A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH MODERATE ALOPECIA AREATA

The purpose of this clinical study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the potential treatment of moderate alopecia areata (AA).
This study is seeking participants who are
* 12 years or older (if permitted by the local IRB/EC and local regulatory health authority)
* have AA with patchy hair loss. The current episode of hair loss has lasted for 6 months or longer but 10 years or less
* do not have any other diseases or conditions affecting hair loss.
Participants will have a 2 in 3 chance of receiving ritlecitinib 50 mg and a 1 in 3 chance of receiving placebo. The placebo looks like the study medicine but does not contain any active ingredients. Participants will not know what you have been assigned to receive. They will take ritlecitinib or placebo once daily by mouth at home for 24 weeks (6 months). After 24 weeks, the assigned treatment may stay the same or be changed to ritlecitinib 50 mg or 100 mg. This change will depend on how participants' alopecia areata responds to the treatment. Participants will receive the newly assigned treatment for another 23 weeks.
About 4 weeks after the last dose, there will be a follow-up visit. At this visit, the team will check on your health. Participants will take part in this study for about 57 weeks. During this time, they will have study visits at the study clinic. Some study checks will be done by phone.
We will compare the experiences of people receiving ritlecitinib to those of people who do not. This will help us determine if ritlecitinib is safe and effective.

开始日期2026-07-31

申办/合作机构

Pfizer Inc.

NCT06795373

/ Withdrawn临床2期IIT

A Single-center, Single-arm, Open-label Phase IIA Clinical Trial to Investigate Efficacy and Safety of Ritlecitinib (PF-06651600) in Participants With Chronic Spontaneous Urticaria

The purpose of this research study is to see if a drug called ritlecitinib is safe and effective for treating chronic spontaneous urticaria (CSU). CSU is hives and itching lasting over six weeks. Ritlecitinib is approved by the Food and Drug Administration (FDA) to treat another condition, but it is not approved for treating CSU. Participation is expected to last 20 weeks and include 7 clinic visits. This study will involve physical examinations, blood tests, looking at and taking pictures of participant's skin and hives, optional skin biopsies, and hearing tests. Eligible participants for this study will take ritlecitinib for 12 weeks and complete a daily diary about their skin and hives. The main risks of being in this study are side effects from ritlecitinib. Less than 1 in 10 people taking ritlecitinib experience diarrhea, acne, hives, rash, inflammation of hair follicles, dizziness, and increased blood levels of creatine phosphokinase (a muscle protein). Participants could also experience a rare but serious side effect, such as shingles, unusual infection, cancer, or blood clot. Benefits of participating in this study include a potential improvement in participant's condition and quality of life. Participating in this study may also help researchers develop new ways of helping future patients.

开始日期2025-12-31

申办/合作机构

Icahn School of Medicine at Mount Sinai

NCT07226531

/ Active, not recruitingN/A

RETROSPECTIVE COHORT STUDY TO ASSESS UTILIZATION AND EFFECTIVENESS OF RITLECITINIB IN A REAL-WORLD POPULATION WITH SEVERE ALOPECIA AREATA IN THE UNITED STATES

Alopecia areata (AA) is a chronic, relapsing T-cell mediated autoimmune disease characterized by nonscarring, typically patchy hair loss that affects people of all ages, races, and genders. In the United States (US), AA has an estimated point prevalence of 1.14% (Beningo et al., 2020). The three most common subtypes of AA are defined by the affected area:
* Patchy alopecia (PA), as seen in 90% of clinical diagnoses: hair loss occurring in one or more patches (ranging from coin-sized to large patches and even full scalp involvement) on the scalp or other parts of the body;
* Alopecia totalis (AT): loss of all or nearly all scalp hair;
* Alopecia universalis (AU): loss of all or nearly all scalp, face, and body hair Traditionally, a range of medications, including corticosteroids, immunotherapy, and minoxidil, are used to treat AA. However, few of these mainstay therapies are supported by robust clinical evidence, limiting the development of widely accepted clinical practice guidelines (Asfour et al., 2023). As a result of suboptimal effectiveness of traditional therapies, patients with AA, particularly those with extensive hair loss, have a persistent unmet medical need. Furthermore, the potential effects of AA on other subgroups, including patients with skin of color, remain undefined. As these subgroups have been historically underrepresented in clinical trials, an additional unmet medical need and evidence gap exists for these patients.
Recent clinical studies have demonstrated efficacy of novel treatments for AA, including ritlecitinib, a JAK3/TEC family kinase inhibitor developed and marketed by Pfizer (King et al., 2023). Ritlecitinib was approved by the US Food and Drug Administration (FDA) in June 2023 for the treatment of severe AA in adults and adolescents aged 12 years or older. Extensive information from clinical trials exists on the safety and efficacy of ritlecitinib, which, along with JAK inhibitors such as baricitinib and deuruxolitinib that are FDA approved for severe alopecia areas in adults 18 and over, have presented needed new therapeutic options for these patients. However, little is known about the clinical effectiveness of ritlecitinib in real-world clinical practice.
The objective of the current study is to evaluate patient characteristics, treatment patterns and related clinical outcomes of patients who initiated ritlecitinib to treat severe AA.

