This study is being done to help better understand how the gut and skin bacteria of the body change when people with acne are treated with Sarecycline or Doxycycline. The bacteria in the gut and on the skin will be studied to see how each treatment may affect them and whether they change the profile of the bacteria that is present.

开始日期2026-04-20

申办/合作机构

Integrative Skin Science and Research

[+1]

CTR20253571

/ CompletedN/A

盐酸沙瑞环素片在健康参与者中随机、开放、两制剂、单次给药、两周期、双交叉空腹和餐后状态下的生物等效性试验

主要目的：以烟台鲁银药业有限公司研制的盐酸沙瑞环素片为受试制剂，以Almirall LLC持证的盐酸沙瑞环素片（商品名：Seysara®）为参比制剂，考察两制剂在空腹及餐后状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性。次要目的：评价中国健康参与者单次空腹/餐后口服盐酸沙瑞环素片受试制剂和参比制剂后的安全性。

开始日期2025-10-13

申办/合作机构

烟台鲁银药业有限公司

NCT06461299

/ Completed临床4期IIT

A Single-Center Pilot Study to Evaluate the Efficacy, Safety, and Tolerability of Sarecycline for Treating Periorificial Dermatitis

开始日期2023-07-17

申办/合作机构-

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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项与盐酸沙瑞环素相关的文献（医药）

2026-04-01·Journal of Cosmetic Dermatology

Beyond Isotretinoin: A Narrative Review of Emerging Systemic Therapies for Moderate‐to‐Severe Acne

Review

作者: Tommasino, Nello ; Annunziata, Maria Carmela ; Potestio, Luca ; Napolitano, Maddalena

ABSTRACT:

Background:

Acne vulgaris is a common inflammatory skin disorder with significant psychosocial impact. While isotretinoin remains the gold standard for moderate‐to‐severe cases, its adverse effects and teratogenicity underscore the need for alternative systemic therapies.

Objective:

To review emerging systemic treatments for acne beyond isotretinoin, evaluating their efficacy, safety, and potential clinical applications.

Methods:

A narrative review was conducted through PubMed, Scopus, and Web of Science, including studies from January 2015 to June 2025. Eligible publications focused on systemic treatments for moderate‐to‐severe acne, excluding topical‐only and non‐peer‐reviewed studies.

Results:

Promising alternatives include the narrow‐spectrum antibiotic sarecycline, hormonal agents such as spironolactone and combined oral contraceptives, and metformin in patients with polycystic ovary syndrome. Biologic therapies, phosphodiesterase‐4 inhibitors, oral probiotics, and novel agents like montelukast and CAMP factor vaccines are also under investigation. These treatments show varying degrees of efficacy and improved safety profiles, but most lack head‐to‐head comparisons with isotretinoin.

Conclusion:

Several systemic options beyond isotretinoin have emerged, showing potential in specific subgroups or as adjunctive therapies. However, further large‐scale comparative studies are needed to define their roles within evidence‐based acne management algorithms.

2026-01-06·JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY

No pharmacovigilance signal of intracranial hypertension associated with glycylcyclines: a FAERS-based disproportionality analysis

Article

Abstract:

Background and objective:

Benign intracranial hypertension, i.e. increased intracranial pressure, is a well-known rare adverse effect of tetracyclines, but its association with glycylcyclines (tetracycline-like antibiotics) was not confirmed. To investigate whether there are signals in an adverse events database for increased intracranial pressure after using tigecycline and eravacycline, and to compare it with probably existing signals for tetracyclines.

Methods:

This secondary research was based on the FDA Adverse Event Reporting System (FAERS) Database. Disproportionality analysis was conducted and the following disproportionality indices were calculated: reporting odds ratios (ROR), Yule’s Q, proportional reporting ratio (PRR) and the information component (IC) for ‘intracranial pressure increased’ and ‘pseudotumor cerebri’ adverse events.

Results:

Significant signals for adverse event ‘intracranial pressure increased’ were found for doxycycline (ROR ± 95%CI = 27.19 ± 4.95), tetracycline (ROR ± 95%CI = 79.29 ± 24.64) and minocycline (ROR ± 95%CI = 59.53 ± 16.39). Signals for omadacycline and sarecycline were not found, primarily due to the small number of reports. In the database, there were no reports of increased intracranial pressure, pseudotumor cerebri or intracranial hypertension for both tigecycline and eravacycline.

Conclusions:

Although structurally related to tetracyclines, glycylcyclines are not associated with increased intracranial pressure based on current pharmacovigilance data. This may warrant re-evaluation of SmPC warnings and supports safer use in patients with suspected intracranial hypertension when no better alternatives are available.

2025-12-01·The Journal of clinical and aesthetic dermatology

Optimal Use Recommendations and Stewardship Principles with Oral Antibiotics in Acne Vulgaris Management: An Expert Consensus Panel.

Review

作者: Zakria, Danny ; Rosenberg, Angela L ; Burshtein, Joshua ; Bartley, Brooke ; Del Rosso, James Q ; Kwong, Pearl ; Rieder, Evan ; Keri, Jonette ; Hebert, Adelaide A ; Harper, Julie ; Gold, Linda Stein ; Shah, Milaan ; Baldwin, Hilary ; DeBusk, Lauren

BACKGROUND:

The purpose of this meeting was for an expert panel to analyze current literature and provide updated consensus statements regarding the optimal management, safety, and efficacy of oral antibiotics in acne vulgaris (AV).

