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.

NCT07228390

/ Recruiting临床2期

A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 16-WEEK STUDY EVALUATING THE SAFETY AND EFFICACY OF RITLECITINIB (PF-06651600) IN ADULTS WITH MODERATE TO SEVERE HIDRADENITIS SUPPURATIVA

The purpose of this study is to learn about the safety and effects of the study medicine (called Ritlecitinib) for the possible treatment of hidradenitis suppurativa (HS). HS is a disease causing long lasting painful red skin lumps.
This study is seeking participants who:
* have moderate or severe HS
* have previously received antibiotics for HS that did not help, or could not tolerate antibiotics Participants will be randomly (like a flip of coin) assigned to receive either the study medicine or a placebo (a pill that looks like the study medicine but does not contain any medicine). The study medicine or placebo will be taken by mouth once daily at home. For the first part of the study, participants will receive a loading (starting) dose. For the next part of the study, participants will receive a maintenance (ongoing) dose.
Participants will take part in the study for about 24 weeks (about 6 months). There will be about 10 study clinic visits: a screening visit, Day 1, and then every 1, 2, or 4 weeks until week 16. At each visit, participants will report on their health and have tests such as physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will record when they take the study medicine and their HS symptoms every day in an eDiary on a mobile phone.
The experiences of participants receiving the study medicine will be compared to those receiving placebo to help see if the study medicine is safe and effective.

开始日期2025-11-13

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

登录后查看更多信息

100 项与甲苯磺酸利特昔替尼相关的转化医学

登录后查看更多信息

100 项与甲苯磺酸利特昔替尼相关的专利（医药）

登录后查看更多信息

236

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.