开始日期2025-12-22

申办/合作机构

Pfizer Inc.

100 项与甲苯磺酸利特昔替尼相关的临床结果

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100 项与甲苯磺酸利特昔替尼相关的转化医学

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100 项与甲苯磺酸利特昔替尼相关的专利（医药）

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246

项与甲苯磺酸利特昔替尼相关的文献（医药）

2026-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Patient preferences for treatment characteristics of Janus kinase inhibitors for alopecia areata: a discrete choice experiment

Article

作者: Barghout, Victoria ; Mostaghimi, Arash ; Mesinkovska, Natasha ; Deering, Kathleen L. ; Harshaw, Qing ; Ferro, Thomas J.

BACKGROUND:

Janus kinase inhibitors (JAKis) can improve hair regrowth in alopecia areata (AA).

OBJECTIVE:

This study examined which treatment attributes patients value most when evaluating hypothetical JAKi-based therapies.

METHODS:

A discrete choice experiment was conducted among adults with ≥50% hair loss, recruited through the National Alopecia Areata Foundation (February-March 2024). Participants completed 10 binary choices comparing three hypothetical JAKi attributes: proportion with scalp hair regrowth, time to initial hair regrowth, and dosing frequency; safety attributes were held constant across profiles because the safety profiles were similar among JAKis approved for AA. Relative importance (RI) was calculated using preference weights. Additionally, participants ranked three blinded treatment profiles developed from phase 2b-3 data: drug profile A (baricitinib 4 mg), drug profile B (ritlecitinib 50 mg), and drug profile C (deuruxolitinib 8 mg).

RESULTS:

Among 302 patients (85% women, 81% White, mean age 43.2 years), the most valued attribute was scalp regrowth (RI = 60.0%), followed by time to initial regrowth (28.2%) and dosing frequency (11.7%). Drug profile C was most preferred (83%), and drug profile B was least preferred (85%).

CONCLUSION:

When considering efficacy only, patients prioritize higher efficacy and faster time to hair regrowth above dosing convenience in JAKi treatment preferences for AA.

2026-12-31·JOURNAL OF DERMATOLOGICAL TREATMENT

Post-marketing safety signals of four JAK inhibitors for alopecia areata: an indication-restricted FAERS pharmacovigilance study

Article

作者: Lei, Ziyi ; Cen, Junjie ; Zhan, Jinshan ; Xu, Yantao ; Wan, Miaojian ; Tang, Xin

METHODS:

Reports associated with JAK inhibitors in AA (2015-2025) were retrieved from the FDA Adverse Event Reporting System (FAERS). Disproportionality analyses utilized within-class and external non-JAK comparisons. Additionally, time-to-onset (TTO), serious adverse event (SAE) profiles, and sensitivity analyses were assessed.

RESULTS:

Among 1,905 identified reports (baricitinib [n = 881], ritlecitinib [n = 515], tofacitinib [n = 489], ruxolitinib [n = 20]), safety signals varied across agents. Tofacitinib showed signals involving neuropsychiatric and autoimmune events; baricitinib was associated with thrombocytosis, deep vein thrombosis, and breast cancer; ruxolitinib with pyrexia and elevated blood cholesterol; and ritlecitinib with gastrointestinal events and creatine phosphokinase elevation. TTO patterns were also heterogeneous, with earlier onset for tofacitinib and ruxolitinib, clustering within the first month for ritlecitinib, and a relatively delayed onset for baricitinib. Across the class, serious outcomes were most commonly related to infections, although the distribution of clinical outcomes differed by agent.

CONCLUSIONS:

JAK inhibitors used in AA demonstrated heterogeneous post-marketing safety patterns not fully captured by class-level warnings. These findings support agent-specific surveillance and individualized risk assessment in clinical practice.