METHODS:

A thorough literature search was conducted across PubMed, Scopus, and Google Scholar to identify English-language original research articles evaluating the use of oral antibiotics for AV. An expert panel of 8 dermatologists, specializing in the management of AV, convened to assess the findings and develop statements regarding oral antibiotics for AV. Each statement was approved through a modified Delphi process, and a strength of recommendation was assigned based on the Strength of Recommendation Taxonomy (SORT) criteria.

RESULTS:

A total of 544 articles regarding the safety, efficacy, and management of oral antibiotics for AV were identified through the literature search. Following a rigorous screening process, 17 articles were deemed relevant to the research questions and provided to the panelists for review prior to the roundtable discussion. The panel reached unanimous agreement on 10 consensus statements and recommendations, assigning seven a strength of A, one a strength of B, and two a strength of C.

CONCLUSION:

The expert panel concluded that oral antibiotics can be used in the treatment of moderate-to-severe AV, oral antibiotics should be combined with topical treatments, and duration of use should be determined based on individualized patient care. Tetracyclines are recognized options for AV therapy, with sarecycline considered a preferred option for AV due to its targeted mode of action, unique ribosomal binding properties, narrow spectrum of antibiotic activity, lower bacterial resistance risk, and overall better tolerability. Additionally, tetracyclines should be avoided in pregnancy and in young children.