437

项与甲苯磺酸利特昔替尼相关的新闻（医药）

11 小时之前

·九洲药业

【速递】从对症缓解到根源干预 | 白癜风治疗现状与当下靶点药物新机遇

每年的6月25日是“世界白癜风日”（World Vitiligo Day）。该纪念日旨在提高公众对白癜风的认知、减少社会污名，并推动全球在诊疗与研究领域的进展。该日期的设立与迈克尔·杰克逊有关（其生日为6月25日，他本人也公开患有白癜风），以提高公众关注度。长期以来，白癜风一直被误解为“单纯的皮肤美观问题”，但事实上，白癜风是一种以黑色素细胞破坏为特征的慢性获得性色素脱失性疾病，具有明确的免疫学基础，并常与其他自身免疫性疾病（如甲状腺相关疾病）存在相关性。临床观察显示，许多患者所承受的心理负担与社会歧视，往往远超疾病本身的躯体影响。 JiuZhou Express 一、现有治疗方案及临床痛点白癜风通常分为：非节段型白癜风（最常见，呈对称或泛发性）节段型白癜风（局限分布，相对稳定）传统治疗体系目前临床治疗主要包括“四大支柱”： ✔外用糖皮质激素（TCS）适用于早期、小面积皮损，是一线治疗之一。 ✔外用钙调神经磷酸酶抑制剂（TCI）如他克莫司、吡美莫司，常用于面颈部等敏感区域。 ✔光疗窄谱中波紫外线（NB-UVB） 308nm准分子光/激光是目前促进复色常用物理治疗手段之一。 ✔ 系统性糖皮质激素主要用于快速进展期，以短期控制病情为目标。主要临床痛点复色缓慢且不完全：尤其是手足、指端及黏膜区域反应较差。长期用药副作用：外用激素可能导致皮肤萎缩等问题；系统用药存在代谢与全身副作用风险。使用负担重：大面积皮损患者长期外用治疗依从性较差。复发问题突出：停药或停止光疗后部分区域可再次脱色，提示存在“免疫记忆”机制。二、新兴治疗进展：机制导向的突破近年来研究集中于“IFN-γ—JAK-STAT通路”相关的免疫调控机制，使JAK抑制剂成为最活跃的研发方向之一。 JAK抑制剂相关治疗 ✔ 芦可替尼乳膏（Ruxolitinib cream）目前是首个获得FDA批准用于白癜风的外用JAK1/2抑制剂。 Ⅲ期TRuE-V1/V2研究显示：治疗52周后，约半数患者面部复色达到较显著改善（F-VASI75水平），安全性总体良好，以轻度局部不良反应为主。 ✔ 口服JAK抑制剂（研究阶段为主）乌帕替尼（Upadacitinib，JAK1抑制剂）瑞特西替尼（Ritlecitinib，JAK3/TEC抑制剂） Povorcitinib（选择性JAK1抑制剂）现有临床研究显示，这些药物在部分患者中可改善面部及全身白斑，但目前仍主要处于临床试验阶段。其他在研或辅助疗法外用JAK1抑制剂（如SHR0302等在研制剂）部分国产及国际药物仍处于早期或中期临床研究阶段。 PDE4抑制剂（如罗氟司特乳膏）通过抗炎及调节免疫微环境，早期研究显示在部分患者中可能促进复色。 α-MSH类似物（如Afamelanotide）多以植入剂或联合光疗形式研究使用，可增强光疗反应，但目前仍属辅助探索性治疗。重要提示：口服或系统免疫调节药物在带来疗效潜力的同时，也需要重点关注感染风险及其他系统性不良反应，必须在严格医学监测下使用。白癜风治疗药物汇总表三、未来方向：从控制到长期稳定 “免疫记忆”清除策略研究发现，皮肤中残留的组织驻留记忆T细胞（TRM细胞）可能参与复发过程，其存活与IL-15信号相关。因此，针对IL-15或相关通路的生物制剂（如AMG 714等）正在研究中，有望在未来降低复发风险，但目前仍未进入成熟临床应用阶段。联合治疗成为主流趋势未来治疗更可能采用多模态组合策略：系统免疫调节（抑制疾病活动）局部药物（促进复色）光疗（增强黑色素再生）必要时结合移植技术（如稳定期皮肤移植）治疗将更强调分型、分期与个体化策略。人工智能辅助精准医疗 AI在白斑影像识别、进展预测与疗效评估方面具有潜力，有望帮助医生更早识别进展风险并优化治疗窗口，但目前仍处于辅助工具阶段，而非独立决策系统。总结白癜风的治疗正从传统“经验性治疗”逐步迈向“机制驱动的精准免疫调控时代”。 JAK抑制剂的出现标志着重要突破，但整体治疗仍以长期控制、促进复色与降低复发风险为核心目标，而非真正意义上的“根治”。参考文献 1. Qiu, Y., et al. (2026). Recent Advances in Vitiligo Treatment. ImmunoTargets and Therapy, 15, 1-12. 2. Hebebrand, M. (2026). A New Era in Vitiligo Management: From Topicals to Systemic Orals. Dermatology Times, 47(3), 18-22. 3. Ezzedine, K., Tannous, R., Pearson, T. F., & Harris, J. E. (2025). Recent clinical and mechanistic insights into vitiligo offer new treatment options for cell-specific autoimmunity. Journal of Clinical Investigation, 135(1), e185785. 4. Hamzavi, I., et al. (2026). Treatment priorities and unmet needs according to adults and adolescents with nonsegmental vitiligo in the United States. Journal of Dermatological Treatment, 37(2), 104-111. 5. Passeron, T., et al. (2024). Efficacy and safety of oral ritlecitinib in patients with active non-segmental vitiligo: a randomized, double-blind, phase 2b clinical trial. The Lancet, 403(10432), 1151-1160. 免责声明本公众号注明原创的内容权利均属九洲药业所有，未经授权，不得擅自使用或许可他人使用。如需获得授权，请和九洲药业提前联系。已获得授权的，应在授权范围内使用，并注明来源且不得再全部或部分转授权他人。本公众号对转载、分享的内容、陈述、观点判断保持中立，不对所包含内容的合法性、准确性、可靠性或完善性提供任何明示或暗示的保证，该等内容版权归原作者所有，仅供学习参考之用，若对转载、分享的内容有任何权利疑问，烦请联系九洲药业。

