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更新于：2026-04-16
Clindamycin Phosphate
克林霉素磷酸酯
更新于：2026-04-16
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 美国 (1972-10-02), |
最高研发阶段(中国)批准上市 |
特殊审评快速通道 (美国) |
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结构/序列
分子式C18H34ClN2O8PS |
InChIKeyUFUVLHLTWXBHGZ-MGZQPHGTSA-N |
CAS号24729-96-2 |
关联
32
项与 克林霉素磷酸酯 相关的临床试验NCT07474194
Comparative Study of the Effect of Preoperative Clindamycin Vaginal Cream Versus Vaginal Cleansing With Povidone-iodine on Postoperative Infections After Cesarean Section
CTRI/2025/04/085538
Randomized Controlled Trial on Shalmali Transdermal Patch against Clindamycin gelin Acne vulgaris - NIL
CTIS2024-519263-18-00
Prevention of Group G/C Streptococcus Infections during Labour and postpartum - a randomized controlled multicenter trial (POGSI)
100 项与 克林霉素磷酸酯 相关的临床结果
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100 项与 克林霉素磷酸酯 相关的转化医学
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100 项与 克林霉素磷酸酯 相关的专利（医药）
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586
项与 克林霉素磷酸酯 相关的文献（医药）2026-12-31JOURNAL OF DERMATOLOGICAL TREATMENT
Long-term efficacy and tolerability of clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel for acne: pooled results from two 6-month studies
Article
作者: Tanghetti, Emil A. ; Wroblewski, Karol ; Ghannoum, Mahmoud ; Harper, Julie C. ; Kircik, Leon H. ; Baldwin, Hilary ; Draelos, Zoe D. ; Gold, Linda Stein
AIM:
Given the chronic nature of acne, two 6-month studies were conducted to evaluate the long-term efficacy and tolerability of clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB)-the only approved triple-combination acne topical-and its effects on scarring/dyspigmentation in participants with moderate to severe acne.
MATERIALS AND METHODS:
Data were pooled from 2 identical, open-label, single-center studies conducted in participants (N = 50) aged ≥12 years with Investigator's Global Assessment (IGA) score of 3/4. Endpoints included change from baseline in IGA score, inflammatory/noninflammatory lesions, skin appearance (dryness, postinflammatory hyperpigmentation [PIH], postinflammatory erythema [PIE]), and scarring. Adverse events and tolerability (itching, burning, redness, swelling) were assessed.
RESULTS:
At week 24, 67% of participants achieved treatment success, and significant reductions from baseline in inflammatory (88%) and noninflammatory (68%) lesions were observed (p < 0.001, both). Significant reductions in scarring (33%), investigator- and participant-assessed PIH (71%; 78%, respectively), and PIE (77%; 77%, respectively) were demonstrated (p < 0.001, all). Most participants (>70%) reported no tolerability issues throughout the studies. Seven adverse events occurred; 4 were related to CAB, and 3 led to study discontinuation (BPO allergy [n = 2], irritant contact dermatitis to BPO [n = 1]).
CONCLUSIONS:
These findings suggest that CAB is an appropriate and effective topical option for the long-term treatment of acne vulgaris.
2025-12-31JOURNAL OF DERMATOLOGICAL TREATMENT
Efficacy and safety of fixed-dose clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel in Hispanic participants with moderate-to-severe acne: a pooled analysis
Article
作者: Callender, Valerie D. ; Cook-Bolden, Fran E. ; Alexis, Andrew F. ; Guenin, Eric ; Gold, Linda Stein ; Baldwin, Hilary
INTRODUCTION:
Clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel is the only fixed-dose, triple-combination approved for acne. In phase 2 and 3 studies, CAB demonstrated superior efficacy to vehicle and component dyads. This post hoc analysis examined efficacy/tolerability of CAB in 147 self-identified Hispanic/Latino participants (referred to as Hispanic).
METHODS:
Data were pooled from one phase 2 (NCT03170388) and two phase 3 (NCT04214652, NCT04214639) double-blind, 12-week studies. Eligible participants aged ≥9 years with moderate to severe acne were randomized to once-daily CAB or vehicle. Endpoints included ≥2-grade reduction from baseline in Evaluator's Global Severity Score with clear/almost clear skin (treatment success) and inflammatory/noninflammatory lesion counts. Treatment-emergent adverse events (TEAEs) were assessed.
