂）是慢性手部湿疹管理的重要组成部分。润肤剂有助于保持和补充皮肤表皮水分，减少瘙痒，延长疾病发作间隔。对于急性和渗出性手部湿疹，可首选具有抗菌作用的亲水性乳膏或凝胶，而慢性手部湿疹可能更适合选择油包水型软膏剂。 外用糖皮质激素是慢性手部湿疹的主要替代疗法，短期使用证据等级较低，而中长期使用证据等级为中等。短期内急性干预治疗，可使用传统外用糖皮质激素，如丙酸氯倍他索或曲安奈德。如果需长期使用，为了减少可能出现的不良反应，如表皮屏障修复受损，可考虑使用治疗指数更高的外用糖皮质激素，如糠酸莫米松乳膏。 钙调磷酸酶抑制剂是非甾体抗炎药，有软膏（0.03%和0.1%的他克莫司软膏适用于成人，0.03%适用于年龄≥2岁的儿童）和乳膏（1%的吡美莫司乳膏适用于年龄≥2岁的患者）两种类型，被批准用于治疗特应性皮炎，但不用于治疗其他原因引起的手部湿疹。尽管目前只有少部分短期试验证据支持使用0.1%的他克莫司软膏，但其仍被推荐用于外用糖皮质激素难治性或需要长期治疗的手部湿疹患者的二线短期治疗，因为从现有证据来看用药具备安全性，不会干扰表皮屏障修复。尚无令人信服的证据表明，吡美莫司乳膏适用于治疗手部湿疹。病情缓解后，通常以每周2~3次的频率，使用外用糖皮质激素或钙调磷酸酶抑制剂作为二级预防策略应该是可行的。 Delgocitinib属于外用泛JAK抑制剂，已被日本监管局批准用于治疗特应性皮炎。鉴于其在两项随机双盲对照试验中展现出的良好疗效和安全性，最近被欧盟委员会（EC）推荐用于治疗无法使用外用糖皮质激素或外用糖皮质治疗效果不佳的成人严重慢性手部湿疹。Delgocitinib的批准主要是基于包括DELTA 1和DELTA 2临床3期试验的结果，这些试验评估了delgocitinib相较于安慰剂的安全性和疗效。两项试验均达到了其主要和所有次要终点，详细试验结果发布于今年7月的《柳叶刀》。 两项试验的主要终点是第16周时研究者整体评估的慢性手部湿疹治疗成功（IGA-CHE TS）。治疗成功定义为IGA-CHE评分为0（皮损清除）或1（皮损几乎清除），且较基线至少提高两级。试验数据显示，在第16周时，delgocitinib治疗组比对照组有更高比例的患者达到IGA-CHE治疗成功的标准。DELTA 1中delgocitinib治疗组患者达到治疗成功标准的患者比例为20%，对照组为10%。在DELTA 2中delgocitinib治疗组达标的患者比例为29%，对照组为7%（两项试验均P≤0.0055）。报告不良事件的患者比例在delgocitinib治疗组和对照组中相似，发生率至少为2%的最常见不良事件（如鼻咽炎）在两组中相似。 光疗 如果外用措施无法控制病情，则可考虑短期光疗（通常为4~8周），但需要考虑到光疗相对周期较长，且长期应用可能存在不良反应，如皮肤癌风险（非黑色素瘤）。 系统治疗 若外用治疗和支持性措施均无法充分控制疾病时，可能需要系统治疗。阿利维A酸是首个在欧洲获准用于治疗手部湿疹的口服药物，鉴于其高质量的临床试验证据和真实世界证据，最近的欧洲指南将其作为一线系统性治疗选择。常规治疗周期长达24周，若用药后症状有所改善但未完全“治愈”，可考虑延长用药时长。对于用药效果良好，但停药后复发的患者，重新开启治疗可能是有效的。需要注意的是，阿利维A酸具有致畸性，在治疗前、治疗期间和治疗后1个月内均需做好避孕措施。用药后可能出现的不良反应是短暂性头痛、胆固醇、甘油三酯、转氨酶升高和甲状腺功能水平降低，因此需要定期抽血检查相关指标。 目前尚未有系统性糖皮质激素用于治疗慢性手部湿疹治疗的临床试验证据，根据相关指南建议，仅在严重手部湿疹急性干预时可考虑短期使用，通常为0.5~1.0 mg/kg/d泼尼松龙，而后2~3周逐步减量。 此外，部分系统性治疗被批准用于治疗中重度特应性皮炎，如短期和长期使用的全身性JAK抑制剂abrocitinib、baricitinib和upadacitinib，以及长期应用的生物制剂，如dupilumab、tralokinumab和lebrikizumab，可能是特应性皮炎伴手部湿疹或重度特应性手部湿疹患者的全身性治疗替代选择。