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2025-09-30

申办/合作机构

Icahn School of Medicine at Mount Sinai

NCT07029828

/ Not yet recruiting临床3期

A LONG-TERM, DOUBLE-BLIND EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN PARTICIPANTS WITH SEVERE ALOPECIA AREATA WHO PREVIOUSLY COMPLETED STUDIES B7981027 OR B7981031

The purpose of this clinical trial is to learn about long-term safety and long-term effects of the study medicine (called ritlecitinib) for the potential treatment of severe alopecia areata, a condition that causes hair loss.
This study is seeking participants who have:
* previously completed one of Pfizer's pediatric studies for Alopecia Areata (B7981027 or B7981031).
* at least 50% scalp hair loss due to alopecia areata (for participants enrolling from the study B7981031).
* received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports.
All participants in this study will receive the study medicine (ritlecitinib). Participants who received ritlecitinib higher or lower doses in the parent Study B7981027 will continue receiving the same ritlecitinib dose in this trial.
Participants who received placebo in the parent Study B7981027 and all participants from parent Study B7981031 will receive either higher or lower dose of ritlecitinib in this trial.
The study medicine is a capsule that is taken by mouth. It is taken 1 time each day at home.
The study will help see if ritlecitinib is safe and effective. Participants will take part in this study for a duration of up to 3 years (36 months). During this time, they will have 17 study visits at the study clinic. The study team will also call participants once a month over the phone.

开始日期2025-07-14

申办/合作机构

Pfizer Inc.

NCT07029711

/ Not yet recruiting临床3期

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Ritlecitinib in Pediatric Participants 6 to Less Than 12 Years of Age With Severe Alopecia Areata

The purpose of this study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the possible treatment of severe alopecia areata. Alopecia areata is a condition that causes hair loss.
This study is seeking participants who have:
* at least 50% scalp hair loss due to alopecia areata.
* received varicella vaccination (2 doses) or have been infected by varicella zoster virus before based on blood test reports.
* history of clinical response failure to alopecia areata treatment (for children in EU/UK only).
All participants in this study will receive either study medicine (ritlecitinib) or placebo. A placebo does not have any medicine in it but looks just like the medicine being studied.
One-third of participants will receive ritlecitinib higher dose, one-third participants will receive ritlecitinib lower dose, and one-third participants will receive placebo.
The study medicine is a capsule that is taken by mouth. It is taken once each day at home.
The study will compare the experiences of participants receiving ritlecitinib to participants receiving placebo. This will help see if ritlecitinib is safe and effective.
Participants will take part in this study for 6 months. During this time, they will have 8 study visits at the study clinic. The study team will also call participants about 8 times over the phone.

开始日期2025-07-14

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

186

项与甲苯磺酸利特昔替尼相关的文献（医药）

2025-08-01·BRITISH JOURNAL OF CLINICAL PHARMACOLOGY

Drug–drug interaction profile of ritlecitinib as perpetrator and victim through cytochrome P450

Article

作者: Kalluru, Hindu ; Lejeune, Alexandre ; Hee, Brian ; Purohit, Vivek S. ; Dowty, Martin E. ; Plotka, Anna ; Huh, Yeamin

Aims:

To assess the effect of a potent cytochrome P450 (CYP) 3A inhibitor and CYP inducer on the pharmacokinetics of ritlecitinib, a JAK3/TEC family kinase inhibitor, and assess the effect of ritlecitinib on the pharmacokinetics of CYP substrates (midazolam, efavirenz, tolbutamide, caffeine and oral contraceptives [ethinyl oestradiol and levonorgestrel]) in healthy adults.

Methods:

Seven clinical drug–drug interaction studies were analysed. Pharmacokinetic parameters for drugs as measured in blood plasma were used to estimate the drug interaction potential with ritlecitinib as a perpetrator or victim.