RESULTS:
At week 12, 56.2% of CAB-treated participants achieved treatment success vs 18.4% with vehicle (p < 0.001). Reductions in inflammatory/noninflammatory lesions were 77.1%/76.2% with CAB vs 56.4%/45.0% with vehicle, respectively (p < 0.001, all). CAB TEAE rates were similar to overall study populations (27.0% vs 24.6%-36.2%). Baseline hyperpigmentation scores decreased from 0.6 to 0.3 (1 = mild) at week 12 with CAB. CAB gel was efficacious, safe, and well tolerated in Hispanic participants. Limitations include lack of Fitzpatrick skin phototype and short study duration.
CONCLUSIONS:
This study provides support for acne treatment with CAB in ethnically diverse populations.
2025-12-01Journal of Drugs in Dermatology
Clindamycin Phosphate 1.2%/Adapalene 0.15%/ Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne: A Pooled Analysis by Age
Article
作者: Tanghetti, Emil A. ; Woolery-Lloyd, Heather C. ; Guenin, Eric ; Draelos, Zoe D. ; Kircik, Leon H. ; Harper, Julie C. ; Baldwin, Hilary ; Eichenfield, Lawrence F. ; Graber, Emmy
BACKGROUND:
Acne pathophysiology and presentation may differ between pediatric/adolescent/young adult (9-24 years) and adult (≥25 years) patients. Fixed-dose clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel demonstrated superior efficacy to vehicle and component dyads with good safety/tolerability in 3 clinical trials of acne. This post hoc analysis evaluated the efficacy/safety of CAB in pediatric/adolescent/young adult ("younger") vs adult participants.
METHODS:
In one phase 2 (NCT03170388) and two phase 3 (NCT04214652, NCT04214639) trials, participants aged greater than or equal to 9 years with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Pooled data were analyzed for participants grouped by age: younger (9-24 years; n=515) and adult (greater than or equal to 25 years; n=142). Endpoints included the percentage of participants achieving treatment success (greater than or equal to 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin) and least squares mean percent change from baseline in inflammatory/noninflammatory lesions at week 12. Treatment-emergent adverse events (TEAEs) were evaluated throughout.
RESULTS:
At week 12, approximately half of CAB-treated participants in both age groups achieved treatment success (9-24: 50.6%; greater than or equal to 25: 49.0%) vs less than one-fourth with vehicle (15.7%; 20.6%; P<0.01, both). Across groups, CAB yielded >70% reductions in inflammatory/noninflammatory lesions vs 45% to 62% with vehicle (P≤0.001, all). For all endpoints, CAB efficacy was similar across age groups. Most TEAEs with CAB were of mild-to-moderate severity, and there were no age-related trends in safety/tolerability.
CONCLUSIONS:
Fixed-dose, triple-combination CAB gel was efficacious and well tolerated in participants with moderate-to-severe acne, regardless of age. Approximately half of the participants achieved clear/almost clear skin, with >70% reductions in lesion counts.