22 小时之前

·信狐药迅

四款1类国产新药：江苏威凯尔维卡格雷、华奥泰HB0017、正大天晴维特柯妥拜单抗、上海泰昶VGR-R01提交上市申请|新受理（6.22-6.28）

本周药品注册受理数据，分门别类呈现，一目了然。(6.22-6.28）新药上市申请药品名称企业注册分类受理号维卡格雷胶囊江苏威凯尔医药科技股份有限公司 1 CXHS2600091 HB0017注射液上海华奥泰生物药业股份有限公司 1 CXSS2600100 注射用维特柯妥拜单抗上海正大天晴医药科技开发有限公司 1 CXSS2600096 VGR-R01 上海泰昶生物技术有限公司 1 CXSS2600097 新药临床申请药品名称企业注册分类受理号 CS0159片凯思凯迪(上海)医药科技股份有限公司 1 CXHL2600763 IG001119片阳光安津(南京)生物医药科技有限公司 1 CXHL2600765 IG001119片阳光安津(南京)生物医药科技有限公司 1 CXHL2600764 EIK1005片诺为泰医药科技(上海)有限公司 1 CXHL2600768 EIK1005片诺为泰医药科技(上海)有限公司 1 CXHL2600767 EIK1005片诺为泰医药科技(上海)有限公司 1 CXHL2600766 SA030注射液苏州时安生物技术有限公司 1 CXHL2600757 HRS-4139片福建盛迪医药有限公司 1 CXHL2600756 HRS-4139片福建盛迪医药有限公司 1 CXHL2600755 HRS-4139片福建盛迪医药有限公司 1 CXHL2600754 DX1002片广州安好医药科技有限公司 1 CXHL2600759 WD-890片浙江文达医药科技有限公司 1 CXHL2600760 注射用QHL-1231 上海亲合力生物医药科技股份有限公司 1 CXHL2600758 EIK1001注射液诺为泰医药科技(上海)有限公司 1 CXHL2600746 HE006片南昌弘益药业有限公司 1 CXHL2600751 HE006片南昌弘益药业有限公司 1 CXHL2600750 吸入用BD77 百灵毓秀(珠海)医药有限公司 1 CXHL2600749 177Lu-JLT003注射液北京吉伦泰医药有限公司 1 CXHL2600748 BST01散深圳鼎邦生物科技有限公司 1 CXHL2600747 AHB-137注射液杭州浩博医药有限公司 1 CXHL2600743 MT2004胶囊西安奥立泰医药科技有限公司 1 CXHL2600745 MT2004胶囊西安奥立泰医药科技有限公司 1 CXHL2600744 SYH9087注射液北京抗创联生物制药技术研究有限公司 2.2 CXHL2600762 TH5112 吉林天衡药业有限公司 2.2 CXHL2600761 BCM993 上海云晟研新生物科技股份有限公司 2.2 CXHL2600753 左氧氟沙星雾化吸入溶液浙江百代医药科技有限公司 2.4 CXHL2600752 新型流感病毒mRNA疫苗华兰生物疫苗股份有限公司 1.2 CXSL2600658 EP-0210单抗注射液成都优洛生物科技有限公司 1 CXSL2600678 ELPIS人脐带间充质干细胞注射液北京顺欣祥宇生物科技有限公司 1 CXSL2600679 META 10-19注射液深圳莱芒生物科技有限公司 1 CXSL2600672 META 10-19注射液深圳莱芒生物科技有限公司 1 CXSL2600671 注射用YL217 苏州宜联生物医药有限公司 1 CXSL2600675 BXP-001注射液深圳贝湾生物科技有限公司 1 CXSL2600674 META 10-19注射液深圳莱芒生物科技有限公司 1 CXSL2600673 EP-0210单抗注射液成都优洛生物科技有限公司 1 CXSL2600677 注射用BL-M09D1 成都百利多特生物药业有限责任公司 1 CXSL2600676 SCT650C 注射液神州细胞工程有限公司 1 CXSL2600668 靶向CD19基因修饰的异体嵌合抗原受体T细胞注射液上海邦耀生物医药有限公司 1 CXSL2600663 TQB2922注射液(皮下注射) 上海正大天晴医药科技开发有限公司 1 CXSL2600667 注射用HS-20110 上海翰森生物医药科技有限公司 1 CXSL2600666 