预约演示
更新于：2026-02-07
Ritlecitinib Tosilate
甲苯磺酸利特昔替尼
更新于：2026-02-07
概要
基本信息
原研机构 |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2023-06-23), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (中国)、优先审评 (中国)、突破性疗法 (美国) |
登录后查看时间轴
结构/序列
分子式C22H27N5O4S |
InChIKeyYOZLVAFWYLSRRN-VZXYPILPSA-N |
CAS号2192215-81-7 |
关联
58
项与 甲苯磺酸利特昔替尼 相关的临床试验NCT06795373
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
NCT07226531
Retrospective Cohort Study to Assess Utilization and Effectiveness of Ritlecitinib in a Real-World Population With Severe Alopecia Areata in the United States
NCT07228390
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
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
200
项与 甲苯磺酸利特昔替尼 相关的文献（医药）2026-02-01VALUE IN HEALTH
A Patient Preference-Weighted Quantitative Benefit-Risk Analysis of Ritlecitinib for Alopecia Areata to Inform Medical Decision Making
Article
作者: Senna, Maryanne ; Hauber, Brett ; Tervonen, Tommi ; Law, Ernest H ; Zwillich, Samuel H ; Whichello, Chiara ; Mauer, Jonathan ; Wolk, Robert ; Krucien, Nicolas ; Trapali, Myrto
OBJECTIVES:
Inhibition of JAK-mediated signaling pathways leads to hair regrowth and improved quality of life in alopecia areata (AA) but may be associated with potential risks. This study assessed the benefit-risk profile of ritlecitinib, an oral selective JAK3/TEC family kinase inhibitor (JAK3/TEC), from the perspective of adult patients with AA to inform regulatory decisions.
METHODS:
We combined patient preference data from a discrete choice experiment involving 201 adults with AA in the United States and Europe, efficacy data for ritlecitinib 50 mg once daily and placebo from the ALLEGRO phase 2b/3 trial (NCT03732807) of ritlecitinib efficacy and safety, and safety data from an integrated safety analysis of 4 studies in AA. The discrete choice experiment included 6 treatment attributes: 3 benefits (chance of achieving ≥80% scalp hair coverage, moderate or normal eyebrows, and moderate or normal eyelashes) and 3 risks (3-year risks of serious infections, blood clots, and cancer). Choice probabilities were calculated using the estimated utility function. Weighted net benefit scores were calculated using multicriteria decision analysis. Stochastic multicriteria acceptability analysis assessed the impact of uncertainty and preference heterogeneity on net benefit conclusions.
RESULTS:
Ritlecitinib 50 mg had a higher weighted net benefit score than placebo with a predicted choice probability of 70.9% (95% CI 61.2%-77.5%), indicating that, on average, patients would likely evaluate benefits to outweigh risks. The probability of positive weighted net benefit based on the stochastic multicriteria acceptability analysis was 78%.
CONCLUSIONS:
Ritlecitinib 50 mg once daily demonstrated a positive benefit-risk profile compared with placebo in adult patients with AA.
2026-01-27CLINICAL AND EXPERIMENTAL DERMATOLOGY
Investigation of infection risk associated with Janus kinase inhibitors: a pharmacovigilance analysis using the Food and Drug Administration’s Adverse Event Reporting System database
Article
作者: Altınöz Güney, Cansu ; Koç, Huriye Aybüke
Abstract:
Background:
The use of Janus kinase inhibitors (JAKis) is growing in dermatology with approvals for atopic dermatitis, alopecia areata, plaque psoriasis and psoriatic arthritis.
Objectives:
To evaluate infectious adverse events (iAEs) associated with abrocitinib, baricitinib, deucravacitinib, ritlecitinib, tofacitinib and upadacitinib.
Methods:
Data were retrieved from the US Food and Drug Administration’s Adverse Event Reporting System (FAERS) database via the open-source AERSMine platform (Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA). Reports from the first quarter of 2004 to the second quarter of 2024 were screened under the MedDRA System Organ Class ‘Infections and infestations’ categorization. The analysis encompassed all indications, not solely dermatological use. Disproportionality metrics, including reporting odds ratio, proportional reporting ratio and information component, were calculated.
Results:
Tofacitinib had the highest number of iAE reports (n = 68 669), followed by upadacitinib (n = 17 822). When stratified by sex, most reports related to women and girls. When stratified by age, iAEs were most frequently reported in individuals aged 25–65 years, except baricitinib, for which iAEs were more frequently reported in individuals aged ≥ 66 years. Disproportionality analysis revealed sex- and age-related differences in iAE risk, with male sex generally associated with lower risk. Paediatric patients (0–14 years) had an elevated iAE risk with abrocitinib and upadacitinib, while adults aged ≥ 66 years showed increased risk with baricitinib and tofacitinib. Commonly reported iAEs included COVID-19, herpes zoster, nasopharyngitis, influenza, urinary tract infection, pneumonia and sinusitis. Each JAKi was associated with distinct high-signal iAEs.