122

项与盐酸沙瑞环素相关的新闻（医药）

2026-05-24

·朱慧兰教授工作室

2026 EADV春季研讨会痤疮和毛囊炎专场报道

2026年EADV春季研讨会于2026年5月7-9日在希腊雅典国际会议中心举办，来自91个国家的2400多名皮肤性病领域学者参加了会议，会议共有28个专场，在此重点跟大家分享痤疮和毛囊炎专场的学术内容。（图片由作者提供） Acne 痤疮专场来自希腊雅典国立和卡波迪斯特里安大学的Aikaterini Liakou教授以“Syndromic acne”为讲题，将综合征性痤疮视为更广泛的自身炎症性疾病谱系的一部分，这类疾病以重度痤疮、化脓性汗腺炎、坏疽性脓皮病、关节炎及全身性炎症为特征。常见的综合征有PASH、PAPASH、PAPA、PASS、PsAPASH、SAPHO等。她指出，越来越多的证据表明这些疾病与先天免疫失调、炎症小体及NF-κB通路激活、以及致病性基因变异相关。其临床表现可能不只局限于皮肤范围，累及关节炎和炎症性肠病样特征。治疗需采用多学科、个体化方案，包括抗生素、维A酸类药物、糖皮质激素、免疫调节剂及靶向生物制剂。此外，针对多囊卵巢综合征相关痤疮，强调了高雄激素血症在发病中的作用，治疗需结合抗雄激素药物、二甲双胍及体重管理。来自乌克兰国立医科大学的Pavel Chernyshov教授以“Drug-induced acne”为讲题，讨论了药物诱发性痤疮，重点介绍了靶向肿瘤及免疫治疗药物可引发形态、发生时间及严重程度各异的痤疮样皮疹。EGFR抑制剂相关皮疹尤为常见，并且在某些情况下与良好的肿瘤治疗结局相关。药物诱发痤疮的治疗应遵循EADV德尔菲共识，采用分级治疗（外用、口服抗生素、异维A酸等）。除非危及生命，否则不建议轻易停用原发疾病的治疗药物。来自阿尔巴尼亚地拉那 Venus激光与美容皮肤科诊所的Brunilda Bardhi博士以“Acne scar management”为讲题，概述了驱动痤疮瘢痕形成的关键机制，包括持续存在的炎症、皮脂腺破坏和伤口愈合不良，以及延迟治疗、疾病复发、遗传易感性和体重指数升高等危险因素。痤疮瘢痕的管理高度个体化，需根据瘢痕形态、严重程度、皮肤类型、患者期望及社会状况来选择治疗方案。Bardhi博士综述了化学剥脱、微针治疗、皮下分离术、注射填充、富血小板血浆、射频设备以及剥脱性与非剥脱性激光疗法，这些方法常联合使用以优化疗效，。越来越多的证据支持采用基于多模态激光的综合治疗方法。Bardhi博士最后强调减少痤疮瘢痕形成的最佳方法是预防。来自德国勃兰登堡医学院的Christos Zouboulis教授以“New treatments”为讲题，综述了痤疮的新兴及前沿治疗方法，将痤疮描述为一种毛囊皮脂腺单位的慢性炎症性疾病。在已确立的疗法中，个体化剂量的口服异维A酸被视为最优的系统性治疗方案，它能有效清除皮损，具有良好耐受性，并能缩短疗程和降低复发率。口服激素类抗雄激素药物也已显示出对面部及躯干痤疮具有渐进性的长期改善效果。较新的疗法包括沙瑞环素、外用米诺环素泡沫剂、克拉司酮乳膏、曲法罗汀以及固定剂量的三联外用复方制剂。展望未来，Zouboulis教授讨论了靶向皮脂腺的1726 nm激光、调节PPARγ的外用疗法、可溶性微针纳米颗粒递送系统，以及针对痤疮丙酸杆菌特定菌株的mRNA痤疮疫苗——该疫苗目前已进入早期临床试验阶段。 Focus on folliculitis 毛囊炎专场来自波兰华沙内务与行政部中央临床医院的Malgorzata Maj教授以“Demodex-induced folliculitis”为讲题，介绍蠕形螨诱导性毛囊炎是一种由蠕形螨在毛囊皮脂腺单位内过度增殖引起的炎症性皮肤病。诊断依赖于临床怀疑，并通过皮肤刮片或活检样本中显微镜下鉴定出蠕形螨来支持，尤其对于常规毛囊炎治疗无效的病例。除显微镜鉴定外，高清光学相关断层扫描（HD-OCT）、高分辨率反射式共聚焦显微镜（RCM）也用于诊断蠕形螨诱导的毛囊炎，能够在无需侵入性皮肤活检或取样的情况下检测毛囊中的蠕形螨。