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.

488

项与甲苯磺酸利特昔替尼相关的新闻（医药）

2026-07-31

·药事纵横

辉瑞JAK3抑制剂治疗白癜风的3期临床试验取得阳性顶线结果

7月30日，辉瑞对外宣布，两项评估每日一次 LITFULO 在患有活动期与稳定期非节段型白癜风（NSV）、且疾病严重程度跨度广泛的患者中疗效与安全性的 III 期临床试验取得阳性顶线结果。TRANQUILLO 研究纳入 12 岁及以上患者，而 TRANQUILLO 2 仅纳入成人患者。在各研究中，LITFULO 50 mg 与 100 mg 两个剂量组在面部与全身白癜风面积评分指数（VASI）的共同主要终点上，均较安慰剂实现了显著且具有临床意义的改善。基于上述结果，辉瑞拟在全球范围内提交监管申报文件，将 LITFULO 作为 NSV 成人患者的潜在新型口服全身治疗药物。 "LITFULO 由辉瑞内部发现，具有独特的作用机制，靶向 TEC 家族激酶与 JAK3，由此形成了其独特的临床特征，"辉瑞炎症与免疫学首席医学官 Michael Vincent 医学博士、哲学博士表示。"LITFULO 在非节段型白癜风 TRANQUILLO 关键性研究中取得的阳性结果，建立在我们在皮肤病学领域的深厚专长以及 LITFULO 治疗重度斑秃的经验之上，包括其已获证实的疗效与特征明确的安全性特征。这些发现让我们确信，若获得批准，LITFULO 有望成为 NSV 成人患者的一种新型口服全身治疗选择，显著改善并有可能维持面部与全身的色素再生。" NSV 是一种慢性自身免疫病，免疫系统攻击黑色素生成细胞，导致色素丧失，并随着时间推移在皮肤/毛发上出现白色斑疹与斑块¹。NSV 可在任何年龄、任何肤色类型中出现，导致皮肤任何部位发生色素脱失，常累及面部、颈部、手部等高度暴露区域²。尽管白癜风常被当作美容问题处理，但它是一种严重的自身免疫病，对患者生活的影响远超躯体症状²˒³。由于 NSV 属于慢性病，可能需要全身治疗方案，以帮助患者恢复皮肤色素并长期维持色素再生。在两项研究中，与安慰剂相比，接受 LITFULO 治疗的患者在第 52 周达到 F-VASI75（面部白癜风面积评分指数较基线改善 ≥75%）与 T-VASI50（全身白癜风面积评分指数较基线改善 ≥50%）的比例显著更高。在美国，共同主要终点为第 52 周达到 F-VASI75 的患者比例与第 52 周达到 T-VASI50 的患者比例。在美国以外的国家，第 52 周 F-VASI75 为主要终点，第 52 周 T-VASI50 为关键次要终点。 LITFULO 在 NSV 中的安全性特征与斑秃中已确立的安全性特征一致，未观察到新的安全信号。总体而言，各治疗组间出现治疗期不良事件（TEAEs）的患者比例相近。 "罹患非节段型白癜风会对患者的日常生活产生深远影响。许多患者因非节段型白癜风不可预测的特性，以及当前可用治疗的局限性而感到沮丧，迫切寻求能够针对根本疾病的更多选择²，"Henry Ford Health 皮肤科及 Hamzavi Dermatology Specialists 高级主治医师 Iltefat Hamzavi 医学博士表示。"