Results:

Midazolam exposure (area under plasma concentration–time curve from time 0 to infinity [AUCinf]) and peak exposure (maximum concentration [Cmax]) were increased by ≈169% and ≈80.1%, respectively, in the presence of ritlecitinib. Efavirenz exposure (AUC0–72) and peak exposure (Cmax) were similar in the presence and absence of ritlecitinib coadministration. Tolbutamide pharmacokinetic parameters (AUCinf and Cmax) were not affected by multiple ritlecitinib doses. In the presence of ritlecitinib, AUCinf and Cmax of caffeine increased by ≈165% and ≈10%, respectively. AUCinf and Cmax of ethinyl oestradiol decreased by ≈18% and ≈12%, respectively, following coadministration of multiple ritlecitinib 200 mg once‐daily doses, but no relevant change was observed following multiple 50 mg once‐daily doses. Ritlecitinib doses did not affect the pharmacokinetics of levonorgestrel. Coadministration following multiple itraconazole doses increased ritlecitinib AUCinf by ≈15%. Coadministration following multiple rifampicin doses decreased AUCinf of ritlecitinib by ≈45%.

Conclusions:

Ritlecitinib is a moderate inhibitor of CYP3A and CYP1A2. Strong CYP inducers can reduce ritlecitinib concentrations, but not to clinically relevant levels leading to lack of benefit.

2025-07-01·PHARMACOLOGICAL RESEARCH

Orally effective FDA-approved protein kinase targeted covalent inhibitors (TCIs): A 2025 update

Review

作者: Roskoski, Robert

Because aberrations of protein kinase activity play causal roles in several human diseases, this family of enzymes is one of the most important drug targets of the 21st century. Of the 88 protein kinase antagonists that are approved by the FDA, eleven of them form irreversible covalent complexes with their target enzymes. The clinical efficacy of ibrutinib, a Bruton tyrosine kinase blocker, in the treatment of mantle cell lymphoma following its 2013 approval helped to overcome a general bias against the development of irreversible drug inhibitors. Other approved targeted covalent inhibitors include acalabrutinib and zanubrutinib, which also block Bruton tyrosine kinase. Afatinib, dacomitinib, lazertinib, mobocertinib, and osimertinib inhibit members of the epidermal growth factor receptor family (ErbB1/2/3/4) and are used in the treatment of non-small cell lung cancers. Neratinib inhibits ErbB2 and is used in the management of ErbB2/HER2-positive breast cancer. Futibatinib blocks the fibroblast growth factor receptor family and is prescribed for the treatment of cholangiocarcinoma while ritlecitinib, which inhibits JAK3, is used in the management of alopecia areata. The eleven drugs considered in this review have a common mechanism of action involving the addition of a protein cysteine thiolate anion (proteinS:) to an acrylamide or an acrylamide-like derivative producing a thioether. The development of targeted covalent inhibitors is gaining acceptance as a valuable component of the medicinal chemist's toolbox and has made a significant impact on the development of protein kinase antagonists and receptor modulators.

2025-07-01·PEDIATRIC DERMATOLOGY

A Phase 1, Open‐Label Study of the Pharmacokinetics of Ritlecitinib in Children Aged 6–12 Years With Alopecia Areata

Article

作者: Huh, Yeamin ; Browning, John ; Zhu, Jing “Daisy” ; Smith, Stacy ; Wolk, Robert ; Gonzalez, Mercedes E. ; Plotka, Anna ; Parvatini, Shyam

ABSTRACT:

Background:

Alopecia areata (AA) is an autoimmune disease characterized by hair loss that can negatively impact quality of life. AA has a significant pediatric prevalence; however, no systemic treatments are approved for AA in patients aged < 12 years. Ritlecitinib, a JAK3/TEC family kinase inhibitor, is approved to treat adults and adolescents with severe AA aged ≥ 12 years. This study evaluated ritlecitinib pharmacokinetic (PK) parameters and safety in pediatric patients with AA aged 6 to < 12 years.