治疗的核心在于降低蠕形螨密度并控制相关的炎症。最常用疗法包括：外用伊维菌素、氯菊酯、甲硝唑、苯甲酸苄酯、克罗米通、硫磺制剂或口服伊维菌素。对于重症或难治性病例，可考虑联合治疗。并且认为该疾病的治疗应该由皮肤科医生、眼科医生、微生物学专家、皮肤病理学专家以及患者等共同决策。意大利卡塔尼亚大学的Giuseppe Micali教授以“Folliculitis decalvans”为讲题，介绍秃发性毛囊炎为一种原发性中性粒细胞性瘢痕性脱发，通常呈慢性复发性病程。其病因尚未完全明确，涉及遗传易感性、细菌生物膜、表皮屏障受损、创伤、毛囊口先天性异常、局部免疫系统功能紊乱等多因素。束发症被认为是临床一种诊断性体征。鉴别诊断需与原发淋巴细胞性瘢痕性脱发如盘状红斑狼疮、毛发扁平苔藓、额部纤维化性脱发、经典Brocq假性斑秃、中央离心性瘢痕性脱发、毛囊粘蛋白病、脱发性棘状毛囊角化病等鉴别，但临床上也存在毛囊性脱发与毛发扁平苔藓两者重叠或过渡的状态。秃发性毛囊炎治疗目标是控制炎症、阻止脱发进展以及消除症状，毛发再生无法预期。目前尚无 EMA 或 FDA 批准的药物，所有用药均为超说明书使用。治疗方案包括局部治疗（外用糖皮质激素、外用抗生素、他克莫司、氨苯砜、抗菌清洁剂）、皮损内注射糖皮质激素、光动力疗法、全身治疗（口服抗生素、口服糖皮质激素、异维A酸、羟氯喹、环孢素、口服氨苯砜）、生物制剂与小分子药物（肿瘤坏死因子（TNF）抑制剂、 Janus 激酶（JAK）抑制剂）、其他治疗（手术切除、激光治疗、毛发移植）等，且需要长期维持治疗。波斯尼亚和黑塞哥维那萨拉热窝大学的Tamara Jovovic Sadikovic教授以“Malassezia (Pityrosporum) folliculitis”为讲题，他指出马拉色菌毛囊炎并非传统观念上的一种机会性浅表真菌感染，而是存在皮肤真菌群落的失衡、宿主免疫调节异常和皮脂腺微环境的改变等紊乱。最新的观点认为马拉色菌不仅作为病原体，还作为微生物组的调节因子发挥作用。其典型临床特征为单一形态的毛囊性丘疹和脓疱、瘙痒、无粉刺、对称分布于躯干。当痤疮治疗无改善、使用抗生素后加重时需要考虑该诊断。主要治疗目标是减少马拉色菌在毛囊内的负荷、控制炎症和瘙痒、恢复皮肤微生物组平衡、减少因皮脂分泌过多导致的复发。治疗方案取决于疾病严重程度、受累范围、复发模式和免疫状态。抗真菌药物仍是治疗的基础，局部治疗对轻症有效，口服唑类抗真菌药对广泛、难治性病例有效，异维A 酸可能对某些特定患者有效，维持治疗策略至关重要，包括抗真菌维持治疗（如：如酮康唑洗剂每周 1-2 次或二硫化硒洗剂每周 1 次）、生活方式干预（如：出汗后及时淋浴、穿着宽松透气的衣物、避免使用油性护肤品）、尽量减少不必要的抗生素使用等。该领域的发展方向包括微生物组调控、抗毒力策略、设备辅助治疗等。波兰卡托维兹西里西亚医科大学的Karina Polak博士“Drug-induced folliculitis”为题，综述了药物诱发毛囊炎的现有证据、临床见解及管理策略，旨在支持早期识别、准确鉴别诊断，并在不必要中断必要治疗的前提下优化患者护理。理解药物诱发毛囊炎的临床谱系和诊断标准，包括其与寻常痤疮及其他毛囊炎的不同之处。识别与毛囊炎相关的常见药物类别及其机制，重点关注EGFR抑制剂和免疫抑制剂。应用基于证据的管理策略，包括停药、外用及系统性治疗，以及跨学科协作考量，以改善患者预后。 *若图片或版权有问题，请联系我们调整或进行删除图文来源：优麦医生

免疫疗法

2026-05-11

·BioSpace

Almirall Continues Its Positive Trajectory in Q1 2026 in Line With Expectations – Led by 19.3% YoY Growth of Its European Dermatology Business

