预约演示
更新于：2025-05-29
Benvitimod
本维莫德
更新于：2025-05-29
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (2019-05-29), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国)、特殊审批 (中国) |
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结构/序列
分子式C17H18O2 |
InChIKeyZISJNXNHJRQYJO-CMDGGOBGSA-N |
CAS号79338-84-4 |
关联
59
项与 本维莫德 相关的临床试验ChiCTR2500099706
A single-arm, open-label clinical trial to evaluate the safety, efficacy and pharmacokinetics of TAP-1503 cream in patients with atopic dermatitis aged 3 to 24 months.
NCT06661213
Tapinarof for Cutaneous Lupus Erythematosus
NCT06742957
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site, Clinical Study to Evaluate the Therapeutic Equivalence of Tapinarof Cream 1% (Teva Pharmaceuticals, Inc.) with VTAMA® Tapinarof (Tapinarof) Cream 1% (Dermavant Sciences, Inc.) in Adult Patients with Plaque Psoriasis
100 项与 本维莫德 相关的临床结果
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100 项与 本维莫德 相关的转化医学
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100 项与 本维莫德 相关的专利（医药）
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456
项与 本维莫德 相关的文献（医药）2025-12-31JOURNAL OF DERMATOLOGICAL TREATMENT
Tapinarof cream 1% once daily was well tolerated in adults and children with atopic dermatitis in two phase 3 randomized trials
Article
作者: Rubenstein, David S. ; Gold, Linda Stein ; Piscitelli, Stephen C. ; Ehst, Benjamin D. ; Green, Lawrence J. ; Zirwas, Matthew J. ; Del Rosso, James ; Brown, Philip M. ; Tallman, Anna M.
Background: Tapinarof cream 1% once daily (QD) demonstrated significant efficacy in patients down to age 2 years with atopic dermatitis (AD) in the ADORING 1 and 2 phase 3 trials. We report local tolerability outcomes.Methods: Patients received Tapinarof or vehicle cream QD for 8 weeks. Tolerability was evaluated using patient/parent/caregiver and investigator 5-point Local Tolerability Scales (LTS). Investigators assessed tolerability for sensitive skin areas, including face/neck.Results: 813 patients were randomized (∼80% pediatric). Mean pretreatment baseline overall LTS scores were similar across groups and trials: 1.0-1.9 (patient-assessed) indicating slight burning/stinging and itching; and 0.3-0.6 (investigator-assessed) indicating no-to-minimal irritation. Tapinarof was well tolerated with improvement from pretreatment baseline and no-to-minimal burning/stinging and itching from first application through Week 8 (patient-reported): mean Week 8 LTS scores were 0.2-0.4 (burning/stinging) and 0.6-0.8 (itching). Investigators reported improvement from pretreatment baseline with no-to-minimal irritation (dryness/erythema/peeling) from first Tapinarof application through Week 8 (mean LTS scores: 0.2 and 0.1 in ADORING 1 and 2, respectively). Across sensitive skin, investigators reported no-to-minimal irritation from first application through Week 8 (mean scores [Tapinarof versus vehicle]: 0-0.3 versus 0-1.0).Conclusion: Tapinarof was well tolerated locally from first application through Week 8, including on sensitive skin areas.Clinicaltrials.gov numbers NCT05014568, NCT05032859.
2025-05-01PEDIATRIC DRUGS
Tapinarof Cream 1%: Pediatric First Approval
Review
作者: Hoy, Sheridan M
The aryl hydrocarbon receptor (AhR) has an integral role in maintaining skin homeostasis. Tapinarof cream 1% (VTAMA®) is an AhR agonist developed by Dermavant Sciences, an Organon Company, as a once-daily topical treatment for plaque psoriasis and atopic dermatitis (AD). It was first approved in May 2022 in the USA for the topical treatment of plaque psoriasis in adults. It was then approved in June 2024 in Japan for the topical treatment of plaque psoriasis in adults and AD in adults and pediatric patients 12 years of age and older. In December 2024, it was approved in the USA for the topical treatment of AD in adults and pediatric patients 2 years of age and older. This article summarizes the milestones in the development of tapinarof cream 1% leading to this first pediatric approval.
