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更新于：2026-02-27
Sonidegib Phosphate
磷酸索立德吉
更新于：2026-02-27
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2015-07-24), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、临床急需境外新药 (中国) |
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结构/序列
分子式C26H32F3N3O11P2 |
InChIKeyRWIVSVMMGFFZIJ-VWDRLOGHSA-N |
CAS号1218778-77-8 |
关联
56
项与 磷酸索立德吉 相关的临床试验CTIS2024-515989-14-00
A phase II study of Sonidegib in Nevoid Basal Cell Carcinoma Syndrome (Gorlin) syndrome and sporadic BCC patients in EADO stage IIb. SIBLINGS TRIAL
NCT05669339
AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma
ACTRN12623001216606
Single-institution, single-arm, open-label phase II basket study investigating the effect of mutation and/or elevated hedgehog (Hh) expression-directed smoothened inhibitor sonidegib in patients with advanced solid malignancies
100 项与 磷酸索立德吉 相关的临床结果
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100 项与 磷酸索立德吉 相关的转化医学
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100 项与 磷酸索立德吉 相关的专利（医药）
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433
项与 磷酸索立德吉 相关的文献（医药）2026-04-01TISSUE & CELL
U0126 induces osteoclast differentiation via the p38-NFATc-1 signaling pathway
Article
作者: Huang, Xiaofeng ; Wang, Jiran ; Chen, Shuzhen ; Liu, Jinan ; Chen, Guangyong ; Jia, Xueting
Osteoclast differentiation plays an important role in bone metabolic diseases, such as osteoporosis, osteosclerosis and so on. In the study, we found that the ERK inhibitor, U0126, significantly increased the number of multinucleated osteoclasts after inducing differentiation of mouse mononuclear macrophage RAW264.7 cells. The Shh-p38-NFATc-1 signaling pathway has been reported to induce osteoclast differentiation in our previous work, and here U0126 also could increase pp38 and NFATc-1 expression as well as NFATc-1 entrance into the nucleus. Animal experiment demonstrated that U0126 accelerated tooth eruption in newborn mice and promoted alveolar bone resorption by inducing osteoclastogenesis. Furthermore, U0126 can rescue delayed tooth eruption caused by LDE225 (a Shh inhibitor) suppression of the p38 signaling pathway. Cytological experiments also revealed that U0126 could rescue the osteoclastic inhibitory effect of LDE225, but not Doramapimod (a p38 inhibitor). Therefore, we conclude that U0126 promotes osteoclast differentiation via the p38-NFATc-1 signaling pathway and relieves the inhibitory effect of LDE225 on osteoclastogenesis. Our study may provide a scientific foundation for dental treatment strategies to enhance osteoclast function in addressing tooth eruption issues, such as impacted teeth, delayed eruption of permanent teeth, and cranioclavicular dysplasia syndrome (CCD). It will also serve as a method for future research into novel approaches to treating disorders linked to bone metabolism.
2026-03-01INTERNATIONAL JOURNAL OF DERMATOLOGY
Evaluation of Sonidegib Cytoreductive Activity in Locally Advanced Basal Cell Carcinoma Treatment: A Delphi Consensus
Article
作者: Tagliaferri, Luca ; Peris, Ketty ; Queirolo, Paola ; Dika, Emi ; Fargnoli, Maria Concetta ; Paradisi, Andrea ; Massi, Daniela ; Portincasa, Aurelio ; Caracò, Corrado ; Mandalà, Mario ; Ascierto, Paolo Antonio ; Quaglino, Pietro
ABSTRACT:
Background:
Basal cell carcinoma (
BCC
) is the most common cancer worldwide. If lesions are not treated for years or relapse after surgery and/or radiotherapy, they can become ‘locally advanced’ (
laBCC
). In some challenging
BCC
patients, the risk of a significant functional/aesthetic deficit advises against both complete surgical resection and radiotherapy. Medical therapies, such as the hedgehog pathway inhibitor (
HHI
) sonidegib, may be helpful to make patients eligible for other potentially curative techniques or for the long‐term management of refractory cases or cases that are unsuitable for surgery and radiotherapy. A multidisciplinary board organized a Delphi consensus to understand the agreement around the cytoreductive HHI approach.
Methods:
A Delphi questionnaire with 17 statements (with a 7‐point Likert scale) was administered via a customized web‐based platform to Italian specialists with clinical activity/expertise in
laBCC
. In the second‐round physicians were asked to answer the same statements considering the interquartile range of each question as an index of their colleagues' responses.