Methods:

In this single‐group, uncontrolled, open‐label study, participants received ritlecitinib 20 mg once daily for 7 days. PK parameters of ritlecitinib on Day 7 were measured and summarized descriptively. Safety outcomes, including incidence of adverse events (AEs), were evaluated.

Results:

Fifteen participants were enrolled and 14 (93.3%) completed the study. The median time to maximum concentration (Tmax) for plasma concentrations of ritlecitinib on Day 7 was ~0.5 h. The mean half‐life of ritlecitinib was ~1.19 h. Geometric means (% coefficient of variation) for area under the curve from 0 to 24 h (AUC24) and maximum concentration (Cmax) were 437.5 ng·h/mL (30%) and 208.7 ng/mL (38%), respectively. Four AEs were experienced by 3 participants, with 1 AE of urticaria resulting in permanent discontinuation. No severe AEs, serious AEs, or clinically meaningful laboratory abnormalities were reported.

Conclusions:

Ritlecitinib PK parameters in pediatric patients were successfully characterized in the present study. Ritlecitinib 20 mg once daily was generally well tolerated in pediatric patients with AA.

Trial Registration:

NCT05650333

251

项与甲苯磺酸利特昔替尼相关的新闻（医药）

2025-07-21

·动脉网

200亿蓝海市场，首个抑制剂上市在即

中国逾200亿元白癜风市场，下半年有望大爆发。2024年3月，康哲药业取得Incyte选择性口服JAK1抑制剂芦可替尼（povorcitinib）在中国及东南亚11国的独家许可权利。作为FDA唯一获批的外用JAK1/JAK2抑制剂，芦可替尼乳膏（商品名 Opzelura）于2022年7月获批白癜风适应症，并可用于皮损复色。白癜风适应症获批前一年，芦可替尼软膏全年销量仅470万美元。杀入白癜风市场后迅速放量，2024年已达5.1亿美元，暴涨109倍。有海外市场亮眼表现在先，康哲药业协同Incyte火速推进国内药物审批。芦可替尼乳膏白癜风适应症的Ⅲ期全球多中心临床试验于2024年6月开展，最优剂量组中，24周达到主要终点F-VASI75（面部白癜风面积评分指数）较基线降低至少75%的患者占比达到了29.9%，与艾伯维乌帕替尼片（19.1%）、辉瑞利特昔替尼胶囊（12.1%）拉出显著差距。国内真实世界研究也在同期展开。博鳌超级医院皮肤医学中心团队共在此项研究中纳入111名年龄大于12岁的非节段型白癜风患者。对应研究结果显示，49.5%的患者用药24周时面部白斑面积或色素恢复达到了75%的改善（F-VASI 75）；64.9%的患者达到50%的改善（FVASI 50）；17.1%的患者达到90%的改善（F-VASI 90）；13.6%的患者全身白斑面积或色素恢复达到了50%的改善（T-VASI 50）。2024年9月，NMPA已受理康哲药业递交的NDA，预期2025年下半年上市，抢滩在即。012300万患者蓝海市场，国内无药获批芦可替尼乳膏的临床进展之所以备受瞩目，是因为国内尚无获批白癜风适应症的化药上市，常规治疗药物也不能很好应对病情。作为一种色素脱失性皮肤病，白癜风常见却有着复杂的发病机制。现阶段研究认为：白癜风由皮肤黑素细胞被破坏导致，整个过程涉及自身免疫紊乱（如抗黑素细胞抗体攻击、T 细胞浸润）、氧化应激损伤、黑素细胞自毁、遗传易感性等多重机制。