HS-20117-2注射液上海翰森生物医药科技有限公司 1 CXSL2600665 注射用BL-B01D1 百时美施贵宝(中国)投资有限公司 1 CXSL2600664 SKB118注射液四川科伦博泰生物医药股份有限公司 1 CXSL2600669 Pumitamig注射液百时美施贵宝(中国)投资有限公司 1 CXSL2600670 注射用BLB101 江苏贝联生物科技有限公司 1 CXSL2600661 SCTB41注射液神州细胞工程有限公司 1 CXSL2600662 TVAX-008注射液远大赛威信生命科学(杭州)有限公司 1 CXSL2600659 注射用LYNC-101 翎泰天润生物技术(上海)有限公司 1 CXSL2600660 仿制药申请药品名称企业注册分类受理号坎地沙坦酯氢氯噻嗪片(Ⅱ) 合肥合源药业有限公司 3 CYHS2601502 氨溴特罗口服溶液重庆科瑞南海制药有限责任公司 3 CYHS2601508 盐酸溴己新口服溶液广东南国药业有限公司 3 CYHS2601507 盐酸溴己新口服溶液广东南国药业有限公司 3 CYHS2601506 注射用甲磺酸萘莫司他广东健信制药股份有限公司 3 CYHS2601505 注射用甲磺酸萘莫司他广东健信制药股份有限公司 3 CYHS2601504 聚普瑞锌口崩片吉林省博大伟业制药有限公司 3 CYHS2601515 比拉斯汀口崩片山东朗诺制药有限公司 3 CYHS2601514 硫酸特布他林注射液江苏福邦药业有限公司 3 CYHS2601511 硫酸特布他林注射液江苏福邦药业有限公司 3 CYHS2601509 1.5 mmol/L钙碳酸氢钠血滤置换液成都青山利康药业股份有限公司 3 CYHS2601492 盐酸苯海拉明注射液安徽威尔曼制药有限公司 3 CYHS2601497 碳酸氢钠血滤置换液(钾2mmol/L无钙) 石家庄四药有限公司 3 CYHS2601500 注射用甲磺酸萘莫司他浙江同伍生物医药有限公司 3 CYHS2601495 注射用甲磺酸萘莫司他浙江同伍生物医药有限公司 3 CYHS2601494 注射用甲磺酸萘莫司他重庆莱美药业股份有限公司 3 CYHS2601499 铝镁匹林片(II) 唐山利康药业有限责任公司 3 CYHS2601479 草酸艾司西酞普兰口服溶液常州四药制药有限公司 3 CYHS2601486 注射用磷霉素钠海南全星制药有限公司 3 CYHS2601484 注射用磷霉素钠海南全星制药有限公司 3 CYHS2601483 注射用磷霉素钠海南全星制药有限公司 3 CYHS2601481 磷酸奥司他韦颗粒浙江尖峰药业有限公司 3 CYHS2601485 左氧氟沙星滴耳液武汉五景药业有限公司 3 CYHS2601468 米诺地尔搽剂湖北长江瑞益医药科技有限公司 3 CYHS2601475 米诺地尔搽剂湖北长江瑞益医药科技有限公司 3 CYHS2601474 注射用甲磺酸萘莫司他北京赛升药业股份有限公司 3 CYHS2601465 注射用甲磺酸萘莫司他北京赛升药业股份有限公司 3 CYHS2601464 注射用甲磺酸萘莫司他广州瑞尔医药科技有限公司 3 CYHS2601470 注射用甲磺酸萘莫司他广州瑞尔医药科技有限公司 3 CYHS2601469 盐酸多西环素片福建海西新药创制股份有限公司 3 CYHS2601459 乙酰半胱氨酸片浙江金华康恩贝生物制药有限公司 3 CYHS2601460 苯磺酸左氨氯地平片安徽肽渡生物医药科技有限公司 4 CYHS2601503 甲硝唑凝胶湖北长江瑞益医药科技有限公司 4 CYHS2601501 克霉唑阴道片成都倍特药业股份有限公司 4 CYHS2601513 氨甲环酸片重庆科瑞制药(集团)有限公司 4 CYHS2601512 复方托吡卡胺滴眼液北京汇恩兰德制药股份有限公司 4 CYHS2601510 溴芬酸钠滴眼液石家庄四药有限公司 4 CYHS2601517 卡贝缩宫素注射液南京海纳制药有限公司 4 CYHS2601516 乌帕替尼缓释片山东济坤生物制药有限公司 4 CYHS2601493 美沙拉秦栓牡丹江恒远药业股份有限公司 4 CYHS2601498 克林霉素磷酸酯外用溶液杭州万邦天诚药业有限公司 4 CYHS2601496 氧昆明卡斯尔化工产品有限公司 4 CYHS2601480 氯替泼诺混悬滴眼液津药和平(天津)制药有限公司 4 CYHS2601478 