Almirall's European Dermatology business delivered solid growth of 19.3% YoY, reaching €166.3 MM in Q1 2026, driven by strong momentum across key growth drivers. This contributed to overall Net Sales of €291 MM, up 2.2% YoY and reflecting 9% growth on a Last-Twelve-Months (LTM) basis. Performance continues to be driven by the biologics portfolio, with Ilumetri ® showing 11.8% increase in sales vs Q1 2025 (total of €61.6 MM), and Ebglyss ® delivering €41.9 MM quarterly sales – more than 2x YoY – boosted by sustained growth in recent launch countries. Strong performance of the broad dermatology product portfolio in line with expectations – products driving relevance of Almirall in medical dermatology, including Wynzora ® (20.8%, total of €9.3 MM) and Klisyri ® (7.2%, total of €7.4 MM). Total EBITDA was €67.5 MM, corresponding to 23.2% over Net Sales – improvement versus FY 2025 (21%). Continued R&D pipeline progress includes the start of phase I of anti-IL-13/OX40L bispecific antibody, and a new collaboration with China-based biotech Huaota for the development of a novel monoclonal antibody in medical dermatology. Reiterated guidance for the full year 2026: 9-12% growth and € 270MM to € 290MM EBITDA – scrip dividend of €0.19 per share approved by the AGM on 8 th May 2026. BARCELONA--(BUSINESS WIRE)-- Almirall, S.A. (ALM), a global pharmaceutical company dedicated to medical dermatology, today announced its financial results for the first quarter of 2026. Almirall continued to deliver on the company’s growth trajectory in line with expectations and the long-term strategy, led by 19.3% YoY growth of its European Dermatology business to €166.3 MM. During Q1 2026, total Net Sales increased by 2.2% YoY to €291 MM, with growth mainly driven by the biologics and continuously increasing contributions from the broader dermatology portfolio. EBITDA was €67.5 MM, corresponding to 23.2% over Net Sales, representing an improvement versus FY 2025 (21%) and aligned with full year guidance (the YoY comparison includes a divestment/outlicencing in Q1 2025. Ebglyss ® (lebrikizumab, for the systemic treatment of moderate to severe atopic dermatitis) continued its strong growth, delivering total Net Sales of €41.9 MM, representing more than a twofold increase YoY. The brand´s performance was driven by the continued strong trajectory in recent launch countries, reflecting sustained patient need and growing access. Ilumetri ® (tildrakizumab, for the systemic treatment of moderate to severe psoriasis), continued to deliver double digit growth in Q1 2026 representing an increase of 11.8% YoY, with total Net Sales of €61.6 MM, demonstrating the strong market position of Ilumetri ® and the continued relevance of anti IL23 therapies in the competitive psoriasis market segment. The broad dermatology product portfolio continued to grow in line with expectations, reinforcing Almirall’s relevance as a leading medical dermatology partner in Europe. Wynzora ® (psoriasis) delivered €9.3 MM in Net Sales, representing 20.8% growth YoY, and Klisyri ® (actinic keratosis) achieved €7.4 MM in Net Sales, growing 7.2% YoY. Almirall continued to advance its medical dermatology pipeline during the quarter, reinforcing the company’s commitment to long-term innovation in medical dermatology. Progress in Q1 2026 included the initiation of a Phase I clinical study for an anti IL 13/OX40L bispecific antibody, supporting Almirall’s ambition to develop differentiated immunology assets. The company also announced a new collaboration with China-based biotech company Huaota, focused on the co-development of a novel monoclonal antibody for medical dermatology, which demonstrates Almirall’s approach to partnerships to further strengthen the company´s innovation strategy. “We continue to advance our leadership in medical dermatology, delivering Q1 results in line with expectations and consensus, led by strong, sustained growth in our European Dermatology business. The continued performance of Ebglyss ® and Ilumetri ® , together with the strong growth of our broader portfolio, highlight the benefits of our focus on medical dermatology and our commercial excellence. Our underlying business momentum remains strong which enables us to advance our pipeline and expand our innovation footprint through new collaborations. This positions Almirall well to deliver against our mid-term guidance and our long-term ambition to deliver sustained growth as a leader in medical dermatology.” Carlos Gallardo, Almirall Chairman and CEO Q1 2026 Q1 2025 Variation Total Revenue 292.4 286.1 2.2% Net Sales 291.0 284.6 2.2% Other Income 1.4 1.5 (6.7%) Gross Profit 186.7 190.4 (1.9%) % of sales 64.2% 66.9% Total EBITDA 67.5 70.9 (4.8%) Net Income 15.3 21.6 (29.2%) Normalised Net Income 16.1 22.1 (27.1%) 2026 Full Year Guidance Full year guidance for 2026: Net Sales: 9% to 12% growth. EBITDA between € 270MM to € 290MM R&D pipeline Almirall’s continued investment in its leading R&D capabilities and medical dermatology pipeline remains closely aligned with the company’s long-term commitment to positively impact patients and society, while further strengthening its leadership in medical dermatology. Continued R&D pipeline progress in Q1 2026 included the initiation of a Phase I clinical study for an anti IL-13/OX40L bispecific antibody, supporting Almirall’s focus on advancing next-generation biologics in medical dermatology. Almirall´s partner Lilly presented positive top-line results from the pivotal Phase 3 ADorable-1 trial evaluating efficacy and safety of lebrikizumab for children and adolescents with moderate-to-severe atopic dermatitis. At the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, Colorado, Almirall presented long-term interim results from the ongoing Phase 3b ADlong study, where lebrikizumab delivered long-term disease control for up to four years in patients with moderate-to-severe atopic dermatitis. In parallel, ongoing clinical development includes the recently initiated Phase III study evaluating lebrikizumab in patients with nummular eczema, a distinct and burdensome condition with biological overlap with atopic dermatitis. Almirall also announced a new collaboration with China-based biotech Huaota for the development of a novel monoclonal antibody in medical dermatology. Almirall continues to expand the clinical and real-world evidence base supporting its key biologics, Ebglyss ® (lebrikizumab) and Ilumetri ® (tildrakizumab). Lifecycle management activities will continue to strengthen Almirall’s key priority products with several ongoing clinical studies supporting the biologics in AD and PSO as part of ongoing collaborative programs with its partners Lilly and Sun Pharma, respectively, to grow patient access and product value. Additional pipeline programs are expected to progress into phase II/PoC studies during 2026, including an anti-IL-21 monoclonal antibody targeting hidradenitis suppurativa. Partnership with the dermatology community Collaboration with dermatologists and life-science experts remains fundamental to Almirall’s commitment to advancing medical dermatology. Through these partnerships, the company continues to drive scientific exchange and deepen the understanding of skin diseases, therapeutic approaches, and their impact on patients, with a clear focus on delivering evidence-based, patient-centred care. In March, at the 2026 AAD, Almirall presented a broad range of new clinical and real-world evidence across atopic dermatitis, psoriasis, actinic keratosis, and acne. More than 15 posters were presented, leading with 9 on lebrikizumab, two on tildrakizumab showing the final 2-year results of the POSITIVE study on patient wellbeing, and new analyses for tirbanibulin, and new results and analysis for sarecycline. In March, Almirall hosted the 17th edition of its Skin Academy in Prague, bringing together leading dermatology experts from around the world. As a key scientific platform in medical dermatology, Skin Academy continues to foster collaboration, exchange on best practices, and innovation to address some of the most complex health challenges in the field of dermatology. Dividend and Investor Calendar 2026 On 8th May, the Annual General Shareholder Meeting approved the distribution of a dividend, for the amount of €0.19 per share. This will be applied using the flexible dividend system in line with prior years, which will offer shareholders the option to receive the agreed dividend in cash and/or in shares. H1 2026 Financial Results – 24th July 2026 9M 2026 Financial Results – 9th November 2026 About Almirall Almirall is a global biopharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients' world by helping them realize their hopes and dreams for a healthy life . We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients’ needs. Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM, total revenue in 2025: €1114.5 MM, over 2100 employees globally). Almirall products help to improve the lives of patients every day and are available in over 100 countries. For more information, please visit Legal notice: This document includes only summary information and is not intended to be exhaustive. The facts, figures, and opinions contained in this document, in addition to the historical ones, are "forward-looking statements." These statements are based on the information currently available and the best estimates and assumptions that the Company considers reasonable. These statements involve risks and uncertainties beyond the control of the Company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The Company expressly disclaims any obligation to revise or update any forward-looking statements, goals, or estimates contained in this document to reflect any changes in the assumptions, events, or circumstances on which such forward-looking statements are based, unless required by the applicable law. Contacts Corporate Communications: corporate.communication@almirall.com Phone: +34 93 291 35 08 Investor Relations investors@almirall.com Phone: (+34) 93 291 30 87