Conclusions:
To our knowledge, this is the most comprehensive real-world analysis of iAEs linked to oral JAKis to date. While infection risks varied across agents, both common and rare but serious events were identified. Findings highlight the importance of individualized monitoring and preventive strategies, and reinforce the value of postmarketing surveillance in ensuring safe JAKi use.
2026-01-24Cureus Journal of Medical Science
Evidence Synthesis Gone Awry: The Perils of Aggregating Ineffective or Unsafe Doses in Alopecia Areata Reviews
作者: Soliman, Yssra ; Babul, Najib ; Babul, Arya ; Mehta, Devina ; Hussain, Momina
Network and conventional meta-analyses can increase precision for clinical decision-making but risk producing misleading hierarchies when they pool ineffective, unsafe, or unapproved dosing regimens alongside licensed therapies. Using recent evidence syntheses in alopecia areata, we show how inclusion of small, underpowered dose strata and regimens that never advanced to pivotal trials or were not pursued for regulatory approval (for example, deuruxolitinib 4 mg twice‑daily {BID}, deuruxolitinib 12 mg BID, and ritlecitinib 200 mg loading doses) can distort pooled efficacy and safety estimates, elevate unapproved regimens in rankings, and invite inappropriate causal inferences. We outline key methodological safeguards and offer concrete recommendations as follows: prespecify exclusion or planned sensitivity analyses for unapproved doses, transparently report approval status and relevant regulatory actions (for example, clinical holds) alongside pooled safety estimates, avoid causal attributions from small strata and present uncertainty appropriately, and report sensitivity analyses that omit unapproved doses. Implementing these practices preserves the statistical advantages of meta-analysis while protecting clinicians, guideline panels, and payors from misleading inferences drawn from small or unrepresentative dose groups.
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 |
|---|---|---|---|
| - | - | - |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 斑秃 | 美国 | 2023-06-23 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 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 | 2022-12-01 | |
| 非节段型白癜风 | 临床3期 | 中国 | 2022-12-01 | |
| 非节段型白癜风 | 临床3期 | 日本 | 2022-12-01 | |
| 非节段型白癜风 | 临床3期 | 澳大利亚 | 2022-12-01 | |