在这些试验中，LITFULO（利特昔替尼）在面部与全身色素再生两方面均展现出显著改善，该发现进一步印证了 LITFULO 推动全身治疗新范式的潜力，造福那些疾病负担超出单纯局部治疗可及范围的患者。" TRANQUILLO 与 TRANQUILLO 2 的更多结果将在未来的医学会议上公布。 LITFULO 于 2023 年获美国食品药品监督管理局（FDA）批准，用于治疗成人及 12 岁及以上青少年的重度斑秃。辉瑞计划于 2026 年启动一项关键性研究，评估 LITFULO 治疗中重度斑秃的疗效。关于 TRANQUILLO 临床试验项目 III 期 TRANQUILLO 临床开发项目包含两项关键性试验 TRANQUILLO 与 TRANQUILLO 2，以及一项长期扩展试验 TRANQUILLO LTE，供在母研究中完成治疗的 TRANQUILLO 参与者继续参加。TRANQUILLO 与 TRANQUILLO LTE 纳入成人及青少年，而 TRANQUILLO 2 仅纳入成人。该项目在患有活动期或稳定期 NSV、疾病严重程度跨度广泛且面部受累的患者中评估 LITFULO 的疗效与安全性： TRANQUILLO：评估每日一次 50 mg LITFULO，共纳入 607 例成人及青少年。 TRANQUILLO 2：评估每日一次 50 mg 或 100 mg LITFULO，共纳入 1,567 例成人；涉及 50 mg 剂量的比较属于探索性与描述性性质。两项试验在全球 271 个研究中心共评估了 2,174 例 NSV 患者。两项试验在美国的共同主要终点为：第 52 周面部 VASI 较基线改善 ≥75%（F-VASI75）的患者比例第 52 周全身 VASI 较基线改善 ≥50%（T-VASI50）的患者比例在美国以外的国家，第 52 周达到 F-VASI75 的患者比例为首要终点，第 52 周达到 T-VASI50 的患者比例为关键次要终点。有关两项试验的更多信息，请访问 ClinicalTrials.gov 查询 Tranquillo 与 Tranquillo 2。关于 LITFULO™（利特昔替尼） LITFULO 是一种口服的 Janus 激酶 3（JAK3）与 TEC 家族激酶抑制剂，目前正在非节段型白癜风中进行研究。通过靶向疾病中涉及的关键免疫信号通路，LITFULO 被认为可调节参与黑素细胞破坏的免疫细胞活性。 LITFULO 目前已获批用于治疗成人及 12 岁及以上青少年的重度斑秃，其作用靶点为驱动毛囊损伤与脱发的潜在免疫机制。凭借其双重作用机制，LITFULO 已展现出解决斑秃与非节段型白癜风共同潜在的免疫介导病理的潜力。 LITFULO 已在美国、欧盟、加拿大、日本、中国与英国获批用于治疗成人及 12 岁及以上青少年的重度斑秃。 LITFULO 的开发项目覆盖多种免疫介导的皮肤病，包括斑秃、非节段型白癜风、慢性自发性荨麻疹与化脓性汗腺炎，体现了在皮肤病学领域聚焦的开发策略。立即扫码加入药事纵横交流群

