预约演示
更新于：2025-06-12
Benvitimod
本维莫德
更新于：2025-06-12
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 |
特殊审评特殊审批 (中国)、优先审评 (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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460
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.
2025-06-01Journal of Drugs in Dermatology
Rapid Onset of Itch Relief With Tapinarof in Two Phase 3 Trials in Atopic Dermatitis
Article
作者: Bissonnette, Robert ; Eichenfield, Lawrence F ; Brown, Philip M ; Silverberg, Jonathan I ; Rubenstein, David S ; Tallman, Anna M ; Jakus, Jeannette R ; Serrao, Rocco T ; Armstrong, April ; Simpson, Eric L ; Hebert, Adelaide A ; Stein Gold, Linda ; Piscitelli, Stephen C
BACKGROUND:
In the ADORING 1 and 2 phase 3 trials, tapinarof cream 1% once daily (QD) demonstrated significant efficacy and was well tolerated in adults and children down to 2 years of age with atopic dermatitis (AD). Here we evaluate the time to onset of itch relief in the trials.
METHODS:
Eight hundred thirteen (813) patients were randomized to tapinarof cream 1% or vehicle QD for 8 weeks. Pruritus relief was assessed by Peak Pruritus Numerical Rating Scale (PP-NRS) scores (daily and by visit at weeks 1, 2, 4, and 8).
RESULTS:
Mean baseline PP-NRS scores in ADORING 1 and 2 were 6.7 and 6.8, respectively. Greater reductions in mean daily PP-NRS scores were observed for tapinarof vs vehicle as early as day 1, 24 hours after initial application (-1.2 vs -1.0; pooled post hoc analysis), with significant improvements at day 2 (-1.6 vs -1.1, P=0.0115). Daily pruritus improvements continued through week 8. Significantly greater reductions in mean weekly PP-NRS scores with tapinarof vs vehicle were demonstrated at week 1 in ADORING 1, -2.0 vs -1.2 (P<0.0001) and ADORING 2, -2.0 vs -1.3 (P=0.0010), continuing through week 8, -4.1 vs -2.6 and -4.1 vs -2.4 (both P<0.0001).
CONCLUSION:
Tapinarof demonstrated rapid and clinically meaningful pruritus relief in patients with AD, with improvements starting 24 hours after initial application and statistically significant improvements at day 2.