一些小规模的观察性研究和相关特应性皮炎研究的事后分析显示，应用dupilumab、upadacitinib和abrocitinib具有一定的有效性。目前正在开展相关临床试验中。 辅助治疗 健康教育有助于加强人们自我管理意识，这是慢性病护理的重要组成部分。一般初级预防指提高人们意识和做出行为改变，以及对于高风险人群（如特应性皮炎患者）采取相关保护皮肤措施。二级预防可包含：面对面教育和实践研讨会、提供个人防护措施（如防护手套、避免接触过敏原和刺激物、手部清洁、使用润肤剂等）。对于严重和顽固性手部湿疹，采取三级预防措施是必要的，如在门诊或住院时选择专科治疗中心。 仍有待解决的问题 由于不同手部湿疹患者的症状、病程和治疗反应存在较大差异，因此在疾病分类上尚缺乏普遍可接受的分类标准，也因此影响了后续的诊断、疾病活动评估和选择合理治疗方案。类似地，尽管有较多的慢性手部湿疹的评估工具，但不同评估工具之间也存在较大差异，未来需要整合现有证据，将不同类型手部湿疹划分到合理的亚型分类中，开发基于指南共识核心而衍生的合理评估工具，制定针对预防和治疗措施的标准化评价标准，这也有利于未来开展更多临床试验，解决慢性手部湿疹患者未竟需求。 小结 手部湿疹是一种非常普遍的皮肤病，多达2/3的患者可能发展为慢性病，严重影响个人正常生活。慢性手部湿疹的临床症状随着时间的推移，在严重程度和皮肤外观表现上会有所不同。影响其发病的因素也较多，主要是当前或既往患有特应性皮炎，或是长期暴露于过敏原。治疗策略包括患者教育、避免接触过敏原、采取一级至三级预防措施，合理使用外用糖皮质激素、钙调磷酸酶抑制剂或泛JAK抑制剂等，必要时可考虑光疗、阿利维A酸全身治疗等措施。未来仍需开展更多研究，以了解慢性手部湿疹的亚型和潜在发病机制，以及比较不同治疗的有效性和安全性。 点击文末“阅读原文/Read more”，即可访问The Lancet官网阅读完整论文。 推荐阅读 欢迎投稿：学术成果、前沿进展、临床干货等主题均可，点此了解投稿详情。 参考资料（可上下滑动查看） [1] Weidinger S, Novak N. Hand eczema. Lancet. 2024 Dec 14;404(10470):2476-2486. doi: 10.1016/S0140-6736(24)01810-5. Epub 2024 Nov 29. PMID: 39615508. [2] European Commission Approves LEO Pharma’s Anzupgo® (delgocitinib) Cream for Adults with Moderate to Severe Chronic Hand Eczema (CHE). Retrieved September 23, 2024 from https://www.businesswire.com/news/home/20240923751725/en [3] LEO Pharma Announces Positive Phase 3 Head-to-head Data Results from DELTA FORCE Trial Comparing Delgocitinib Cream With Alitretinoin Capsules in Adults With Severe Chronic Hand Eczema (CHE). Retrieved January 24, 2024 from https://www.businesswire.com/news/home/20240123989016/en 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医学新视点」微信公众号留言联系。 如有其他合作需求，请联系wuxi_media@wuxiapptec.com 分享，点赞，在看，传递医学新知