258
项与 克林霉素磷酸酯 相关的新闻（医药）2026-04-10
2026-04-10
100 项与 克林霉素磷酸酯 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 |
|---|---|---|---|
| 腹腔脓肿 | 美国 | 2026-02-12 | |
| 脓胸 | 美国 | 2026-02-12 | |
| 子宫内膜炎 | 美国 | 2026-02-12 | |
| 感染性阴道炎 | 美国 | 2026-02-12 | |
| 肺脓肿 | 美国 | 2026-02-12 | |
| 骨髓炎 | 美国 | 2026-02-12 | |
| 腹膜炎 | 美国 | 2026-02-12 | |
| 输卵管-卵巢脓肿 | 美国 | 2026-02-12 | |
| 厌氧菌感染 | 美国 | 2017-04-20 | |
| 骨和关节感染 | 美国 | 2017-04-20 | |
| 妇科感染 | 美国 | 2017-04-20 | |
| 下呼吸道感染 | 美国 | 2017-04-20 | |
| 脓毒症 | 美国 | 2017-04-20 | |
| 皮肤和皮肤结构感染 | 美国 | 2017-04-20 | |
| 脓疱性痤疮 | 日本 | 2002-07-05 | |
| 细菌性阴道炎 | 美国 | 1992-08-11 | |
| 急性支气管炎 | 日本 | 1991-10-04 | |
| 出血性败血症 | 日本 | 1991-10-04 | |
| 喉炎 | 日本 | 1991-10-04 | |
| 中耳炎 | 日本 | 1991-10-04 |
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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3期 | 307 | DARE-BV1clindamycin phosphate (Clindamycin Phosphate Vaginal Gel, 2%) | 鬱蓋範鹹膚鬱窪觸遞構 = 鬱獵齋醖蓋襯醖齋築壓 廠廠範範鹹鑰餘窪鏇窪 (鹽糧範窪窪窪餘築範構, 鹹鬱鹹衊齋積糧淵願蓋 ~ 獵構鏇鏇淵繭蓋鏇製願) 更多 | - | 2021-07-02 | ||
DARE-BV1clindamycin phosphate (Placebo Vaginal Gel (Universal HEC Placebo Gel)) | 鬱蓋範鹹膚鬱窪觸遞構 = 廠窪鹹願艱壓醖網鹹膚 廠廠範範鹹鑰餘窪鏇窪 (鹽糧範窪窪窪餘築範構, 廠鹽遞鹽獵窪顧糧築願 ~ 衊網構憲製繭鹽膚鹹齋) 更多 | ||||||
临床3期 | 1,236 | (Test Product) | 夢構繭顧繭窪蓋繭糧積(顧鏇構觸鑰壓艱顧積衊) = 範壓鹹壓網積築鏇築窪 鏇蓋齋蓋襯壓選壓廠衊 (夢顧蓋醖遞獵構願製夢, 36.10) 更多 | - | 2021-05-04 | ||
(Reference Product) | 夢構繭顧繭窪蓋繭糧積(顧鏇構觸鑰壓艱顧積衊) = 鬱衊壓願選鏇顧齋蓋廠 鏇蓋齋蓋襯壓選壓廠衊 (夢顧蓋醖遞獵構願製夢, 36.83) 更多 | ||||||
临床3期 | 307 | 夢糧願糧顧獵鬱餘簾網(壓獵襯鹹餘願觸窪觸糧) = 遞膚簾構網鹽製夢淵醖 鬱鏇積網夢襯鹹顧壓網 (淵範鹽獵鹽衊製網艱構 ) 更多 | 积极 | 2020-12-07 | |||
Placebo | 夢糧願糧顧獵鬱餘簾網(壓獵襯鹹餘願觸窪觸糧) = 網繭夢顧鹹鹽遞憲範網 鬱鏇積網夢襯鹹顧壓網 (淵範鹽獵鹽衊製網艱構 ) 更多 | ||||||
临床2期 | 591 | (Benzoyl Peroxide/Clindamycin + Tazarotene) | 齋襯窪繭膚築艱構製糧(積範顧顧選網觸製憲繭) = 積築窪選繭製淵遞艱網 廠構獵積廠鏇衊獵願鏇 (鏇繭衊醖積製鬱獵窪鑰, 14.35) 更多 | - | 2017-03-06 | ||
Clindamycin+Benzoyl Peroxide (Benzoyl Peroxide/Clindamycin + Vehicle Cream) | 齋襯窪繭膚築艱構製糧(積範顧顧選網觸製憲繭) = 鹽襯範襯齋膚製衊鹹艱 廠構獵積廠鏇衊獵願鏇 (鏇繭衊醖積製鬱獵窪鑰, 14.45) 更多 | ||||||
临床3期 | 1,018 | (Duac Once Daily Gel) | 製窪餘鏇鑰衊膚鬱製簾(壓獵鹽憲構獵鹽膚觸壓) = 醖選夢積醖廠廠繭壓顧 壓獵齋顧簾積構憲構鹽 (繭醖獵製糧壓繭糧願獵, 1.05) 更多 | - | 2014-11-25 | ||
(Dalin Gel) | 製窪餘鏇鑰衊膚鬱製簾(壓獵鹽憲構獵鹽膚觸壓) = 繭憲齋願網選憲鑰糧膚 壓獵齋顧簾積構憲構鹽 (繭醖獵製糧壓繭糧願獵, 1.03) 更多 |
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