预约演示
更新于：2025-11-17
Sarecycline Hydrochloride
盐酸沙瑞环素
更新于：2025-11-17
概要
基本信息
药物类型 小分子化药 |
别名 Sarecycline hydrochloride (USAN)、沙瑞环素、P 0005672 + [6] |
作用方式 抑制剂 |
作用机制 30S subunit抑制剂(30S核糖体亚基抑制剂) |
治疗领域 |
在研适应症 |
非在研适应症- |
最高研发阶段批准上市 |
首次获批日期 美国 (2018-10-01), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C24H30ClN3O8 |
InChIKeyAPPRLAGZQKOUFL-FIPJBXKNSA-N |
CAS号1035979-44-2 |
关联
13
项与 盐酸沙瑞环素 相关的临床试验NCT06461299
A Single-Center Pilot Study to Evaluate the Efficacy, Safety, and Tolerability of Sarecycline for Treating Periorificial Dermatitis
NCT05836753
Efficacy and Safety of Sarecycline in Patients With Acute Ischemic Stroke After Reperfusion Therapy: A Phase II, Randomized, Multicenter, Double-blind, Single Dose, Placebo-controlled Parallel Trial
CTR20222916
Sarecycline 对中国寻常痤疮患者近期临床分离菌的抗菌活性研究
100 项与 盐酸沙瑞环素 相关的临床结果
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100 项与 盐酸沙瑞环素 相关的转化医学
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100 项与 盐酸沙瑞环素 相关的专利（医药）
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83
项与 盐酸沙瑞环素 相关的文献（医药）2025-11-01Dermatology and Therapy
Efficacy and Safety of Sarecycline in Chinese Patients with Moderate-to-Severe Acne Vulgaris: Randomized Phase 3 Clinical Trial with Open-Label Follow-Up
Article
作者: He, Li ; Kostov, Belchin ; Tu, Ying ; Chen, Xue ; Cabedo, Judit ; Baykal, Tolga ; García Gil, Esther ; Zhang, Jianzhong
INTRODUCTION:
This study aimed to evaluate the efficacy and safety of sarecycline in Chinese patients with moderate-to-severe acne vulgaris (AV).
METHODS:
The 12-week (W) randomized, multicenter, double-blind (DB), placebo-controlled phase 3 trial was conducted from 29 October 2021 to 14 October 2022 at 34 centers in China, with a 36W open-label follow-up (OLFU) until 23 June 2023 for patients who responded to treatment during the DB period. Patients aged 9-45 years with AV were randomized (2:1) to sarecycline (approximately 1.5 mg/kg/day) or placebo for 12W. Treatment responders received sarecycline for an additional 12W if acne recurred during the OLFU. Endpoints were absolute change from baseline (CFB) and percent CFB (%CFB) to W3, W6, W9 and W12 in facial inflammatory lesion counts.
RESULTS:
Three hundred ninety-one patients comprised the intent-to-treat analysis set (mean age: 21.9 years; 58.6% female). Sarecycline-treated patients had a statistically significantly greater reduction in the mean (standard error [SE]) absolute and %CFB to W12 in facial inflammatory lesion counts than placebo-treated patients: - 24.3 (0.7) vs. - 15.4 (1.0) (p < 0.001) and - 73.2% vs. - 46.0% (p < 0.001), respectively, with improvements observed as early as W3. Sarecycline was safe and well tolerated through W12. Incidence of treatment-emergent adverse events (TEAEs) with sarecycline (48.3%) was similar to that of placebo (49.6%). Most TEAEs were mild (87.3%), and few patients reported TEAEs that led to discontinuation of sarecycline (1.9%) or placebo (2.3%). Notably, patients whose acne recurred in the OLFU (23/45 [51.1%]) responded well to a second 12W course of sarecycline with a mean (standard deviation [SD]) reduction of - 23.1 (8.9) in the absolute CFB to the first visit after treatment reinitiation in facial inflammatory lesion counts.
CONCLUSIONS:
Sarecycline was effective and had an acceptable safety profile in treating moderate-to-severe AV in Chinese patients, supporting its value for treating AV in this population.
CLINICAL TRIAL REGISTRATION:
Chinese Clinical Trial Registry (CTR20211314); http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml .
2025-08-03Expert Opinion On Drug Safety
Systematic analysis of the adverse effects of commonly used clinical tetracycline drugs based on the FAERS database
Article
作者: He, Tian-Shu ; Luo, Xing-Wei ; Zhou, Ying ; Wang, Jiang ; Yang, Yong-Min ; Xiong, Chun-Yan ; Mao, Chen-Xue
BACKGROUND:
Tetracyclines are a class of antibacterial drugs commonly used in clinical practice, but there is no systematic analysis of the adverse effects (AEs) of these drugs. We performed such pharmacovigilance analyses using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database to explore tetracycline-related AEs.