依达拉奉右莰醇注射用浓溶液新乡市常乐制药有限责任公司 4 CYHS2601487 注射用紫杉醇(白蛋白结合型) 广州玻思韬控释药业有限公司 4 CYHS2601482 盐酸莫西沙星氯化钠注射液浙江都邦药业股份有限公司 4 CYHS2601488 艾拉莫德片华北制药股份有限公司 4 CYHS2601490 阿达帕林过氧苯甲酰凝胶要智达(武汉)医药有限公司 4 CYHS2601489 艾托格列净片山东诺明康药物研究院有限公司 4 CYHS2601491 醋酸地非法林注射液成都诺和晟鸿生物制药有限公司 4 CYHS2601463 硝苯地平控释片山东鲁抗医药集团赛特有限责任公司 4 CYHS2601467 巴瑞替尼片广州大光制药有限公司 4 CYHS2601466 注射用甲泼尼龙琥珀酸钠武汉人福药业有限责任公司 4 CYHS2601473 注射用甲泼尼龙琥珀酸钠武汉人福药业有限责任公司 4 CYHS2601472 马来酸左氨氯地平片常州瑞明药业股份有限公司 4 CYHS2601477 马来酸左氨氯地平片常州瑞明药业股份有限公司 4 CYHS2601476 环硅酸锆钠散南京正大天晴制药有限公司 4 CYHS2601462 环硅酸锆钠散南京正大天晴制药有限公司 4 CYHS2601461 水痘减毒活疫苗北京万泰生物药业有限公司 3.3 CXSS2600098 重组人促卵泡激素注射液齐鲁制药有限公司 3.3 CXSS2600102 重组人促卵泡激素注射液齐鲁制药有限公司 3.3 CXSS2600101 破伤风人免疫球蛋白郑州莱士血液制品有限公司 3.4 CXSS2600099 硝呋太尔制霉菌素阴道软胶囊广东恒健制药有限公司 4 CYHL2600075 盐酸艾司氯胺酮鼻喷雾剂宜昌人福药业有限责任公司 4 CYHL2600074 进口申请药品名称企业注册分类受理号甲苯磺酸他拉唑帕利胶囊 Pfizer Europe MA EEIG 2.4 JXHS2600071 甲苯磺酸他拉唑帕利胶囊 Pfizer Europe MA EEIG 2.4 JXHS2600070 甲苯磺酸他拉唑帕利胶囊 Pfizer Europe MA EEIG 2.4 JXHS2600069 甲苯磺酸他拉唑帕利胶囊 Pfizer Europe MA EEIG 2.4 JXHS2600068 恩考芬尼胶囊 PIERRE FABRE MEDICAMENT 5.1 JXHS2600072 托雷奇单抗注射液 AstraZeneca AB 1 JXSS2600055 莱达西贝普注射液 LIB Therapeutics, Inc. 3.1 JXSS2600054 Laroprovstat瑞舒伐他汀片 AstraZeneca AB 1 JXHL2600223 Laroprovstat瑞舒伐他汀片 AstraZeneca AB 1 JXHL2600222 甲苯磺酸利特昔替尼胶囊 Pfizer Inc. 2.4 JXHL2600226 甲苯磺酸利特昔替尼胶囊 Pfizer Inc. 2.4 JXHL2600225 Encorafenib胶囊 Pfizer Inc. 5.1 JXHL2600227 Elafibranor片 Ipsen Biopharmaceuticals 5.1 JXHL2600224 Mezagitamab注射剂 Takeda Development Center Americas, Inc. 1 JXSL2600147 AZD2287 AstraZeneca AB 1 JXSL2600149 AZD2284 AstraZeneca AB 1 JXSL2600148 DS-1062a ASTRAZENECA AB 2.2 JXSL2600150 中药相关申请药品名称企业注册分类受理号小儿化积颗粒海南葫芦娃药业集团股份有限公司 2.2 CXZS2600034 泻白散颗粒广州王老吉药业股份有限公司 3.1 CXZS2600033 清金化痰汤颗粒湖南九典制药股份有限公司 3.1 CXZS2600032 薷蒿达湿颗粒杭州鸿育医药科技有限公司 1.1 CXZL2600056 注：绿色字体部分为潜在首仿品种；咸达数据2026年5月每月药讯已出！关注“咸达数据”，微信关键词回复 ” 年+月，如202605” 获得最新药迅！不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

