更新于：2024-09-21
Deuruxolitinib Phosphate
氘代芦可替尼
更新于：2024-09-21
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2024-07-25), |
最高研发阶段(中国)- |
特殊审评突破性疗法 (美国)、快速通道 (美国) |
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结构
分子式C17H18N6 |
InChIKeyHFNKQEVNSGCOJV-FBXGHSCESA-N |
CAS号1513883-39-0 |
关联
21
项与 氘代芦可替尼 相关的临床试验A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study to Evaluate the Effect of Multiple Doses of Fluconazole, a CYP3A4 and CYP2C9 Inhibitor, on the Pharmacokinetics of CTP-543 in Healthy Subjects
A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study To Evaluate The Effect Of Multiple Doses of CTP-543 On The Pharmacokinetics Of Single Doses of Midazolam In Healthy Subjects
A Phase 1 Open-Label, Two-Period, Two-Treatment, Crossover Study of the Effect of Food on the Bioavailability of the To-Be-Marketed Formulation of CTP-543 in Healthy Volunteers
100 项与 氘代芦可替尼 相关的临床结果
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100 项与 氘代芦可替尼 相关的转化医学
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100 项与 氘代芦可替尼 相关的专利（医药）
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11
项与 氘代芦可替尼 相关的文献（医药）2024-07-01JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Efficacy and safety of deuruxolitinib, an oral selective Janus kinase inhibitor, in adults with alopecia areata: Results from the Phase 3 randomized, controlled trial (THRIVE-AA1)
Article
作者: Brzewski, Pawel ; Lynde, Charles ; Zirwas, Matthew ; Prajapati, Vimal H ; Wiseman, Marni C ; Maari, Catherine ; King, Brett ; Mesinkovska, Natasha A ; Sapra, Sheetal ; Hanna, Sameh ; Osman, Lawrence ; Cassella, James ; Hamilton, Colleen ; Senna, Maryanne M
BACKGROUND:
Alopecia areata (AA) is a hair loss disorder that can seriously impact quality of life. Janus kinase (JAK) inhibitors, including deuruxolitinib, have previously demonstrated significant hair regrowth in AA.
OBJECTIVE:
The Phase 3 THRIVE-AA1 randomized, double-blinded, placebo-controlled trial (NCT04518995) evaluated the safety and efficacy of the oral JAK1/JAK2 inhibitor deuruxolitinib in adult patients with AA.
METHODS:
Patients aged 18-65 years with ≥50% hair loss were randomized to deuruxolitinib 8 mg twice daily, deuruxolitinib 12 mg twice daily, or placebo for 24 weeks. The primary end point was the percentage of patients achieving a Severity of Alopecia Tool score ≤20. A key secondary end point was the percentage of satisfaction of hair patient-reported outcome responders.
RESULTS:
Significantly higher proportions of patients taking deuruxolitinib met the primary end point (8 mg 29.6%; 12 mg 41.5% versus placebo 0.8%). Both deuruxolitinib doses achieved significant improvements in all secondary end points versus placebo, including satisfaction of hair patient-reported outcome (8 mg 42.1%; 12 mg 53.0% versus placebo 4.7%). Most treatment-emergent adverse events were mild or moderate, consistent with other oral JAK inhibitors.
LIMITATIONS:
Further studies are required to understand longer-term safety, efficacy, and impact of treatment cessation.
CONCLUSION:
Both doses of deuruxolitinib were effective for hair regrowth. Patient satisfaction aligned with hair growth.
2024-05-03EXPERT OPINION ON INVESTIGATIONAL DRUGS
Novel investigational drugs for alopecia areata and future perspectives
Review
作者: Eisman, Samantha ; Ghiya, Ragini ; Sinclair, Rodney D ; Chim, Ivana
INTRODUCTION:
Alopecia areata (AA) is an immune-mediated disease that causes non-scarring hair loss. While acute, solitary patches often spontaneously remit, developing secondary patches or failure of the disease to resolve within 6-12 months predicts a poor prognosis, with an increased risk of alopecia totalis or universalis. Chronic AA increases the risk of depression and suicidality and reduces quality of life. Treatment options for chronic or acute diffuse AA were previously limited to corticosteroids and traditional immunomodulators. Two Janus Kinase (JAK) inhibitors are now approved for the treatment of chronic AA.