临床结果临床3期上市批准临床1期财报

2026-04-07

·针画Skin

异维A酸副作用太多不敢吃？新一代痤疮口服药超全盘点

INTRODUCTION 引言 “医生，我吃异维A酸副作用太大了，有没有别的口服药可以选？” 异维A酸是痤疮治疗的“王牌”，效果确实好，但它的副作用也让不少患者望而却步——皮肤黏膜干燥、血脂升高、肝功能异常，还有严格的避孕要求。有些患者因为无法耐受，中途停药；有些患者因为担心副作用，根本不敢开始。有没有效果不错、副作用更小、更适合特定人群的系统治疗选择？近期发表在《Journal of Cosmetic Dermatology》上的一篇综述，系统梳理了异维A酸之外的口服痤疮治疗新选择，从窄谱抗生素、激素治疗、二甲双胍到生物制剂、益生菌，全都盘点了一遍。今天我们就来拆解一下这篇综述，看看除了异维A酸，还有哪些口服药值得关注，分别适合什么样的患者。关注针画skin，了解更多皮肤美容资讯~ 2026年，你最想突破哪一项？注射材料？技术部位？品牌产品？扫码填写问卷，今年学什么由你来定！抗生素窄谱是方向，耐药是红线传统口服抗生素（如多西环素、米诺环素）的问题在于：广谱，容易破坏肠道菌群，还催生耐药。近年来，窄谱抗生素成了新方向。 1. 沙雷环素（Sarecycline）这是目前最值得关注的新一代口服四环素类抗生素。特点： · 窄谱：主要针对痤疮丙酸杆菌（C. acnes），对肠道革兰阴性菌影响小，更符合抗生素管理原则 · 低光敏性：相比多西环素，光敏反应发生率很低（≤1%） · 适用年龄：9岁以上即可使用临床数据： · 两项III期临床试验（SC1401和SC1402）显示，沙雷环素在第3周就开始显著优于安慰剂，效果持续到12周 · IGA治疗成功率接近60% · 患者报告结局（Skindex-16、ASIS评分）也显著改善 · 对躯干痤疮同样有效：12周时胸部IGA成功率33.42% vs 安慰剂20.77%，背部33.07% vs 21.91% · 不良反应主要是头痛、鼻咽炎、恶心，停药率仅2.5% 临床定位：适合需要口服抗生素、但又担心光敏性和肠道菌群紊乱的患者，尤其适合躯干痤疮。但注意：没有与异维A酸或传统四环素的头对头比较，疗效优于安慰剂，是否优于多西环素尚不明确。 2. 口服锌锌不是新药，但值得重新认识。作用机制：抗炎、抑制痤疮丙酸杆菌脂肪酶活性、调节免疫，且不产生耐药。临床数据：一项开放标签研究显示，口服锌与赖甲环素（lymecycline）相比非劣效，且安全性更好，不影响肠道菌群。临床定位：低成本、耐受性好、不产生耐药，适合需要长期抗炎但不适合用抗生素的患者。尤其适合对抗生素有顾虑或不能耐受的患者。 3. 还在研究阶段的抗生素 Pentobra：肽-氨基糖苷类分子，体外杀痤疮丙酸杆菌脂肪酶效果优于妥布霉素，尚未获批 p-carboethoxy衍生物：靶向痤疮丙酸杆菌的机械敏感离子通道（MscL），仅动物实验阶段激素治疗女性患者的有效选择激素治疗不是“新药”，但它们在异维A酸之外的替代价值越来越被重视。 1. 螺内酯证据等级：最高。临床数据： · 一项纳入1086例患者的Meta分析：螺内酯100mg/天 vs 安慰剂，总皮损数减少6.85，痤疮严重指数改善6.33 · 另一项Meta分析：治疗成功OR=2.51（vs 安慰剂或多西环素） · 与多西环素头对头比较：治疗6个月后，螺内酯组的成功率是多西环素的2.87倍（p=0.007），且生活质量改善更明显不良反应：多为轻度（头痛、头晕、月经不规律），无严重不良事件，无高钾血症导致的停药。临床定位：成年女性痤疮的极佳选择，尤其适合高雄激素表现（月经前加重、多毛、脱发等）。但注意：超说明书用药，缺乏男性数据，长期安全性数据仍有限。 2. 口服避孕药（COCs）临床数据：6个月时效果与口服抗生素相当，对炎性和非炎性皮损均有效。不良反应：乳房胀痛、突破性出血，高风险人群有血栓风险。临床定位：有避孕需求的女性痤疮患者。需排除血栓高危因素（吸烟、肥胖、偏头痛等）。二甲双胍不只是降糖药二甲双胍在痤疮治疗中的价值，主要针对伴有胰岛素抵抗或多囊卵巢综合征（PCOS）的患者。作用机制：降低IGF-1水平，改善胰岛素抵抗，间接抑制雄激素合成。临床数据： · Meta分析（51项研究，2405例PCOS患者）：二甲双胍单用或联合使用均能改善痤疮 · 一项RCT：四环素+过氧化苯甲酰基础上，加用二甲双胍（850mg/天）的患者，12周后皮损改善率71.4%，对照组65.3%；治疗成功率66.7% vs 43.2% · 另一项研究：多囊卵巢综合征女性用二甲双胍500mg 每天三次，3周即显效，维持至8周 · 男性数据：一项小样本研究显示，二甲双胍+低热量饮食对伴有代谢异常的男性痤疮患者也有效临床定位：尤其适合多囊卵巢综合征合并痤疮的女性患者，也适用于伴有胰岛素抵抗、代谢综合征的痤疮患者。相比异维A酸，无致畸风险，不引起严重干燥，还能改善代谢。益生菌辅助治疗的新思路口服益生菌通过免疫调节（提高IL-10、降低IL-8）来改善痤疮。