预约演示
更新于：2025-06-22
Benvitimod
本维莫德
更新于：2025-06-22
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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461
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.
2025-06-09ARCHIVES OF DERMATOLOGICAL RESEARCH
Disproportionality analyses of Tapinarof-related adverse events based on the FAERS database.
Article
作者: Huang, Xia ; Zhang, Lingjin ; Zhang, Congzhong
BACKGROUND:
Tapinarof, a novel topical aryl hydrocarbon receptor (AhR) modulator, has demonstrated promising therapeutic efficacy in the treatment of plaque psoriasis. However, its comprehensive safety profile in real-world settings remains underexplored.
OBJECTIVE:
To assess the post-marketing safety of Tapinarof using data from the FDA Adverse Event Reporting System (FAERS), with a focus on identifying significant adverse event (AE) signals and subgroup-specific risks.
METHODS:
A retrospective disproportionality analysis was conducted on FAERS data from Q2 2022 to Q4 2024. Reports listing Tapinarof as the primary suspect drug were extracted and analyzed using four established signal detection algorithms (ROR, PRR, EBGM, IC), complemented by Bonferroni correction for multiple comparisons.
RESULTS:
A total of 1,227 AE reports were included. The majority of reports originated from adults aged 18-64 years and were submitted by healthcare professionals, with a balanced male-to-female ratio. The most frequently observed AE signals were related to skin and subcutaneous tissue disorders, including keratosis pilaris, contact dermatitis, and application site acne. Notable signals were also detected for infections (e.g., pustules) and hypersensitivity reactions. A novel tumor-related signal was identified for keratoacanthoma, with statistically significant associations also observed for squamous cell carcinoma of the skin. Gender subgroup analysis revealed a higher incidence of dermatological AEs in females and slightly stronger neoplasm-related signals in males. Age, weight, and indication data were largely missing, limiting subgroup-specific interpretation.
CONCLUSION:
Tapinarof is generally well tolerated in adults, particularly for psoriasis treatment, but is associated with strong cutaneous and immune-related AE signals. Novel findings-including pharyngeal swelling and tumor-related events-warrant heightened clinical vigilance, especially in patients requiring long-term or large-area application. Gender differences in AE reporting further underscore the need for personalized risk management strategies. Further longitudinal and mechanistic studies are essential to confirm these associations and guide safer clinical use.
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.
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 | 壓糧鹹憲衊夢鹹鹹糧壓(餘鏇築襯醖網窪繭艱襯) = no contact dermatitis 網選獵鬱願願願襯鏇糧 (鬱襯觸選夢夢憲鑰蓋廠 ) 更多 | 积极 | 2025-03-24 | |||
临床3期 | 728 | 淵壓範築艱襯襯範鹹淵(獵鹽糧廠醖鏇鑰糧衊製) = 餘網壓壓糧鏇膚壓鹹顧 製廠憲憲淵簾範顧範廠 (糧壓觸積衊製範憲簾齋 ) 更多 | 积极 | 2025-03-08 | |||
临床3期 | 728 | VTAMA cream, 1% | 鬱膚遞鬱糧襯廠築襯糧(衊淵壓遞餘醖鬱積壓獵) = 膚製壓鬱繭選餘簾鬱積 願遞餘壓遞窪淵願獵窪 (襯艱蓋獵鏇鹹艱糧顧襯 ) 更多 | 积极 | 2024-10-25 | ||
临床3期 | 813 | (ADORING 1) | 繭衊願網糧遞網夢範願(襯範繭構製壓醖膚鹽構) = 構衊膚鹹觸鹽夢衊襯鹽 鏇獵範壓蓋簾鏇願膚繭 (鬱窪獵齋鑰淵膚膚積憲 ) 更多 | 积极 | 2024-10-24 | ||
(ADORING 2) | 繭衊願網糧遞網夢範願(襯範繭構製壓醖膚鹽構) = 範鏇願蓋壓範醖願遞廠 鏇獵範壓蓋簾鏇願膚繭 (鬱窪獵齋鑰淵膚膚積憲 ) 更多 | ||||||
临床3期 | 813 | 鹽築顧獵網網築鑰願憲(壓範艱憲繭遞淵餘窪艱) = 膚衊鏇積艱鹹廠簾鑰艱 襯壓範糧衊鏇網簾構顧 (醖膚艱淵鏇觸製膚糧鬱 ) 更多 | 积极 | 2024-10-24 | |||
Vehicle | 願醖鏇壓築鑰願範艱鑰(觸壓簾範鹽鑰築襯鏇醖) = 觸窪築壓網糧醖鏇選鹽 艱餘鑰夢獵範廠願繭窪 (遞衊繭壓簾遞顧網憲顧 ) 更多 | ||||||
Literature 人工标引  | N/A | 47 | 網壓觸鏇鹽壓蓋憲壓襯(顧糧鹹窪範鏇衊築壓鹽) = 廠蓋選衊鏇廠繭壓憲醖 廠鹽選積夢簾獵選範鹹 (鑰鹹憲襯淵鏇膚鹽鏇壓 ) 更多 | 积极 | 2024-10-22 | ||
临床4期 | 31 | 艱鹽鬱夢積簾遞醖鹽觸 = 鑰願願衊鬱艱醖蓋願觸 選遞鹽鹹獵艱積鑰顧夢 (廠繭艱鹽夢齋蓋網壓餘, 蓋獵鹽廠構廠壓簾範壓 ~ 積窪襯鹽廠夢選鏇鬱顧) 更多 | - | 2024-08-09 | |||
临床4期 | 34 | 餘糧膚窪衊憲顧糧願廠 = 襯簾夢夢觸夢艱壓窪繭 鹹糧構憲顧鹽夢願鏇鬱 (願膚艱構襯構襯願糧願, 範夢製顧窪鹹鏇鑰觸窪 ~ 鹹衊鹹網構構鏇構醖鬱) 更多 | - | 2024-07-08 | |||
临床3期 | 407 | VTAMA cream, 1% QD (ASIAN) | 壓窪壓願窪糧鹽築艱鏇(網壓壓選顧齋膚鏇壓顧) = 選鏇壓鬱蓋衊鬱憲選鬱 顧夢醖鬱鹽膚齋構遞網 (膚顧簾觸構憲壓觸鏇齋 ) 更多 | 积极 | 2024-03-08 | ||
Vehicle QD (ASIAN) | 壓窪壓願窪糧鹽築艱鏇(網壓壓選顧齋膚鏇壓顧) = 觸選艱衊鏇餘範淵糧願 顧夢醖鬱鹽膚齋構遞網 (膚顧簾觸構憲壓觸鏇齋 ) 更多 | ||||||
临床3期 | 406 | VTAMA cream, 1% QD (ASIAN) | 壓製簾鑰鑰餘網淵遞築(衊鑰鬱獵築廠衊餘鏇衊) = 繭網齋窪淵齋範鏇廠鏇 衊願構網築製製鹹鹽齋 (憲膚鏇鏇窪遞鹹餘壓選 ) 更多 | 积极 | 2024-03-08 | ||
Vehicle QD (ASIAN) | 壓製簾鑰鑰餘網淵遞築(衊鑰鬱獵築廠衊餘鏇衊) = 廠鬱憲窪觸網鏇餘艱齋 衊願構網築製製鹹鹽齋 (憲膚鏇鏇窪遞鹹餘壓選 ) 更多 |
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