2026-08-01·CURRENT OPINION IN PHARMACOLOGY

Alopecia areata: Mechanisms, targeted therapies, and translational challenges

Review

作者: Kumar, Pawan ; Kumar, Virender ; Sahoo, Saurabh

Alopecia areata (AA) is an immune-mediated disorder characterized by non-scarring hair loss and substantial psychosocial burden. Although recent advances have clarified key pathogenic mechanisms and expanded therapeutic options, important uncertainties persist regarding disease heterogeneity, treatment durability, and long-term safety. Central to AA pathogenesis is the collapse of hair follicle immune privilege, driven primarily by cytotoxic CD8⁺ NKG2D⁺ T-cells and sustained by interferon-γ-dependent Janus kinase-signal transducer and activator of transcription (JAK-STAT) signaling. However, emerging evidence indicates immunological variability across patient subsets, including inconsistent contributions from T helper cell pathways and regulatory immune dysfunction. The clinical approval of JAK inhibitors-baricitinib, ritlecitinib, and deuruxolitinib-represents a major therapeutic milestone, validating targeted immune modulation as an effective strategy for moderate-to-severe AA. Nevertheless, relapse following treatment discontinuation, interindividual variability in response, and unresolved long-term safety considerations highlight the limitations of current approaches. In parallel, regenerative therapies, microbiome-based interventions, gene-targeted strategies, and device-assisted technologies are under investigation, yet most face substantial translational, regulatory, and scalability challenges. This review critically synthesizes current evidence on AA pathogenesis and therapy, with particular emphasis on unresolved controversies, translational barriers, and clinical implications. By integrating mechanistic insights with emerging clinical data, the article highlights priorities for future research, including biomarker development, precision medicine approaches, and strategies aimed at achieving durable disease control rather than transient immune suppression.

505

项与甲苯磺酸利特昔替尼相关的新闻（医药）

19 小时之前

·药时代

辉瑞斑秃新药，两项3期研究成功！

中文共：2000字预计阅读时间：5分钟 2026年7月30日，辉瑞宣布其斑秃新药利特昔替尼（ritlecitinib，商品名：LITFULO/乐菲诺）再迎关键突破，两项针对非节段型白癜风（NSV）的III期临床试验斩获积极顶线结果。这并不令人意外，早在斑秃适应症获批时，业界就已将白癜风视为该药的下一个逻辑延伸。 ritlecitinib是由辉瑞开发的全球首个靶向JAK3和Tec的不可逆抑制剂，开发用于治疗多种免疫介导的炎症性疾病，如斑秃、白癜风和炎症性肠病（IBD）。2023年6月，该药首次获得美国FDA批准，用于治疗12岁及以上青少年和成人重度斑秃患者。彼时，辉瑞算是拥有最多上市JAK抑制剂的MNC，Xeljanz（2012年美国上市）、Xeljanz XR（2016年美国上市）、Cibinqo（2021年美国上市），每一款JAK抑制剂都有属于自己的市场定位/优势人群。瞄准NSV这一市场，主要基于以下几点：患者基数大：白癜风作为一种常见的自身免疫性色素脱失病，全球发病率达 0.5%—2%。其中非节段型白癜风占比超 90%。根据《白癜风诊疗共识（2021版）》，仅中国白癜风患者约1400万。治疗手段有限：目前主流的治疗药物包括钙调磷酸酶抑制剂（TCI）、糖皮质激素（TCS）、维生素D3衍生物（卡泊三醇软膏），但糖皮质激素不良反应发生率较高，钙调磷酸酶抑制剂及维生素D3衍生物缺少长期使用风险的证据，大部分指南及共识持谨慎态度。 2022年，Incyte的Opzelura（芦可替尼乳膏）获FDA批准用于治疗非节段性白癜风，证明了靶向JAK通路可以实现“药物驱动的复色”。但其乳膏剂型天然受限：大面积皮损患者涂抹负担沉重。口服无疑成为更优选择，但迄今为止，Opzelura仍是唯一批准用于治疗NSV的药物。本次取得突破的TRANQUILLO临床项目，是迄今为止白癜风口服全身治疗领域规模最大的III期临床研究。项目包含两项核心关键试验及长期扩展试验，在全球271个研究中心累计入组2174例不同疾病严重程度、涵盖活动期与稳定期的NSV患者。其中，TRANQUILLO研究纳入12岁及以上青少年与成人患者，验证50mg每日一次剂量的疗效与安全性；TRANQUILLO 2聚焦成人人群，同步探索50mg、100mg双剂量方案，为临床剂量选择提供充足数据支撑。疗效数据显示，经过52周规范治疗，ritlecitinib50mg、100mg剂量组相较安慰剂，在面部白癜风面积评分指数（F-VASI）、全身白癜风面积评分指数（T-VASI）两大核心维度，均实现统计学显著且临床意义明确的改善。试验核心终点F-VASI75（面部皮损复色改善≥75%）、T-VASI50（全身皮损复色改善≥50%）的患者应答率大幅优于安慰剂组。值得注意的是，试验采用差异化全球终点设计，美国地区将两项指标设为共同主要终点，海外市场以F-VASI75为核心终点、T-VASI50为关键次要终点，适配全球不同监管标准，为后续全球同步获批奠定基础。安全性是慢病口服药物落地临床的核心关键。本次III期研究中，各治疗组治疗期间不良事件（TEAE）发生率基本持平，不良反应可控可管理。作为靶向JAK3/TEC的高选择性抑制剂，ritlecitinib通过共价结合JAK3独有Cys909残基实现精准抑制，对JAK1、JAK2、TYK2的抑制活性较传统泛JAK抑制剂高出千倍以上，有效规避了广谱JAK抑制带来的广泛副作用，差异化机制赋予其更优的临床耐受性。在行业竞争层面，当前白癜风全身治疗赛道仍处于蓝海阶段，多数在研药物尚处于早期研发阶段。ritlecitinib大规模III期阳性数据、成熟的安全体系、差异化靶点优势，率先完成关键临床验证，有望成为全球首个获批用于成人非节段性白癜风的JAK3/TEC靶向口服药物，抢占市场先发优势。需要客观正视的是，作为JAK家族抑制剂，ritlecitinib仍保留品类固有安全警示，包括严重感染、血栓、心血管风险、肿瘤风险等黑框警告，临床应用需严格筛查禁忌症、规范监测血常规、肝功能及结核感染情况，规避高危人群用药风险。参考资料： 1.https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-topline-phase-3-results-litfulo 2.狙击JAK3：Pfizer的Litfulo，一颗新星冉冉升起（药怪站住） 3.白癜风市场迎来革命性药物（药事纵横） 4.其他公开资料封面图来源：药时代两位高管同月离职后，传奇生物更新管理层名单 2026-07-31 35亿美元！数据造假、频繁裁员、无临床管线，这家体内CAR-T公司被强生拿下了？ 2026-07-30 ORR从33.6%骤降至15.7%！FDA逐例核查实锤「疗效注水」 2026-07-29 版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击查看更多精彩内容！