临床数据： · 一项双盲安慰剂对照研究：Lactobacillus rhamnosus GG（益生菌菌株，简称为 LGG）治疗12周，痤疮显著改善，皮肤活检显示IGF-1水平下降 · 另一项研究：多种益生菌联合，8周后炎性皮损、皮脂分泌率、脱屑评分均显著改善 · 联合治疗研究：益生菌+米诺环素组效果优于单用米诺环素临床定位：作为辅助治疗，不适合单用。尤其适合对抗生素不耐受或希望减少抗生素使用的患者。但菌株、剂量、疗程缺乏标准化，证据质量有限。生物制剂与免疫调节剂仅限难治性特殊类型这类药物证据级别较低，仅有个案报告和小型病例系列，不适合常规使用。 1. 阿达木单抗（抗TNF-α）个案报道：用于聚合性痤疮、SAPHO综合征一例报道：阿达木单抗+光动力疗法治疗18岁重度痤疮患者，效果良好 2. 司库奇尤单抗/瑞莎珠单抗（抗IL-17/IL-23）个案报道用于SAPHO综合征但一项抗IL-17A（CJM112）的RCT显示，与安慰剂相比无显著差异，说明不是所有炎症性痤疮都对IL-17阻断有反应 3. 阿普米司特（PDE-4抑制剂）个案报道：用于异维A酸诱发的暴发性痤疮、SAPHO综合征一例15岁患者，停用异维A酸后加用阿普米司特，6周明显改善，10个月皮损清除临床定位：仅限常规治疗无效的特殊类型痤疮（聚合性痤疮、暴发性痤疮、SAPHO综合征等）。不适用于普通中度至重度痤疮。实验性方向孟鲁司特、CAMP因子疫苗 1.孟鲁司特（白三烯受体拮抗剂）： · 一项研究：30例患者治疗12周，严重程度评分从33.93降至20.6 · 另一项研究：与多西环素相比无显著差异 · 联合多西环素：效果优于单用多西环素 · 证据有限，需要更多RCT验证。 ▼ 更多治疗细节，扫码私信小编获取!👇🏻👇🏻👇🏻 2.CAMP因子疫苗： · 动物实验：抗CAMP因子抗体可减少痤疮丙酸杆菌定植，不影响共生菌群 · 仅动物实验，无人体数据临床实践建议怎么选？基于现有证据，可以为不同患者群体提供以下参考： 1. 成年女性痤疮，尤其高雄激素表现 → 首选螺内酯（100mg/天），或口服避孕药（有避孕需求且无禁忌） 2. 多囊卵巢综合征合并痤疮 → 二甲双胍（500-850mg bid或tid），可单用或联合其他治疗 3. 需要口服抗生素，但担心光敏性和肠道菌群 → 沙雷环素（1.5mg/kg/天），尤其适合躯干痤疮 4. 对抗生素有顾虑，或需要长期抗炎 → 口服锌（低成本、无耐药、耐受性好） 5. 希望减少抗生素使用，作为辅助 → 口服益生菌（联合治疗，不单用） 6. 常规治疗无效的聚合性痤疮、SAPHO综合征 → 考虑阿达木单抗或阿普米司特（个案证据，需谨慎） 7. 重度痤疮、有瘢痕风险、无禁忌 → 异维A酸仍是金标准，其他方案多作为替代或辅助本期总结异维A酸仍是中重度痤疮的疗效标杆，但其副作用和致畸风险限制了部分患者的使用。新兴系统治疗为不同人群提供了替代或辅助选择：沙雷环素窄谱、低光毒，适合躯干痤疮；螺内酯是成年女性（尤其高雄激素表现）的优效方案；二甲双胍对PCOS合并痤疮患者兼具代谢调节和皮损改善作用；口服锌、益生菌等作为抗生素管理友好的辅助手段也值得关注。生物制剂仅限难治性特殊类型（如聚合性痤疮、SAPHO综合征）。未来需更多头对头研究明确这些新疗法的临床定位。 TAKE HOME MESSAGE 1.异维A酸仍是金标准：疗效最强，但副作用和致畸性限制了部分患者的使用。 2.沙雷环素：窄谱四环素，低光毒性，对躯干痤疮有效，3周起效，抗生素管理友好。 3.口服锌：非劣效于赖甲环素，无耐药风险，低成本、耐受性好。 4.螺内酯：成年女性痤疮的优质选择，100mg/天，效果优于多西环素（6个月时成功率2.87倍）。 5.二甲双胍：PCOS合并痤疮的首选辅助，降低IGF-1，改善代谢，无致畸风险。 6.口服避孕药：有避孕需求的女性，6个月效果与口服抗生素相当。 7.益生菌：作为辅助，可减少抗生素使用，但标准化不足。 8.生物制剂/PDE-4抑制剂：仅限难治性特殊类型（聚合性痤疮、SAPHO等），证据为个案级别。 9.实验性：孟鲁司特需更多数据，CAMP因子疫苗仅动物实验。 10.个体化选择：根据患者性别、年龄、激素状态、代谢情况、治疗偏好选择最适合的方案，异维A酸不可替代但也不必“死磕”。参考文献 Tommasino N, Annunziata MC, Potestio L, Napolitano M. Beyond isotretinoin: a narrative review of emerging systemic therapies for moderate-to-severe acne. J Cosmet Dermatol. 2026; in press. ▼ 关注针画Skin，私信小编，获取原文! 关注针画InjArt，加入针画万人学习社群关注美学医理，了解更多医美人的实用美学！关注针画InjArtGlobal，了解更多国际医美咨询~ 声明再次强调:本平台文章仅用于学术探讨，供医疗专业人士阅读，不做任何商业用途。扫描下方二维码加入针画万人学习社群每月15节前沿医学好课

