The goal of this randomized clinical trial is to test the topical drug clascoterone in patients with pilonidal disease, which is a common, benign skin condition of the gluteal cleft. The main questions it aims to answer are:
* Does clascoterone improve the severity of pilonidal disease as scored by a physician?
* Does clascoterone improve patient symptoms due to pilonidal disease?
* Does clascoterone improve the inflammation seen under the microscope in pilonidal disease removed at surgery Participants will apply clascoterone or a placebo cream to the diseased area for 3 months. They will be assessed every 4 weeks for disease severity assessed by a physician viewing patient photos and a symptom-based survey.
Researchers will compare participants who received clascoterone treatment to those who received placebo.

开始日期2025-01-10

申办/合作机构

University of Pennsylvania

NCT06454708

/ Completed临床1期

An Open Phase I Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Single Dose and Repeat Dose Topical Administrations of Clascoterone Cream, 1% in Healthy Chinese Adult Subjects

The primary objective of this study is to determine the pharmacokinetics (PK) of Clascoterone Cream, 1% after single dose and repeat dose topical administrations in healthy Chinese adult subjects.

开始日期2024-08-01

申办/合作机构

浙江三生蔓迪药业有限公司

100 项与克拉司酮相关的临床结果

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100 项与克拉司酮相关的转化医学

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100 项与克拉司酮相关的专利（医药）

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项与克拉司酮相关的文献（医药）

2025-04-01·Journal of Drugs in Dermatology

Improvement in Skin Moisturization and Lack of Barrier Damage Following Treatment With Clascoterone Cream 1%

Article

作者: Kyeremateng, Kizito ; Squittieri, Nicholas ; D. Draelos, Zoe

BACKGROUND:

Topical medications commonly prescribed for the treatment of acne vulgaris may be limited by application-site dryness, which can result in skin barrier damage. This study aimed to evaluate the effects of clascoterone cream 1% on skin barrier properties in acne-prone individuals.

METHODS:

Participants ≥18 years of age with acne-prone skin were enrolled in a single-center, split-face study and randomized to twice-daily treatment with clascoterone cream 1% (approximately 0.5 g) to the right or left side of the face for 2 weeks. The primary and secondary endpoints were the changes in corneometry reading and transepidermal water loss (TEWL), respectively, between treated and untreated sides at week 2. Tolerability was evaluated from the severity of dryness, erythema, scaling, irritation, tightness, stinging, itching, and burning for each side using a 5-point scale from 0 (none) to 4 (severe).

RESULTS:

This study enrolled 50 participants (female, n = 38) with a mean ± standard deviation (SD) age of 31.1 ± 8.9 years. The mean ± SD corneometry reading was significantly higher for the treated vs untreated side at week 2 (131.3 ± 42.9 vs 113.9 ± 36.6; P<0.001). There was no difference in TEWL between treated and untreated sides at any time point assessed. All tolerability parameters evaluated were rated as absent or minimal through week 2 for both sides.

CONCLUSION:

Twice-daily treatment with clascoterone cream 1% for 2 weeks was associated with increased moisturization and maintenance of skin barrier function as assessed by corneometry and TEWL and was otherwise well tolerated. J Drugs Dermatol. 2025;24(4):397-402. doi:10.36849/JDD.8774.

2025-02-01·EUROPEAN JOURNAL OF DERMATOLOGY

Four years of study by an expert group on truncal acne: where are we now?

Review

作者: Dreno, Brigitte ; Claudel, Jean Paul ; Leccia, Marie Thérèse ; Auffret, Nicole ; Ballanger, Fabienne

Until recently, interest in truncal acne has been low, resulting in only a small amount of published data, focussing mainly on therapeutic options previously developed for facial acne. This report provides a summary of the work carried out since 2020 on truncal acne by a group of experts in acne. The expert group reviewed their own studies as well as more recently published articles on truncal acne and its management in daily clinical practice. The experts produced four publications dating from 2020 onwards on the different issues regarding truncal acne, ranging from physiopathology, aetiology, assessment of severity, and treatment to quality of life in adolescents. Since these studies began, six other publications on truncal acne have been published. Of these, four concern investigative data on clascoterone, sarecyline and a dermocosmetic; one is a review on the management of truncal acne and acne scars, and one is an update of the American acne treatment guidelines. Moreover, the authors confirmed that interest in truncal acne has significantly increased over recent years and that new treatment options for truncal acne are either being developed or are already available. Truncal acne has significantly gained interest over recent years, and novel assessment tools and treatments are available to manage this condition efficiently. However, international treatment guidelines require updating, considering the importance of truncal acne.