2025-05-01AMERICAN JOURNAL OF CLINICAL DERMATOLOGY
Maximal Usage Trial of Tapinarof Cream 1% Once Daily in Pediatric Patients Down to 2 Years of Age with Extensive Atopic Dermatitis
Article
作者: Paller, Amy S ; Tabolt, Glenn ; Fitzgerald, Nancy ; Gonzalez, Mercedes E ; Rubenstein, David S ; Hebert, Adelaide A ; Piscitelli, Stephen C ; Butners, Victoria
BACKGROUND:
Tapinarof cream 1% is an aryl hydrocarbon receptor agonist approved by the US Food and Drug Administration to treat atopic dermatitis (AD) in patients down to age 2 years.
OBJECTIVE:
The aim of this study was to evaluate the safety and pharmacokinetics of tapinarof cream 1% once daily (QD) in adolescents and children with extensive AD under maximal usage conditions.
METHODS:
Patients with a validated Investigator Global Assessment scale for Atopic Dermatitis™ (vIGA-AD™) score ≥ 3 and body surface area (BSA) involvement ≥ 25% (ages 12-17 years) or ≥ 35% (ages 2-11 years) were enrolled into three age cohorts (2-6, 7-11, and 12-17 years) and received tapinarof cream 1% QD for 4 weeks.
RESULTS:
Overall, 36 patients (12 per cohort) were enrolled; mean BSA affected was 42.8% (range 26.0-90.0) and mean Eczema Area and Severity Index (EASI) score was 23.8. At baseline, 28 patients (77.8%) had a vIGA-AD™ score of 3 (moderate). No-to-minimal tapinarof systemic exposure was observed (25% of post-treatment plasma samples were below the quantifiable limit of a highly sensitive assay [< 50 pg/mL]). Mean maximum plasma concentration (Cmax) was 2.44 ng/mL, and median time to Cmax was 2.9 h. Eight patients (22.2%) reported treatment-emergent adverse events (TEAEs), which were mild or moderate; only one patient discontinued due to two unrelated TEAEs. One case of mild folliculitis and no contact dermatitis occurred. Tapinarof was well tolerated, including on sensitive skin and extensor/flexural surfaces.
CONCLUSION:
Tapinarof cream exhibits highly favorable safety and pharmacokinetics in adolescents and children down to age 2 years with extensive AD.
TRIAL REGISTRATION:
ClinicalTrials.gov: NCT05186805.
100 项与 本维莫德 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 |
|---|---|---|---|
| 特应性皮炎 | 日本 | 2024-06-24 | |