2026-08-03

·今日头条

2026年7月底全球新药临床进展盘点，9项关键数据一文速览

什么是新药临床试验关键进展？新药临床试验关键进展是指创新药在I-III期临床研究中达到主要终点、获得监管机构IND批准或完成新阶段临床登记的事件。这些进展直接决定药物能否上市、何时上市，是医药研发产业链中最核心的里程碑节点。据药渡TrialPro临床数据库统计，2026年7月最后一周（7月27日—8月2日），全球共有9项重要临床进展发布，覆盖肿瘤、自免、代谢、精神类等多条赛道。一、III期临床结果发布（5项） 1. 阿斯利康Sonesitatug Vedotin — 全球首个CLDN18.2 ADC III期OS获益项目内容药物名称 Sonesitatug Vedotin（Sone-Ve / AZD0901）研发公司阿斯利康（从康诺亚/乐普合资公司KYM Biosciences引进）适应症 CLDN18.2阳性晚期胃癌/胃食管结合部癌临床阶段 III期临床代号 CLARITY-Gastric01 发布日期 2026-07-27 核心数据三线及后线人群OS达主要终点；二线及后线整体人群OS达关键次要终点，均具有统计学显著性。PFS呈现改善趋势但未达统计学显著。安全性良好，无新安全信号意义全球首个靶向CLDN18.2的ADC在III期试验中证实总生存获益。阿斯利康预测销售峰值30-50亿美元 Sonesitatug Vedotin是阿斯利康从中国Biotech引进的ADC资产，2023年2月康诺亚与乐普通过合资公司以6300万美元首付+超11亿美元总额授权给阿斯利康。该药已获FDA孤儿药认定和快速通道认定，中国NMPA授予突破性疗法认定。约60%的胃癌/GEJ癌患者CLDN18.2表达≥25%，市场规模显著。 2. 石药集团盐酸阿姆西汀— 国产抑郁症新药III期阳性项目内容药物名称盐酸阿姆西汀（HA1406）研发公司石药集团适应症抑郁症临床阶段 III期临床代号 HA1406-007 发布日期 2026-07-27 核心数据治疗第8周末MADRS评分较基线变化值显著优于安慰剂，且数值上优于阳性对照药。多项次要终点均显示良好获益趋势，安全性良好盐酸阿姆西汀肠溶片是石药集团自主研发的抗抑郁1类新药，本次III期阳性结果标志着国产创新药在精神类药物领域的持续突破。 3. 诺诚健华Fadeucravacitinib — 银屑病TYK2抑制剂III期达主要终点项目内容药物名称 Fadeucravacitinib 研发公司诺诚健华适应症中重度斑块状银屑病临床阶段 III期发布日期 2026-07-27 核心数据研究达到主要终点，具有高度显著统计学意义和临床意义的改善。同时达到多个次要终点，各项疗效评价指标均显示一致的显著治疗效果 Fadeucravacitinib是诺诚健华自主研发的TYK2抑制剂，瞄准百亿美元银屑病市场。本次III期阳性为国产TYK2抑制剂商业化奠定关键基础。 4. 翰森制药 Risvutatug Rezetecan — B7-H3 ADC骨肉瘤III期PFS阳性项目内容药物名称 Risvutatug Rezetecan 研发公司翰森制药适应症骨肉瘤临床阶段 III期临床代号 ARTEMIS-011 发布日期 2026-07-28 核心数据与化疗组相比，PFS显示出具有统计学显著性和临床意义的改善。次要终点（包括总生存期和研究者评估的PFS）亦观察到一致获益 Risvutatug Rezetecan是翰森制药开发的靶向B7-H3的ADC药物，骨肉瘤是高度未满足的临床需求领域，该药是首个在骨肉瘤III期中达到PFS主要终点的B7-H3 ADC。 5. 辉瑞利特昔替尼— 白癜风III期双研究阳性项目内容药物名称利特昔替尼（Ritlecitinib）研发公司辉瑞适应症非节段性白癜风临床阶段 III期临床代号 TRANQUILLO；TRANQUILLO 2 发布日期 2026-07-30 核心数据利特昔替尼组达到T-VASI 50（全身白癜风面积指数评分降低≥50%）和F-VASI 75（面部面积指数评分降低≥75%）的患者比例均显著高于安慰剂组利特昔替尼是JAK3抑制剂，此前已获FDA批准用于斑秃。本次白癜风III期双研究阳性，有望拓展至自身免疫性皮肤病领域。二、IND获批与临床登记（4项） 6. 科伦博泰SKB565 — 首个双载荷ADC获批临床项目内容药物名称 SKB565 研发公司科伦博泰适应症晚期实体瘤发布日期 2026-07-27 详情新型双载荷ADC药物获CDE临床试验许可，为科伦博泰首个进入临床阶段的双载荷ADC 双载荷ADC是下一代ADC技术方向，通过在同一抗体上偶联两种不同机制毒素，克服耐药并提升疗效。科伦博泰在ADC领域已有TROP2 ADC（芦康沙妥珠单抗）获批上市，双载荷平台标志着技术迭代加速。 7. 