2025-01-01·The Journal of clinical and aesthetic dermatology

Prospective Pilot Evaluation of the Safety, Tolerability, and Efficacy of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel plus Clascoterone 1% Cream in Adult Patients with Acne.

Article

作者: Swenson, Kirsten ; Yu, Zizi ; Graber, Emmy

Background:

Acne vulgaris (acne) is a common disorder with a complex, multi-faceted pathophysiology. To date, there has not been a single topical treatment that targets all aspects of acne pathophysiology (ie, increased sebum production, presence of Cutibacterium acnes, inflammation, and follicular hyperkeratinization). As such, topical treatments need to be utilized in combination to target all four of the major recognized pathophysiologic components in acne lesion formation.

Objective:

This single-center prospective evaluation assessed the safety, tolerability, and efficacy of clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide (BPO) 3.1% gel used concurrently with clascoterone 1% cream for treatment of acne in an eight-week, open-label pilot evaluation.

Methods:

Six subjects (N=6), aged 21 to 27, were enrolled and evaluated at Week 0, Week 2, Week 4, and Week 8 with respect to erythema, dryness, and inflammatory lesion count (ILC).

Results:

ILC decreased from 23.50 +/- 8.17 at baseline to 9.50 +/- 7.53 at Week 8 from baseline to Week 12. Average subject-reported adherence rate was 93.81%, and the most commonly reported side effects were burning/stinging and erythema; all were rated as mild.

Conclusion:

This pilot evaluation, albeit small and open-label, demonstrates promising results for the first studied combination of topical agents to target all four aspects of acne pathophysiology. Further large-scale studies are needed to further elucidate the additive efficacy and side effect profile when these two topical medications are used concomitantly.

项与克拉司酮相关的新闻（医药）

2025-05-06

·蒲公英Ouryao

一周｜国际法规药事(04.28-05.04)