譬如在免疫通路中，JAK-STAT 通路被过度激活，会促使炎症因子释放，加剧对黑素细胞的攻击；氧化应激通路中，活性氧簇积累会损伤黑素细胞的结构和功能；黑素细胞自身代谢通路异常，如酪氨酸酶活性降低，会影响黑色素合成；细胞凋亡通路失衡，则会导致黑素细胞过度凋亡。正是因为“多因素叠加”与“多通路参与”，药物研发者很难以找到普适性的核心靶点，同时作用于上述所有路径。国内患者现阶段通常选择外用糖皮质激素、钙调磷酸酶抑制剂、维生素D衍生物、中药制剂等用药，可以一定程度控制皮损扩散、促进黑素细胞迁移和功能修复。但这些化药属于off-label，均未获批白癜风适应症，且每一种药物都在安全性和功能上存在局限性，若长期使用外用糖皮质激素可能导致皮肤萎缩，钙调磷酸酶抑制剂则易引起局部刺激，不能大面积使用。此外，高复发与慢见效也是众多白癜风患者面临的常态，致使很多患者在治疗过程中选择放弃。白癜风治疗常用药物及优缺点（数据来源：华福证券、蛋壳研究院）空白的市场中，中国亟需一批有效的、强针对性的药物，应对这里近2300万白癜风患者的潜在用药需求。这是康哲药业成立以来面临的最大机遇。02白癜风的“魔力”虽有Incyte独家许可在前，但置身200亿创新药蓝海，康哲药业也需面对一大批后来者的强力冲击。传统胃药和眼科老牌代理泰恩康当下最具竞争力。一方面，泰恩康握有的CKBA软膏由上海交大团队王宏林团队基于乳香天然产物结构改造而来，创新性地选择了NF-κB作为靶点，可抑制乙酰辅酶A羧化酶（ACC1/ACC2）的催化活性与脂肪酸代谢途径，调控皮肤组织中记忆性CD8+ TRM细胞的杀伤功能，避免其产生的 IFN-y杀伤黑素细胞，进而改善白癜风动物模型的白斑症状，最快本月内公布完整Ⅱ期临床试验完整数据。另一方面，2025年6月16日王宏林团队又联合杭州市第三人民医院许爱娥团队（曾负责CKBA软膏Ⅱ期临床试验Leading PI）在Immunity (IF 25.5)在线发布论文“Nociceptor-derived CGRP enhances dermal type I conventional dendritic cell function to drive autoreactive CD8+ T cell responses in vitiligo”。该研究首次揭示了白癜风致病新机制：“感觉神经元-CGRP-cDC1-CD8+ T细胞”神经免疫轴，阐明了感觉神经元及其通过CGRP-CALCRL轴向真皮cDC1细胞传递信号在白癜风发病中的关键作用，又借助改造的0.1% 瑞美吉泮软膏，阻断该神经免疫轴，在临床试验中展现出良好的治疗效果。泰恩康能否转化新的科研研究尚无定论，CKBA软膏的成功进展已为泰恩康谋得转机。白癜风药物的消费动力不亚于医美。好比司美格鲁肽，优质疗效自会引来泼天流量，推动产品快速落地市场。乐观预期下，泰恩康在二级市场中扶摇直上。即便已是连续两年业务不振，2024年营收萎缩5.23%，净利暴跌超三成，股价也能在一年之内连翻两番，由10元左右暴涨至超40元。这便是白癜风适应症的潜力？泰恩康外，国内JAK靶点阵营恒瑞医药SHR0302 碱凝胶、石药集团SYHX1901、明慧医药MH004乳胶膏，泽璟制药盐酸吉卡昔替尼、华东医药HDM3010等在研药物同样进展靠前，均选择JAK靶点（SYHX1901为Syk、JAK双靶点）。中国白癜风药物研发格局（数据来源：医药魔方、华福证券）石药集团的SYHX1901在上述药物之中拥有较为创新的机制。作为双靶点抑制剂，它对JAK 激酶和 SyK 激酶各亚型均展现出较强的抑制活性。参考SYHX1901在银屑病中的疗效，若在白癜风临床试验中能有效抑制炎症反应，减少免疫细胞对黑素细胞的攻击，理论上可促进黑素细胞的恢复和功能重建，实现白斑复色。华东医药HDM3010是目前国内白癜风适应症中进展最快的药品，从IND到开启白癜风适应症Ⅲ期临床试验用了不到一年时间。它的作用机制与芦可替尼乳膏一致，即通过JAK 抑制剂中断触发攻击正常黑色素细胞的免疫系统信号而发挥作用。如果Ⅲ期临床试验进展顺利且在今年年末前给出试验结果。HDM3010有望在2026年上半年完成上市。落后康哲药业约半年的身位，华东医药仍然保留着角逐百亿白癜风市场的空间。总的来说，虽然国内白癜风赛道仍是一片蓝海，但在主流JAK靶点上有康哲药业/Incyte、艾伯维、辉瑞在前，进展靠后的药企很难通过疗效突破后来居上。这是一个略显尴尬的时点。是追求审批速度尽快入场，还是同泰恩康一样寻求创新的机制，留给他们决断的时间已经不再充裕。*封面图片来源：123rf如果您认同文章中的观点、信息，或想进一步讨论，请与我们联系；也可加入动脉网行业社群，结交更多志同道合的好友。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。文中如果涉及企业信息和数据，均由受访者向分析师提供并确认。动脉网，未来医疗服务平台