疫苗申请上市信使RNA

2026-06-28

·化妆品知识科普

免疫、激素、代谢三维靶向：新一代防脱靶点前沿科普

雄激素性脱发（AGA）与休止期脱发是大众最常见两类脱发。传统防脱方案多聚焦雄激素、血管扩张，仅能缓解部分症状；近年干细胞、皮肤免疫、细胞代谢领域研究证实，毛囊干细胞持续休眠是两类脱发共通核心病理，JAK、TREM2、PRLR、MPC、NPC六大靶点，分别从免疫微环境、内分泌激素、细胞能量代谢三层通路调控毛囊静息开关，形成全新多维度防脱体系。本文结合现代医学研究进展，系统拆解各靶点作用逻辑与应用前景。一、核心共用通路：JAK-STAT5是毛囊休眠总开关无论免疫、激素还是代谢信号，最终都会汇聚至JAK-STAT5通路，这条通路是锁定毛囊干细胞休眠的核心分子枢纽，也是所有新兴靶点的共同底层逻辑。真皮巨噬细胞分泌OSM、催乳素结合毛囊PRLR受体后，均会激活细胞内JAK激酶，使STAT5蛋白磷酸化并入核，持续抑制毛囊干细胞增殖分化，拉长休止期、抑制生长期启动，最终表现为掉发增多、新发细软、毛囊微小化。雄激素脱发伴随长期慢性炎症，休止期脱发由压力、产后、熬夜引发激素紊乱，二者都会过度激活STAT5，加重毛囊休眠状态。靶点一：抑制JAK，直接切断休眠信号 JAK抑制剂是目前唯一完成大规模人体临床试验、获批上市的靶向防脱药物，成熟度最高。作用原理：阻断JAK1/JAK2/JAK3激酶活性，抑制OSM、催乳素、炎症因子上游信号传导，下调STAT5活化，同步减轻头皮炎症浸润、恢复毛囊免疫豁免权。对于斑秃、休止期脱发、轻中度雄脱均有效，可同时缓解免疫攻击与干细胞休眠双重问题。临床进展：口服巴瑞替尼、利特昔替尼、国产吉卡昔替尼已获批重度斑秃；外用JAK小分子制剂进入二期临床，规避口服全身副作用。三期数据显示，规范治疗24周可显著提升毛囊密度、缩短休止期时长。局限：仅阻断下游信号，无法解决上游巨噬细胞过度活化、催乳素升高、代谢异常根源，停药后通路易复燃，需搭配上游靶点协同使用。二、免疫微环境靶点：TREM2，解除毛囊“休眠刹车” 皮肤真皮层TREM2⁺巨噬细胞是维持毛囊静息的关键免疫细胞，也是前文科普文章核心机制，在压力型、炎症型休止期脱发中作用突出。作用原理：慢性压力、头皮炎症会诱导TREM2巨噬细胞大量增殖，持续释放OSM因子，持续激活JAK-STAT5，死死锁住毛囊干细胞，相当于给毛囊踩死刹车；抑制TREM2可减少巨噬细胞OSM分泌，从源头降低STAT5活性，唤醒休眠毛囊。同时改善真皮微环境，提升促生发Treg细胞功能，平衡免疫“油门与刹车”。研究阶段：目前仅小鼠模型、人体毛囊体外培养验证有效，中和OSM抗体、TREM2小分子抑制剂均处于临床前研发，暂无上市制剂。适用人群：熬夜焦虑、术后产后、头皮敏感炎症诱发的休止期脱发，对单纯激素型雄脱单独使用效果有限。三、内分泌激素靶点：降低催乳素、阻断PRLR，改善激素源性脱发催乳素（PRL）紊乱是女性休止期脱发、女性型雄激素脱发的隐藏诱因，产后、长期熬夜、情绪压抑人群极易出现血清或头皮局部催乳素升高。靶点二：阻断PRLR（催乳素受体）作用原理：毛囊外根鞘高表达PRLR，催乳素与受体结合后独立激活JAK2-STAT5通路，加速毛囊提前进入退行期、延长休止期；阻断PRLR可阻止激素信号传入毛囊上皮，不干扰全身性激素平衡，区别于传统抗雄药物。