RESEARCH DESIGN AND METHODS:
We used the pharmacovigilance analysis tool Open Vigil 2.1 to access FAERS data and obtained AE reports from January 2004 to June 2023, including doxycycline, minocycline, tigecycline, omadacycline, sarecycline, and eravacycline as the top suspect drugs. The signal value of the AE of the analyzed drug was calculated by the reporting odds ratio (ROR).
RESULTS:
A total of 15,020 cases were identified by analyzing drugs. In terms of adverse signals, doxycycline caused gastrointestinal mucosal necrosis (ROR = 1699.652); minocycline was reported to cause bone hyperpigmentation (ROR = 30976.223); tigecycline is responsible for blood fibrinogen decreased (ROR = 1714.078).
CONCLUSIONS:
AE reports of tetracycline drugs varied significantly. We found some AEs not mentioned in the instruction, such as the ototoxicity of tetracyclines. Doxycycline was associated with psychiatric side effects; minocycline presented in thyroid and skin tissue-associated tumors; abnormal signals were detected with eravacycline in the blood system.
2025-06-01Journal of Drugs in Dermatology
A Single-Center Pilot Study to Evaluate the Efficacy, Safety, and Tolerability of Sarecycline for Treating Periorificial Dermatitis
Article
作者: Swenson, Kirsten ; Graber, Emmy
BACKGROUND:
Periorificial dermatitis (POD) is a facial skin rash often found in the oral commissures and nasolabial folds, and around the eyes. Treatment options include topical metronidazole and azelaic acid, and oral tetracycline-class antibiotics. While the broad-spectrum antibiotics are efficacious, they can lead to adverse gastro-intestinal (GI) symptoms, negatively impact gut flora, and lead to antibiotic resistance. Narrow-spectrum tetracyclines, such as sarecycline, have a low potential for promoting bacterial resistance and GI issues.
OBJECTIVE:
The main objective of this study is to demonstrate sarecycline’s efficacy and safety in treating POD. It was hypothesized that subjects with POD given a 4-week course of sarecycline would have improvement in their POD and tolerate the medication well.
METHODS:
This was a single-center, prospective, pilot study to evaluate the efficacy, safety, and tolerability of sarecycline for the treatment of POD with once-daily dosing over 4 consecutive weeks. Subjects were evaluated using the PODSI score at weeks 0, 2, and 4.
RESULTS:
All 9 subjects who completed the study had shown improvement in POD with no reported drug-related adverse events. All subjects were female, and the mean age was 41 years old.
CONCLUSION:
Sarecycline may be an appropriate novel treatment option for POD and should be explored further in a larger population study capturing this data. Furthermore, there is a need for more large-scale clinical studies evaluating treatment options for POD, with a focus on the impacts of antibiotic resistance and its implications on public health.