临床3期免疫疗法上市批准

2025-07-17

·药事纵横

JAK抑制剂新上市！专治“寸草不生”

2025年7月14日，印度太阳制药（Sun Pharmaceutical Industries Limited）宣布，其治疗重度斑秃的新药LEQSELVI™（deuruxolitinib）8mg片剂已正式在美国上市，供医疗服务提供者和重度斑秃患者使用。该药适用于治疗成人重度斑秃，为这一疾病领域带来了全新的治疗选择。斑秃是一种自身免疫性疾病，免疫系统攻击毛囊，导致头皮和身体毛发部分或全部脱落。头皮是最常见的受累部位，但任何有毛发的部位都可能单独或与头皮同时受累。该疾病可终生发病，男性和女性均可发病。斑秃可能与严重的心理后果相关，包括焦虑和抑郁。Leqselvi是一种每天两次口服选择性Janus激酶(JAK)JAK1和JAK2抑制剂，旨在阻断Janus激酶(JAK)。这两种酶在严重斑秃的发病机制中起着关键作用。通过破坏这些通路，Leqselvi旨在阻止脱发进展并促进头发再生。该药获批用于治疗成人重度斑秃（头皮毛发脱落至少50%）是基于两项3期临床试验的积极结果：THRIVE-AA1(NCT04518995)和THRIVE-AA2(NCT04797650)。两项随机、双盲、安慰剂对照临床试验共纳入1223名18-65岁的重度斑秃患者（头皮脱发面积≥50%），评估了服药24周后的头皮毛发再生情况。结果显示，约三分之一的患者在24周时几乎恢复全部头发，3%的患者甚至在8周内就实现了80%以上的头皮覆盖率。这些数据充分证明了LEQSELVI™疗效显著且起效迅速。作为一种口服JAK1和JAK2抑制剂，LEQSELVI的推荐剂量为8mg，每日两次，可与食物同服或空腹服用。如果出现严重感染或血液学异常，可能需要中断治疗。在开始使用Leqselvi治疗之前，建议进行评估和免疫接种。需注意，该药禁用于CYP2C9慢代谢者及正在服用中强效CYP2C9抑制剂的患者，也不建议与其他JAK抑制剂、生物免疫调节剂等联用。其潜在风险包括严重感染、恶性肿瘤、心血管事件、血栓、胃肠道穿孔等，用药前需进行结核病筛查、CYP2C9基因型检测及血常规检查等。常见不良反应包括头痛、痤疮、鼻咽炎等。在医学领域，斑秃一直是个棘手的难题。它是一种自身免疫性疾病，免疫系统会错误地将毛囊当作敌人进行攻击，导致局部或广泛的脱发。在过去很长一段时间里，医学界始终没有找到有效的系统性治疗方案，直到JAK抑制剂出现，才为斑秃的治疗带来了新的希望。基于突破性的临床成果，Baricitinib于2022年6月获得FDA批准用于治疗严重斑秃成人患者，成为FDA批准的首个用于治疗斑秃的系统性疗法，其后，FDA于2023年6月批准Ritlecitinib上市，用于治疗12岁以上严重斑秃患者，这也是FDA首次批准用于重度斑秃青少年（12+）患者的治疗药物。从全球研发态势来看，斑秃治疗领域从2024年便迎来快速发展期。根据公开信息，全球约有70款在研新药处于不同开发阶段，其中多款已进入临床试验。这些在研药物的作用靶点也呈现出多元化趋势：除JAK靶点外，针对S1PR家族、OX40、LILRA4等创新靶点的探索，正在不断拓展临床治疗选择。相信在未来会有更多的创新药落地，为更多斑秃患者重拾健康与自信。Ref:https://www.prnewswire.com/news-releases/us-fda--approves-leqselvi-deuruxolitinib-an-oral-jak-inhibitor-for-the-treatment-of-severe-alopecia-areata-302207222.html药事纵横投稿须知：稿费已上调，欢迎投稿