前沿进展：全球首款抗PRLR生发抗体ABS-201已进入一期临床，专门针对高催乳素相关脱发，规避非那雄胺性功能、内分泌紊乱副作用，是女性脱发全新赛道。靶点三：降低循环催乳素通过调节下丘脑-垂体功能减少体内催乳素分泌，适配高泌乳素血症、产后脱发人群。与PRLR阻断属于上下游搭配：前者减少激素生成，后者阻断毛囊接收信号，双重抑制STAT5通路，协同改善休止期大量掉发。四、细胞代谢底层靶点：MPC、NPC，调控干细胞信号敏感度激素与免疫信号能否成功激活STAT5，完全由毛囊细胞内代谢状态决定，MPC、NPC是调控代谢的两大核心载体，也是近年脱发新药研发热门方向。靶点四：调节线粒体丙酮酸载体MPC 作用原理：MPC是线粒体内丙酮酸转运蛋白，MPC高活性时，毛囊干细胞偏向氧化代谢，对OSM、催乳素、STAT5休眠信号极度敏感；抑制MPC会迫使细胞切换糖酵解模式，生成乳酸阻断STAT5核转位，即便存在激素、炎症抑制信号，干细胞仍能自主启动增殖，唤醒微小化休眠毛囊。同时MPC调控Treg、巨噬细胞极化，间接减少OSM释放，形成代谢-免疫双向正向调节。临床突破：MPC抑制剂PP405完成二期临床，不干预雄激素通路，无激素相关副作用，试验数据显示31%受试者毛囊密度提升20%以上，兼顾雄脱与休止期脱发，是区别于传统药物的全新代谢类靶点。靶点五：下调NPC胆固醇转运载体 NPC蛋白负责毛囊干细胞内胆固醇转运，胆固醇堆积会放大STAT5转录活性，加重毛囊静息；同时升高真皮乳头DHT敏感性，加剧毛囊微小化。下调NPC可降低细胞内胆固醇蓄积，双重削弱雄激素与STAT5两条抑制通路，适配合并出油多、细软短发的雄激素脱发人群。目前NPC相关提取物仅应用于外用洗护，小分子抑制剂仍处于基础研究阶段。五、六大靶点通路关联与临床搭配逻辑六大靶点并非独立存在，而是形成三层联动调控网络：表层免疫层：抑制TREM2→减少OSM分泌；中层激素层：降催乳素、阻断PRLR→减少激素刺激；底层代谢层：调控MPC、下调NPC→降低细胞对抑制信号敏感度；共同下游：抑制JAK→阻断STAT5休眠总开关。雄激素脱发以雄激素敏感+代谢异常为主，优先搭配MPC、NPC、JAK抑制剂；产后、压力休止期脱发以激素紊乱、免疫失衡为主，优先TREM2、PRLR、降催乳素靶点；重度脱发可多靶点联用，从根源、通路、下游全方位解除毛囊休眠，弥补单一传统药物作用局限。六、现状总结与理性认知现阶段仅JAK抑制剂完成人体大规模临床，MPC抑制剂进入二期，PRLR抗体一期临床，TREM2、NPC靶点仍停留在基础动物实验。市面上多数洗护产品仅添加靶点相关植物提取物，作用强度远低于小分子药物，仅作辅助护理，无法替代正规治疗。传统防脱侧重扩张血管、抑制5α还原酶，仅能延缓毛囊萎缩；而JAK、TREM2、PRLR、MPC、NPC靶向通路直击毛囊干细胞休眠核心机制，覆盖雄激素脱发、休止期脱发核心病理。未来多靶点联合制剂将成为防脱研发主流，但仍需区分毛囊休眠与完全坏死：上述靶点仅能唤醒休眠毛囊，对晚期瘢痕、彻底微小化毛囊无再生效果，需理性看待各类靶向产品预期。