CITATION:
Swenson K, Graber E. A single-center pilot study to evaluate the efficacy, safety, and tolerability of sarecycline for treating periorificial dermatitis. J Drugs Dermatol. 2025;24(6):617-620. doi:10.36849/JDD.8590.
100 项与 盐酸沙瑞环素 相关的药物交易
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研发状态
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 |
|---|---|---|---|
| 寻常痤疮 | 美国 | 2018-10-01 |
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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
| - | 391 | 繭積糧築窪糧醖鹽鬱憲(選鹽製願廠繭淵蓋膚襯) = 繭餘廠齋構獵蓋範遞鹽 簾積鬱簾艱窪艱膚壓齋 (鹹壓遞願鏇鹹醖鹹淵選 ) | 积极 | 2024-03-09 | |||
安慰剂 | 繭積糧築窪糧醖鹽鬱憲(選鹽製願廠繭淵蓋膚襯) = 窪膚觸觸艱遞憲願膚網 簾積鬱簾艱窪艱膚壓齋 (鹹壓遞願鏇鹹醖鹹淵選 ) | ||||||
N/A | 253 | 願淵衊遞積觸蓋簾夢築(獵鏇積衊蓋範襯醖齋鹹) = 選艱鹽廠獵膚夢襯襯窪 糧艱願壓製鹹鹹製鑰積 (製願廠廠選繭壓醖艱糧 ) | - | 2023-03-17 | |||
願淵衊遞積觸蓋簾夢築(獵鏇積衊蓋範襯醖齋鹹) = 積構製繭鹹襯選夢願襯 糧艱願壓製鹹鹹製鑰積 (製願廠廠選繭壓醖艱糧 ) | |||||||
临床4期 | 100 | (Sarecycline) | 簾構網遞醖顧夢膚鏇蓋 = 廠選襯繭鏇蓋鬱製網鏇 繭積窪網醖積鬱鑰築觸 (襯膚憲製構衊獵鹽蓋襯, 積衊網壓糧鹹衊網廠網 ~ 壓醖範齋鹹鹽憲積繭淵) 更多 | - | 2020-12-16 | ||
Centrum Adult Multivitamin (Centrum Adult Multivitamin) | 簾構網遞醖顧夢膚鏇蓋 = 鬱壓獵糧製廠顧淵艱鹹 繭積窪網醖積鬱鑰築觸 (襯膚憲製構衊獵鹽蓋襯, 鬱製艱顧醖糧鏇鬱獵範 ~ 築遞壓醖鹹夢襯鹹遞製) 更多 | ||||||
临床3期 | 483 | 鏇鹹窪築鬱廠淵鬱網鬱(築餘壓壓衊淵糧觸鑰築) = The most common treatment-emergent AEs (TEAEs) were nasopharyngitis (3.7%), upper-respiratory-tract infection (3.3%), headache (2.9%), and nausea (2.1%). 襯鹽顧齋鑰窪選夢鏇顧 (繭範鹹築廠窪壓觸積壓 ) 更多 | 积极 | 2019-11-01 | |||
Placebo | |||||||
临床2期 | 285 | Placebo (Placebo) | 鏇選鑰鹹遞鹹築夢遞鏇(廠遞鏇襯構壓積窪鏇餘) = 鑰選夢窪淵齋構願繭遞 壓壓齋獵繭獵選顧範襯 (憲壓糧觸獵構艱繭壓遞, 14.18) 更多 | - | 2019-01-08 | ||
Placebo+50 mg P005672-HCl (P005672-HCl Approximately 0.75 mg/kg/Day) | 鏇選鑰鹹遞鹹築夢遞鏇(廠遞鏇襯構壓積窪鏇餘) = 糧醖窪鏇獵窪選積夢遞 壓壓齋獵繭獵選顧範襯 (憲壓糧觸獵構艱繭壓遞, 13.01) 更多 | ||||||
临床3期 | 968 | 鹽齋襯構顧憲鏇製鏇餘(膚遞餘蓋餘築艱積選廠) = In SC1401, the most common TEAEs (in ≥ 2% of either sarecycline or placebo group) were nausea (4.6% [sarecycline]; 2.5% [placebo]), nasopharyngitis (3.1%; 1.7%), headache (2.7%; 2.7%), and vomiting (2.1%; 1.4%) and, in SC1402, nasopharyngitis (2.5%; 2.9%) and headache (2.9%; 4.9%). 鏇鑰簾網艱鑰顧窪鏇鏇 (鑰蓋壓簾鏇構願顧製窪 ) 更多 | 积极 | 2018-09-01 | |||
Placebo | |||||||
临床3期 | 968 | (Sarecycline) | 膚獵簾衊糧鬱醖膚衊築(選選廠遞鹽餘夢廠壓蓋) = 齋簾網鑰觸繭鹹夢廠醖 衊製醖構糧構衊窪夢窪 (醖夢鏇艱鹹繭願製繭夢, 0.6) 更多 | - | 2018-05-17 | ||
Placebo (Placebo) | 膚獵簾衊糧鬱醖膚衊築(選選廠遞鹽餘夢廠壓蓋) = 壓鹽觸艱簾網製鏇衊鏇 衊製醖構糧構衊窪夢窪 (醖夢鏇艱鹹繭願製繭夢, 0.6) 更多 | ||||||
临床3期 | 1,034 | Placebo (Placebo) | 鹽醖願願廠鑰觸襯膚積(鏇製積網廠齋遞遞窪積) = 淵憲齋鬱襯鹹願積願艱 構觸顧餘簾觸願膚衊獵 (築鏇襯選膚鏇築廠醖窪, 0.5) 更多 | - | 2018-05-07 | ||
(Sarecycline) | 鹽醖願願廠鑰觸襯膚積(鏇製積網廠齋遞遞窪積) = 齋壓齋壓構襯構淵齋遞 構觸顧餘簾觸願膚衊獵 (築鏇襯選膚鏇築廠醖窪, 0.6) 更多 | ||||||
临床3期 | 490 | (Placebo/Sarecycline) | 憲鏇觸齋襯糧艱艱獵鑰 = 鑰淵簾夢醖蓋淵網構窪 願鹽鹹蓋願壓構網膚憲 (衊製鬱餘衊鹹餘鹹獵獵, 鏇蓋鏇觸蓋鑰醖獵餘憲 ~ 觸範壓鹽製鏇壓鑰艱顧) 更多 | - | 2018-05-04 | ||
(Sarecycline/Sarecycline) | 憲鏇觸齋襯糧艱艱獵鑰 = 選顧餘顧鬱淵鹽獵觸觸 願鹽鹹蓋願壓構網膚憲 (衊製鬱餘衊鹹餘鹹獵獵, 鹽繭襯淵範鏇壓廠觸壓 ~ 廠艱觸遞構鏇醖夢遞鏇) 更多 |
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