百利天恒BL-M07D1 — HER2 ADC新适应症III期启动项目内容药物名称 BL-M07D1 研发公司百利天恒适应症 HER2 IHC3+晚期结直肠癌发布日期 2026-07-27 详情登记一项III期研究，评估BL-M07D1在经奥沙利铂、氟尿嘧啶和伊立替康治疗失败的晚期结直肠癌患者中的疗效和安全性百利天恒核心产品BL-B01D1（双抗ADC）已有多项III期推进，BL-M07D1为其HER2 ADC管线的新适应症拓展，瞄准结直肠癌后线治疗。 8. 恒瑞医药SHR-1139 — 银屑病II期临床登记项目内容药物名称 SHR-1139 研发公司恒瑞医药适应症斑块状银屑病发布日期 2026-07-28 详情登记II期临床试验，主要终点为治疗第16周sPGA应答为0或1的参与者比例恒瑞在自免领域持续布局，SHR-1139为银屑病新管线，与诺诚健华Fadeucravacitinib形成同赛道竞争。 9. 默沙东MK-2010 — PD-1/VEGF双抗新增两项II期项目内容药物名称 MK-2010（LM-299）研发公司默沙东（从礼新医药引进）适应症晚期实体瘤发布日期 2026-07-31 详情默沙东瑞士官网新增两项II期临床研究登记（MK-2010-002和MK-2010-003），均处于"Study in start-up"阶段 MK-2010是默沙东从礼新医药引进的PD-1/VEGF双抗，PD-1/VEGF双抗是当前肿瘤免疫最热门赛道之一，康方生物依沃西（AK112）已在III期中击败K药，默沙东加速推进MK-2010布局该赛道。三、同期重磅：恒瑞HRS-7535口服GLP-1 III期减重阳性项目内容药物名称 HRS-7535（海外代号KAI-7535）研发公司恒瑞医药适应症成人肥胖及超重临床阶段 III期临床代号 HARBOR-1 发布日期 2026-08-02 核心数据 180mg每日一次剂量组治疗44周体重较基线下降9.8%，减重效果尚未达平台期，耐受性良好后续计划2026年内向NMPA申报上市 HRS-7535是恒瑞医药自主研发的口服小分子GLP-1受体激动剂。2024年5月，恒瑞将该品种（连同HRS-9531等GLP-1产品组合）除大中华区外全球权益授权给美国Kailera Therapeutics，交易总额最高60亿美元。口服小分子GLP-1赛道竞争格局：药物公司剂型减重数据状态 Orforglipron（Foundayo）礼来口服小分子 72周减重12.4%（36mg组） 2026年4月获FDA批准上市 HRS-7535 恒瑞医药口服小分子 44周减重9.8%（180mg组） III期阳性，计划年内NDA HDM1002 华东医药口服小分子 II期推进中 II期 Danuglipron 辉瑞口服小分子 III期终止已终止四、本周临床进展总览序号药物名称研发公司适应症进展类型日期 1 Sonesitatug Vedotin 阿斯利康胃癌 III期OS阳性 7/27 2 盐酸阿姆西汀石药集团抑郁症 III期阳性 7/27 3 Fadeucravacitinib 诺诚健华银屑病 III期阳性 7/27 4 SKB565 科伦博泰晚期实体瘤 IND获批 7/27 5 BL-M07D1 百利天恒晚期结直肠癌 III期登记 7/27 6 Risvutatug Rezetecan 翰森制药骨肉瘤 III期PFS阳性 7/28 7 SHR-1139 恒瑞医药银屑病 II期登记 7/28 8 利特昔替尼辉瑞白癜风 III期双研究阳性 7/30 9 MK-2010 默沙东晚期实体瘤 II期新增登记 7/31 10 HRS-7535 恒瑞医药肥胖/超重 III期减重阳性 8/2 五、常见问题（FAQ） Q1：CLDN18.2 ADC为什么重要？ CLDN18.2在约60%的胃癌/胃食管结合部癌中表达≥25%，是全球胃癌靶向治疗最热门靶点之一。Sonesitatug Vedotin是全球首个在III期中证实OS获益的CLDN18.2 ADC，验证了该靶点的临床价值。 Q2：口服小分子GLP-1相比注射剂有什么优势？口服小分子GLP-1无需注射、无需冷链储运、生产成本更低、患者依从性更高。礼来Orforglipron已于2026年4月获FDA批准，月费149-349美元，显著低于注射型GLP-1。 Q3：双载荷ADC和传统ADC有什么区别？双载荷ADC在同一抗体分子上偶联两种不同机制的毒素分子，可同时打击多个杀伤路径，克服单毒素耐药问题。科伦博泰SKB565是国内首批进入临床的双载荷ADC之一。 Q4：PD-1/VEGF双抗为什么是热门赛道？ PD-1/VEGF双抗同时阻断免疫检查点和肿瘤血管生成两条通路，具有"1+1>2"的协同效应。康方生物依沃西已在III期头对头试验中击败帕博利珠单抗，验证了该机制的临床优势，默沙东、恒瑞等均在加速布局。 Q5：药渡TrialPro临床数据库能查到什么？药渡TrialPro临床数据库收录全球临床试验登记信息、进展追踪、结果数据，覆盖中美欧等主要监管区域的临床试验动态，支持按药物、靶点、适应症、企业等多维度检索与筛选。数据来源：药渡TrialPro临床数据库（data.pharmacodia.com）