◆ ◆ ◆ ◆Paul's Insight2025年4月28日-5月4日◆ ◆ ◆ ◆过去一周（4月28日至5月4日），全球制药监管与行业机构发布了多项重要动态。美国FDA在细胞产品安全和质量管理等领域持续发力；欧盟EMA在临床前新方法学新药审批上有新的更新；欧洲药典EDQM进一步完善CEP电子提交流程；英国MHRA在疫苗审批、给药创新和执法行动上齐头并进；美国PDA重启区域分会，并探讨前沿疫苗传递技术；ISPE则描绘了生物制造设施与数字化转型的未来蓝图。美国FDA细胞产品安全和质量/GMP两大领域持续发力1. 人源细胞组织产品安全管理新指南草案5月2日，美国FDA的生物制品评估与研究中心（CBER）发布两份针对人源细胞、组织及衍生产品（HCT/P）的指南草案。一是《减少HCT/P相关脓毒症病原体传播风险的建议》，更新了2007年供体资格决策中脓毒症筛查与检测标准；二是《减少HCT/P中结核分枝杆菌传播风险的建议》，在专用检测工具面世前，明确了结核病史与风险因素评估的推荐措施。两份草案现正面向公众征询意见，反馈截止日期为7月7日。图：美国FDA发布两份针对人源细胞、组织及衍生产品（HCT/P）的指南草案https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-reduce-risk-transmission-disease-agents-associated-sepsis-human-cells-tissues-and2. 质量管理成熟度原型评估计划FDA药品评估与研究中心（CDER）宣布，将启动自愿质量管理成熟度（QMM）原型评估计划的第二轮工作。该计划面向符合条件的药品生产企业开放申请，申请者需具备已完成注册、具备检查记录，并在美国市场有商业化分销产品等资格。入选企业将接受由三名CDER工作人员组成的QMM评估团队的系统性评估，评估不涉及负责cGMP合规的FDA检查人员。为期五天的评估将围绕企业的质量管理实践进行，企业将提前收到评估议程，并需安排适当人员参与。评估结束后，企业将收到一份详尽的评估报告，内容包括各实践领域的评分、说明、优势亮点及改进建议，并有机会与评估团队面对面沟通报告内容、提出问题或反馈意见。图：FDA启动质量管理成熟度原型评估计划第二轮工作https://www.federalregister.gov/documents/2025/04/23/2025-06968/voluntary-quality-management-maturity-prototype-assessment-protocol-evaluation-program3. 电商平台执法力度再升级4月29日，FDA向电商巨头亚马逊发出警告信，指控其平台销售未经FDA批准的新药，包括多款声称用于纹身前后镇痛的外用制剂。FDA通过亚马逊网站采购样品后确认，相关产品均未获FDA许可且标签不合规，构成对《联邦食品、药品和化妆品法案》第301条的违反。此次行动彰显FDA对线上销售渠道监管的持续加码。图：FDA向电商巨头亚马逊发出警告信https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amazoncom-inc-689355-041720254. 泛疫苗（广谱疫苗）新体系——“金标准”项目5月1日，美国卫生部（HHS）和国立卫生研究院（NIH）联合宣布启动“金标准”（Generation Gold Standard）泛疫苗开发项目，计划投入约5亿美元，研发可同时对抗多种流感和冠状病毒株的广谱疫苗。项目将采用β-丙内酯灭活全病毒技术，目前已在实验室中制备了针对H5N1与多种冠状病毒的候选疫苗。图：美国官方宣布开发泛疫苗（广谱疫苗）新体系https://www.hhs.gov/press-room/hhs-nih-announces-generation-gold-standard.html美国PDA分会动态与疫苗给药创新1. 波多黎各分会重新启动5月2日，PDA发表文章宣布重启波多黎各分会，新任负责人Myrta Atiles将聚焦AI等新兴技术应用，推动区域人才培养与技术创新。2月25日于波多黎各举办的“加速创新，快速惠及患者”会议，探讨了无菌加工、技术转移敏捷性及监管加速等话题。波多黎各是全球重要的制药制造中心之一，拥有高度集中的制药和生物制药产业，对该地区经济具有支柱性作用。图：PDA宣布波多黎各分会重新启动https://www.pda.org/pda-letter-portal/home/full-article/pda-puerto-rico-chapter-reignites2. 微针阵列贴片（MAP）疫苗给药创新4月29日，PDA发布文章聚焦微针阵列贴片（MAP）这一新兴疫苗传递技术。MAP通过不足一毫米的微针将疫苗递送至皮肤表层，激活免疫反应，具备减少剂量、简化冷链物流、提高接种率等优势。其材料多为可溶性或可降解聚合物，具备良好生物相容性。临床研究显示，MAP在安全性和免疫效果上表现优异，尤其适用于资源有限地区。尽管仍面临生产、监管等挑战，MAP有望成为未来全球疫苗接种的重要工具。图：PDA探讨疫苗给药创新https://www.pda.org/pda-letter-portal/home/full-article/microneedle-array-patches-for-vaccine-delivery欧盟EMA临床前研究新方法学与新药审批1. 推动新方法学（NAM）替代动物试验欧洲药品管理局（EMA）表示，其正积极推动在药物研发和测试中采用新的方法学（NAM），以减少动物使用，践行“3R”原则（替代、减少、优化）。这些新技术包括器官芯片、类器官、体外细胞模型和计算机建模，旨在在确保药物安全有效的同时，提高科学预测性并减少伦理争议。EMA通过其创新工作组（ITF）为开发者提供免费咨询平台，帮助新方法更顺利地被纳入监管体系。图：EMA推动新方法学替代动物试验https://www.ema.europa.eu/en/human-regulatory-overview/research-development/ethical-use-animals-medicine-testing/regulatory-acceptance-new-approach-methodologies-nams-reduce-animal-use-testing2. 