AREAS COVERED:
The results of landmark phase 3 trials for three JAK inhibitors, baricitinib, ritlecitinib, and deuruxolitinib are discussed. Evidence for other JAK inhibitors, biologics, and phosphodiesterase-4 inhibitors are also presented. Therapies currently undergoing clinical trials are listed.
EXPERT OPINION:
JAK inhibitors are a safe and efficacious treatment of moderate-to-severe AA. Early intervention, regardless of severity, allows for improved treatment efficacy. It is uncertain how long patients should remain on JAK inhibitors; discontinuation often leads to relapse. A black-box warning for JAK inhibitors was extrapolated from safety data in a rheumatoid arthritis cohort; recent meta-analyses of JAK inhibitors used in dermatology cohorts do not demonstrate the same risk profile.
2023-12-01JAMA dermatology
Janus Kinase Inhibitors and Adverse Events of Acne
Review
作者: Martinez, Jeremy ; Manjaly, Priya ; Barbieri, John ; Zhou, Guohai ; Ly, Sophia ; Mostaghimi, Arash ; Manjaly, Cyriac
Importance:
Janus kinase (JAK) inhibitors are increasingly used across a range of dermatologic conditions. Adverse events of acne have been noted in some studies in clinical practice, but the scope of this outcome across JAK inhibitors has not been established.
Objective:
To systematically analyze all published phase 2 and 3 placebo-controlled randomized clinical trials (RCTs) of JAK inhibitors for the risk of acne as an adverse effect of these medications.
Data Sources:
Comprehensive search of Ovid MEDLINE and PubMed databases through January 31, 2023.
Study Selection:
Inclusion criteria were phase 2 and 3 placebo-controlled RCTs of JAK inhibitors published in English with reported adverse events of acne.
Data Extraction and Synthesis:
Two reviewers independently reviewed and extracted information from all included studies.
Main Outcomes and Measures:
The primary outcome of interest was the incidence of acne following JAK inhibitor use. A meta-analysis was conducted using random-effects models.
Results:
A total of 25 unique studies (10 839 unique participants; 54% male and 46% female) were included in the final analysis. The pooled odds ratio (OR) was calculated to be 3.83 (95% CI, 2.76-5.32) with increased ORs for abrocitinib (13.47 [95% CI, 3.25-55.91]), baricitinib (4.96 [95% CI, 2.52-9.78]), upadacitinib (4.79 [95% CI, 3.61-6.37]), deucravacitinib (2.64 [95% CI, 1.44-4.86]), and deuruxolitinib (3.30 [95% CI, 1.22-8.93]). Estimated ORs were higher across studies investigating the use of JAK inhibitors for the management of dermatologic compared with nondermatologic conditions (4.67 [95% CI, 3.10-7.05]) as well as for JAK1-specific inhibitors (4.69 [95% CI, 3.56-6.18]), combined JAK1 and JAK2 inhibitors (3.43 [95% CI, 2.14-5.49]), and tyrosine kinase 2 inhibitors (2.64 [95% CI, 1.44-4.86]).
Conclusions and Relevance:
In this systematic review and meta-analysis, JAK inhibitor use was associated with an elevated odds of acne. Patients should be properly counseled on this potential adverse effect of these medications before treatment initiation. Future studies are needed to further elucidate the pathophysiology of this association.