2026-08-03

·百度百家

2026年7月底全球新药临床进展盘点

9项关键数据一文速览撰文：药渡什么是新药临床试验关键进展？新药临床试验关键进展是指创新药在I-III期临床研究中达到主要终点、获得监管机构IND批准或完成新阶段临床登记的事件。这些进展直接决定药物能否上市、何时上市，是医药研发产业链中最核心的里程碑节点。据药渡TrialPro临床数据库统计，2026年7月最后一周（7月27日—8月2日），全球共有9项重要临床进展发布，覆盖肿瘤、自免、代谢、精神类等多条赛道。一、III期临床结果发布（5项） 1. 阿斯利康 Sonesitatug Vedotin — 全球首个CLDN18.2 ADC III期OS获益 Sonesitatug Vedotin是阿斯利康从中国Biotech引进的ADC资产，2023年2月康诺亚与乐普通过合资公司以6300万美元首付+超11亿美元总额授权给阿斯利康。该药已获FDA孤儿药认定和快速通道认定，中国NMPA授予突破性疗法认定。约60%的胃癌/GEJ癌患者CLDN18.2表达≥25%，市场规模显著。 2. 石药集团盐酸阿姆西汀 — 国产抑郁症新药III期阳性盐酸阿姆西汀肠溶片是石药集团自主研发的抗抑郁1类新药，本次III期阳性结果标志着国产创新药在精神类药物领域的持续突破。 3. 诺诚健华 Fadeucravacitinib — 银屑病TYK2抑制剂III期达主要终点 Fadeucravacitinib是诺诚健华自主研发的TYK2抑制剂，瞄准百亿美元银屑病市场。本次III期阳性为国产TYK2抑制剂商业化奠定关键基础。 4. 翰森制药 Risvutatug Rezetecan — B7-H3 ADC骨肉瘤III期PFS阳性 Risvutatug Rezetecan是翰森制药开发的靶向B7-H3的ADC药物，骨肉瘤是高度未满足的临床需求领域，该药是首个在骨肉瘤III期中达到PFS主要终点的B7-H3 ADC。 5. 辉瑞利特昔替尼 — 白癜风III期双研究阳性利特昔替尼是JAK3抑制剂，此前已获FDA批准用于斑秃。本次白癜风III期双研究阳性，有望拓展至自身免疫性皮肤病领域。二、IND获批与临床登记（4项） 6. 科伦博泰 SKB565 — 首个双载荷ADC获批临床双载荷ADC是下一代ADC技术方向，通过在同一抗体上偶联两种不同机制毒素，克服耐药并提升疗效。科伦博泰在ADC领域已有TROP2 ADC（芦康沙妥珠单抗）获批上市，双载荷平台标志着技术迭代加速。 7. 百利天恒 BL-M07D1 — HER2 ADC新适应症III期启动百利天恒核心产品BL-B01D1（双抗ADC）已有多项III期推进，BL-M07D1为其HER2 ADC管线的新适应症拓展，瞄准结直肠癌后线治疗。 8. 恒瑞医药 SHR-1139 — 银屑病II期临床登记恒瑞在自免领域持续布局，SHR-1139为银屑病新管线，与诺诚健华Fadeucravacitinib形成同赛道竞争。 9. 默沙东 MK-2010 — PD-1/VEGF双抗新增两项II期 MK-2010是默沙东从礼新医药引进的PD-1/VEGF双抗，PD-1/VEGF双抗是当前肿瘤免疫最热门赛道之一，康方生物依沃西（AK112）已在III期中击败K药，默沙东加速推进MK-2010布局该赛道。三、同期重磅：恒瑞HRS-7535口服GLP-1 III期减重阳性 HRS-7535是恒瑞医药自主研发的口服小分子GLP-1受体激动剂。2024年5月，恒瑞将该品种（连同HRS-9531等GLP-1产品组合）除大中华区外全球权益授权给美国Kailera Therapeutics，交易总额最高60亿美元。口服小分子GLP-1赛道竞争格局：四、本周临床进展总览五、常见问题（FAQ） Q1：CLDN18.2 ADC为什么重要？ CLDN18.2在约60%的胃癌/胃食管结合部癌中表达≥25%，是全球胃癌靶向治疗最热门靶点之一。Sonesitatug Vedotin是全球首个在III期中证实OS获益的CLDN18.2 ADC，验证了该靶点的临床价值。 Q2：口服小分子GLP-1相比注射剂有什么优势？口服小分子GLP-1无需注射、无需冷链储运、生产成本更低、患者依从性更高。礼来Orforglipron已于2026年4月获FDA批准，月费149-349美元，显著低于注射型GLP-1。 Q3：双载荷ADC和传统ADC有什么区别？双载荷ADC在同一抗体分子上偶联两种不同机制的毒素分子，可同时打击多个杀伤路径，克服单毒素耐药问题。科伦博泰SKB565是国内首批进入临床的双载荷ADC之一。 Q4：PD-1/VEGF双抗为什么是热门赛道？ PD-1/VEGF双抗同时阻断免疫检查点和肿瘤血管生成两条通路，具有"1+1>2"的协同效应。康方生物依沃西已在III期头对头试验中击败帕博利珠单抗，验证了该机制的临床优势，默沙东、恒瑞等均在加速布局。 Q5：药渡TrialPro临床数据库能查到什么？药渡TrialPro临床数据库收录全球临床试验登记信息、进展追踪、结果数据，覆盖中美欧等主要监管区域的临床试验动态，支持按药物、靶点、适应症、企业等多维度检索与筛选。数据来源：药渡TrialPro临床数据库