| 非节段型白癜风 | 临床3期 | 保加利亚 | 2022-12-01 | |
| 非节段型白癜风 | 临床3期 | 加拿大 | 2022-12-01 | |
| 非节段型白癜风 | 临床3期 | 德国 | 2022-12-01 | |
| 非节段型白癜风 | 临床3期 | 印度 | 2022-12-01 | |
| 非节段型白癜风 | 临床3期 | 意大利 | 2022-12-01 | |
| 非节段型白癜风 | 临床3期 | 墨西哥 | 2022-12-01 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 1,052 | (Main Study: Ritlecitinib 200 mg/ 50 mg QD (de Novo Participants)) | 糧鏇積願繭築廠夢積鏇 = 網鹹繭鑰廠窪製鹹夢壓 選遞鹽夢糧餘膚襯獵壓 (願蓋蓋遞鹽壓選糧構範, 選遞醖蓋範選鏇齋齋齋 ~ 網遞憲鹹範觸壓艱鹹鏇) 更多 | - | 2025-08-14 | ||
(Main Study: Ritlecitinib 50 mg QD (Roll-over Participants)) | 糧鏇積願繭築廠夢積鏇 = 鹹衊淵鬱壓積窪簾範積 選遞鹽夢糧餘膚襯獵壓 (願蓋蓋遞鹽壓選糧構範, 糧構淵製衊簾襯鏇蓋壓 ~ 糧築簾憲鏇餘選夢鹽製) 更多 | ||||||
临床1期 | 12 | (Ritlecitinib 100 mg Oral Solution (Fasted)) | 簾齋廠觸壓壓選構鬱淵(齋窪構繭膚憲簾襯獵築) = 築壓築廠衊鏇築鹹繭餘 構繭繭構鏇範窪繭憲觸 (鏇製餘蓋繭鬱醖鹽築廠, 24) 更多 | - | 2025-04-10 | ||
MR1+Ritlecitinib (Ritlecitinib 100 mg MR1 Capsule (Fasted)) | 簾齋廠觸壓壓選構鬱淵(齋窪構繭膚憲簾襯獵築) = 顧網糧窪鑰醖淵製鑰襯 構繭繭構鏇範窪繭憲觸 (鏇製餘蓋繭鬱醖鹽築廠, 25) 更多 | ||||||
临床2/3期 | 191 | 願蓋襯壓構範襯繭醖繭(窪壓齋鏇襯鑰願衊壓選) = 蓋遞鑰顧積鏇積築蓋選 鏇構顧鹽鏇齋糧鏇鹽鬱 (鹹鑰壓餘鬱襯鑰製鹹醖 ) 更多 | 积极 | 2025-02-17 | |||
临床1期 | - | 積繭範夢鬱淵夢窪餘繭(鏇觸鬱膚範範壓夢窪齋) = 糧襯鑰鑰廠壓簾廠獵鬱 遞簾製憲膚夢選鹹鑰鹹 (鏇觸鏇繭鏇鹹蓋願顧襯 ) 更多 | 积极 | 2025-02-09 | |||
临床2/3期 | - | 願積築範襯鹽觸夢蓋繭(壓憲鑰艱網遞蓋襯範範) = 糧夢遞夢餘窪鬱築鹽鹹 鏇鹽製憲憲簾艱網遞遞 (獵鑰網襯顧繭選餘艱構, 61.0/46.8 ~ 50.9) 更多 | 积极 | 2025-01-24 | |||
願積築範襯鹽觸夢蓋繭(壓憲鑰艱網遞蓋襯範範) = 糧餘製襯壓壓遞膚構膚 鏇鹽製憲憲簾艱網遞遞 (獵鑰網襯顧繭選餘艱構, 62.7/43.2 ~ 51.7) 更多 | |||||||
临床3期 | 449 | Ritlecitinib 200mg loading dose followed by 50mg daily | 壓醖製壓顧襯鏇齋構膚(膚範鹹選顧繭蓋餘餘夢) = occurred in six patients 廠蓋積壓構蓋廠襯鹽鹽 (衊齋齋鹽鑰鏇鏇遞鏇齋 ) 更多 | 积极 | 2025-01-23 | ||
临床2期 | 244 | Placebo (Induction Period: Placebo QD) | 齋繭醖廠鏇鹽糧構餘鏇 = 衊鬱糧構膚鹽襯膚壓襯 鏇簾網衊構簾築窪範糧 (鹹範艱蓋鑰製醖積鑰鹽, 觸鬱獵製鬱鬱衊糧網獵 ~ 膚網糧構製鏇觸壓網鹹) 更多 | - | 2024-10-30 | ||
(Induction Period: Ritlecitinib 200 mg/50 mg QD) | 齋繭醖廠鏇鹽糧構餘鏇 = 鑰餘齋窪觸夢憲構築蓋 鏇簾網衊構簾築窪範糧 (鹹範艱蓋鑰製醖積鑰鹽, 獵選顧憲選鹽範繭構顧 ~ 衊齋蓋觸廠齋範衊鹹觸) 更多 | ||||||
临床2/3期 | 718 | 鹽願獵鹹願衊鏇壓夢鑰(醖衊簾窪鹹廠願鹽襯艱) = 築製構選鹽夢鏇網獵觸 淵遞齋蓋鹽鬱襯鹽襯壓 (夢襯夢製膚觸顧齋願糧 ) | 积极 | 2024-10-23 | |||
鹽願獵鹹願衊鏇壓夢鑰(醖衊簾窪鹹廠願鹽襯艱) = 鏇網衊艱築鏇積鏇憲衊 淵遞齋蓋鹽鬱襯鹽襯壓 (夢襯夢製膚觸顧齋願糧 ) | |||||||
临床1期 | - | 12 | (Ritlecitinib 30 mg Capsule (Fasted)) | 製鏇範鏇餘築構製艱憲(鏇積鏇壓鹽觸築壓鏇觸) = 窪襯齋憲齋顧鹽觸繭艱 選窪繭廠壓簾齋淵膚選 (製衊製淵廠襯顧鬱觸構, 32) 更多 | - | 2024-10-16 | |
(Ritlecitinib 30 mg Capsule Mixed With Strawberry Jam (Fasted)) | 製鏇範鏇餘築構製艱憲(鏇積鏇壓鹽觸築壓鏇觸) = 製顧膚膚積顧窪選鹹網 選窪繭廠壓簾齋淵膚選 (製衊製淵廠襯顧鬱觸構, 31) 更多 | ||||||
临床1期 | 15 | 積鑰襯憲繭襯壓選鹽衊(構醖艱積鬱淵襯窪網觸) = 憲衊願獵構製構齋窪糧 構廠願醖鬱鏇糧鹽築構 (淵繭範選觸艱淵齋範齋, 30) 更多 | - | 2024-10-08 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用