对Winlevi（clascoterone）给出负面意见4月25日，EMA人用药品委员会（CHMP）对意大利Cassiopea公司申请的痤疮治疗药Winlevi（clascoterone）提出负面意见，认为其在12至18岁青少年中的潜在风险大于获益。Winlevi作为一种新型雄激素受体阻断药，虽以乳膏形式用于治疗寻常痤疮，但可能抑制下丘脑、垂体及肾上腺功能，影响青少年的生长发育与性成熟。尽管企业提交的数据显示风险较低，并提出相应的风险控制措施，CHMP仍认为证据不足，最终建议拒绝其上市许可申请。图：EMA对痤疮治疗药的评审提出负面意见https://www.ema.europa.eu/en/medicines/human/EPAR/winlevi欧洲EDQMCEP电子化提交流程再升级5月2日，EDQM宣布，将接受基于eCTD验证标准v8.1的CEP申请，同时在2025年5月31日前继续兼容v7.1版本，以确保提交过程平稳过渡。此举旨在应对当前EU M1包中跟踪表位置要求与EDQM实际流程不一致的问题。图：CEP电子化提交流程再升级https://www.edqm.eu/en/w/validation-of-ectd-submissions-for-cep-applications英国MHRA新药审评与打击非法药品行动1. Vimkunya基孔肯雅疫苗获批5月1日，英国药品和健康产品监管局（MHRA）通过国际认可程序（IRP）批准Vimkunya疫苗，用于预防12岁及以上人群感染基孔肯雅病毒。基孔肯雅病由受感染蚊子传播，常见于亚洲、非洲及美洲的亚热带地区，患者通常出现发热、皮疹及关节剧烈疼痛，症状可能持续数月甚至数年。Vimkunya疫苗的批准基于IRP机制，该机制允许MHRA借鉴国际可信监管机构的专业评估，以加快英国患者的用药可及性。MHRA在IRP框架下仍保留对证据强度不足的申请予以拒绝的权力。图：MHRA通过国际认可程序（IRP）批准疫苗https://www.gov.uk/government/news/vimkunya-vaccine-approved-to-prevent-disease-caused-by-the-chikungunya-virus-in-people-12-years-of-age-and-older2. 纳武利尤单抗皮下注射新给药方案批准4月30日，英国MHRA批准纳武利尤单抗（nivolumab，商品名Opdivo）皮下注射新配方，将给药时间从传统的30–60分钟静脉输注大幅缩短至仅需3–5分钟，适用于包括肺癌、黑色素瘤等多种肿瘤类型，显著提升患者治疗舒适度与临床操作效率。该药由百时美施贵宝（BMS）研发，是一款程序性死亡受体-1（PD-1）抑制剂，可通过激活免疫系统识别并攻击肿瘤细胞。图：纳武利尤单抗皮下注射给药方案批准https://www.gov.uk/government/news/mhra-authorises-cancer-treatment-variation-with-an-administration-time-of-3-5-minutes3. 打击非法药品4月29日凌晨，英国MHRA在英格兰中西部及西北部发起大规模突袭行动，逮捕了12名涉嫌组织药品贩运的犯罪嫌疑人。这也是MHRA历史上规模最大的一次此类刑事调查。执法人员在现场查获了大量非法药物和犯罪资产：数十万剂包括类鸦片镇痛药和抗焦虑药在内的受控药物被缴获。图：英国MHRA打击非法药品行动https://www.gov.uk/government/news/twelve-arrested-in-mhras-biggest-ever-crackdown-on-organised-medicines-trafficking国际ISPE上周，ISPE发布了两篇预告文章，介绍2025年ISPE生物技术大会将重点讨论的两大主题：1. 生物制造设施的未来格局在“设施生命周期”专场中，行业专家将探讨如何从传统的静态基础设施，转型为灵活、自适应的生产生态系统，以应对多样化治疗模式对速度、可持续性和敏捷制造的需求。重点议题包括：武田制药展示的实时产能建模、模块化建设与数字化集成实践，以及如何通过应用ISO 14644-16等国际标准，实现洁净室的节能设计和运营效率最大化。2. 人工智能/机器学习与生物技术融合趋势在“利用人工智能和机器学习(AI/ML) 加速生物制药发展”专场，专家们将分享AI/ML在药物研发、临床试验优化、智能制造及供应链管理中的应用实例，展示其如何加速产品上市并提升运营效率。讨论内容包括支持AI部署的数据架构建设、AI驱动的持续工艺确认（CPV）与实时放行（RTR）、mRNA项目中的可解释性建模，以及通过强化学习实现自主运营与技能传承的前沿探索。图：ISPE发布了预告文章，介绍2025年ISPE生物技术大会将重点讨论的主题https://ispe.org/pharmaceutical-engineering/ispeak/trends-and-opportunities-how-artificial-intelligence-ai-and结语回顾一周动态，各大监管机构和行业组织在药品安全、监管创新、技术应用和执法合规等方面均有进展。FDA聚焦细胞治疗与质量管理、EMA强调替代动物试验与风险评估、EDQM优化电子提交流程、MHRA加速疫苗与给药方案审批并加强执法、PDA与ISPE则在疫苗传递与生物制造数字化等方面绘制蓝图。这些举措体现了全球制药监管与行业在科学进步、伦理责任和患者需求三者之间的协调与平衡，共同推动药品研发和监管迈向更加智能、高效和安全的未来。END声明：本文仅代表作者个人观点，不代表任何组织及本公众号立场，如有不当之处，敬请指正。如需转载，请注明作者及来源：蒲公英Biopharma。活动推荐5月8日 | 线上 | 双维度解锁无菌药品生产污染防控策略5月16日 | 线上 |《VHP生物指示剂的应用》5月22日 | 线下 | 2025中国无菌药品制造创新发展论坛