100 项与甲苯磺酸利特昔替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB14924

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
斑秃	美国	Pfizer Inc.	2023-06-23

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
非节段型白癜风	临床3期	美国	Pfizer Inc.	2022-12-01
非节段型白癜风	临床3期	中国	Pfizer Inc.	2022-12-01
非节段型白癜风	临床3期	日本	Pfizer Inc.	2022-12-01
非节段型白癜风	临床3期	澳大利亚	Pfizer Inc.	2022-12-01
非节段型白癜风	临床3期	保加利亚	Pfizer Inc.	2022-12-01
非节段型白癜风	临床3期	加拿大	Pfizer Inc.	2022-12-01
非节段型白癜风	临床3期	德国	Pfizer Inc.	2022-12-01
非节段型白癜风	临床3期	印度	Pfizer Inc.	2022-12-01
非节段型白癜风	临床3期	意大利	Pfizer Inc.	2022-12-01
非节段型白癜风	临床3期	墨西哥	Pfizer Inc.	2022-12-01

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临床结果

适应症

分期

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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


NCT05583526 \| NCT06163326 \| NCT06072183 (Tranquillo, Pubmed \| Dermatol Ther (Heidelb))	临床3期	非节段型白癜风	1,990	Ritlecitinib 100 mg	繭糧壓獵製鏇醖餘廠選(壓觸鏇製齋鹹顧範蓋糧) = 觸積繭鹽遞選網衊築願夢糧獵選鹽鏇夢淵襯淵 (夢獵衊鹹願積鬱製製觸 ) 更多	积极	2026-05-22
	临床3期	非节段型白癜风	1,990	Placebo	醖夢遞構憲鏇積積膚膚(餘衊鹹鬱壓夢願製醖廠) = 壓網網製獵淵願壓積膚襯鹹夢衊選顧選遞顧積 (鑰齋蓋襯窪糧醖餘襯簾 )	积极	2026-05-22
AAD2026	N/A	斑秃	32	Ritlecitinib 50mg	夢齋廠餘餘構餘淵簾餘(衊夢膚糧蓋構選齋淵齋) = 遞鏇淵鹽廠夢遞蓋糧繭淵窪製鹹構鹹淵鏇遞壓 (簾網齋艱衊積遞觸鏇選 ) 更多	积极	2026-03-27
NCT03732807 (ALLEGRO-2b/3, AAD2026)	临床2期	斑秃	27	Ritlecitinib 50 mg	獵糧鹹鬱膚鹽蓋積遞選(顧鬱積膚範憲選獵淵簾) = 獵衊積壓淵蓋遞鏇鏇鬱獵網衊襯鹽鬱醖壓構鹽 (艱夢廠壓築糧鹽構選積 ) 更多	积极	2026-03-27
NCT03732807 (ALLEGRO-2b/3, AAD2026)	临床2/3期	斑秃	300	Ritlecitinib 50 mg	鹹醖鏇築艱觸廠顧淵積(顧鹽鑰糧願鹽衊齋願鏇) = 衊艱淵積鏇壓製糧餘範醖積觸鹽製繭構鹹遞壓 (積憲窪鹽獵鏇鹽築鹹獵 ) 更多	积极	2026-03-27
AAD2026	N/A	斑秃	129	Tofacitinib	獵願醖製廠簾簾廠鬱鹹(觸襯顧築廠衊鹽蓋範選) = 網蓋餘選夢鹹獵選觸壓鬱膚願積蓋艱齋獵積膚 (製膚獵積餘願鏇願鏇簾 ) 更多	不佳	2026-03-27