100 项与甲苯磺酸利特昔替尼相关的药物交易

登录后查看更多信息

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,

后查看更多信息

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,

后查看更多信息

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

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

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	蓋鬱衊繭獵鏇夢膚壓鹹(獵窪壓鬱構願蓋製壓鏇) = 廠醖膚膚夢窪夢鏇積築蓋積壓夢醖鹹鑰齋願繭 (鹹顧網遞蓋鹽選廠鑰醖 ) 更多	积极	2026-05-22
	临床3期	非节段型白癜风	1,990	Placebo	積淵廠鑰齋獵選醖蓋襯(夢繭鏇襯鬱艱簾淵顧醖) = 獵遞醖齋遞齋鹹築糧廠遞襯鏇壓製製積淵襯構 (構膚顧鏇獵觸淵壓齋構 )	积极	2026-05-22
AAD2026	N/A	斑秃	32	Ritlecitinib 50mg	網網夢選選壓艱簾築窪(淵衊選鏇餘顧積廠顧觸) = 糧鑰觸簾壓衊廠壓餘膚憲觸糧遞顧淵夢遞夢窪 (餘選醖餘遞繭夢築積顧 ) 更多	积极	2026-03-27
NCT03732807 (ALLEGRO-2b/3, AAD2026)	临床2/3期	斑秃	300	Ritlecitinib 50 mg	繭顧齋窪糧壓鏇築淵壓(鏇蓋衊遞鑰壓廠醖築遞) = 繭糧憲鹽遞淵淵製齋醖顧積膚網鹹願鬱選築餘 (顧鬱鹹艱鑰廠餘鏇積遞 ) 更多	积极	2026-03-27
NCT03732807 (ALLEGRO-2b/3, AAD2026)	临床2期	斑秃	27	Ritlecitinib 50 mg	憲醖淵遞壓獵膚繭鹹網(蓋鹽顧觸膚觸製壓獵壓) = 淵簾艱範構網膚鹽窪鏇窪艱築艱簾憲餘選膚糧 (願鏇齋鏇選範網願廠構 ) 更多	积极	2026-03-27
AAD2026	N/A	斑秃	129	Tofacitinib	衊積觸網夢鹹膚醖壓網(襯憲簾簾鑰簾網積夢願) = 鏇艱鹽齋願衊糧顧醖顧鹹積鏇壓鹹願糧蓋艱夢 (憲鏇餘艱窪襯獵觸積製 ) 更多	不佳	2026-03-27
AAD2026	N/A	斑秃	129	Baricitinib	鬱艱窪夢鹹鑰襯窪艱鬱(選願膚選膚衊選廠襯範) = 夢簾夢蓋積範製簾鑰餘衊構窪艱夢艱鹽齋鑰夢 (淵願遞鑰艱夢憲淵膚鏇 )	不佳	2026-03-27
AAD2026	N/A	普遍性脱发	329	Tofacitinib	夢築獵鬱觸繭憲艱願壓(憲艱襯糧範構網鑰淵願) = 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. 顧顧鹹糧選獵淵鏇鬱簾 (襯鹹憲鹽鏇願夢網齋鹹 )	积极	2026-03-27
NCT03732807 (ALLEGRO, Pubmed \| Value Health)	临床2/3期	斑秃	201	Ritlecitinib 50 mg once daily	鏇顧選簾觸淵觸觸艱構(顧顧廠繭糧衊鹹餘壓簾) = 範餘醖蓋夢憲構鑰顧遞鬱繭鏇夢鑰鹽願鬱艱積 (齋積製餘糧齋鬱夢鹹範 ) 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))	鏇網襯鹽鏇膚餘顧簾遞 = 憲製鏇糧廠夢齋蓋簾襯積衊範鹹鹽餘壓鹹獵遞 (衊夢鑰夢範壓糧網衊淵, 夢鬱醖壓繭衊繭齋窪憲 ~ 範窪膚顧襯夢醖鹽網齋) 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))	鏇網襯鹽鏇膚餘顧簾遞 = 餘觸獵壓襯襯顧製製願積衊範鹹鹽餘壓鹹獵遞 (衊夢鑰夢範壓糧網衊淵, 衊鏇夢憲網蓋積醖積衊 ~ 顧願構繭積鹹醖製鏇齋) 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	壓膚鹽簾鹽窪窪繭夢餘(遞壓廠襯獵餘繭鹹構憲) = 襯製憲鬱獵製艱廠憲蓋繭醖獵醖艱淵艱選鑰鹽 (餘繭遞鬱範鑰選構製齋 ) 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	選積構觸築齋齋憲憲窪(鏇鏇鏇夢願築觸簾醖鏇) = occurred in six patients 蓋廠鏇蓋網遞鏇積積衊 (觸蓋艱膚選艱獵艱膚築 ) 更多	积极	2025-06-01