疫苗基因疗法加速审批

2025-04-22

·米内网

儿科药市场火热！超330款新品亮相，石四药、济川、健民发威，57个独家品种冲刺新国谈

精彩内容近年来，国家密集出台多项激励政策，合力驱动儿科药创新研发。据不完全统计，2023-2024年获批的儿科药中，约有55个品种为首次获批上市，集中在神经系统药物、抗肿瘤和免疫调节剂等治疗大类，涉及石四药、济川、健民等知名药企。日前，国家医保局发文明确2025国谈时间或将前移，85款儿科药有望冲刺新国谈，溶液剂及注射剂在数量上领跑；独家品种（含剂型独家，下同）为主力军，有57个产品在列。米内网数据显示，近年来我国儿科药市场销售额均保持良好的增长态势，除2020年受疫情影响首次出现下滑，其余年份销售额增速均在6%以上，市场潜力十足。其中在中国三大终端六大市场（统计范围详见本文末），儿科中成药2023年销售规模突破180亿元，2024上半年收获超95亿元，预计全年销售额将再创新高。近年来中国三大终端六大市场儿科中成药销售趋势（单位：万元）来源：米内网格局数据库超330个儿科药来势汹汹！石四药、健民......大展拳脚伴随临床用药需求的激增，近年来儿科药申报量、获批量均呈现明显上升趋势。2020-2024年在中国获批上市的儿科药数量分别为26个、47个、66个、92个和106个，五年间合计获批新品数超过330个，进一步缓解儿童用药适宜剂型少、规格少等问题。据不完全统计，2023-2024年获批的儿科药中，约有55个品种为首次获批上市，其中口服溶液剂占比接近四成，满足儿科用药便利性的需求；治疗大类上以神经系统药物、抗肿瘤和免疫调节剂为主，分别占13个和10个席位，消化系统及代谢药（9个）、血液和造血系统药物（5个）、全身用抗感染药物（5个）则位居其后。具体产品方面，恒瑞医药的注射用塞替派可用于重型β-地中海贫血儿童（＜18周岁）异基因造血干细胞移植（allo-HSCT）前预处理，是国内首个获批移植预处理相关适应症的塞替派产品。据此前恒瑞公告显示，公司的该产品已先后于2018年和2022年在美国、欧洲获批上市。它的到来无疑为移植治愈儿童重型β-地贫带来了新希望。小儿豉翘清热糖浆为济川药业的独家儿科感冒中成药，是在小儿豉翘清热颗粒基础上改良所得，米内网数据显示，小儿豉翘清热颗粒近年来在中国三大终端六大市场销售额保持快速增长，2023年拿下超27亿元的佳绩。小儿紫贝宣肺糖浆为健民药业的独家儿科止咳祛痰中成药，其组方源于国家级名老中医经验方，具有良好的临床应用基础，在治疗小儿急性支气管炎风热犯肺证咳嗽方面疗效显著，且安全性好。近年来中国三大终端六大市场小儿豉翘清热颗粒销售趋势（单位：万元）来源：米内网格局数据库从审评审批路径上看，共有46个药品（不含预防用生物制品，下同）通过优先审评审批程序得以加快上市，其中独家品种有33个，占比超过七成，包括兴齐眼药的延缓儿童近视进展用药硫酸阿托品滴眼液、石家庄四药的罕见病Dravet综合征治疗药司替戊醇干混悬剂、亿帆医药用于先天性高胰岛素性低血糖血症的二氮嗪口服混悬液、恒瑞医药的广谱抗肿瘤药环磷酰胺胶囊、以及辉瑞用于治疗青少年特应性皮炎的阿布昔替尼片等。2023-2024年通过优先审评审批获批上市的儿科药注：带*为独家品种来源：米内网综合数据库85款儿科药剑指新国谈，独家品种成“爆款”为了让更多患儿用上“质优价廉”的儿科药，推进其加快准入医保成为国家的重要任务之一。比如：2019-2024版医保目录调整方案中均明确指出，重点调整及优先纳入儿科药，其中2021版医保目录经谈判准入的34个独家儿科药平均降价55.6%；2024版医保目录也纳入了多款儿科药，不乏济川药业的小儿豉翘清热糖浆和盐酸非索非那定干混悬剂、健民药业的小儿紫贝宣肺糖浆、石四药的司替戊醇干混悬剂、诺华的盐酸伊普可泮胶囊等独家品种。