上市批准临床3期突破性疗法临床结果

2025-07-14

·FiercePharma

Sun Pharma's alopecia med Leqselvi hits US market after Incyte patent settlement

Incyte's lawsuit claiming patent infringement had previously prevented Sun Pharma from launching its Leqselvi. After resolving a patent dispute with Incyte, Sun Pharma has officially launched its JAK inhibitor Leqselvi in the U.S.Sun’s Leqselvi is now available for prescription to eligible patients with severe alopecia areata nationwide, the company announced on Monday. The drug is poised to compete with Pfizer’s rivaling Litfulo and Eli Lilly and Incyte’s first-to-market Olumiant.“Adding Leqselvi to our dermatology portfolio represents a key milestone for the business and an important advancement for the alopecia areata community,” Sun’s CEO Richard Ascroft said in the company’s release.The launch comes after a legal back-and-forth with Incyte has now ended in a settlement agreement. While the specific terms of the settlement and license agreement are confidential, Incyte offered Sun a limited, non-exclusive license to certain patents for Leqselvi’s U.S. use in agreed-upon non-hematology/oncology indications, including alopecia areata. In exchange, Sun will pay Incyte an upfront plus royalty payments until the patents expire.The two will “mutually release” each other of claims stemming from the litigation and are to seek dismissal of the pending lawsuit at a New Jersey U.S. District Court, Sun announced in a separate press release.Incyte calls the agreement a “successful settlement” and a “positive outcome” that “aligns with Incyte’s long-term business objectives,” the company said in its own press release.Incyte had come after Sun and its Leqselvi with a 2024 lawsuit claiming that the drug is structurally identical to its own blockbuster JAK inhibitor franchise ruxolitinib, which is marketed as oral Jakafi and topical Opzelura. The patent in question covers ruxolitinib’s use in immune-related diseases, skin disorders, myeloid proliferative disorders and cancer.One main concern of Incyte’s suit was that Leqselvi would be sold at a lower price than Jakafi, potentially leading to off-label prescriptions of Sun’s cheaper option to treat indications covered by Incyte’s older offering. In its complaint, the company suggested that Leqselvi’s launch could prompt price erosion for Jakafi, lost licensing royalties from its Eli Lilly-partnered JAK inhibitor Olumiant in alopecia, layoffs and decreased R&D opportunities.Sun, for its part, maintained that its product doesn’t infringe on Incyte’s patent and the off-label concerns were speculative. Either way, Incyte’s lawsuit caused an injunction blocking Sun’s U.S. rollout, which was initially planned for October of last year after it snagged FDA approval in July. Leqselvi, or deuruxolitinib, is a deuterated form of ruxolitinib. Deuterated drugs replace hydrogen atoms with deuterium atoms to effectively boost a medicine’s pharmacokinetic properties.Sun scored a win from the U.S. Court of Appeals in April, gaining a clearance for Leqselvi to launch in the U.S.Leqselvi’s entrance in the alopecia market could signal a heated sales battle between Sun, Incyte and Pfizer. Pfizer’s Litfulo has the broadest label of the three, with an indication that covers both adults and adolescents, while the other two can only treat adults. Alopecia areata may impact up to 2.5% of the U.S. and global population during their lifetime, according to Sun.Pfizer has not revealed Litfulo sales outcomes since its 2023 approval, but Lilly reported $957 million in Olumiant sales over 2024. Incyte receives tiered, double-digit royalties from its Lilly collaboration on the drug, which is also approved to treat COVID-19 and rheumatoid arthritis.