临床结果临床3期临床成功

2026-07-31

·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！

2026-07-30

·药明康德

强生双特异性抗体疗法获优先审评资格；治疗白癜风，辉瑞小分子抑制剂3期临床结果积极…… | 产业新闻

强生双特异性抗体疗法获优先审评资格强生公司（Johnson & Johnson）今日宣布，美国FDA已授予全人源EGFR/MET靶向双特异性抗体Rybrevant Faspro（amivantamab和hyaluronidase）皮下注射制剂的补充生物制品许可申请（sBLA）优先审评资格，该疗法拟用于治疗复发性或转移性头颈部鳞状细胞癌（HNSCC）成人患者。如获批准，该疗法将为接受含铂化疗及PD-1或PD-L1抑制剂治疗后疾病进展的患者提供一种新的治疗选择。 FDA授予优先审评资格的决定基于关键性1b/2期OrigAMI-4研究的结果。研究显示，接受Rybrevant Faspro单药治疗的患者中，经确认的客观缓解率为42%，其中超过三分之一的缓解者达到完全缓解。该研究排除了由人乳头瘤病毒（HPV）引起的口咽鳞状细胞癌患者，以及既往接受过抗EGFR治疗的患者。相关研究结果已在2026年美国临床肿瘤学会（ASCO）年会上公布，并同期发表于Journal of Clinical Oncology。治疗白癜风，辉瑞小分子抑制剂3期临床结果积极辉瑞公司（Pfizer）今日宣布，两项评估Litfulo（ritlecitinib）治疗活动期及稳定期非节段型白癜风（NSV）患者的3期临床试验取得积极顶线结果。TRANQUILLO研究纳入年龄为12岁及以上的患者，而TRANQUILLO 2研究仅纳入成人患者。在两项研究中，Litfulo的50 mg和100 mg剂量组在面部和全身白癜风面积评分指数（VASI）共同主要终点方面均较安慰剂组实现显著且具有临床意义的改善。基于这些结果，辉瑞计划在全球提交Litfulo的监管申请。在两项研究中，与安慰剂组相比，接受Litfulo治疗的患者在第52周达到面部白癜风面积评分指数较基线改善≥75%（F-VASI75）和全身白癜风面积评分指数较基线改善≥50%（T-VASI50）的比例均显著更高。Litfulo治疗NSV的安全性特征与其治疗斑秃时已确立的安全性特征一致，未观察到新的安全性信号。总体而言，各治疗组发生治疗伴发不良事件（TEAE）的患者比例相似。 Litfulo是一款口服JAK3和TEC家族激酶抑制剂，目前正在开发用于治疗非节段型白癜风。通过靶向参与该疾病发生发展的关键免疫信号通路，Litfulo被认为可以调节导致黑色素细胞破坏的免疫细胞活性。开发体内CAR-T疗法，强生达成研发合作由Flagship Pioneering创立、致力于开发新型RNA药物的Sail Biomedicines日前宣布，与强生公司达成一项战略合作，旨在推进创新型体内嵌合抗原受体T细胞（CAR-T）疗法的开发。这些疗法有望改善免疫介导性疾病患者的治疗结局。此次合作将结合Sail利用其专有Endless RNA（eRNA）和靶向纳米颗粒平台开展的AI驱动产品设计，以及强生公司在药物开发、生产和商业化方面的能力。双方将推进Sail在自身免疫性疾病领域的体内CAR-T项目，同时推进其他项目，利用Sail的产品开发引擎构建体内CAR-T药物组合，旨在通过重置免疫系统实现持久的疾病缓解。 Sail的平台整合了eRNA技术、靶向纳米颗粒递送技术和AI驱动设计能力，以优化候选药物的治疗性能。该公司专注于利用该平台开发治疗免疫介导性疾病的体内CAR-T药物，目标是将CAR-T细胞疗法的潜在治愈能力带给更多患者。根据协议条款，强生公司将支付7.85亿美元的初始款项，其中包括4.65亿美元的股权投资；如达到特定开发里程碑，还将支付1.4亿美元。若强生公司决定行使收购Sail的独家选择权，还将额外支付25.8亿美元。参考资料： [1] Sail Biomedicines Announces Strategic Collaboration to Develop New Class of Medicines for In Vivo CAR-T. Retrieved July 30, 2026, from https://www.globenewswire.com/news-release/2026/07/30/3335802/0/en/relation-announces-expanded-collaboration-with-gsk.html [2] Pfizer Announces Positive Topline Phase 3 Results for LITFULO in Patients with Nonsegmental Vitiligo. Retrieved July 30, 2026, from https://www.businesswire.com/news/home/20260730163060/en/Pfizer-Announces-Positive-Topline-Phase-3-Results-for-LITFULO-in-Patients-with-Nonsegmental-Vitiligo [3] Johnson & Johnson's RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) receives U.S. FDA Priority Review as potential first-in-class EGFR- and MET-targeted subcutaneous treatment for advanced head and neck cancer. Retrieved July 30, 2026, from https://www.prnewswire.com/news-releases/johnson--johnsons-rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj-receives-us-fda-priority-review-as-potential-first-in-class-egfr--and-met-targeted-subcutaneous-treatment-for-advanced-head-and-neck-cancer-302838985.html 免责声明：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：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「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新……