据今年1月国家医保局召开的新闻发布会透露：2025国谈或在4月启动申报，争取9月结束医保谈判、发布新版医保目录；新药申报时间为2025年4月1日-2025年5月底。据不完全统计，目前至少有85款儿科药有望参与今年新国谈，其中独家品种“霸屏”，有57个产品在列；从剂型上看，溶液剂和注射剂为主力军，合计占比超60%；按治疗大类统计，神经系统药物、消化系统及代谢药在数量上领跑，分别占17个和16个席位。有望参与2025国谈的儿科药注：带*为独家品种来源：米内网综合数据库、公开数据健民药业的小儿牛黄退热贴膏是近日获批上市的中药1.1类新药，具有退热解表、清热解毒的功效，用于小儿急性上呼吸道感染风热证所致的发热（38.5℃及以下）。该新药的上市为急性上呼吸道感染风热证所致的1至5岁发热儿童患者提供了新的治疗选择。青峰医药的口服溶液用盐酸万古霉素是一种糖肽类抗生素，用于革兰氏阳性菌所致的严重感染，如心内膜炎、骨髓炎、败血症或软组织感染等。凭借独特药理特性和给药优势，该产品为肠道耐药菌感染患者，尤其是儿童患者，提供了更高效、安全的治疗方案。米内网数据显示，2023年中国三大终端六大市场万古霉素销售规模接近24亿元，同比增长6.14%。氯法拉滨注射液和二氮嗪口服混悬液均为亿帆医药近年获批上市的新品，其中前者用于治疗儿童难治性/复发性急性淋巴细胞白血病，后者可用于先天性高胰岛素性低血糖血症（CHI）。据悉，上述两款儿科药均已出现在2024国谈初审药品名单，今年能否一鼓作气共同挺进2025版医保目录，我们拭目以待。五月将至，新一轮国谈虽“迟迟未有动静”，但启动时间前移似乎是大势所趋。届时，2025版医保目录将有哪些新亮点？又有哪些品种能成功入选？米内网将持续跟进。激励政策火力全开，助推儿科药创新研发另一方面，为进一步解决儿科临床“急难愁盼”的用药需求，近年来，国家各职能部门多措并举强化儿科用药保障，合力为企业创新研发提供新思路。2025年1月，国务院办公厅发布的《关于全面深化药品医疗器械监管改革促进医药产业高质量发展的意见》提及，对符合条件的儿童用药品给予一定的市场独占期，为药品创新研发提供了政策支持；2024年9月，国家卫健委公布《第五批鼓励研发申报儿童药品清单》，阿尼芬净注射剂、柯拉特龙乳膏剂等15个临床急需儿科药品种位列其中；2024年6月，CDE发布《关于在中心网站“儿童用药专栏”持续公示优先审评审批的儿童用药批准信息的通告》，以便研发单位更好地了解和把握儿科药创新研发方向；2024年4月，国家药监局发布《药审中心关于已上市药品说明书增加儿童用药信息工作细则（试行）》，对品种遴选范围、说明书修订与审核流程，以及品种申报程序等作进一步的明确，提高临床安全用药水平......2024年至今国家发布的部分鼓励儿科药研发政策来源：国家药监局、国务院办公厅等，米内网整理中国是全球第二大儿科用药市场，根据国家统计局的数据，2020年0-14岁少儿人口数为2.53亿人，约占全国总人口数的18%。随着国家鼓励生育政策的全面铺开，儿科用药需求也随之增加。预计在相关政策和用药需求的驱动下，未来儿科药市场将迎来巨大的发展机遇。来源：米内网数据库、国家医保局官网等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至4月22日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