AAD2026	N/A	斑秃	129	Baricitinib	鹽簾鬱繭顧糧鹹衊選選(鏇鬱齋齋範鹽醖簾鬱繭) = 簾繭築獵醖窪醖築醖鬱網糧構獵顧淵醖壓簾淵 (鏇築獵蓋築範築鹽夢壓 )	不佳	2026-03-27
AAD2026	N/A	普遍性脱发	329	Tofacitinib	夢廠襯壓齋夢鑰顧鹽構(獵積鬱願壓鏇鹹鑰餘獵) = Tofacitinib was associated with shingles, acneiform eruptions, infections, gastrointestinal symptoms, weight gain, and one case of multiple sclerosis. Ruxolitinib caused mild cytopenias and gastrointestinal issues; upadacitinib led to hair depigmentation; filgotinib caused acneiform eruptions. Safety data for ritlecitinib, abrocitinib, and deuruxolitinib were limited. 鹽遞獵鑰糧鬱壓鏇膚鏇 (顧鹽築築範網淵網觸鏇 )	积极	2026-03-27
NCT03732807 (ALLEGRO, Pubmed \| Value Health)	临床2/3期	斑秃	201	Ritlecitinib 50 mg once daily	襯積餘選構糧壓廠簾艱(窪積鹽選糧願鑰鏇製壓) = 憲膚鬱蓋鏇鏇夢鏇鹹襯繭網築積衊構齋壓廠蓋 (鑰淵醖顧壓壓鹽選醖構 ) 更多	积极	2026-02-01
NCT04006457 (ALLEGRO \| ALLEGRO-LT, CTgov)	临床3期	斑秃	1,057	Ritlecitinib (Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants))	淵壓襯範夢範繭築範艱 = 獵壓壓遞築鹹鏇襯選網簾憲醖鹽鏇鏇簾範齋簾 (衊鹽願憲艱選醖鹽獵網, 鑰蓋製觸簾鬱醖顧壓襯 ~ 醖選鑰鏇觸膚夢廠壓範) 更多	-	2025-08-14
NCT04006457 (ALLEGRO \| ALLEGRO-LT, CTgov)	临床3期	斑秃	1,057	Ritlecitinib (Main Study: Ritlecitinib 50 mg QD (Roll-over Participants))	淵壓襯範夢範繭築範艱 = 顧觸簾積壓廠艱範壓憲簾憲醖鹽鏇鏇簾範齋簾 (衊鹽願憲艱選醖鹽獵網, 積顧願築壓襯醖廠鹹憲 ~ 齋夢製蓋簾鏇艱簾衊顧) 更多	-	2025-08-14
NCT03732807 \| NCT04006457 (ALLEGRO, Pubmed \| J Eur Acad Dermatol Venereol)	临床2/3期	斑秃	191	Ritlecitinib 50 mg	遞襯齋艱廠衊壓製窪鏇(鬱鏇網築顧夢顧壓範鬱) = 艱壓鬱築憲壓淵壓網網鹽窪鏇積遞艱鏇製餘鬱 (襯顧獵鑰廠淵鏇顧獵製 ) 更多	积极	2025-06-01
NCT04006457 (ALLEGRO-LT, Pubmed \| J Eur Acad Dermatol Venereol)	临床3期	斑秃	449	Ritlecitinib 200mg loading dose followed by 50mg daily	廠壓艱網襯願夢醖簾鹽(淵艱簾廠夢鬱蓋構醖夢) = occurred in six patients 衊膚衊窪夢襯鑰顧繭鬱 (鑰遞壓觸網網醖獵願壓 ) 更多	积极	2025-06-01