上市批准专利侵权引进/卖出

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


NCT06172348 (CTgov)	临床1期	白癜风	12	Ritlecitinib (Ritlecitinib 100 mg Oral Solution (Fasted))	壓願築選衊夢淵網膚鏇(餘艱窪襯夢鑰遞網製襯) = 獵範構廠築顧醖願獵壓蓋簾鏇蓋構製簾繭願繭 (廠鑰蓋獵範願鏇選獵鏇, 24) 更多	-	2025-04-10
				MR1+Ritlecitinib (Ritlecitinib 100 mg MR1 Capsule (Fasted))	壓願築選衊夢淵網膚鏇(餘艱窪襯夢鑰遞網製襯) = 醖襯蓋壓憲願鬱廠願壓蓋簾鏇蓋構製簾繭願繭 (廠鑰蓋獵範願鏇選獵鏇, 25) 更多
ALLEGRO (Pubmed \| J Eur Acad Dermatol Venereol)	临床2/3期	斑秃	191	Ritlecitinib 50 mg	糧獵窪蓋膚夢遞構糧簾(鹽鑰壓鹹衊選構積選繭) = 簾餘築簾憲鬱鏇網觸廠憲齋簾衊衊糧憲選遞積 (糧餘餘淵鑰製襯選獵餘 ) 更多	积极	2025-02-17
NCT05650333 (Phase 1, Pubmed \| Pediatr Dermatol)	临床1期	斑秃	-	Ritlecitinib 20 mg	醖願襯築憲範襯艱淵廠(糧繭鑰觸鹽憲餘夢繭襯) = 夢繭衊夢艱鹽鑰餘製鑰築醖觸夢範糧顧壓鑰觸 (壓顧積範製鹽窪夢窪鑰 ) 更多	积极	2025-02-09
NCT04006457 (ALLEGRO, Pubmed \| Br J Dermatol)	临床2/3期	斑秃	-	Ritlecitinib 50mg daily	製選淵遞淵糧蓋積壓鏇(獵餘襯鑰繭鏇選製顧蓋) = 願選網繭淵憲鏇衊選窪醖衊醖襯顧鹹選艱網顧 (襯鑰構觸鏇繭構齋醖憲, 61.0/46.8 ~ 50.9) 更多	积极	2025-01-24
				Ritlecitinib 200mg/50mg daily	製選淵遞淵糧蓋積壓鏇(獵餘襯鑰繭鏇選製顧蓋) = 夢鏇鹽艱鏇襯鏇鑰憲艱醖衊醖襯顧鹹選艱網顧 (襯鑰構觸鏇繭構齋醖憲, 62.7/43.2 ~ 51.7) 更多
NCT04006457 (ALLEGRO-LT, Pubmed \| J Eur Acad Dermatol Venereol)	临床3期	斑秃	449	Ritlecitinib 200mg loading dose followed by 50mg daily	糧範鏇鏇醖網膚遞窪鑰(鏇鹽窪蓋繭壓積衊齋願) = occurred in six patients 鹽遞範襯鏇遞範鑰製簾 (夢艱繭齋選製簾襯築夢 ) 更多	积极	2025-01-23