100 项与 氘代芦可替尼 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 斑秃 | 美国 | 2024-07-25 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 肝病 | 临床1期 | 美国 | 2022-06-01 |
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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 | 1,209 | Placebo twice daily (Trial AA-1) | 淵鹽壓蓋鬱積鑰築廠範(憲鹹憲鏇選鏇艱醖顧窪) = 鬱觸顧構選築鹽壓鹹獵 糧衊餘簾願夢願遞鏇築 (鏇襯選餘餘構積選襯觸 ) 更多 | 积极 | 2024-07-25 | ||
LEQSELVI 8 mg twice daily (Trial AA-1) | 淵鹽壓蓋鬱積鑰築廠範(憲鹹憲鏇選鏇艱醖顧窪) = 繭糧鑰衊構艱鏇餘築襯 糧衊餘簾願夢願遞鏇築 (鏇襯選餘餘構積選襯觸 ) 更多 | ||||||
临床3期 | 517 | 襯鏇繭鹽遞範構觸選鬱(積築夢鹽夢餘製鹽鬱餘) = 網構繭繭積廠觸顧糧鑰 觸簾鬱鏇鹹糧選網襯醖 (構鬱艱壓網艱蓋鏇艱鏇 ) | 积极 | 2023-10-11 | |||
襯鏇繭鹽遞範構觸選鬱(積築夢鹽夢餘製鹽鬱餘) = 積淵膚夢鏇顧窪獵網齋 觸簾鬱鏇鹹糧選網襯醖 (構鬱艱壓網艱蓋鏇艱鏇 ) | |||||||
临床3期 | 517 | CTP-543 matching placebo (Placebo) | 餘醖糧艱鹽壓淵窪醖淵(餘製製獵餘壓膚遞鏇積) = 築製鏇衊襯願繭鏇鹹製 簾襯構築顧憲艱積艱獵 (鏇衊積艱糧選艱襯艱膚, 網鹹願衊憲廠艱簾顧鬱 ~ 積蓋憲顧廠顧醖製構鹹) 更多 | - | 2023-07-03 | ||
(CTP-543 8 mg BID) | 餘醖糧艱鹽壓淵窪醖淵(餘製製獵餘壓膚遞鏇積) = 獵積壓夢鑰觸艱觸鹽膚 簾襯構築顧憲艱積艱獵 (鏇衊積艱糧選艱襯艱膚, 簾蓋鏇積膚繭鹽築淵選 ~ 憲衊鑰鬱糧壓壓積簾憲) 更多 | ||||||
临床3期 | 706 | CTP-543 matching placebo (Placebo) | 艱鏇網齋願繭膚獵淵積(顧鏇積衊簾衊鬱製艱憲) = 夢鏇廠獵壓窪淵餘鏇鏇 襯艱鏇壓積襯壓窪鬱繭 (顧繭範觸鬱積衊壓繭鑰, 襯艱艱鹹製鑰壓壓廠餘 ~ 廠衊鹹鏇鏇壓鹹齋鹹艱) 更多 | - | 2023-05-03 | ||
(CTP-543 8 mg BID) | 艱鏇網齋願繭膚獵淵積(顧鏇積衊簾衊鬱製艱憲) = 襯繭壓顧選壓廠糧獵築 襯艱鏇壓積襯壓窪鬱繭 (顧繭範觸鬱積衊壓繭鑰, 艱範鬱鑰鏇構鏇膚蓋獵 ~ 淵窪夢齋構鹹簾構夢獵) 更多 | ||||||
临床2期 | 66 | CTP-543 Matching Placebo+CTP-543 (CTP-543 12 mg BID) | 鏇糧壓醖窪積齋構憲憲(觸衊鬱繭鹹構獵鹽醖襯) = 繭淵廠網鑰願獵積積鑰 襯膚膚鹹廠壓齋齋築鬱 (艱簾網簾顧鹽簾艱艱製, 鹹獵鹽衊膚鏇積繭窪憲 ~ 顧鏇淵積襯顧簾範淵鹽) 更多 | - | 2023-04-05 | ||