100 项与盐酸沙瑞环素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10666 D10667	盐酸沙瑞环素	J01AA14	DB12035

研发状态

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	Almirall LLC	2018-10-01

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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


AAD2026	临床3期	寻常痤疮	1,256	Sarecycline	憲膚鹽積齋簾襯廠窪窪(網窪膚顧衊製觸築襯構) = 糧製獵鬱齋網糧簾繭窪顧壓窪構壓繭顧範餘築 (築窪齋醖衊願壓鹹衊鹹 ) 更多	积极	2026-03-27
				Placebo	憲膚鹽積齋簾襯廠窪窪(網窪膚顧衊製觸築襯構) = 構醖廠醖積蓋構製廠齋顧壓窪構壓繭顧範餘築 (築窪齋醖衊願壓鹹衊鹹 ) 更多
CTR20211314 (AAD2024)	-	严重痤疮	391	沙瑞环素	範鹽憲夢蓋繭願夢願憲(膚製憲齋網網簾糧憲糧) = 願夢襯獵醖廠獵選築糧憲襯築襯鹹網廠簾鹽糧 (遞獵鹹築齋網顧淵壓淵 )	积极	2024-03-09
				安慰剂	範鹽憲夢蓋繭願夢願憲(膚製憲齋網網簾糧憲糧) = 鬱製願鹽壓淵淵蓋網遞憲襯築襯鹹網廠簾鹽糧 (遞獵鹹築齋網顧淵壓淵 )
PROSES (AAD2024)	N/A	寻常痤疮	300	Sarecycline	顧壓壓範餘糧膚繭膚衊(廠簾網鏇夢齋獵顧選壓) = 製衊範襯膚壓淵網鹽範齋築窪醖鬱淵範顧鬱範 (鑰壓鬱醖糧餘鹽簾艱選 ) 更多	积极	2024-03-08
NCT04820673 (PROSES, AAD2023)	N/A	中度至重度痤疮	253	sarecycline	網艱艱鏇窪遞願製廠襯(衊夢網鑰窪願網膚鹹壓) = 積膚網顧襯壓淵構衊壓醖膚壓簾簾繭襯艱淵齋 (餘繭遞窪築網衊顧壓壓 )	-	2023-03-17
				sarecycline	網艱艱鏇窪遞願製廠襯(衊夢網鑰窪願網膚鹹壓) = 鏇鏇簾衊餘淵積觸餘簾醖膚壓簾簾繭襯艱淵齋 (餘繭遞窪築網衊顧壓壓 )
NCT04555525 (CTgov)	临床4期	玫瑰痤疮	100	sarecycline (Sarecycline)	範蓋範鹽鏇窪積繭顧網 = 鬱選醖範壓鹽壓獵醖鹽膚積獵廠鑰膚壓齋餘遞 (齋鹹齋醖鏇築鏇醖獵選, 願獵簾憲鹹鏇衊憲鏇襯 ~ 憲窪鹽餘獵鑰壓繭壓壓) 更多	-	2020-12-16
				Centrum Adult Multivitamin (Centrum Adult Multivitamin)	範蓋範鹽鏇窪積繭顧網 = 壓窪餘觸網蓋鹹簾鹹鹽膚積獵廠鑰膚壓齋餘遞 (齋鹹齋醖鏇築鏇醖獵選, 獵糧蓋構蓋醖膚簾淵簾 ~ 壓築繭糧築艱鑰繭憲壓) 更多
NCT02413346 (Pubmed) 人工标引	临床3期	寻常痤疮	483	Sarecycline	鬱網鹽鹽範壓顧顧廠鹹(遞鹹網鏇獵窪襯獵製憲) = The most common treatment-emergent AEs (TEAEs) were nasopharyngitis (3.7%), upper-respiratory-tract infection (3.3%), headache (2.9%), and nausea (2.1%). 築網鹹範觸遞齋憲獵觸 (餘觸簾網遞鹹網糧觸襯 ) 更多	积极	2019-11-01
				Placebo
NCT01628549 (PR-10411, CTgov)	临床2期	寻常痤疮	285	Placebo (Placebo)	鑰遞壓獵蓋鑰糧鑰餘鏇(淵鬱鹽遞積齋衊壓網蓋) = 鹽鏇艱獵選齋醖繭遞衊淵淵蓋膚築範範壓襯衊 (蓋範選鏇廠構積鹹顧觸, 14.18) 更多	-	2019-01-08
				Placebo+50 mg P005672-HCl (P005672-HCl Approximately 0.75 mg/kg/Day)	鑰遞壓獵蓋鑰糧鑰餘鏇(淵鬱鹽遞積齋衊壓網蓋) = 膚襯襯選願鹹襯鹽衊遞淵淵蓋膚築範範壓襯衊 (蓋範選鏇廠構積鹹顧觸, 13.01) 更多
NCT02320149 (SC1401, Pubmed) 人工标引	临床3期	寻常痤疮	968	Sarecycline	夢憲淵齋廠積壓獵構壓(遞選蓋觸艱選範蓋艱夢) = 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%). 齋夢鑰顧襯鬱製鑰積構 (夢糧觸鹹醖鹹襯遞觸鹽 ) 更多	积极	2018-09-01
				Placebo
NCT02320149 (SC1401, CTgov)	临床3期	寻常痤疮	968	Sarecycline (Sarecycline)	壓衊憲網構壓遞遞鹽窪(憲顧襯簾鹹鑰觸顧夢鑰) = 積醖壓構獵鬱觸餘齋顧觸蓋鹹鑰繭鹽築襯衊遞 (選餘壓鹹構糧構憲醖廠, 0.6) 更多	-	2018-05-17
				Placebo (Placebo)	壓衊憲網構壓遞遞鹽窪(憲顧襯簾鹹鑰觸顧夢鑰) = 憲獵鹹餘夢繭糧範餘製觸蓋鹹鑰繭鹽築襯衊遞 (選餘壓鹹構糧構憲醖廠, 0.6) 更多
NCT02322866 (SC1402, CTgov)	临床3期	寻常痤疮	1,034	Placebo (Placebo)	遞築鏇醖齋鹹遞顧簾餘(鹹衊鏇積製繭簾蓋鏇廠) = 艱簾選築衊膚觸製齋繭鏇憲築襯積廠遞蓋鏇憲 (繭壓築餘構齋顧憲鬱積, 0.5) 更多	-	2018-05-07
				Sarecycline (Sarecycline)	遞築鏇醖齋鹹遞顧簾餘(鹹衊鏇積製繭簾蓋鏇廠) = 膚醖壓範簾簾艱襯憲簾鏇憲築襯積廠遞蓋鏇憲 (繭壓築餘構齋顧憲鬱積, 0.6) 更多