上市批准

2025-02-09

·Pharmaindustrial

Cosmo and Glenmark Receive UK MHRA Approval of Winlevi for Treatment of Acne

Cosmo Pharmaceuticals has announced that Glenmark has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to market Winlevi® in the United Kingdom. Winlevi® is a topical treatment for acne vulgaris in patients aged 12 years and older, marking a significant milestone in the commitment of both companies to providing innovative, patient-focused dermatology solutions. Winlevi® is the first topical acne treatment in nearly 40 years with a first-in-class mechanism of action. Its active ingredient, clascoterone, is the first commercially available topical androgen receptor inhibitor, targeting androgen receptors in sebaceous glands with no systemic anti-androgen effects, and as such it can be used safely in both males and females. This approach is believed to help reduce sebum production and intervene early in acne pathogenesis. Two identical phase 3 studies demonstrated that clascoterone cream,1 percent, applied topically twice daily for 12 weeks, was more effective than the application of vehicle cream in achieving the Investigator’s Global Assessment (IGA) of success, reducing non-inflammatory lesion count (NILC) and inflammatory lesion count (ILC) in patients with facial acne vulgaris. clascoterone cream, 1 percent, was generally well tolerated. As part of the agreement signed in September 2023, Glenmark has in-licensed the product from Cosmo Pharmaceuticals for distribution in Europe and South Africa. This collaboration underscores Glenmark’s and Cosmo’s dedication to expanding its dermatology portfolio and addressing the unmet needs of patients with acne vulgaris, a condition that affects millions of individuals worldwide and can cause both physical discomfort and psychological distress. Giovanni Di Napoli, Chief Executive Officer of Cosmo, commented,“We are thrilled that Winlevi® has been approved for the UK market, bringing an innovative approach to acne treatment. This milestone underscores our commitment, alongside Glenmark, to providing patients with breakthrough solutions that address not just the physical symptoms of acne, but also its emotional impact. We take great pride in expanding access to this game-changing therapy and making a real difference in patients’ lives.” "We are excited to receive the approval and bring Winlevi® to the UK market, offering patients a new and efficacious treatment for acne. This approval by the MHRA represents a significant step forward in our mission to enhance dermatology care. Our partnership with Cosmo Pharmaceuticals plays an important role in enabling us to expand our dermatology portfolio, and we are proud to offer this new treatment to market that can improve the quality of life for those living with acne," said Christoph Stoller, President & Business Head - Europe and Emerging Markets, Glenmark Pharmaceuticals. “The approval of Winlevi® for the UK market marks a crucial milestone in Glenmark’s ongoing efforts to evolve dermatology treatments,” said Xavier Mesrobian, Executive Vice President and Business Head – Europe, Glenmark SA. “We are focused on delivering therapies that address the clinical needs of patients and with Winlevi®, we are looking forward to offering an efficacious treatment option for individuals managing acne, a condition that can significantly impact self-confidence and daily life,” added Mesrobian. Acne vulgaris is one of the most common skin conditions, impacting more than 90 percent of the world’s population at some point in their lives. It can have both physical and emotional consequences, affecting individuals’ self-esteem and mental health.

临床3期上市批准临床结果

100 项与克拉司酮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11451	克拉司酮	G03HA	DB12499

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
寻常痤疮	美国	Sun Pharmaceutical Industries Ltd.	2020-08-26

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
男性雄激素源性脱发	临床3期	美国	Cassiopea SpA	2023-06-21
男性雄激素源性脱发	临床3期	格鲁吉亚	Cassiopea SpA	2023-06-21
雄激素脱发	临床3期	美国	Cassiopea SpA	2023-06-21
雄激素脱发	临床3期	格鲁吉亚	Cassiopea SpA	2023-06-21
玫瑰痤疮	临床2期	美国	Sun Pharmaceutical Industries Ltd.	2025-03-14