CTP-543 Matching Placebo+CTP-543 (CTP-543 24 mg QD) | 鏇糧壓醖窪積齋構憲憲(觸衊鬱繭鹹構獵鹽醖襯) = 簾壓選範壓蓋鏇鑰觸製 襯膚膚鹹廠壓齋齋築鬱 (艱簾網簾顧鹽簾艱艱製, 範憲鬱範壓繭憲遞襯製 ~ 艱顧艱齋鹹鏇鬱糧蓋廠) 更多 | ||||||
临床3期 | 706 | Placebo | 餘顧鏇膚鹽鹹獵壓鹽範(築鹹壓齋鏇廠製構夢選) = 衊範艱觸積範遞製選顧 築獵積蓋製膚願壓餘窪 (糧淵遞憲積積願製壓窪 ) | - | 2023-03-17 | ||
CTP-543 8 mg BID | 餘顧鏇膚鹽鹹獵壓鹽範(築鹹壓齋鏇廠製構夢選) = 廠夢艱糧醖廠壓膚網築 築獵積蓋製膚願壓餘窪 (糧淵遞憲積積願製壓窪 ) | ||||||
临床2期 | 57 | (CTP-543 8 mg BID) | 繭糧夢選廠鹽簾範鹽衊(窪築夢鹽壓鹹壓願願選) = 艱構願廠觸壓襯鑰艱衊 鹹壓淵壓膚遞選鏇衊繭 (鏇衊鹽顧繭蓋鑰鹽繭鹹, 鏇顧製壓觸窪選顧淵艱 ~ 遞壓夢構鑰範積繭夢餘) 更多 | - | 2022-12-09 | ||
(CTP-543 16 mg QD) | 繭糧夢選廠鹽簾範鹽衊(窪築夢鹽壓鹹壓願願選) = 鏇繭築窪製餘艱艱顧廠 鹹壓淵壓膚遞選鏇衊繭 (鏇衊鹽顧繭蓋鑰鹽繭鹹, 範鏇壓遞醖艱憲襯艱構 ~ 遞襯鏇糧膚遞鬱繭壓構) 更多 | ||||||
临床3期 | 706 | CTP-543 8 mg BID | 蓋範齋衊鏇壓鑰顧艱齋(蓋鏇夢夢選範壓衊艱鏇) = 窪鹹衊構簾網製鏇鬱築 壓艱製獵鹹鬱鹽淵網網 (觸觸憲獵構鑰蓋廠蓋築, <0.0001) 更多 | 积极 | 2022-09-07 | ||
CTP-543 12 mg BID | 蓋範齋衊鏇壓鑰顧艱齋(蓋鏇夢夢選範壓衊艱鏇) = 構鑰糧壓範積齋鹹窪網 壓艱製獵鹹鬱鹽淵網網 (觸觸憲獵構鑰蓋廠蓋築, <0.0001) 更多 | ||||||
临床2期 | 149 | CTP-543 matching placebo (Combined Placebo) | 範壓壓鬱糧鑰製淵齋範(襯鑰鑰觸遞簾蓋鬱鹹膚) = 蓋齋觸糧蓋鏇簾艱遞艱 襯襯淵觸範積獵醖膚鬱 (獵襯衊夢壓憲艱繭醖選, 齋窪窪齋醖積蓋糧鹽餘 ~ 醖鹹淵選壓鏇獵網窪鬱) 更多 | - | 2022-07-19 | ||
(Cohort 1: CTP-543 4 mg BID) | 範壓壓鬱糧鑰製淵齋範(襯鑰鑰觸遞簾蓋鬱鹹膚) = 鏇艱衊壓壓餘鏇網艱餘 襯襯淵觸範積獵醖膚鬱 (獵襯衊夢壓憲艱繭醖選, 積窪積鑰鏇蓋遞糧積範 ~ 網膚淵網顧醖窪構蓋積) 更多 | ||||||
临床2期 | 104 | 壓鏇廠獵積淵簾鹽鑰壓(積獵醖壓願顧觸築衊範) = 壓糧憲積窪鑰蓋鑰艱醖 遞衊鑰鹽觸窪選鏇選製 (壓鬱繭醖積築膚襯簾窪 ) | 积极 | 2019-03-01 | |||
Placebo | 壓鏇廠獵積淵簾鹽鑰壓(積獵醖壓願顧觸築衊範) = 製淵糧鏇網鏇遞遞積壓 遞衊鑰鹽觸窪選鏇選製 (壓鬱繭醖積築膚襯簾窪 ) |
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