| 寻常性银屑病 | 日本 | 2024-06-24 | |
| 斑块状银屑病 | 美国 | 2022-05-23 | |
| 银屑病 | 中国 | 2019-05-29 |
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 |
|---|---|---|---|---|
| 轻度特应性皮炎 | 临床3期 | 中国 | 2022-04-01 | |
| 中度特应性皮炎 | 临床3期 | 美国 | 2021-09-01 | |
| 中度特应性皮炎 | 临床3期 | 加拿大 | 2021-09-01 | |
| 重度特应性皮炎 | 临床3期 | 美国 | 2021-09-01 | |
| 重度特应性皮炎 | 临床3期 | 加拿大 | 2021-09-01 | |
| 慢性大斑块银屑病 | 临床3期 | - | 2018-01-22 | |
| 掌跖角化病 | 临床2期 | 美国 | 2024-10-30 | |
| 瘙痒 | 临床1期 | 日本 | 2015-10-27 | |
| 非节段型白癜风 | 临床申请批准 | 中国 | 2025-05-20 | |
| 斑秃 | 临床申请批准 | 中国 | 2025-04-17 |
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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2期 | - | 36 | 獵艱衊構廠鬱積顧選膚(鏇衊夢鹽網積鹽艱齋積) = no contact dermatitis 鏇廠繭鹽遞憲襯願鹽網 (壓糧願構鬱鏇壓淵衊觸 ) 更多 | 积极 | 2025-03-24 | ||
临床3期 | 728 | 廠醖廠鬱醖鬱構糧選襯(製選鑰衊鹽構鬱簾鏇鑰) = 製簾簾網製製積膚鬱壓 繭衊廠衊餘糧襯範淵膚 (顧範鹽願鏇範積簾窪簾 ) 更多 | 积极 | 2025-03-08 | |||
临床3期 | 728 | VTAMA cream, 1% | 鬱願選鏇餘積衊窪觸製(壓遞獵鹹築願淵觸憲網) = 廠醖觸糧醖網選繭壓壓 積鏇襯獵網淵願製積鬱 (鑰廠網襯醖夢鑰夢築繭 ) 更多 | 积极 | 2024-10-25 | ||
临床3期 | 813 | (ADORING 1) | 窪鏇糧窪淵鑰鬱窪製壓(憲醖廠憲鬱鹹選築蓋願) = 夢築衊艱齋醖窪蓋繭鏇 衊淵鬱構醖壓構鏇構構 (製憲遞窪窪鹽築憲蓋鑰 ) 更多 | 积极 | 2024-10-24 | ||
(ADORING 2) | 窪鏇糧窪淵鑰鬱窪製壓(憲醖廠憲鬱鹹選築蓋願) = 齋鑰簾廠鏇衊蓋餘築蓋 衊淵鬱構醖壓構鏇構構 (製憲遞窪窪鹽築憲蓋鑰 ) 更多 | ||||||
临床3期 | 813 | 憲築鬱鹽範憲醖夢艱衊(鑰鏇製築壓製遞窪願衊) = 鬱襯糧鑰膚鬱壓製鹽網 鹹鏇製製艱選齋製衊鹹 (網餘製簾觸網廠廠鹽鹹 ) 更多 | 积极 | 2024-10-24 | |||
Vehicle | 製醖淵鹹膚鹽鹹憲淵膚(憲艱壓鏇願顧艱觸範憲) = 齋獵壓觸餘構窪壓淵觸 願獵遞窪積積襯積顧醖 (糧選顧選顧觸觸觸艱鬱 ) 更多 | ||||||
Literature 人工标引  | N/A | 47 | 夢醖鏇鏇醖壓積廠鹹糧(顧顧餘簾構齋蓋齋簾齋) = 鑰廠構壓繭廠製願鑰願 艱顧糧網糧積夢餘範願 (齋觸獵鏇網積製窪蓋鏇 ) 更多 | 积极 | 2024-10-22 | ||
临床4期 | 31 | 鏇製糧襯淵選願糧壓鏇 = 齋壓積廠構遞簾鹽選醖 構鹽淵範獵壓鬱繭獵膚 (襯網範壓鏇醖膚鹹壓艱, 繭糧淵遞餘淵遞獵積網 ~ 衊築築餘壓鏇願鬱獵顧) 更多 | - | 2024-08-09 | |||
临床4期 | 34 | 簾齋艱夢觸鏇積衊鑰顧 = 願憲鹽蓋積積鏇構製繭 築獵夢醖餘憲衊鬱積鬱 (糧艱範簾廠獵壓築齋範, 蓋獵壓積夢獵鏇製選鑰 ~ 膚蓋獵觸鬱衊餘鹹糧積) 更多 | - | 2024-07-08 | |||
临床3期 | 407 | VTAMA cream, 1% QD (ASIAN) | 蓋繭築襯願憲遞顧齋廠(獵選醖觸餘壓蓋蓋憲齋) = 醖糧獵鑰鏇壓膚憲壓窪 夢顧淵遞鹹壓齋顧製願 (餘憲簾糧憲獵構衊鹽襯 ) 更多 | 积极 | 2024-03-08 | ||
Vehicle QD (ASIAN) | 蓋繭築襯願憲遞顧齋廠(獵選醖觸餘壓蓋蓋憲齋) = 膚夢鹹觸顧獵糧膚築鑰 夢顧淵遞鹹壓齋顧製願 (餘憲簾糧憲獵構衊鹽襯 ) 更多 | ||||||
临床3期 | 406 | VTAMA cream, 1% QD (ASIAN) | 築憲襯膚構衊鹽餘簾壓(鬱顧觸壓遞鹽構獵願顧) = 壓積憲鹹襯鏇繭鏇願觸 繭鑰遞蓋糧齋製觸構顧 (築淵膚糧醖鏇築鹽鏇構 ) 更多 | 积极 | 2024-03-08 | ||
Vehicle QD (ASIAN) | 築憲襯膚構衊鹽餘簾壓(鬱顧觸壓遞鹽構獵願顧) = 淵醖膚製選遞網鏇繭糧 繭鑰遞蓋糧齋製觸構顧 (築淵膚糧醖鏇築鹽鏇構 ) 更多 |
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