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06415305 (CTgov)	临床4期	寻常痤疮	10	Winlevi (clascoterone) 1% cream	膚顧鹹夢餘廠憲鹹壓襯 = 選壓艱憲夢蓋餘鹹積襯範顧鹹襯獵鏇製壓蓋觸 (鬱製遞夢衊遞範淵膚選, 壓網憲鏇醖選遞觸製鹽 ~ 壓夢觸蓋醖願鏇鹹願範) 更多	-	2025-05-07
Health Canada 人工标引	临床3期	寻常痤疮	1,421	WINLEVI (Trial 1)	築糧築願鏇蓋窪窪鏇膚(襯壓糧膚範襯願衊願鏇) = 鹽鹽築廠餘願壓襯壓鬱鬱願蓋餘簾範獵襯網網 (艱夢鹽繭窪願醖夢鬱網 ) 更多	积极	2023-09-08
				Vehicle (Trial 1)	築糧築願鏇蓋窪窪鏇膚(襯壓糧膚範襯願衊願鏇) = 蓋夢製網範齋壓簾齋願鬱願蓋餘簾範獵襯網網 (艱夢鹽繭窪願醖夢鬱網 ) 更多
AAD2023	临床3期	寻常痤疮	-	Clascoterone cream 1%	廠願範選積窪齋醖窪齋(蓋窪蓋鏇鏇衊襯襯夢顧) = 觸餘網衊鹹餘窪繭艱鏇壓獵齋糧艱鹹鏇製醖憲 (鑰糧壓簾積鏇糧選築蓋 )	-	2023-03-17
				Vehicle	廠願範選積窪齋醖窪齋(蓋窪蓋鏇鏇衊襯襯夢顧) = 蓋窪夢餘鏇鬱獵憲蓋鏇壓獵齋糧艱鹹鏇製醖憲 (鑰糧壓簾積鏇糧選築蓋 )
NCT02682264 (AAD2023)	临床3期	寻常痤疮	598	Clascoterone cream 1%	衊鏇淵鏇獵選淵憲鑰衊(鹽遞鑰壓獵鏇膚廠鏇範) = 夢觸製觸願鹽襯膚鬱遞衊觸壓積衊積鑰獵繭淵 (鏇遞簾憲餘鏇衊遞遞簾 ) 更多	-	2023-03-17
NCT02608476 (CB-03-01/26, CTgov)	临床3期	寻常痤疮	732	CB-03-01 cream, 1% (CB-03-01 Cream)	鹽廠範獵顧襯鏇網網觸 = 窪鑰鹹鬱襯選鬱築膚夢壓襯獵鬱齋餘繭遞蓋積 (鏇觸醖築繭構襯衊廠構, 遞壓積願糧憲憲鏇繭獵 ~ 夢夢憲繭鑰膚遞選淵構) 更多	-	2020-11-20
				Vehicle cream (Vehicle Cream)	鹽廠範獵顧襯鏇網網觸 = 製醖廠膚選構餘齋獵齋壓襯獵鬱齋餘繭遞蓋積 (鏇觸醖築繭構襯衊廠構, 構遞蓋範築網窪繭遞願 ~ 廠襯醖齋築鹽築鹹憲選) 更多
NCT02608450 (CB-03-01/25, CTgov)	临床3期	寻常痤疮	708	CB-03-01 cream, 1% (CB-03-01 Cream)	窪餘鏇鹹糧獵簾簾獵顧 = 製簾鑰觸鬱獵淵積廠艱壓鏇醖糧夢繭製製淵網 (願襯顧鏇艱膚簾廠艱膚, 齋構夢醖齋蓋壓衊鏇顧 ~ 醖醖築遞壓遞餘鑰願餘) 更多	-	2020-11-20
				Vehicle cream (Vehicle Cream)	窪餘鏇鹹糧獵簾簾獵顧 = 鬱廠製獵選膚糧壓憲簾壓鏇醖糧夢繭製製淵網 (願襯顧鏇艱膚簾廠艱膚, 築鹽構醖艱網積積廠顧 ~ 膚廠窪鏇廠積網齋顧蓋) 更多
NCT02682264 (CTgov)	临床3期	寻常痤疮	609	CB-03-01 cream, 1%	獵淵積艱鏇憲艱築鬱壓 = 鹽鏇艱憲鹹襯蓋廠膚鏇顧遞簾簾襯醖憲積積襯 (餘製構壓簾鏇範積鏇築, 願淵觸鑰繭築餘艱積餘 ~ 夢壓獵廠願齋衊構選憲) 更多	-	2020-11-17
NCT01831960 (CTgov)	临床2期	寻常痤疮	42	Cortexolone 17α-Propionate (Cortexolone 17α-Propionate (Cohort 1))	餘憲築網鹹積積鹹窪觸(範繭範窪選鏇衊窪鹽顧) = 廠築膚淵鑰鏇觸蓋廠築鏇醖壓願獵鑰壓膚鏇鹽 (膚窪壓積膚獵膚糧築製, 5.98) 更多	-	2020-11-17
				Cortexolone 17α-Propionate (Cortexolone 17α-Propionate (Cohort 2))	餘憲築網鹹積積鹹窪觸(範繭範窪選鏇衊窪鹽顧) = 獵蓋蓋繭淵衊鹹製艱顧鏇醖壓願獵鑰壓膚鏇鹽 (膚窪壓積膚獵膚糧築製, 4.71) 更多
NCT01631474 (CTgov)	临床2期	寻常痤疮	363	CB-03-01 (Low-dose Active, BID)	齋夢積壓簾憲壓構鹹壓 = 選衊襯鬱鏇選憲餘鏇醖鹹廠選製憲簾構遞淵鹹 (繭壓鹹顧膚齋顧廠鬱製, 鹽襯淵壓夢窪壓簾鏇鏇 ~ 膚願簾構鹹積鑰製選廠) 更多	-	2020-11-16
				CB-03-01 (Medium-dose Active, BID)	齋夢積壓簾憲壓構鹹壓 = 壓憲糧夢餘鏇憲鹽製窪鹹廠選製憲簾構遞淵鹹 (繭壓鹹顧膚齋顧廠鬱製, 夢範範積憲簾鬱艱範鑰 ~ 醖遞網鑰艱糧積窪糧衊) 更多
NCT02720627 (CTgov)	临床2期	寻常痤疮	27	cortexolone 17α-propionate	範願窪網衊窪範構觸憲(顧壓醖構糧鹹艱淵鏇憲) = 艱夢顧鹽窪醖淵築窪蓋積齋鬱醖積簾憲鹹鹹鑰 (鹽膚鹽膚齋鹽範憲襯餘, 4.90) 更多	-	2020-10-19