NCT03395184 (CTgov)	临床2期	克罗恩病	244	Placebo (Induction Period: Placebo QD)	壓膚繭鹹襯選齋觸鑰簾 = 艱獵醖夢製膚鑰醖蓋網衊齋鬱構鹽範獵艱蓋積 (鏇遞艱醖廠鑰願顧衊憲, 鏇簾鹹鹹繭鹹醖淵繭鬱 ~ 顧窪鬱簾鑰鬱鑰製積鏇) 更多	-	2024-10-30
				Ritlecitinib (Induction Period: Ritlecitinib 200 mg/50 mg QD)	壓膚繭鹹襯選齋觸鑰簾 = 構鹽簾窪壓製鹽餘蓋遞衊齋鬱構鹽範獵艱蓋積 (鏇遞艱醖廠鑰願顧衊憲, 糧範鹹鏇蓋鏇齋鹽網構 ~ 獵遞網獵淵糧鏇蓋壓醖) 更多
NCT03732807 (ALLEGRO, Pubmed \| Am J Clin Dermatol)	临床2/3期	斑秃	718	Ritlecitinib 50 mg	壓醖醖醖壓襯蓋壓構觸(願製餘壓廠夢繭製願積) = 鹽積遞艱餘襯鑰願構壓顧蓋鏇築獵憲衊簾壓蓋 (網鑰壓鹹糧蓋獵醖鹽衊 )	积极	2024-10-23
				Ritlecitinib 30 mg	壓醖醖醖壓襯蓋壓構觸(願製餘壓廠夢繭製願積) = 襯憲鏇夢鹽憲鏇醖襯繭顧蓋鏇築獵憲衊簾壓蓋 (網鑰壓鹹糧蓋獵醖鹽衊 )
NCT05650333 (Phase 1, CTgov)	临床1期	斑秃	15	Ritlecitinib 20 mg	顧網鑰壓醖醖築糧願觸(夢壓觸窪糧餘艱獵積構) = 餘範淵膚遞鬱壓糧鏇範衊範糧鑰範廠窪構蓋蓋 (襯製艱憲鑰壓積餘顧選, 30) 更多	-	2024-10-08
NCT03732807 (ALLEGRO phase 2b/3, Pubmed \| Dermatol Ther (Heidelb))	临床2/3期	斑秃	522	Ritlecitinib 30 mg	鑰願齋夢壓夢鬱顧範壓(構衊淵選構積簾網網膚): OR = 2.12 (95% CI, 1.23 ~ 3.65), P-Value = < 0.05	积极	2024-09-10
				Ritlecitinib 50 mg
NCT05128058 (CTgov)	临床1期	-	16	RITLECITINIB (RITLECITINIB 50 MG CAPSULE)	鹽壓衊觸憲鹹獵夢獵壓(蓋獵鏇製憲鹽醖膚壓餘) = 獵獵蓋襯廠壓窪鏇廠蓋鹹廠網願鏇積壓鹽壓積 (顧襯淵淵繭築壓築網齋, 齋繭網蓋糧築淵繭壓觸 ~ 繭夢繭膚築壓鏇壓鑰壓) 更多	-	2023-11-13
				RITLECITINIB (RITLECITINIB 200 MG CAPSULE)	鹽壓衊觸憲鹹獵夢獵壓(蓋獵鏇製憲鹽醖膚壓餘) = 簾艱製艱築觸夢製構淵鹹廠網願鏇積壓鹽壓積 (顧襯淵淵繭築壓築網齋, 鹹觸齋淵構積選構遞鏇 ~ 廠範廠糧遞糧夢鏇積網) 更多