Results:
Forty‐seven panelists, representative of the Italian territory, answered the questionnaire at the first round. For 16/17 statements of the Delphi, at the second round, more than 75% of panelists assigned a score of 4 or more reaching agreement; these statements also reached a high consensus, as the panelists assigned similar scores, with a low interquartile range.
Conclusions:
In the absence of solid scientific evidence, this article offers consensus‐based recommendations on which patients may benefit from cytoreductive
HHI
, how to conduct the cytoreductive therapy, how to assess response to it and how to perform the surgery.
2026-02-01HEAD AND NECK-JOURNAL FOR THE SCIENCES AND SPECIALTIES OF THE HEAD AND NECK
Safety and Efficacy of Vismodegib and Sonidegib in Advanced Basal Cell Carcinoma of the Head and Neck: A Systematic Review and Meta‐Analysis
Review
作者: Cevik, Jevan ; Ramakrishnan, Anand ; Doyle, Cindy M.
ABSTRACT:
Importance:
Basal cell carcinoma (BCC) is the most prevalent malignancy globally, with 75% occurring in the head and neck. Hedgehog pathway inhibitors (HHIs) may provide a treatment for locally advanced BCC (laBCC) and metastatic BCC (mBCC) of the head and neck.
Objective:
This systematic review and meta‐analysis aimed to evaluate the safety and efficacy of these treatments specifically in the head and neck region.
Data Sources:
An electronic database search was conducted in June 2024 across Embase, MEDLINE, CINAHL, and
ClinicalTrials.gov
. There were no date limits applied, with search constraints consisting of the English language.
Study Selection:
Included were studies involving adults with confirmed laBCC or mBCC of the head and neck treated with either vismodegib or sonidegib, with histological or radiological confirmation. Studies were excluded if they involved concurrent treatments or lacked quantitative measures. After full text review was completed, there were 17 studies for inclusion.
Data Extraction and Synthesis:
This systematic review and meta‐analysis were conducted in accordance with PRISMA guidelines using two independent observers. Data extraction was performed using a standardized Microsoft Excel Form. Statistical analyses were conducted using meta‐analysis software on jamovi using a random effects model.
Main Outcome(s) and Measure(s):
This study initially aimed to investigate both systemic immunotherapies and targeted therapies, but no articles were identified for systemic immunotherapies for laBCC or mBCC of the head and neck region. Thus, the sole focus of this article became targeted therapies. Primary outcomes assessed were overall response rate (ORR), complete response (CR), and partial response (PR), alongside the prevalence of adverse effects.
Findings:
Seventeen studies involving 522 patients were analyzed, revealing a pooled
ORR
of 84.2% (95%
CI
: 77.1–91.3),
CR
of 33.8%, and
PR
of 47.7%. Common adverse effects included muscle spasms, dysgeusia, and fatigue, with a discontinuation rate of 13.2% due to adverse events.
Conclusions and Relevance:
This systematic review and meta‐analysis demonstrated a high efficacy of vismodegib and sonidegib for treating advanced BCCs in the head and neck region, suggesting a viable option when surgery is not feasible. Further high‐quality research is necessary to optimize treatment outcomes for this patient population.
100 项与 磷酸索立德吉 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 |
|---|---|---|---|
| 转移性基底细胞癌 | 澳大利亚 | 2015-08-10 | |
| 基底细胞癌 | 美国 | 2015-07-24 |
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 |
|---|---|---|---|---|
| 基底细胞痣综合征 | 临床3期 | 意大利 | 2010-06-29 | |
| 复发性皮肤癌 | 临床2期 | 美国 | 2015-02-01 | |
| 多发性骨髓瘤 | 临床2期 | 美国 | 2015-01-01 | |
| 急性淋巴细胞白血病 | 临床2期 | 美国 | 2014-02-01 | |
| 急性髓性白血病 | 临床2期 | 美国 | 2014-02-01 | |
| 慢性期慢性髓性白血病 | 临床2期 | 美国 | 2014-02-01 | |
| 血液肿瘤 | 临床2期 | 美国 | 2014-02-01 | |
| 髓母细胞瘤 | 临床2期 | 美国 | 2014-02-01 | |
| 胰腺腺癌 | 临床2期 | 美国 | 2014-02-01 | |
| 实体瘤 | 临床2期 | 美国 | 2014-02-01 |
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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
N/A | 13 | 選壓鏇網衊網遞鏇獵顧(選觸糧範鹽鬱夢廠鑰製) = 餘遞醖餘衊壓糧顧構鏇 觸選範觸願鏇積鬱鹽襯 (襯網構襯鹹範積淵遞鏇 ) 更多 | 积极 | 2025-03-07 | |||
選壓鏇網衊網遞鏇獵顧(選觸糧範鹽鬱夢廠鑰製) = 鹽網製齋衊顧鹽觸網蓋 觸選範觸願鏇積鬱鹽襯 (襯網構襯鹹範積淵遞鏇 ) 更多 | |||||||
N/A | 3,774 | 築鹹顧艱觸窪窪艱蓋積(構壓築積蓋鬱築網醖獵) = 願網鬱構繭網鹹壓簾膚 願壓壓獵鑰廠夢網餘憲 (憲淵鑰廠憲顧鑰襯選蓋 ) 更多 | 积极 | 2025-03-07 | |||
築鹹顧艱觸窪窪艱蓋積(構壓築積蓋鬱築網醖獵) = 鹽艱衊糧構顧顧繭淵膚 願壓壓獵鑰廠夢網餘憲 (憲淵鑰廠憲顧鑰襯選蓋 ) 更多 | |||||||
N/A | 321 | 繭選壓製鬱鏇鹹遞構襯(製憲蓋憲淵蓋蓋鑰鬱鹽) = Most TEAEs were ≤ grade 2 and the most common were muscle spasms (43.9%), dysgeusia (37.1%), and alopecia (30.2%) 餘繭製選糧繭選鏇網簾 (網獵夢齋鏇遞衊襯蓋網 ) 更多 | 积极 | 2024-11-14 | |||
临床2期 | 66 | 壓鑰構製範簾繭糧廠遞(積選繭選襯鹹鬱齋獵鬱) = 齋憲積鏇選壓鹹鬱鏇餘 構廠構鏇壓鑰範製糧鹹 (壓積憲鑰蓋衊鬱壓鹽製, 68 ~ 100) 更多 | 积极 | 2024-03-08 | |||
(CR) | 壓鑰構製範簾繭糧廠遞(積選繭選襯鹹鬱齋獵鬱) = 遞選鬱鑰繭範襯願廠艱 構廠構鏇壓鑰範製糧鹹 (壓積憲鑰蓋衊鬱壓鹽製, 54 ~ 94) 更多 | ||||||
N/A | 1,706 | Sonic hedgehog inhibitors (SHHis) vismodegib and sonidegib | 壓遞膚鬱廠獵繭鏇淵膚(鏇醖鬱夢壓簾顧鹹獵蓋) = 鹽顧網構鬱鑰積餘壓範 鏇鏇壓觸簾網襯簾衊餘 (窪選顧夢鏇願繭鹹蓋願 ) | 积极 | 2024-03-08 | ||
临床2期 | 194 | 範膚窪築糧遞積鏇構鏇(廠觸構繭鹽夢構襯繭範) = 選膚鏇壓襯願廠淵製壓 築夢齋鹽廠網鏇衊觸衊 (蓋廠製齋淵醖顧鏇蓋膚, 15.1 ~ NE) | - | 2023-10-11 | |||
N/A | - | - | 鹽鹽襯範壓廠鬱鏇鑰選(網淵齋廠衊膚構齋餘觸) = 鏇壓構鹽製廠艱製觸築 齋構齋鹹簾鏇艱築膚艱 (製衊餘構獵選餘構淵鹽 ) 更多 | - | 2023-07-05 | ||
临床1期 | 33 | 窪繭廠構窪願膚壓網製(餘鑰膚廠壓艱糧襯壓鑰) = 齋淵觸淵鹹衊壓願製鏇 襯積糧構獵憲選願膚鏇 (製鑰鹽遞廠艱網齋遞築 ) 更多 | 积极 | 2023-05-26 | |||
N/A | 局部晚期鳞状细胞癌 新辅助 | 13 | 範廠獵範膚窪鹽獵鑰鑰(鑰鬱簾獵鏇製夢鹹網簾) = 鏇製鹹壓繭淵願壓遞膚 壓簾築鹽膚遞鹹積餘膚 (壓網構糧憲鹽製衊鹽繭, 6.3 ~ 27.3) 更多 | 积极 | 2022-09-07 | ||
临床2期 | 66 | 廠築蓋糧鹹積觸齋築蓋(襯淵鏇顧膚鹹製遞鏇鏇) = 齋艱憲繭膚夢襯築鑰選 淵鏇鬱觸鑰夢淵構醖獵 (壓窪糧窪製餘餘網鏇衊 ) 更多 | - | 2021-11-19 |
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