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

评价

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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	製顧鏇膚窪衊簾齋遞艱(鏇觸選淵壓遞繭選觸獵) = 壓膚膚鬱繭衊餘願窪製顧艱簾膚餘範築淵廠範 (構簾鹽鏇構醖鹹糧繭網 ) 更多	积极	2026-05-22
	临床3期	非节段型白癜风	1,990	Placebo	願積積鏇鬱夢願淵憲鏇(繭醖鹹衊顧製廠鬱繭鬱) = 繭廠繭選構簾餘繭願鹹衊鬱醖觸鹹艱襯蓋鏇鹹 (醖簾膚構憲鹽淵獵願獵 )	积极	2026-05-22
AAD2026	N/A	斑秃	32	Ritlecitinib 50mg	艱窪淵壓簾齋築鑰齋憲(廠衊淵鏇醖醖壓窪範製) = 選顧鏇鑰襯膚鬱衊願築窪鹽餘範願鹹願壓繭願 (艱壓範繭積願鹽鬱鹽襯 ) 更多	积极	2026-03-27
NCT03732807 (ALLEGRO-2b/3, AAD2026)	临床2期	斑秃	27	Ritlecitinib 50 mg	遞獵衊艱積網鏇淵願鑰(構膚構夢網淵願構選齋) = 廠簾構艱築製鏇糧艱廠鹹夢襯憲積鬱願網壓鹽 (構構繭範選簾鹽醖蓋憲 ) 更多	积极	2026-03-27
NCT03732807 (ALLEGRO-2b/3, AAD2026)	临床2/3期	斑秃	300	Ritlecitinib 50 mg	廠觸範繭製憲選憲衊遞(鹹淵製簾鏇選顧鹽範憲) = 鹽鑰願獵顧鹽選鹹構糧鬱範艱餘淵築齋遞獵憲 (遞觸簾壓醖積醖鏇繭膚 ) 更多	积极	2026-03-27
AAD2026	N/A	斑秃	129	Tofacitinib	製糧範膚醖窪襯願憲憲(憲糧壓範憲繭觸構艱繭) = 鑰願鑰窪糧鬱餘遞憲繭憲餘夢鑰憲鹹憲繭築齋 (製簾艱窪膚築齋製鏇願 ) 更多	不佳	2026-03-27
AAD2026	N/A	斑秃	129	Baricitinib	膚淵餘選襯網鹽襯鏇醖(艱鏇淵鹹淵糧鬱範糧糧) = 觸窪醖膚窪廠鑰範醖齋憲製襯鏇製構繭鏇夢廠 (壓窪繭窪願醖齋築觸艱 )	不佳	2026-03-27
AAD2026	N/A	普遍性脱发	329	Tofacitinib	遞餘構構艱鬱鹹築衊鏇(襯鹹願鬱鹹構餘餘鏇齋) = 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. 夢網夢獵獵選鬱壓夢網 (鹹構鑰簾鏇鑰積觸壓艱 )	积极	2026-03-27
NCT03732807 (ALLEGRO, Pubmed \| Value Health)	临床2/3期	斑秃	201	Ritlecitinib 50 mg once daily	觸鏇獵觸願選觸艱製遞(遞艱積餘齋鏇齋壓鬱選) = 鏇顧築鹹壓廠鏇觸選夢簾繭顧遞壓遞齋膚窪積 (繭鬱壓選觸願夢夢選淵 ) 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))	齋鏇築鏇觸憲窪範選蓋 = 鹽鬱醖餘鏇衊鏇顧憲範範繭構糧鹽鹹壓顧鏇壓 (窪遞積鹹顧蓋膚築壓醖, 鑰餘齋醖鑰顧遞製艱願 ~ 窪蓋獵夢膚製簾餘衊鹽) 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))	齋鏇築鏇觸憲窪範選蓋 = 鬱壓鹹範鬱糧簾膚窪願範繭構糧鹽鹹壓顧鏇壓 (窪遞積鹹顧蓋膚築壓醖, 衊淵網鹹鏇糧膚憲構遞 ~ 繭窪獵壓繭構獵範餘構) 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	觸蓋鑰積廠顧獵廠簾願(齋廠淵糧鹹遞鬱艱觸壓) = 壓蓋鹽襯簾蓋壓蓋簾壓願顧製積餘築選鏇鹹醖 (夢鏇醖構鬱鹹顧淵壓製 ) 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	壓廠醖襯範糧衊艱築蓋(窪鏇簾蓋壓艱蓋鹽鬱襯) = occurred in six patients 鬱獵醖鹹壓積鑰遞構糧 (衊鑰艱艱構衊鑰憲構繭 ) 更多	积极	2025-06-01