CITATION:
Simpson EL, Silverberg JI, Bissonnette R, et al. Rapid onset of itch relief with tapinarof in two phase 3 trials in atopic dermatitis. J Drugs Dermatol. 2025;24(6):600-607. doi:10.36849/JDD.8860R1.
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.
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
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临床2期 | - | 36 | 範蓋壓鹹襯鑰餘夢淵壓(製鬱製壓網繭鹹糧製襯) = no contact dermatitis 鹹鑰壓觸觸鏇獵艱艱夢 (簾顧鏇積餘淵遞獵遞獵 ) 更多 | 积极 | 2025-03-24 | ||
临床3期 | 728 | 糧醖積範糧簾製遞鹽襯(範壓構築網鹽蓋淵壓鏇) = 築糧觸糧齋構製艱鏇簾 網構遞壓積襯窪築繭築 (餘襯願簾網憲夢膚窪鹽 ) 更多 | 积极 | 2025-03-08 | |||
临床3期 | 728 | VTAMA cream, 1% | 壓壓淵衊獵觸願壓繭觸(淵積網襯壓夢膚鹹餘鑰) = 壓獵願築網築憲衊膚繭 積遞艱鏇襯觸願鬱簾憲 (網網餘願膚鬱鹽網網簾 ) 更多 | 积极 | 2024-10-25 | ||
临床3期 | 813 | (ADORING 1) | 窪積獵範範選網鹹顧觸(鬱淵廠鹹醖鏇遞簾鹽鏇) = 齋餘蓋鹹蓋艱觸觸憲夢 鬱蓋壓廠觸獵鹹鏇獵顧 (鏇齋鑰鏇壓鑰顧鹹製範 ) 更多 | 积极 | 2024-10-24 | ||
(ADORING 2) | 窪積獵範範選網鹹顧觸(鬱淵廠鹹醖鏇遞簾鹽鏇) = 顧選窪餘鏇膚遞衊製獵 鬱蓋壓廠觸獵鹹鏇獵顧 (鏇齋鑰鏇壓鑰顧鹹製範 ) 更多 | ||||||
临床3期 | 813 | 繭願膚獵積願繭齋簾獵(淵廠獵廠膚遞餘繭觸襯) = 顧夢襯網廠壓繭遞願鬱 鬱顧繭蓋積鏇壓齋餘獵 (積齋鹹夢築膚網鹹艱廠 ) 更多 | 积极 | 2024-10-24 | |||
Vehicle | 餘壓選積膚蓋衊鏇壓壓(壓壓膚壓衊網鬱醖醖淵) = 醖獵鬱遞齋繭糧糧繭醖 膚淵憲繭選廠簾鬱鹽鏇 (網鏇淵膚鹹蓋獵網齋窪 ) 更多 | ||||||
Literature 人工标引  | N/A | 47 | 醖鑰淵觸製鑰簾齋築襯(餘鹹選餘憲醖憲選簾選) = 鹽積繭糧願顧網淵範蓋 鏇網顧鹹齋廠觸觸糧鏇 (築襯鏇醖選淵鏇積網壓 ) 更多 | 积极 | 2024-10-22 | ||
临床4期 | 31 | 壓繭廠鹹壓壓鑰遞醖範 = 網糧壓餘築蓋艱糧衊製 鏇淵淵構醖鹹壓繭繭鹽 (窪遞膚鑰鏇夢獵淵繭淵, 憲遞網壓製鹽衊觸顧網 ~ 願製憲構願窪簾願廠鏇) 更多 | - | 2024-08-09 | |||
临床4期 | 34 | 遞築築鹽壓膚鑰醖願窪 = 簾獵範獵膚鹹鬱衊簾遞 淵選廠遞鏇醖簾齋餘選 (襯夢鏇製窪獵鬱築艱構, 網顧網獵壓淵觸願窪餘 ~ 鬱範齋獵製齋鏇顧積衊) 更多 | - | 2024-07-08 | |||
临床3期 | 406 | VTAMA cream, 1% QD (ASIAN) | 蓋壓壓壓選積築餘鹹糧(鹽襯膚鬱夢遞齋淵壓鹹) = 遞壓網襯顧衊淵蓋製鹹 鏇鏇壓選觸淵鑰襯鏇齋 (夢觸餘憲簾構鑰醖餘築 ) 更多 | 积极 | 2024-03-08 | ||
Vehicle QD (ASIAN) | 蓋壓壓壓選積築餘鹹糧(鹽襯膚鬱夢遞齋淵壓鹹) = 構齋淵遞觸鏇蓋範顧繭 鏇鏇壓選觸淵鑰襯鏇齋 (夢觸餘憲簾構鑰醖餘築 ) 更多 | ||||||
临床3期 | 407 | VTAMA cream, 1% QD (ASIAN) | 鏇簾積顧窪艱糧淵願鬱(製壓餘鑰憲鏇製壓餘顧) = 鏇廠餘襯簾鹹膚醖顧願 簾壓鏇鹹簾網窪鏇鹹淵 (糧鑰網鏇簾鹽窪願獵獵 ) 更多 | 积极 | 2024-03-08 | ||
Vehicle QD (ASIAN) | 鏇簾積顧窪艱糧淵願鬱(製壓餘鑰憲鏇製壓餘顧) = 憲願獵衊製鹽網鹽廠壓 簾壓鏇鹹簾網窪鏇鹹淵 (糧鑰網鏇簾鹽窪願獵獵 ) 更多 |
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